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

NCT03939247 | Terminated DMC

• 1 other identifier: TECARE
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Conditions

Tendinopathy

Keywords

elbow; tendinopathy; physiotherapy; exercise; electrotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• change in pain Intensity

  up to 6 months

• change in pain Pressure thresholds

  up to 6 months

Study Arms (3)

"Conventional PT treatment (CPT)"

OTHER

All treatment sessions include massage, eccentric exercises by means of an isokinetic dynamometer and stretching;

Other: CPT

"CPT + Tecare"

EXPERIMENTAL

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; Other: CPT

"CPT + Placebo Tecare"

SHAM COMPARATOR

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; Other: CPT

Interventions

Inactive Tecaretherapy OTHER

Inactive "Tecaretherapy": the device will not provide any current.

"CPT + Placebo Tecare"

Active Tecaretherapy OTHER

The "Tecaretherapy": consists of using a specific device providing high frequencies (between 300 kHz and 1 MHz) supposed to accelerate the tissues healing process

"CPT + Tecare"

CPT OTHER

Conventional physiotherapy treatment (massage, eccentric exercises, stretching)

"CPT + Placebo Tecare"; "CPT + Tecare"; "Conventional PT treatment (CPT)"

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient suffering from a chronic lateral elbow tendinopathy confirmed by echography

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

CHU Liege

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Tendinopathy; Motor Activity

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

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

Study Officials

• Marc Vanderthommen, Prof

  University of Liege

  PRINCIPAL INVESTIGATOR

• Bénédicte Forthomme, Prof

  University of Liege

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Model Details: Randomized controlled Trial

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 6, 2019
• Study Start: April 25, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)