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

• ClinicalTrials.gov Identifier: NCT03939247
• Recruitment Status: Terminated
• First Posted: May 6, 2019
• Last Update Posted: July 13, 2021
• Sponsor: University of Liege
• Information provided by (Responsible Party): Christophe Demoulin, University of Liege

Study Description

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

Condition or disease	Intervention/treatment	Phase
Tendinopathy	Other: Active Tecaretherapy; Other: Inactive Tecaretherapy; Other: CPT	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled Trial
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: The patients receiving the "Placebo Tecare" will be blinded by using an identical device as in the active group but which cannot provide any current
• Primary Purpose: Treatment
• Official Title: Effectiveness of High Frequency Currents (Tecarethérapie) in Patients With Lateral Elbow Tendonopathy
• Actual Study Start Date: April 25, 2019
• Actual Primary Completion Date: July 1, 2021
• Actual Study Completion Date: July 1, 2021

Arms and Interventions

Arm	Intervention/treatment
"Conventional PT treatment (CPT)"; All treatment sessions include massage, eccentric exercises by means of an isokinetic dynamometer and stretching;	Other: CPT; Conventional physiotherapy treatment (massage, eccentric exercises, stretching)
Experimental: "CPT + Tecare"; 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; The "Tecaretherapy": consists of using a specific device providing high frequencies (between 300 kHz and 1 MHz) supposed to accelerate the tissues healing process; Other: CPT; Conventional physiotherapy treatment (massage, eccentric exercises, stretching)
Sham Comparator: "CPT + Placebo Tecare"; 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; Inactive "Tecaretherapy": the device will not provide any current.; Other: CPT; Conventional physiotherapy treatment (massage, eccentric exercises, stretching)

Outcome Measures

Primary Outcome Measures :

1. change in the "Patient-Rated Tennis Elbow Evaluation" score [ Time Frame: 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 :

1. change in pain Intensity [ Time Frame: up to 6 months ]
   0-10 Numeric rating scale (0 = no pain, 10 = worst imaginable pain)
2. change in pain Pressure thresholds [ Time Frame: up to 6 months ]
   Measured by means of an algometer

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Belgium

CHU Liege

Liège, Belgium, 4000

Sponsors and Collaborators

University of Liege

Investigators

• Principal Investigator: Marc Vanderthommen, Prof; University of Liege
• Principal Investigator: Bénédicte Forthomme, Prof; University of Liege

More Information

• Responsible Party: Christophe Demoulin, Associated Professor, University of Liege
• ClinicalTrials.gov Identifier: NCT03939247
• Other Study ID Numbers: TECARE
• First Posted: May 6, 2019
• Last Update Posted: July 13, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christophe Demoulin, University of Liege:

elbow; tendinopathy; physiotherapy; exercise; electrotherapy

Additional relevant MeSH terms:

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries