Back to resultsEfficacy of Percutaneous Electrolysis in the Treatment of Achilles Tendinopathy
Primary Purpose
Achilles Tendinopathy
Status
Recruiting
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
low intensity percutaneous musculoskeletal electrolysis
Sham application
Silbernagel protocol
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Tendinopathy focused on measuring tendinopathy, physiotherapy, percutaneous electrolysis
Eligibility Criteria
Inclusion Criteria:
- Presence of symptoms in one or both Achilles tendons with a minimum duration of two months. In case the symptoms are bilateral, the intervention or placebo will only be administered and its results evaluated- in the limb with greater symptomatology. If it is not possible to differentiate which one presents greater pain, the right Achilles tendon will be chosen.
- Spontaneous pain of at least three points measured by a visual analog scale (VAS), reproducible by palpation between 2 and 6 cm above the insertion of the Achilles tendon in the calcaneal bone.
- Evidence of tendinopathy by MRI.
- Presence of post-static dyskinesia.
- Willingness to not perform additional treatments (such as footwear modifications, physical therapy, orthotics, injections, or surgery) for Achilles tendon pain during the conduct of the trial.
- Willingness to attempt to discontinue self-administration of medications (NSAIDs) for pain relief Achilles tendon(s) pain for at least 14 days prior to baseline assessment and during the course of the trial.
Exclusion Criteria:
- Presence or suspicion of pregnancy.
- Previous surgical intervention on the AT in the symptomatic leg(s)
- Total or partial rupture in the symptomatic AT
- Chronic ankle instability, in the foot with symptomatic tendon(s).
- Pathologies that can derive in pain in the region of the AT without being proper of the picture. (e.g.: osteoarthritis, impingement syndromes).
- Presence of arthritis or any metabolic or endocrine disorder (type 1 or 2 diabetes).
- Psychological disorders.
- Oncologic history.
- Treatment with quinolones or fluoroquinolones during the last two years.
- Treatment with statins for the control of hypercholesterolemia for more than two months
- Treatments within or at the periphery of the Achilles tendon, with anesthetics, corticosteroids or any other pharmacological agent during the last three months.
- Needle phobia
- Allergy to metal
Sites / Locations
- Maimonides UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Experimental group
Simulated group.
Arm Description
A single weekly intervention of low intensity galvanic currents will be applied in an ultrasound-guided manner.
The application of a single weekly intervention of low intensity galvanic currents will be simulated in an echogenic way, with the equipment turned off.
Outcomes
Primary Outcome Measures
Victorian Institute of Sport Assessment - Achilles - Baseline
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 1
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 2
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 3
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 4
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 5
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 6
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 7
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 8
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 9
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 10
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 11
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 12
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 26
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 52
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Secondary Outcome Measures
visual analog scale - Baseline
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
visual analog scale - Week 1
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
visual analog scale - Week 2
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
visual analog scale - Week 3
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
visual analog scale - Week 4
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
visual analog scale - Week 5
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
visual analog scale - Week 6
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
visual analog scale - Week 7
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
visual analog scale - Week 8
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
visual analog scale - Week 9
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
visual analog scale - Week 10
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
visual analog scale - Week 11
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
visual analog scale - Week 12
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
visual analog scale - Week 26
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
visual analog scale - Week 52
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
The Foot and Ankle Ability Measure - Baseline
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
The Foot and Ankle Ability Measure - Week 1
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
The Foot and Ankle Ability Measure - Week 2
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
The Foot and Ankle Ability Measure - Week 3
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
The Foot and Ankle Ability Measure - Week 4
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
The Foot and Ankle Ability Measure - Week 5
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
The Foot and Ankle Ability Measure - Week 6
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
The Foot and Ankle Ability Measure - Week 7
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
The Foot and Ankle Ability Measure - Week 8
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
The Foot and Ankle Ability Measure - Week 9
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
The Foot and Ankle Ability Measure - Week 10
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
The Foot and Ankle Ability Measure - Week 11
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
The Foot and Ankle Ability Measure - Week 12
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
The Foot and Ankle Ability Measure - Week 26
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
The Foot and Ankle Ability Measure - Week 52
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
ultrasound Shear Wave elastography - baseline
Shear Wave Elastography (SWS), which consists of a special ultrasound methodology that allows quantitative characterization of the elastic capacity of a tissue through the propagation velocity of the ultrasound wave. The Siemens Acuson S2000 system with a model 9L4 linear transducer will be used.
The patients will be placed on a table in ventral decubitus and the ankle outside the plane of the table in neutral position. To determine the point to be scanned, the maximum perpendicular distance between the anterior and posterior limits of the tendon between 2 to 6 cm from the insertion in the calcaneus will be taken and this value will be reported in mm.
The SWS value will be expressed in m/s. The range of SWS is 0-9 m/s. The standard SWS measurement window size shall be 1cm2 , with a region of interest of 3mm. Three measurements will be recorded in each plane (regions of interest) where homogeneous tissue is considered and the average value of the 6 measurements will be reported.
ultrasound Shear Wave elastography - Week 4
Shear Wave Elastography (SWS), which consists of a special ultrasound methodology that allows quantitative characterization of the elastic capacity of a tissue through the propagation velocity of the ultrasound wave. The Siemens Acuson S2000 system with a model 9L4 linear transducer will be used.
The patients will be placed on a table in ventral decubitus and the ankle outside the plane of the table in neutral position. To determine the point to be scanned, the maximum perpendicular distance between the anterior and posterior limits of the tendon between 2 to 6 cm from the insertion in the calcaneus will be taken and this value will be reported in mm.
The SWS value will be expressed in m/s. The range of SWS is 0-9 m/s. The standard SWS measurement window size shall be 1cm2 , with a region of interest of 3mm. Three measurements will be recorded in each plane (regions of interest) where homogeneous tissue is considered and the average value of the 6 measurements will be reported.
ultrasound Shear Wave elastography - Week 8
Shear Wave Elastography (SWS), which consists of a special ultrasound methodology that allows quantitative characterization of the elastic capacity of a tissue through the propagation velocity of the ultrasound wave. The Siemens Acuson S2000 system with a model 9L4 linear transducer will be used.
The patients will be placed on a table in ventral decubitus and the ankle outside the plane of the table in neutral position. To determine the point to be scanned, the maximum perpendicular distance between the anterior and posterior limits of the tendon between 2 to 6 cm from the insertion in the calcaneus will be taken and this value will be reported in mm.
The SWS value will be expressed in m/s. The range of SWS is 0-9 m/s. The standard SWS measurement window size shall be 1cm2 , with a region of interest of 3mm. Three measurements will be recorded in each plane (regions of interest) where homogeneous tissue is considered and the average value of the 6 measurements will be reported.
ultrasound Shear Wave elastography - Week 12
Shear Wave Elastography (SWS), which consists of a special ultrasound methodology that allows quantitative characterization of the elastic capacity of a tissue through the propagation velocity of the ultrasound wave. The Siemens Acuson S2000 system with a model 9L4 linear transducer will be used.
The patients will be placed on a table in ventral decubitus and the ankle outside the plane of the table in neutral position. To determine the point to be scanned, the maximum perpendicular distance between the anterior and posterior limits of the tendon between 2 to 6 cm from the insertion in the calcaneus will be taken and this value will be reported in mm.
The SWS value will be expressed in m/s. The range of SWS is 0-9 m/s. The standard SWS measurement window size shall be 1cm2 , with a region of interest of 3mm. Three measurements will be recorded in each plane (regions of interest) where homogeneous tissue is considered and the average value of the 6 measurements will be reported.
ultrasound Shear Wave elastography - Week 26
Shear Wave Elastography (SWS), which consists of a special ultrasound methodology that allows quantitative characterization of the elastic capacity of a tissue through the propagation velocity of the ultrasound wave. The Siemens Acuson S2000 system with a model 9L4 linear transducer will be used.
The patients will be placed on a table in ventral decubitus and the ankle outside the plane of the table in neutral position. To determine the point to be scanned, the maximum perpendicular distance between the anterior and posterior limits of the tendon between 2 to 6 cm from the insertion in the calcaneus will be taken and this value will be reported in mm.
The SWS value will be expressed in m/s. The range of SWS is 0-9 m/s. The standard SWS measurement window size shall be 1cm2 , with a region of interest of 3mm. Three measurements will be recorded in each plane (regions of interest) where homogeneous tissue is considered and the average value of the 6 measurements will be reported.
ultrasound Shear Wave elastography - Week 52
Shear Wave Elastography (SWS), which consists of a special ultrasound methodology that allows quantitative characterization of the elastic capacity of a tissue through the propagation velocity of the ultrasound wave. The Siemens Acuson S2000 system with a model 9L4 linear transducer will be used.
The patients will be placed on a table in ventral decubitus and the ankle outside the plane of the table in neutral position. To determine the point to be scanned, the maximum perpendicular distance between the anterior and posterior limits of the tendon between 2 to 6 cm from the insertion in the calcaneus will be taken and this value will be reported in mm.
The SWS value will be expressed in m/s. The range of SWS is 0-9 m/s. The standard SWS measurement window size shall be 1cm2 , with a region of interest of 3mm. Three measurements will be recorded in each plane (regions of interest) where homogeneous tissue is considered and the average value of the 6 measurements will be reported.
Vienna Achilles tendon morphological score - MRI - baseline
A 1.5T Siemens Healthcare 1.5T scanner will be used for the MRI evaluation, using a gradient strength of 40 mT/m and an 8-channel coil. The standard MRI protocol will be identical for all examinations and will consist of a localizer set and three morphological MR sequences: 1) a sagittal fat-suppressed sequence; 2) a sagittal T1 sagittal spin echo (SE) sequence and 3) a T2-w sequence.
Once the images are obtained, they will be evaluated with the "Vienna Achilles tendon morphological score" (VIMATS) protocol proposed by Apprich S. (2021) which conforms a semiquantitative rating scale where the score is composed of four different parameters: (1) thickness, (2) continuity, (3) signal and (4) associated pathologies. It has a continuous numerical scale from 0 to 100 where the higher the score, the better the patient's stage.
Vienna Achilles tendon morphological score - MRI - Week 4
A 1.5T Siemens Healthcare 1.5T scanner will be used for the MRI evaluation, using a gradient strength of 40 mT/m and an 8-channel coil. The standard MRI protocol will be identical for all examinations and will consist of a localizer set and three morphological MR sequences: 1) a sagittal fat-suppressed sequence; 2) a sagittal T1 sagittal spin echo (SE) sequence and 3) a T2-w sequence.
Once the images are obtained, they will be evaluated with the "Vienna Achilles tendon morphological score" (VIMATS) protocol proposed by Apprich S. (2021) which conforms a semiquantitative rating scale where the score is composed of four different parameters: (1) thickness, (2) continuity, (3) signal and (4) associated pathologies. It has a continuous numerical scale from 0 to 100 where the higher the score, the better the patient's stage.
Vienna Achilles tendon morphological score - MRI - Week 8
A 1.5T Siemens Healthcare 1.5T scanner will be used for the MRI evaluation, using a gradient strength of 40 mT/m and an 8-channel coil. The standard MRI protocol will be identical for all examinations and will consist of a localizer set and three morphological MR sequences: 1) a sagittal fat-suppressed sequence; 2) a sagittal T1 sagittal spin echo (SE) sequence and 3) a T2-w sequence.
Once the images are obtained, they will be evaluated with the "Vienna Achilles tendon morphological score" (VIMATS) protocol proposed by Apprich S. (2021) which conforms a semiquantitative rating scale where the score is composed of four different parameters: (1) thickness, (2) continuity, (3) signal and (4) associated pathologies. It has a continuous numerical scale from 0 to 100 where the higher the score, the better the patient's stage.
Vienna Achilles tendon morphological score - MRI - Week 12
A 1.5T Siemens Healthcare 1.5T scanner will be used for the MRI evaluation, using a gradient strength of 40 mT/m and an 8-channel coil. The standard MRI protocol will be identical for all examinations and will consist of a localizer set and three morphological MR sequences: 1) a sagittal fat-suppressed sequence; 2) a sagittal T1 sagittal spin echo (SE) sequence and 3) a T2-w sequence.
Once the images are obtained, they will be evaluated with the "Vienna Achilles tendon morphological score" (VIMATS) protocol proposed by Apprich S. (2021) which conforms a semiquantitative rating scale where the score is composed of four different parameters: (1) thickness, (2) continuity, (3) signal and (4) associated pathologies. It has a continuous numerical scale from 0 to 100 where the higher the score, the better the patient's stage.
Vienna Achilles tendon morphological score - MRI - Week 26
A 1.5T Siemens Healthcare 1.5T scanner will be used for the MRI evaluation, using a gradient strength of 40 mT/m and an 8-channel coil. The standard MRI protocol will be identical for all examinations and will consist of a localizer set and three morphological MR sequences: 1) a sagittal fat-suppressed sequence; 2) a sagittal T1 sagittal spin echo (SE) sequence and 3) a T2-w sequence.
Once the images are obtained, they will be evaluated with the "Vienna Achilles tendon morphological score" (VIMATS) protocol proposed by Apprich S. (2021) which conforms a semiquantitative rating scale where the score is composed of four different parameters: (1) thickness, (2) continuity, (3) signal and (4) associated pathologies. It has a continuous numerical scale from 0 to 100 where the higher the score, the better the patient's stage.
Vienna Achilles tendon morphological score - MRI - Week 52
A 1.5T Siemens Healthcare 1.5T scanner will be used for the MRI evaluation, using a gradient strength of 40 mT/m and an 8-channel coil. The standard MRI protocol will be identical for all examinations and will consist of a localizer set and three morphological MR sequences: 1) a sagittal fat-suppressed sequence; 2) a sagittal T1 sagittal spin echo (SE) sequence and 3) a T2-w sequence.
Once the images are obtained, they will be evaluated with the "Vienna Achilles tendon morphological score" (VIMATS) protocol proposed by Apprich S. (2021) which conforms a semiquantitative rating scale where the score is composed of four different parameters: (1) thickness, (2) continuity, (3) signal and (4) associated pathologies. It has a continuous numerical scale from 0 to 100 where the higher the score, the better the patient's stage.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05301959
Brief Title
Efficacy of Percutaneous Electrolysis in the Treatment of Achilles Tendinopathy
Official Title
Evaluation of the Efficacy of Adding Low-intensity Percutaneous Musculoskeletal Electrolysis to the Conservative Treatment of Noninsertional Achilles Tendinopathy: a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maimonides University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Achilles tendinopathy (AT) is one of the most reported myotendinous pathologies due to overuse in the literature. In the general adult population, its incidence is 2.35 cases per 1,000 patients, with no difference between men and women. The international literature reports that up to 29% of patients fail with conservative treatment.
Within physiotherapy, new alternatives for the treatment of tendinopathies arise, applying electric currents percutaneously, which from a mechanical effect associated to the use of a needle and an electric effect by the use of galvanic currents, generate a local inflammatory response; activation of the central nervous system and analgesia.
The aim of the research is to evaluate the efficacy of adding low intensity percutaneous electrolysis to the treatment with a high load eccentric exercise program based on the protocol of Silbernagel et al. in adults with Achilles tendinopathy to improve its functionality.
A randomized, double-blind, blinded, evaluator-blinded, controlled clinical trial will be conducted in parallel groups (experimental treatment vs. sham treatment), with a follow-up at 26 and 52 weeks after the first intervention. Non-probability and intentional sampling will be performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendinopathy
Keywords
tendinopathy, physiotherapy, percutaneous electrolysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized, double-blind, blinded, evaluator-blinded, controlled clinical trial will be conducted in parallel groups (experimental treatment vs. sham treatment), with a follow-up at 26 and 52 weeks after the first intervention. Non-probability and intentional sampling will be performed.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
A single weekly intervention of low intensity galvanic currents will be applied in an ultrasound-guided manner.
Arm Title
Simulated group.
Arm Type
Sham Comparator
Arm Description
The application of a single weekly intervention of low intensity galvanic currents will be simulated in an echogenic way, with the equipment turned off.
Intervention Type
Device
Intervention Name(s)
low intensity percutaneous musculoskeletal electrolysis
Other Intervention Name(s)
percutaneous microelectrolysis
Intervention Description
An acupuncture needle (0.30mm X 25mm) will be introduced into the device's strut. With the equipment on and with a base intensity of 120µA, the acupuncture needle is introduced in a proximal-distal and postero-anterior direction, in the area of the Achilles tendon body. The position of the needle will be checked with ultrasound and once the point to be treated is reached, the working intensity will be increased up to 600 µA. The emission will be maintained until the participant reports a pain of 60/100 in VAS. At that moment, the emission will be paused completely until the participant reports a sensation of at least 20/100 in VAS. After this period the emission will be continued at 600 µA. This cycle will continue until the emission lasts for more than 120 sec, continuously. At this point, the needle will be repositioned to repeat the emission protocol a maximum of 3 times in total.
Intervention Type
Device
Intervention Name(s)
Sham application
Intervention Description
A modification will be made in a second equipment, closing the circuit with a 10kΩ resistor inside the equipment, in the output strand chip. Allowing the simulation of emission without emitting current to the participant and without being able to appreciate any type of alteration in the handling of the equipment, by the operators. Therefore, the same steps will be followed as in the experimental group.
Intervention Type
Other
Intervention Name(s)
Silbernagel protocol
Other Intervention Name(s)
Silbernagel et al. Achilles tendinopathy protocol
Intervention Description
The Silbernagel et al. protocol comprises several heel raising exercises with concentric and eccentric movements, performed on two legs and one leg. It is composed of 3 sets of 15 repetitions and that during the exercises allows pain to be present, but not being disabling. The exercises will be performed only once a day. The progression will be made by changing from standing exercises to monopodal support, moving from concentric-eccentric to purely eccentric loading, adding weight in a backpack (in steps of 5 kg when pain does not exceed 5 in the pain monitoring model) and finally using fast rebound exercises and plyometric exercises.
Primary Outcome Measure Information:
Title
Victorian Institute of Sport Assessment - Achilles - Baseline
Description
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Time Frame
Baseline
Title
Victorian Institute of Sport Assessment - Achilles - Week 1
Description
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Time Frame
one week at study entry
Title
Victorian Institute of Sport Assessment - Achilles - Week 2
Description
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Time Frame
two week at study entry
Title
Victorian Institute of Sport Assessment - Achilles - Week 3
Description
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Time Frame
three week at study entry
Title
Victorian Institute of Sport Assessment - Achilles - Week 4
Description
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Time Frame
four week at study entry
Title
Victorian Institute of Sport Assessment - Achilles - Week 5
Description
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Time Frame
five week at study entry
Title
Victorian Institute of Sport Assessment - Achilles - Week 6
Description
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Time Frame
six week at study entry
Title
Victorian Institute of Sport Assessment - Achilles - Week 7
Description
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Time Frame
seven week at study entry
Title
Victorian Institute of Sport Assessment - Achilles - Week 8
Description
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Time Frame
eight week at study entry
Title
Victorian Institute of Sport Assessment - Achilles - Week 9
Description
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Time Frame
nine week at study entry
Title
Victorian Institute of Sport Assessment - Achilles - Week 10
Description
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Time Frame
ten week at study entry
Title
Victorian Institute of Sport Assessment - Achilles - Week 11
Description
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Time Frame
eleven week at study entry
Title
Victorian Institute of Sport Assessment - Achilles - Week 12
Description
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Time Frame
twelve week at study entry
Title
Victorian Institute of Sport Assessment - Achilles - Week 26
Description
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Time Frame
twenty-six week at study entry
Title
Victorian Institute of Sport Assessment - Achilles - Week 52
Description
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Time Frame
fifty-two week at study entry
Secondary Outcome Measure Information:
Title
visual analog scale - Baseline
Description
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Time Frame
Baseline
Title
visual analog scale - Week 1
Description
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Time Frame
one week at study entry
Title
visual analog scale - Week 2
Description
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Time Frame
Two week at study entry
Title
visual analog scale - Week 3
Description
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Time Frame
three week at study entry
Title
visual analog scale - Week 4
Description
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Time Frame
four week at study entry
Title
visual analog scale - Week 5
Description
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Time Frame
five week at study entry
Title
visual analog scale - Week 6
Description
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Time Frame
six week at study entry
Title
visual analog scale - Week 7
Description
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Time Frame
seven week at study entry
Title
visual analog scale - Week 8
Description
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Time Frame
eight week at study entry
Title
visual analog scale - Week 9
Description
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Time Frame
nine week at study entry
Title
visual analog scale - Week 10
Description
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Time Frame
ten week at study entry
Title
visual analog scale - Week 11
Description
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Time Frame
eleven week at study entry
Title
visual analog scale - Week 12
Description
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Time Frame
twelve week at study entry
Title
visual analog scale - Week 26
Description
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Time Frame
twenty-six week at study entry
Title
visual analog scale - Week 52
Description
The intensity of pain experienced during a sequence of three monopodal countermovement jumps with both hands on the waist will be evaluated on a graduated scale. A maximum of three jumps will be performed and the highest jump will be recorded. Immediately afterwards, participants will be asked to indicate with an "X" on a 100mm line the intensity of pain experienced in the Achilles tendon. It has a scale from 0 (no pain) to 100 (worst pain).
Time Frame
fifty-two week at study entry
Title
The Foot and Ankle Ability Measure - Baseline
Description
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Time Frame
Baseline
Title
The Foot and Ankle Ability Measure - Week 1
Description
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Time Frame
one week at study entry
Title
The Foot and Ankle Ability Measure - Week 2
Description
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Time Frame
two week at study entry
Title
The Foot and Ankle Ability Measure - Week 3
Description
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Time Frame
three week at study entry
Title
The Foot and Ankle Ability Measure - Week 4
Description
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Time Frame
four week at study entry
Title
The Foot and Ankle Ability Measure - Week 5
Description
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Time Frame
five week at study entry
Title
The Foot and Ankle Ability Measure - Week 6
Description
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Time Frame
six week at study entry
Title
The Foot and Ankle Ability Measure - Week 7
Description
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Time Frame
seven week at study entry
Title
The Foot and Ankle Ability Measure - Week 8
Description
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Time Frame
eight week at study entry
Title
The Foot and Ankle Ability Measure - Week 9
Description
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Time Frame
nine week at study entry
Title
The Foot and Ankle Ability Measure - Week 10
Description
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Time Frame
ten week at study entry
Title
The Foot and Ankle Ability Measure - Week 11
Description
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Time Frame
eleven week at study entry
Title
The Foot and Ankle Ability Measure - Week 12
Description
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Time Frame
twelve week at study entry
Title
The Foot and Ankle Ability Measure - Week 26
Description
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Time Frame
twenty-six week at study entry
Title
The Foot and Ankle Ability Measure - Week 52
Description
an evaluative instrument that assesses functional limitations for those with foot- and ankle-related disorders. it's a patient reported outcomes which allows to quantify sport activity and participation. It has a scale from 0 (worst) to 100 (best). It consists of 29 questions, divided into 2 subscales, activities of daily living and sports activities. The criterion for discharge is a value greater than or equal to 90 points.
Time Frame
fifty-two week at study entry
Title
ultrasound Shear Wave elastography - baseline
Description
Shear Wave Elastography (SWS), which consists of a special ultrasound methodology that allows quantitative characterization of the elastic capacity of a tissue through the propagation velocity of the ultrasound wave. The Siemens Acuson S2000 system with a model 9L4 linear transducer will be used.
The patients will be placed on a table in ventral decubitus and the ankle outside the plane of the table in neutral position. To determine the point to be scanned, the maximum perpendicular distance between the anterior and posterior limits of the tendon between 2 to 6 cm from the insertion in the calcaneus will be taken and this value will be reported in mm.
The SWS value will be expressed in m/s. The range of SWS is 0-9 m/s. The standard SWS measurement window size shall be 1cm2 , with a region of interest of 3mm. Three measurements will be recorded in each plane (regions of interest) where homogeneous tissue is considered and the average value of the 6 measurements will be reported.
Time Frame
Baseline
Title
ultrasound Shear Wave elastography - Week 4
Description
Shear Wave Elastography (SWS), which consists of a special ultrasound methodology that allows quantitative characterization of the elastic capacity of a tissue through the propagation velocity of the ultrasound wave. The Siemens Acuson S2000 system with a model 9L4 linear transducer will be used.
The patients will be placed on a table in ventral decubitus and the ankle outside the plane of the table in neutral position. To determine the point to be scanned, the maximum perpendicular distance between the anterior and posterior limits of the tendon between 2 to 6 cm from the insertion in the calcaneus will be taken and this value will be reported in mm.
The SWS value will be expressed in m/s. The range of SWS is 0-9 m/s. The standard SWS measurement window size shall be 1cm2 , with a region of interest of 3mm. Three measurements will be recorded in each plane (regions of interest) where homogeneous tissue is considered and the average value of the 6 measurements will be reported.
Time Frame
four week at study entry
Title
ultrasound Shear Wave elastography - Week 8
Description
Shear Wave Elastography (SWS), which consists of a special ultrasound methodology that allows quantitative characterization of the elastic capacity of a tissue through the propagation velocity of the ultrasound wave. The Siemens Acuson S2000 system with a model 9L4 linear transducer will be used.
The patients will be placed on a table in ventral decubitus and the ankle outside the plane of the table in neutral position. To determine the point to be scanned, the maximum perpendicular distance between the anterior and posterior limits of the tendon between 2 to 6 cm from the insertion in the calcaneus will be taken and this value will be reported in mm.
The SWS value will be expressed in m/s. The range of SWS is 0-9 m/s. The standard SWS measurement window size shall be 1cm2 , with a region of interest of 3mm. Three measurements will be recorded in each plane (regions of interest) where homogeneous tissue is considered and the average value of the 6 measurements will be reported.
Time Frame
eight week at study entry
Title
ultrasound Shear Wave elastography - Week 12
Description
Shear Wave Elastography (SWS), which consists of a special ultrasound methodology that allows quantitative characterization of the elastic capacity of a tissue through the propagation velocity of the ultrasound wave. The Siemens Acuson S2000 system with a model 9L4 linear transducer will be used.
The patients will be placed on a table in ventral decubitus and the ankle outside the plane of the table in neutral position. To determine the point to be scanned, the maximum perpendicular distance between the anterior and posterior limits of the tendon between 2 to 6 cm from the insertion in the calcaneus will be taken and this value will be reported in mm.
The SWS value will be expressed in m/s. The range of SWS is 0-9 m/s. The standard SWS measurement window size shall be 1cm2 , with a region of interest of 3mm. Three measurements will be recorded in each plane (regions of interest) where homogeneous tissue is considered and the average value of the 6 measurements will be reported.
Time Frame
twelve week at study entry
Title
ultrasound Shear Wave elastography - Week 26
Description
Shear Wave Elastography (SWS), which consists of a special ultrasound methodology that allows quantitative characterization of the elastic capacity of a tissue through the propagation velocity of the ultrasound wave. The Siemens Acuson S2000 system with a model 9L4 linear transducer will be used.
The patients will be placed on a table in ventral decubitus and the ankle outside the plane of the table in neutral position. To determine the point to be scanned, the maximum perpendicular distance between the anterior and posterior limits of the tendon between 2 to 6 cm from the insertion in the calcaneus will be taken and this value will be reported in mm.
The SWS value will be expressed in m/s. The range of SWS is 0-9 m/s. The standard SWS measurement window size shall be 1cm2 , with a region of interest of 3mm. Three measurements will be recorded in each plane (regions of interest) where homogeneous tissue is considered and the average value of the 6 measurements will be reported.
Time Frame
twenty-six week at study entry
Title
ultrasound Shear Wave elastography - Week 52
Description
Shear Wave Elastography (SWS), which consists of a special ultrasound methodology that allows quantitative characterization of the elastic capacity of a tissue through the propagation velocity of the ultrasound wave. The Siemens Acuson S2000 system with a model 9L4 linear transducer will be used.
The patients will be placed on a table in ventral decubitus and the ankle outside the plane of the table in neutral position. To determine the point to be scanned, the maximum perpendicular distance between the anterior and posterior limits of the tendon between 2 to 6 cm from the insertion in the calcaneus will be taken and this value will be reported in mm.
The SWS value will be expressed in m/s. The range of SWS is 0-9 m/s. The standard SWS measurement window size shall be 1cm2 , with a region of interest of 3mm. Three measurements will be recorded in each plane (regions of interest) where homogeneous tissue is considered and the average value of the 6 measurements will be reported.
Time Frame
fifty-two week at study entry
Title
Vienna Achilles tendon morphological score - MRI - baseline
Description
A 1.5T Siemens Healthcare 1.5T scanner will be used for the MRI evaluation, using a gradient strength of 40 mT/m and an 8-channel coil. The standard MRI protocol will be identical for all examinations and will consist of a localizer set and three morphological MR sequences: 1) a sagittal fat-suppressed sequence; 2) a sagittal T1 sagittal spin echo (SE) sequence and 3) a T2-w sequence.
Once the images are obtained, they will be evaluated with the "Vienna Achilles tendon morphological score" (VIMATS) protocol proposed by Apprich S. (2021) which conforms a semiquantitative rating scale where the score is composed of four different parameters: (1) thickness, (2) continuity, (3) signal and (4) associated pathologies. It has a continuous numerical scale from 0 to 100 where the higher the score, the better the patient's stage.
Time Frame
Baseline
Title
Vienna Achilles tendon morphological score - MRI - Week 4
Description
A 1.5T Siemens Healthcare 1.5T scanner will be used for the MRI evaluation, using a gradient strength of 40 mT/m and an 8-channel coil. The standard MRI protocol will be identical for all examinations and will consist of a localizer set and three morphological MR sequences: 1) a sagittal fat-suppressed sequence; 2) a sagittal T1 sagittal spin echo (SE) sequence and 3) a T2-w sequence.
Once the images are obtained, they will be evaluated with the "Vienna Achilles tendon morphological score" (VIMATS) protocol proposed by Apprich S. (2021) which conforms a semiquantitative rating scale where the score is composed of four different parameters: (1) thickness, (2) continuity, (3) signal and (4) associated pathologies. It has a continuous numerical scale from 0 to 100 where the higher the score, the better the patient's stage.
Time Frame
four week at study entry
Title
Vienna Achilles tendon morphological score - MRI - Week 8
Description
A 1.5T Siemens Healthcare 1.5T scanner will be used for the MRI evaluation, using a gradient strength of 40 mT/m and an 8-channel coil. The standard MRI protocol will be identical for all examinations and will consist of a localizer set and three morphological MR sequences: 1) a sagittal fat-suppressed sequence; 2) a sagittal T1 sagittal spin echo (SE) sequence and 3) a T2-w sequence.
Once the images are obtained, they will be evaluated with the "Vienna Achilles tendon morphological score" (VIMATS) protocol proposed by Apprich S. (2021) which conforms a semiquantitative rating scale where the score is composed of four different parameters: (1) thickness, (2) continuity, (3) signal and (4) associated pathologies. It has a continuous numerical scale from 0 to 100 where the higher the score, the better the patient's stage.
Time Frame
eight week at study entry
Title
Vienna Achilles tendon morphological score - MRI - Week 12
Description
A 1.5T Siemens Healthcare 1.5T scanner will be used for the MRI evaluation, using a gradient strength of 40 mT/m and an 8-channel coil. The standard MRI protocol will be identical for all examinations and will consist of a localizer set and three morphological MR sequences: 1) a sagittal fat-suppressed sequence; 2) a sagittal T1 sagittal spin echo (SE) sequence and 3) a T2-w sequence.
Once the images are obtained, they will be evaluated with the "Vienna Achilles tendon morphological score" (VIMATS) protocol proposed by Apprich S. (2021) which conforms a semiquantitative rating scale where the score is composed of four different parameters: (1) thickness, (2) continuity, (3) signal and (4) associated pathologies. It has a continuous numerical scale from 0 to 100 where the higher the score, the better the patient's stage.
Time Frame
twelve week at study entry
Title
Vienna Achilles tendon morphological score - MRI - Week 26
Description
A 1.5T Siemens Healthcare 1.5T scanner will be used for the MRI evaluation, using a gradient strength of 40 mT/m and an 8-channel coil. The standard MRI protocol will be identical for all examinations and will consist of a localizer set and three morphological MR sequences: 1) a sagittal fat-suppressed sequence; 2) a sagittal T1 sagittal spin echo (SE) sequence and 3) a T2-w sequence.
Once the images are obtained, they will be evaluated with the "Vienna Achilles tendon morphological score" (VIMATS) protocol proposed by Apprich S. (2021) which conforms a semiquantitative rating scale where the score is composed of four different parameters: (1) thickness, (2) continuity, (3) signal and (4) associated pathologies. It has a continuous numerical scale from 0 to 100 where the higher the score, the better the patient's stage.
Time Frame
twenty-six week at study entry
Title
Vienna Achilles tendon morphological score - MRI - Week 52
Description
A 1.5T Siemens Healthcare 1.5T scanner will be used for the MRI evaluation, using a gradient strength of 40 mT/m and an 8-channel coil. The standard MRI protocol will be identical for all examinations and will consist of a localizer set and three morphological MR sequences: 1) a sagittal fat-suppressed sequence; 2) a sagittal T1 sagittal spin echo (SE) sequence and 3) a T2-w sequence.
Once the images are obtained, they will be evaluated with the "Vienna Achilles tendon morphological score" (VIMATS) protocol proposed by Apprich S. (2021) which conforms a semiquantitative rating scale where the score is composed of four different parameters: (1) thickness, (2) continuity, (3) signal and (4) associated pathologies. It has a continuous numerical scale from 0 to 100 where the higher the score, the better the patient's stage.
Time Frame
fifty-two week at study entry
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of symptoms in one or both Achilles tendons with a minimum duration of two months. In case the symptoms are bilateral, the intervention or placebo will only be administered and its results evaluated- in the limb with greater symptomatology. If it is not possible to differentiate which one presents greater pain, the right Achilles tendon will be chosen.
Spontaneous pain of at least three points measured by a visual analog scale (VAS), reproducible by palpation between 2 and 6 cm above the insertion of the Achilles tendon in the calcaneal bone.
Evidence of tendinopathy by MRI.
Presence of post-static dyskinesia.
Willingness to not perform additional treatments (such as footwear modifications, physical therapy, orthotics, injections, or surgery) for Achilles tendon pain during the conduct of the trial.
Willingness to attempt to discontinue self-administration of medications (NSAIDs) for pain relief Achilles tendon(s) pain for at least 14 days prior to baseline assessment and during the course of the trial.
Exclusion Criteria:
Presence or suspicion of pregnancy.
Previous surgical intervention on the AT in the symptomatic leg(s)
Total or partial rupture in the symptomatic AT
Chronic ankle instability, in the foot with symptomatic tendon(s).
Pathologies that can derive in pain in the region of the AT without being proper of the picture. (e.g.: osteoarthritis, impingement syndromes).
Presence of arthritis or any metabolic or endocrine disorder (type 1 or 2 diabetes).
Psychological disorders.
Oncologic history.
Treatment with quinolones or fluoroquinolones during the last two years.
Treatment with statins for the control of hypercholesterolemia for more than two months
Treatments within or at the periphery of the Achilles tendon, with anesthetics, corticosteroids or any other pharmacological agent during the last three months.
Needle phobia
Allergy to metal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Santiago M d'Almeida, PT SCS
Phone
01140573099
Email
dalmeida.santiago@maimonides.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santiago M d'Almeida, PT SCS
Organizational Affiliation
Maimonides University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maimonides University
City
Ciudad Autonoma de Buenos Aires
State/Province
Caba
ZIP/Postal Code
1405
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Ronzio, DHSc
Phone
+541149051140
Email
ronzio.oscar@maimonides.edu
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Percutaneous Electrolysis in the Treatment of Achilles Tendinopathy
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