Back to resultsEffect of Percutaneous Needle Electrolysis (PNE) on Tendinopathy (PNE)
Primary Purpose
Posterior Tibial Tendon Dysfunction
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Percutaneous needle electrolysis
Therapeutic exercise
Manual therapy
Sponsored by
About this trial
This is an interventional treatment trial for Posterior Tibial Tendon Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Subjects over 18 years of age
- Mild inflammation, swelling and/or tenderness posterior to the medial malleolus
- Pain posterior and/or superior to the medial malleolus, aggravated by activity
- Pain present for at least 3 weeks
- One or more signs of flexible flatfoot deformity, including excessive valgus deformity of the hindfoot during weight bearing and/or excessive foot abduction (many toes sign).
- Pain when performing the Hell Rise Test or performed incorrectly.
- Signs of tenosynovitis on ultrasound examination.
As the inclusion criteria are based on side-to-side comparison all participants had to have unilateral involvement.
Exclusion Criteria:
- Previous surgery on the affected foot, leg or knee.
- Disabling osteoarthritis of the knee on the affected side.
- Fixed hindfoot deformities.
- Recurrent ankle sprains on the affected side.
- Ligament tears or bony abnormalities of the affected foot.
- A physical or medical condition that contraindicates the testing protocol.
- Pregnancy.
- FCD or FLH tendinopathy.
Sites / Locations
- Universidad Rey Juan CarlosRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Intervention group
Arm Description
Patients assigned to this group will receive a session of manual therapy and therapeutic exercise. The manual therapy (TM) treatment for tendinopathies is mainly focused on soft tissue mobilization and deep transverse friction massage (Cyriax). The therapeutic exercise session participants will perform 2 exercises for 4 weeks 3 days per week. The first exercise they will perform will be the Short-Foot Exercise holding the position 5 seconds isometrically. The second exercise will be plantar flexion of the ankle with adduction of the foot and inversion with elastic band in its concentric and eccentric phase. Each exercise will be performed in 3 series of 15 repetitions, with 1 minute rest between series, the exercise session will follow the TM and will last approximately 15-20 minutes.
Participants in this group will receive 4 sessions (once a week during their respective treatment session) of percutaneous electrolysis guided by MUSCULO-SKELETAL ECOGRAPHY, by a physiotherapist with extensive clinical experience in this therapeutic approach. The technique will be applied using a specifically developed and medically certified device (EPI Advanced Medicine®, Barcelona, Spain. EPI®). The galvanic current will be applied using acupuncture needles. In the present study, a 0.30*25 mm needle (Agupunt, Barcelona, Spain) will be used, with an intensity of 2 mA for a total of 3-5 seconds and 3-5 impacts on the liquid content (TTP tenosynovitis) and 2 mA for a total of 3 seconds and 2-3 impacts if in the tendon (intrasubstance). The technique shall be applied under ultrasound guidance. The needle shall be introduced at an angle of 80° in a short-axis cross-section to the skin, with the tip of the needle directed towards the posterior tibial tendon.
Outcomes
Primary Outcome Measures
NUMERICAL SCALE OF PAIN (NSP)
The scale consists of a horizontal line of 11 numbers, at the ends of which are the extreme manifestations of a symptom that allows observers to measure the intensity of pain with maximum reproducibility. On the far left is 0 or the total absence of pain and on the far right is 10 or the maximum pain that can be tolerated. The patient will be asked to select the number where they consider their pain to be. The objective of the scale is to reduce the patient's pain with the intervention and that the pain that he gives us at the beginning, prior to the intervention, decreases until it reaches 0.
FOOT AND ANKLE ABILITY (FAAM)
The FAAM questionnaire consists of 29 items separated into two subscales: the ADL subscale with 21 items and the Sport subscale with 8 items. Each one has a maximum Likert scale score of 5 points ranging from "no difficulty" to "impossible to perform". All scores will be converted to percentages, with a higher percentage indicating a higher level of functionality and lower pathology. At the end of the scale, the functionality percentage will be calculated, ranging from 0% (inability to perform any activity) to 100% (normal functionality level). Finally, patients will rate the condition of their ankle and foot on a 4-point scale that includes "normal," "almost normal," "abnormal," and "severely abnormal." The intention of the study is that the patient recovers 100% of functionality or better the percentage that has been marked prior to the intervention. As in the 4-point scale, the condition of your ankle should be normal.
ULTRASOUND CONTROL
All participants, both in the control and experimental groups, will be examined before the intervention and at the end of the 4 sessions to evaluate possible changes in the tendon, and all invasive interventions will be performed ultrasonographically. We will take as reference the pre-intervention measurement in millimeters and the post-intervention measurement to see if the tendon has undergone changes in its size.
Secondary Outcome Measures
Full Information
NCT ID
NCT05370092
First Posted
March 31, 2022
Last Updated
October 31, 2022
Sponsor
Universidad Rey Juan Carlos
1. Study Identification
Unique Protocol Identification Number
NCT05370092
Brief Title
Effect of Percutaneous Needle Electrolysis (PNE) on Tendinopathy
Acronym
PNE
Official Title
Effect of Percutaneous Needle Electrolysis on Tibialis Posterior Tendinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to test the efficacy of percutaneous electrolysis in posterior tibial tendinopathies. The posterior tibial tendon injury is one of the most frequent pathologies in the lower extremities, and therefore a correct study and evaluation of it is necessary. This study aims to compare the therapeutic effect of percutaneous electrolysis comparing a control group with an experimental group. To evaluate functionality, pain and its ultrasound pattern before and after treatment, in order to assess the efficacy of the treatment.
Detailed Description
A single-blind, longitudinal, randomised, controlled, single-blind, longitudinal, randomised, controlled clinical trial will be conducted. First, the participant will receive a FOOT AND ANKLE ABILITY (FAAM) survey, along with a numerical pain scale, both of which must be completed. Next, an ultrasound study of the foot will be performed, focusing on pain in the inner ankle, to check for possible pathology in the posterior tibial tendon. Finally, the physiotherapist's intervention will be carried out to check the effectiveness of the technique, which may cause some pain, and finally, the numerical pain scale will be passed again. Four sessions will be carried out in four different weeks, always using the same day of the week for the intervention and following the same steps as above. The purpose of this study is to test the efficacy of PD in posterior tibial tendinopathy and whether PD is therefore a safe technique for this type of intervention. All patients will sign an informed consent form and will be informed about the study beforehand.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Tibial Tendon Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients assigned to this group will receive a session of manual therapy and therapeutic exercise. The manual therapy (TM) treatment for tendinopathies is mainly focused on soft tissue mobilization and deep transverse friction massage (Cyriax).
The therapeutic exercise session participants will perform 2 exercises for 4 weeks 3 days per week. The first exercise they will perform will be the Short-Foot Exercise holding the position 5 seconds isometrically. The second exercise will be plantar flexion of the ankle with adduction of the foot and inversion with elastic band in its concentric and eccentric phase. Each exercise will be performed in 3 series of 15 repetitions, with 1 minute rest between series, the exercise session will follow the TM and will last approximately 15-20 minutes.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants in this group will receive 4 sessions (once a week during their respective treatment session) of percutaneous electrolysis guided by MUSCULO-SKELETAL ECOGRAPHY, by a physiotherapist with extensive clinical experience in this therapeutic approach. The technique will be applied using a specifically developed and medically certified device (EPI Advanced Medicine®, Barcelona, Spain. EPI®). The galvanic current will be applied using acupuncture needles. In the present study, a 0.30*25 mm needle (Agupunt, Barcelona, Spain) will be used, with an intensity of 2 mA for a total of 3-5 seconds and 3-5 impacts on the liquid content (TTP tenosynovitis) and 2 mA for a total of 3 seconds and 2-3 impacts if in the tendon (intrasubstance). The technique shall be applied under ultrasound guidance.
The needle shall be introduced at an angle of 80° in a short-axis cross-section to the skin, with the tip of the needle directed towards the posterior tibial tendon.
Intervention Type
Other
Intervention Name(s)
Percutaneous needle electrolysis
Intervention Description
Electrolysis is the process by which water (H2O) and sodium chloride (NaCl) molecules, which are present in the biological tissues and body compartments of our organism, are organically broken down into their constituent chemical elements, regrouping to create entirely new substances such as sodium hydroxide (NaOH), hydrogen gas (H2) and chlorine gas (Cl2). This process occurs thanks to the passage of a flow of direct electric current, also known as galvanic current, which is a totally athermal process. The passage of this current allows a local inflammatory response to occur (increase in lymphocytes and macrophages) as well as an increase in vasodilatation, inducing phagocytosis and biological stimulation of tendon repair.
Intervention Type
Other
Intervention Name(s)
Therapeutic exercise
Intervention Description
The first exercise they will perform will be the Short-Foot Exercise holding the position 5 seconds isometrically. The second exercise will be plantar flexion of the ankle with adduction of the foot and inversion with elastic band in its concentric and eccentric phase
Intervention Type
Other
Intervention Name(s)
Manual therapy
Intervention Description
The manual therapy (TM) treatment for tendinopathies is mainly focused on soft tissue mobilization and deep transverse friction massage (Cyriax).
Primary Outcome Measure Information:
Title
NUMERICAL SCALE OF PAIN (NSP)
Description
The scale consists of a horizontal line of 11 numbers, at the ends of which are the extreme manifestations of a symptom that allows observers to measure the intensity of pain with maximum reproducibility. On the far left is 0 or the total absence of pain and on the far right is 10 or the maximum pain that can be tolerated. The patient will be asked to select the number where they consider their pain to be. The objective of the scale is to reduce the patient's pain with the intervention and that the pain that he gives us at the beginning, prior to the intervention, decreases until it reaches 0.
Time Frame
6 months
Title
FOOT AND ANKLE ABILITY (FAAM)
Description
The FAAM questionnaire consists of 29 items separated into two subscales: the ADL subscale with 21 items and the Sport subscale with 8 items. Each one has a maximum Likert scale score of 5 points ranging from "no difficulty" to "impossible to perform". All scores will be converted to percentages, with a higher percentage indicating a higher level of functionality and lower pathology. At the end of the scale, the functionality percentage will be calculated, ranging from 0% (inability to perform any activity) to 100% (normal functionality level). Finally, patients will rate the condition of their ankle and foot on a 4-point scale that includes "normal," "almost normal," "abnormal," and "severely abnormal." The intention of the study is that the patient recovers 100% of functionality or better the percentage that has been marked prior to the intervention. As in the 4-point scale, the condition of your ankle should be normal.
Time Frame
6 months
Title
ULTRASOUND CONTROL
Description
All participants, both in the control and experimental groups, will be examined before the intervention and at the end of the 4 sessions to evaluate possible changes in the tendon, and all invasive interventions will be performed ultrasonographically. We will take as reference the pre-intervention measurement in millimeters and the post-intervention measurement to see if the tendon has undergone changes in its size.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects over 18 years of age
Mild inflammation, swelling and/or tenderness posterior to the medial malleolus
Pain posterior and/or superior to the medial malleolus, aggravated by activity
Pain present for at least 3 weeks
One or more signs of flexible flatfoot deformity, including excessive valgus deformity of the hindfoot during weight bearing and/or excessive foot abduction (many toes sign).
Pain when performing the Hell Rise Test or performed incorrectly.
Signs of tenosynovitis on ultrasound examination.
As the inclusion criteria are based on side-to-side comparison all participants had to have unilateral involvement.
Exclusion Criteria:
Previous surgery on the affected foot, leg or knee.
Disabling osteoarthritis of the knee on the affected side.
Fixed hindfoot deformities.
Recurrent ankle sprains on the affected side.
Ligament tears or bony abnormalities of the affected foot.
A physical or medical condition that contraindicates the testing protocol.
Pregnancy.
FCD or FLH tendinopathy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Rejas Fernández
Phone
635672505
Ext
+34
Email
a.rejasf.2019@alumnos.urjc.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Rejas Fernández
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose Luis Arias Buría
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ana Isabel De La Llave Rincón
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Study Director
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Madrid
ZIP/Postal Code
28933
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Rejas Fernández
Phone
635672505
Ext
34
Email
a.rejasf.2019@alumnos.urjc.es
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Percutaneous Needle Electrolysis (PNE) on Tendinopathy
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