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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/18/2021.

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

Clinicaltrials.gov identifier NCT03939247

Recruitment Status Recruiting

First Posted May 6, 2019

Last update posted May 6, 2019

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:Tendinopathy
  • Intervention/Treatment: Other: Active Tecaretherapy
    Other: Inactive Tecaretherapy
    Other: CPT
  • Phase: N/A
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
  • Estimated Enrollment: 60 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Randomized controlled Trial
  • Masking: Double (Participant, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Effectiveness of High Frequency Currents (Tecarethérapie) in Patients With Lateral Elbow Tendonopathy
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: September 2020
  • Estimated Study Completion Date: September 2021
Arms and interventions
Arm Intervention/treatment
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)
Other: "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)
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 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
Contacts

Contact: Christophe Demoulin, PhD +3243663895 christophe.demoulin@uliege.be

Locations

Belgium
CHU Liege
Liège

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: University of Liege
  • ClinicalTrials.gov Identifier: NCT03939247 History of Changes
  • Other Study ID Numbers: TECARE
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: May 6, 2019
  • Last Verified: May 2019
  • 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 University of Liege: elbow
    tendinopathy
    physiotherapy
    exercise
    electrotherapy
  • Additional relevant MeSH terms: Tendinopathy