Effectiveness of the Tecaretherapy in Patients With Lateral Elbow Tendinopathy

Study Overview
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Brief Summary
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This RCT aims at investigating the effectiveness of the Tecaretherapy in patients with lateral elbow tendinopathy. 60 patients will be randomized into one of the following 3 groups: Conventional physiotherapy treatment (CPT) (massage, eccentric exercises, stretching); CPT + Tecare (idem CPT group + tecaretherapy during the eccentric exercises) CPT + Placebo Tecare (idem CPT + Tecare group but with an inactive Tecare device) The treatment will include 18 30-minute sessions

Detailed Description
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This RCT aims at investigating the effectiveness of the Tecaretherapy in patients with lateral elbow tendinopathy. 60 patients will be randomized into one of the following 3 groups: Conventional physiotherapy treatment (CPT) (massage, eccentric exercises by means of an isokinetic dynamometer, stretching); CPT + Tecare (idem CPT group + Tecaretherapy during the eccentric exercises) CPT + Placebo Tecare (idem CPT + Tecare group but with an inactive Tecare device) The treatment will include 18 30-minute sessions. The Tecaretherapy consists in using a specific device providing high frequencies (between 300 kHz and 1 MHz) supposed to accelerate the tissues healing process. Outcome sessions will be organized at baseline, after the first 9 sessions, at the end of the treatment as well as 3 and 6 months after the initial treatment session.

Official Title
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Effectiveness of High Frequency Currents (Tecarethérapie) in Patients With Lateral Elbow Tendonopathy

Conditions
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Tendinopathy

Intervention / Treatment
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* Other: Active Tecaretherapy
* Other: Inactive Tecaretherapy
* Other: CPT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient suffering from a chronic lateral elbow tendinopathy confirmed by echography Exclusion Criteria: Patients: with contra-indications for a Tecaretherapy (Pace maker, insuline pump, pregnancy, infection, fever, cancer, thrombophlebitis) reporting injections and/or shockwaves in the past (for the tendinopathy) with an associated neurogenic dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Conventional PT treatment (CPT)<br>All treatment sessions include massage, eccentric exercises by means of an isokinetic dynamometer and stretching; | Other: CPT<br>* Conventional physiotherapy treatment (massage, eccentric exercises, stretching)<br>|
| Experimental: CPT + Tecare<br>All treatment sessions include massage, eccentric exercises by means of an isokinetic dynamometer and stretching (idem CPT group). However, an active Tecaretherapy is also provided during the sessions | Other: Active Tecaretherapy<br>* The Tecaretherapy: consists of using a specific device providing high frequencies (between 300 kHz and 1 MHz) supposed to accelerate the tissues healing process<br>Other: CPT<br>* Conventional physiotherapy treatment (massage, eccentric exercises, stretching)<br>|
| Sham Comparator: CPT + Placebo Tecare<br>All treatment sessions include massage, eccentric exercises by means of an isokinetic dynamometer and stretching (idem CPT group). However, an inactive Tecaretherapy is also provided during the sessions | Other: Inactive Tecaretherapy<br>* Inactive Tecaretherapy: the device will not provide any current.<br>Other: CPT<br>* Conventional physiotherapy treatment (massage, eccentric exercises, stretching)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the Patient-Rated Tennis Elbow Evaluation score | This questionnaire, developped for patients with elbow tendinopathy, consists of one part dealing with pain and a second part dealing with function. Each of the 5 items in part 1 is scored using a NRS, ranging from 0 (no pain) to 10 (worst pain imaginable). Part 2 is subdivided into Specific Activities (6 items) and Usual Activities (4 items). The 10 items of part 2 use a scale of 0 (no difficulty) to 10 (unable to perform an activity) to rate function. The total score is the combined score that rates pain and disability of equal importance. The pain score total (out of 50 points) and the functional subscale (60 points for specific activities, plus 40 points for usual activities to give a function subscale out of 100 points /2 to provide the remaining 50%) provide a total score, ranging from 0 (no pain and no functional impairment) to 100 (worst pain imaginable with a very significant functional deficit). | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in pain Intensity | 0-10 Numeric rating scale (0 = no pain, 10 = worst imaginable pain) | up to 6 months | 
| change in pain Pressure thresholds | Measured by means of an algometer | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elbow, tendinopathy, physiotherapy, exercise, electrotherapy