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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Conventional PT treatment (CPT)" | Other | All treatment sessions include massage, eccentric exercises by means of an isokinetic dynamometer and stretching; |
|
| "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 |
|
| "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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in pain Intensity | 0-10 Numeric rating scale (0 = no pain, 10 = worst imaginable pain) | up to 6 months |
| change in pain Pressure thresholds | Measured by means of an algometer |
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Inclusion Criteria:
Exclusion Criteria:
Patients:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Vanderthommen, Prof | University of Liege | Principal Investigator |
| Bénédicte Forthomme, Prof | University of Liege | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Liege | Liège | 4000 | Belgium |
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C000708228 | 2-cyclohexylidenhydrazo-4-phenyl-thiazole |
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Randomized controlled Trial
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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
| Inactive Tecaretherapy | Other | Inactive "Tecaretherapy": the device will not provide any current. |
|
| CPT | Other | Conventional physiotherapy treatment (massage, eccentric exercises, stretching) |
|
| up to 6 months |
| D001519 |
| Behavior |