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Effectiveness of Tecar Therapy in Patients With Chronic Achilles Tendinopathy

Primary Purpose

Achilles Tendinopathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tecartherapy
Sham
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendinopathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Study participants must have signed the informed consent form in order to evaluate their participation in the study.
  • Actively practice some sporting activity.
  • Have a medical diagnosis of chronic Achilles tendinopathy of more than 3 months of evolution.
  • Not having previously received any tecartherapy treatment.
  • Be over 18 years of age.

Exclusion Criteria:

  • Volunteers who have suffered a sports injury during the last two months or are unable to perform physical activity.
  • Subjects with bilateral tendinopathies.
  • Subjects who report allergies to the conductive cream.
  • Not understanding the information provided by the therapist.
  • Participating in other research studies.
  • Subjects undergoing pharmacological medical treatment that may interfere with the measurements, such as treatment with anticonvulsants, antidepressants.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Tecar group

    Sham Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in numerical pain rating scale (0-10)
    EVA pain scale will be used, where the patient will tell us the pain in numerical form.
    Change in visual analogue scale (0-100 mm)
    EVA pain scale will be used, where the patient will point on a fingertip on a straight line without numbers which has been his perception of pain.

    Secondary Outcome Measures

    Strength (kilograms)
    To measure the strength of the gastrocnemius muscles, a precision dynamometer (Microfeet II) will be used and the maximum force will be analyzed during an isometric contraction of this musculature for 5 seconds. The participant will be placed in supine decubitus with his ankle close to a wall. The dynamometer (Microfeet II) will be placed between the foot and the wall at the level of the metatarsals. The participant will be asked to perform a maximum plantar flexion for five seconds against the dynamometer. The maximum force in kilograms performed by the subject during this test will be recorded.
    Ankle range of motion in loading (degrees)
    The measurement of ankle dorsal flexion range of motion in loading is a variable to be studied. A universal goniometer will be used. The patient will lean against a wall and keeping the heel on the floor will perform the maximum possible dorsal ankle flexion under load until the first sensation of tension. The goniometer will be aligned with one limb parallel to the ground and the other in the direction of the tibia.
    VISA-A questionnaire
    Victorian Institute of Sport Assessment-Achilles Questionnaire, 0-100, higher scores mean a better outcome.
    GROC scale
    Global Rating of Change Scale, (-7) - (+7), higher scores mean a better outcome.
    Cross-sectional area (mm2)
    The cross-sectional section will be measured using a tracing ellipse method with the trace at the edge of the echogenic bony region. The tendon structure will be evaluated and interpreted as abnormal if there are persistent variations in the homogeneous structure, including a hypoechoic signal, hyperechoic signal, peritendinous fluid collection, contour defect or focal thickening of the tendon and noted. In addition, the images will be evaluated by a grayscale detection program capable of detecting intra-tendon changes imperceptible to the human eye.
    Stinfess (N m -1 )
    Measured by myotonometry. It is determined by the relation between the force produced by the mechanical impulse and the depth of tissue deformation. Stiffness should be measured at the point where the patient reports the most pain.
    Longitudinal section (mm)
    Thickness will be measured at the point with the largest anteroposterior diameter.

    Full Information

    First Posted
    September 8, 2022
    Last Updated
    September 13, 2022
    Sponsor
    Universitat Internacional de Catalunya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05539586
    Brief Title
    Effectiveness of Tecar Therapy in Patients With Chronic Achilles Tendinopathy
    Official Title
    Effectiveness of Tecar Therapy in Patients With Chronic Achilles Tendinopathy. Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    July 1, 2024 (Anticipated)
    Study Completion Date
    September 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitat Internacional de Catalunya

    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 is characterized by pain, decreased performance and swelling in and around the tendon. Up to 29% of patients with Achilles tendinopathy may require surgical intervention. It can be complicated by partial tears or complete rupture, placing a long-term burden on the healthcare system and making treatment more difficult. The most common location of Achilles tendinopathy is in the insertional area of the calcaneus, 1.5 to 2 cm cranial to the bone. The most common location of pathologic inflammation was at the fascial intersection of the medial gastrocnemius and soleus when fused with the proximal Achilles tendon (66% of patients and the distal part of the Achilles tendon near the calcaneus. The four cornerstones of tendon histopathology are: cellular activation and increased cell number, increased ground substance, collagen disorganization and neovascularization. In addition, blood supply is one of the most influential factors in tendon tissue repair. A recent clinical trial compared the outcome after low frequency microwave hyperthermia with traditional ultrasound. The hyperthermia group recorded significantly better results after treatment and one month later. The use of deep heating modalities, due to their beneficial effects of increased circulation and cellular metabolism resulting in increased waste and nutrient exchange in a specific area, has long been accepted as part of the treatment of overuse tendinopathies . The application of heat has been reported to improve blood flow and oxygen saturation in the Achilles tendon.Physical therapies based on electrical or electromagnetic stimulation have been used in rehabilitation, in some cases combining electrical therapy with radiofrequency. Specifically, resistive capacitive electrical transfer therapy (CRet) has been used in physical rehabilitation and sports medicine to treat muscle, bone, ligament and tendon injuries. CRet is a non-invasive electrothermal therapy classified as deep thermotherapy, which is based on the application of electrical currents within the radiofrequency range of 300 kHz - 1.2 MHz. he effects attributed to this technique include increased deep and superficial blood circulation, vasodilatation, increased temperature, elimination of excess fluid and increased cell proliferation. Some of these reactions, such as increased blood perfusion, are known to be related to the increase in temperature, but others, such as increased cell proliferation, appear to be primarily related to the passage of current. There are currently numerous treatment proposals for this pathology, however, the only one that has shown significant improvements are eccentric exercise protocols. The only drawback of this type of exercise is that the results are obtained in the long term. There is currently no study that has compared the effectiveness of adding a tecartherapy protocol to the eccentric exercise protocol in chronic Achilles tendinopathy in athletes in the short and medium term in both functional and structural variables.
    Detailed Description
    Achilles tendinopathy is characterized by pain, decreased performance and swelling in and around the tendon. Up to 29% of patients with Achilles tendinopathy may require surgical intervention. It can be complicated by partial tears or complete rupture, placing a long-term burden on the healthcare system and making treatment more difficult. The most common location of Achilles tendinopathy is in the insertional area of the calcaneus, 1.5 to 2 cm cranial to the bone. The most common location of pathologic inflammation was at the fascial intersection of the medial gastrocnemius and soleus when fused with the proximal Achilles tendon (66% of patients and the distal part of the Achilles tendon near the calcaneus. The four cornerstones of tendon histopathology are: cellular activation and increased cell number, increased ground substance, collagen disorganization and neovascularization. In addition, blood supply is one of the most influential factors in tendon tissue repair. There is an animal study in which when the blood supply to the Achilles tendon of a rabbit was decreased, the following changes were observed: the normally attached fascicles of the rabbit tendon separated and the tenocytes became disorganized from the interfascicular spaces. Collagen filaments became acellular and fragmented. Furthermore, it was shown that the changes observed in chronic degenerative tendon disorders in humans are the same as those that occur when the blood supply to the rabbit Achilles tendon is disturbed. This demonstrates that vascular supply is one of the important factors in treating tendon tissue. A recent clinical trial compared the outcome after low frequency microwave hyperthermia with traditional ultrasound. The hyperthermia group recorded significantly better results after treatment and one month later. The use of deep heating modalities, due to their beneficial effects of increased circulation and cellular metabolism resulting in increased waste and nutrient exchange in a specific area, has long been accepted as part of the treatment of overuse tendinopathies . The application of heat has been reported to improve blood flow and oxygen saturation in the Achilles tendon. Thus, thermal agents may be an effective method to treat this type of tendon disorders. Physical therapies based on electrical or electromagnetic stimulation have been used in rehabilitation, in some cases combining electrical therapy with radiofrequency. Specifically, resistive capacitive electrical transfer therapy (CRet) has been used in physical rehabilitation and sports medicine to treat muscle, bone, ligament and tendon injuries. CRet is a non-invasive electrothermal therapy classified as deep thermotherapy, which is based on the application of electrical currents within the radiofrequency range of 300 kHz - 1.2 MHz. While the heat conducted by surface thermotherapy cannot reach the muscle due to the electrical resistance of the tissues, the capacitive-resistive electric currents in CRet therapy can generate heating of deep muscle tissues, which in turn improves hemoglobin saturation. In Europe, CRet is widely used in various medical rehabilitation processes. The physiological effects of this type of physiotherapy are generated by the application to the human body of an electromagnetic field with a frequency of approximately 0.5 MHz. The effects attributed to this technique include increased deep and superficial blood circulation, vasodilatation, increased temperature, elimination of excess fluid and increased cell proliferation. Some of these reactions, such as increased blood perfusion, are known to be related to the increase in temperature, but others, such as increased cell proliferation, appear to be primarily related to the passage of current. It is also true that this increase in tissue temperature, generated through the application of the device, is a physical reaction to the passage of the current (Joule effect). Although there are already clinical publications that support this mechanism, the amount of energy and current that must be transferred to obtain the desired temperature increase is unknown. Moreover, the control of these reactions, by adjusting parameters such as absorbed power and electrode position, are still largely based on the empirical experience of therapists. Recently, new cadaveric publications have been published that support the mechanisms of current flow and thermal changes in this situation, especially a study by López-de-Celis et al. in which the thermal effects and current flow in the myotendinous junction of the medial gastrocnemius and Achilles tendon were demonstrated. With this background, in which thermal effects, current passage and symptomatic improvements have been demonstrated in patients with pathology, the possibility that these treatments improve functional sports capabilities is raised. This hypothesis arises from the fact that the passage of current and thermal changes have been directly related to viscoelastic changes in capsular and muscular tissue. There are currently numerous treatment proposals for this pathology, however, the only one that has shown significant improvements are eccentric exercise protocols. The only drawback of this type of exercise is that the results are obtained in the long term. There is currently no study that has compared the effectiveness of adding a tecartherapy protocol to the eccentric exercise protocol in chronic Achilles tendinopathy in athletes in the short and medium term in both functional and structural variables. Recently, new cadaveric publications have been published that support the mechanisms of current flow and thermal changes in this situation, especially a study by López-de-Celis et al. in which the thermal effects and current flow in the myotendinous junction of the medial gastrocnemius and Achilles tendon were demonstrated. With this background, in which thermal effects, current passage and symptomatic improvements have been demonstrated in patients with pathology, the possibility that these treatments improve functional sports capabilities is raised. This hypothesis arises from the fact that the passage of current and thermal changes have been directly related to viscoelastic changes in capsular and muscular tissue. There are currently numerous treatment proposals for this pathology, however, the only one that has shown significant improvements are eccentric exercise protocols. The only drawback of this type of exercise is that the results are obtained in the long term. There is currently no study that has compared the effectiveness of adding a tecartherapy protocol to the eccentric exercise protocol in chronic Achilles tendinopathy in athletes in the short and medium term in both functional and structural variables.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Achilles Tendinopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tecar group
    Arm Type
    Experimental
    Arm Title
    Sham Group
    Arm Type
    Sham Comparator
    Intervention Type
    Other
    Intervention Name(s)
    Tecartherapy
    Intervention Description
    Patients will receive therapeutic exercise sessions for 7 weeks and 7 tecartherapy sessions.
    Intervention Type
    Other
    Intervention Name(s)
    Sham
    Intervention Description
    Patients will receive therapeutic exercise sessions for 7 weeks and 7 sessions of simulated tecartherapy.
    Primary Outcome Measure Information:
    Title
    Change in numerical pain rating scale (0-10)
    Description
    EVA pain scale will be used, where the patient will tell us the pain in numerical form.
    Time Frame
    Baseline; 3 weeks follow-up; 7 weeks follow-up
    Title
    Change in visual analogue scale (0-100 mm)
    Description
    EVA pain scale will be used, where the patient will point on a fingertip on a straight line without numbers which has been his perception of pain.
    Time Frame
    Baseline; 3 weeks follow-up; 7 weeks follow-up
    Secondary Outcome Measure Information:
    Title
    Strength (kilograms)
    Description
    To measure the strength of the gastrocnemius muscles, a precision dynamometer (Microfeet II) will be used and the maximum force will be analyzed during an isometric contraction of this musculature for 5 seconds. The participant will be placed in supine decubitus with his ankle close to a wall. The dynamometer (Microfeet II) will be placed between the foot and the wall at the level of the metatarsals. The participant will be asked to perform a maximum plantar flexion for five seconds against the dynamometer. The maximum force in kilograms performed by the subject during this test will be recorded.
    Time Frame
    Baseline; 3 weeks follow-up; 7 weeks follow-up
    Title
    Ankle range of motion in loading (degrees)
    Description
    The measurement of ankle dorsal flexion range of motion in loading is a variable to be studied. A universal goniometer will be used. The patient will lean against a wall and keeping the heel on the floor will perform the maximum possible dorsal ankle flexion under load until the first sensation of tension. The goniometer will be aligned with one limb parallel to the ground and the other in the direction of the tibia.
    Time Frame
    Baseline; 3 weeks follow-up; 7 weeks follow-up
    Title
    VISA-A questionnaire
    Description
    Victorian Institute of Sport Assessment-Achilles Questionnaire, 0-100, higher scores mean a better outcome.
    Time Frame
    Baseline; 3 weeks follow-up; 7 weeks follow-up
    Title
    GROC scale
    Description
    Global Rating of Change Scale, (-7) - (+7), higher scores mean a better outcome.
    Time Frame
    Baseline; 3 weeks follow-up; 7 weeks follow-up
    Title
    Cross-sectional area (mm2)
    Description
    The cross-sectional section will be measured using a tracing ellipse method with the trace at the edge of the echogenic bony region. The tendon structure will be evaluated and interpreted as abnormal if there are persistent variations in the homogeneous structure, including a hypoechoic signal, hyperechoic signal, peritendinous fluid collection, contour defect or focal thickening of the tendon and noted. In addition, the images will be evaluated by a grayscale detection program capable of detecting intra-tendon changes imperceptible to the human eye.
    Time Frame
    Baseline; 3 weeks follow-up; 7 weeks follow-up
    Title
    Stinfess (N m -1 )
    Description
    Measured by myotonometry. It is determined by the relation between the force produced by the mechanical impulse and the depth of tissue deformation. Stiffness should be measured at the point where the patient reports the most pain.
    Time Frame
    Baseline; 3 weeks follow-up; 7 weeks follow-up
    Title
    Longitudinal section (mm)
    Description
    Thickness will be measured at the point with the largest anteroposterior diameter.
    Time Frame
    Baseline; 3 weeks follow-up; 7 weeks follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Study participants must have signed the informed consent form in order to evaluate their participation in the study. Actively practice some sporting activity. Have a medical diagnosis of chronic Achilles tendinopathy of more than 3 months of evolution. Not having previously received any tecartherapy treatment. Be over 18 years of age. Exclusion Criteria: Volunteers who have suffered a sports injury during the last two months or are unable to perform physical activity. Subjects with bilateral tendinopathies. Subjects who report allergies to the conductive cream. Not understanding the information provided by the therapist. Participating in other research studies. Subjects undergoing pharmacological medical treatment that may interfere with the measurements, such as treatment with anticonvulsants, antidepressants.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jacobo Rodríguez-Sanz, PhD
    Phone
    636136789
    Email
    jrodriguezs@uic.es

    12. IPD Sharing Statement

    Learn more about this trial

    Effectiveness of Tecar Therapy in Patients With Chronic Achilles Tendinopathy

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