Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Chronic Lateral Epicondylalgia - a Randomized Controlled Trial
| Registry | NCT02304952 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 100 (Estimated) |
| Sponsor | St Goran's Hospital (Other); collaborators: Karolinska Institutet |
| Conditions | Tennis Elbow |
| Interventions | Radiofrequency microtenotomy, Eccentric exercise, Arthrocare Topaz MicroDebrider (Procedure, other, device) |
| Dates | start 2014-09-01, primary completion 2018-09-01 (estimated), completion 2018-09-01 (estimated), first posted 2014-12-02, last updated 2016-07-27 |
| Locations | 1 site in Sweden |
Related Papers Related Patents Related Grants Related Experts
All trials for Tennis Elbow All trials of Radiofrequency microtenotomy All trials of Eccentric exercise
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Eccentric exercise | Active comparator | Other: Eccentric exercise | Conservative treatment with eccentric exercise as self-training |
| Radiofrequency microtenotomy | Active comparator | Procedure: Radiofrequency microtenotomy; Device: Arthrocare Topaz MicroDebrider | A minimally invasive surgery (Topaz) and eccentric exercise as postoperative treatment |
Sex: All, ages: 18 Years to 70 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Capio Sankt Göran Hospital | Stockholm, Stockholm County | Sweden | Recruiting |