Effectiveness of the "Tecaretherapy" in Patients With Lateral Elbow Tendinopathy

Not Applicable

Terminated

• Conditions: Tendinopathy
• Interventions: Other: Inactive Tecaretherapy; Other: Active Tecaretherapy; Other: CPT

• Registration Number: NCT03939247
• Lead Sponsor: University of Liege

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-04-25
• Study First Submitted: 2019-05-01
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-06
• Status Verified: 2021-07
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Last Update Submitted: 2021-07-07
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"CPT + Placebo Tecare"	CPT	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
"CPT + Placebo Tecare"	Inactive Tecaretherapy	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
"CPT + Tecare"	Active Tecaretherapy	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
"Conventional PT treatment (CPT)"	CPT	All treatment sessions include massage, eccentric exercises by means of an isokinetic dynamometer and stretching;
"CPT + Tecare"	CPT	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

Primary Outcome Measures

Name	Time	Method
change in the "Patient-Rated Tennis Elbow Evaluation" score	up to 6 months	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Liege; 🇧🇪 Liège, Belgium