Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Lateral Epicondylalgia

Study Overview
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Brief Summary
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The aim is to study the effects related to function and pain during eccentric exercise and surgery with radiofrequency microtenotomy as post-surgical rehabilitation, compared with only eccentric exercise, in patients with lateral epicondylalgia unilaterally.

Detailed Description
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Of those affected by lateral epicondylalgia will 90% be free of symptoms within 8 months to 2 years with conservative treatment. In this study surgical radiofrequency microtenotomy and eccentric exercise for chronic (more than two year) lateral epicondylalgia that is unilaterally will be used as treatment. Patients is randomized to a group with eccentric exercise or a group with surgical radiofrequency microtenotomy and postoperatively eccentric exercise. Home based eccentric exercise program is instructed by a physical therapist and is performed for three months. Women start with 0.5 kg and men 1.0 kg weight, they perform 3 sets with 5 reps once a day and register pain and exercise in a diary. Function, pain and quality of life will be followed and are carried out after 6 weeks and after 3, 6 and 12 months. The surgery and eccentric exercise is instructed and followed at the investigators clinic.

Official Title
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Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Chronic Lateral Epicondylalgia - a Randomized Controlled Trial

Conditions
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Tennis Elbow

Intervention / Treatment
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* Procedure: Radiofrequency microtenotomy
* Other: Eccentric exercise
* Device: Arthrocare Topaz MicroDebrider


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over the age of 18 and under the age of 70 year lateral epicondylalgia at least two year tried conservative treatment Exclusion Criteria: complicated systemic diseases (such as diabetes) understand spoken and or/written instructions in Swedish

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Eccentric exercise<br>Conservative treatment with eccentric exercise as self-training | Other: Eccentric exercise<br>* Eccentric exercise for 3 months. The exercise will be performed once a day with 3 set and 5 reps, women start with 0.5 and men 1.0 kilo with a 10 % increase every week.<br>|
| Active Comparator: Radiofrequency microtenotomy<br>A minimally invasive surgery (Topaz) and eccentric exercise as postoperative treatment | Procedure: Radiofrequency microtenotomy<br>* For the minimally invasive surgery will Arthrocare Topaz MicroDebrider device be used. A small incision will be made and the tip of the device is placed on surface of the tendon to structure and activated for 0.5 second, at 5 mm distance intervals on the tendon creating a grid-like pattern.<br>* Other names: Minimally invasive surgery;Device: Arthrocare Topaz MicroDebrider<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function. | Function measured with the DASH (Disability of Arm-Shoulder-Hand) Questionnaire and Jamar dynamometer as static maximum grip strength. | 12 month | 
| Pain. | Pain estimated with Visual Analogue Scale (VAS 0-100 mm). | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life. | The Short Form-12 (SF-12) is a questionnaire which measures Quality of Life (QoL), which are both physically and emotionally based. | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lateral epicondylalgia, Pain, Function, Physiotherapy, Quality of Life