Back to resultsEffectiveness of the "Tecaretherapy" in Patients With Lateral Elbow Tendinopathy
Primary Purpose
Tendinopathy
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Active Tecaretherapy
Inactive Tecaretherapy
CPT
Sponsored by
About this trial
This is an interventional treatment trial for Tendinopathy focused on measuring elbow, tendinopathy, physiotherapy, exercise, electrotherapy
Eligibility 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
Sites / Locations
- CHU Liege
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Sham Comparator
Arm Label
"Conventional PT treatment (CPT)"
"CPT + Tecare"
"CPT + Placebo Tecare"
Arm Description
All treatment sessions include massage, eccentric exercises by means of an isokinetic dynamometer and stretching;
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
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
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
change in pain Intensity
0-10 Numeric rating scale (0 = no pain, 10 = worst imaginable pain)
change in pain Pressure thresholds
Measured by means of an algometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03939247
Brief Title
Effectiveness of the "Tecaretherapy" in Patients With Lateral Elbow Tendinopathy
Official Title
Effectiveness of High Frequency Currents (Tecarethérapie) in Patients With Lateral Elbow Tendonopathy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Too difficult to recruit patients
Study Start Date
April 25, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy
Keywords
elbow, tendinopathy, physiotherapy, exercise, electrotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled Trial
Masking
ParticipantOutcomes 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
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
"Conventional PT treatment (CPT)"
Arm Type
Other
Arm Description
All treatment sessions include massage, eccentric exercises by means of an isokinetic dynamometer and stretching;
Arm Title
"CPT + Tecare"
Arm Type
Experimental
Arm Description
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
Arm Title
"CPT + Placebo Tecare"
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Active Tecaretherapy
Intervention Description
The "Tecaretherapy": consists of using a specific device providing high frequencies (between 300 kHz and 1 MHz) supposed to accelerate the tissues healing process
Intervention Type
Other
Intervention Name(s)
Inactive Tecaretherapy
Intervention Description
Inactive "Tecaretherapy": the device will not provide any current.
Intervention Type
Other
Intervention Name(s)
CPT
Intervention Description
Conventional physiotherapy treatment (massage, eccentric exercises, stretching)
Primary Outcome Measure Information:
Title
change in the "Patient-Rated Tennis Elbow Evaluation" score
Description
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).
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
change in pain Intensity
Description
0-10 Numeric rating scale (0 = no pain, 10 = worst imaginable pain)
Time Frame
up to 6 months
Title
change in pain Pressure thresholds
Description
Measured by means of an algometer
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Vanderthommen, Prof
Organizational Affiliation
University of Liege
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bénédicte Forthomme, Prof
Organizational Affiliation
University of Liege
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Liege
City
Liège
ZIP/Postal Code
4000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of the "Tecaretherapy" in Patients With Lateral Elbow Tendinopathy
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