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出境医 / 临床实验 / Effectiveness of the "Tecaretherapy" in Patients With Lateral Elbow Tendinopathy
Effectiveness of the "Tecaretherapy" in Patients With Lateral Elbow Tendinopathy
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) |
| Estimated Enrollment : | 60 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 |
| Estimated Primary Completion Date : | September 2020 |
| Estimated Study Completion Date : | September 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 :
- 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 :
- change in pain Intensity [ Time Frame: up to 6 months ]0-10 Numeric rating scale (0 = no pain, 10 = worst imaginable pain)
- 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
Contacts
| Contact: Christophe Demoulin, PhD | +3243663895 | christophe.demoulin@uliege.be |
Locations
| Belgium | |
| CHU Liege | Recruiting |
| Liège, Belgium, 4000 | |
| Contact: Jean-François Kaux, Prof +3243668241 jfkaux@chuliege.be | |
Sponsors and Collaborators
University of Liege
Investigators
| Principal Investigator: | Marc Vanderthommen, Prof | University of Liege | |
| Principal Investigator: | Bénédicte Forthomme, Prof | University of Liege |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 1, 2019 | ||||||
| First Posted Date ICMJE | May 6, 2019 | ||||||
| Last Update Posted Date | May 6, 2019 | ||||||
| Actual Study Start Date ICMJE | April 25, 2019 | ||||||
| Estimated Primary Completion Date | September 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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).
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | No Changes Posted | ||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Effectiveness of the "Tecaretherapy" in Patients With Lateral Elbow Tendinopathy | ||||||
| Official Title ICMJE | Effectiveness of High Frequency Currents (Tecarethérapie) in Patients With Lateral Elbow Tendonopathy | ||||||
| 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:
|
||||||
| 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:
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 Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | 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
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| Condition ICMJE | Tendinopathy | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE |
60 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | September 2021 | ||||||
| Estimated Primary Completion Date | September 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria: Patients:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 55 Years (Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Belgium | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03939247 | ||||||
| Other Study ID Numbers ICMJE | TECARE | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Christophe Demoulin, University of Liege | ||||||
| Study Sponsor ICMJE | University of Liege | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | University of Liege | ||||||
| Verification Date | May 2019 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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