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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eccentric exercise | Active Comparator | Conservative treatment with eccentric exercise as self-training |
|
| Radiofrequency microtenotomy | Active Comparator | A minimally invasive surgery (Topaz) and eccentric exercise as postoperative treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency microtenotomy | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lena B Boman, PT, MSc | Contact | +46858701637 | lena.boman@capiostgoran.se |
| Name | Affiliation | Role |
|---|---|---|
| Annette Heijne, PT, PhD | Karolinska Institutet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capio Sankt Göran Hospital | Recruiting | Stockholm | Stockholm County | S-112 81 | Sweden |
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019060 | Minimally Invasive Surgical Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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|
|
| Eccentric exercise | Other | 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. |
|
| Arthrocare Topaz MicroDebrider | Device |
|
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |