Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Lateral Epicondylalgia

Not Applicable

• Conditions: Tennis Elbow
• Interventions: Other: Eccentric exercise; Procedure: Radiofrequency microtenotomy; Device: Arthrocare Topaz MicroDebrider

• Registration Number: NCT02304952
• Lead Sponsor: Capio Sankt Görans Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-11-24
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-02
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-07-27
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eccentric exercise	Eccentric exercise	Conservative treatment with eccentric exercise as self-training
Radiofrequency microtenotomy	Arthrocare Topaz MicroDebrider	A minimally invasive surgery (Topaz) and eccentric exercise as postoperative treatment
Radiofrequency microtenotomy	Radiofrequency microtenotomy	A minimally invasive surgery (Topaz) and eccentric exercise as postoperative treatment

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Capio Sankt Göran Hospital; 🇸🇪 Stockholm, Sweden