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

Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03939247
• Other study ID #: TECARE
• Status: Terminated
• Phase: N/A
• Start date: April 25, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: July 2021
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Tendinopathy

Intervention

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
• Inactive Tecaretherapy
Inactive "Tecaretherapy": the device will not provide any current.
• CPT
Conventional physiotherapy treatment (massage, eccentric exercises, stretching)

Locations

Country	Name	City	State
Belgium	CHU Liege	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	change in pain Intensity	0-10 Numeric rating scale (0 = no pain, 10 = worst imaginable pain)	up to 6 months
Secondary	change in pain Pressure thresholds	Measured by means of an algometer	up to 6 months