Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Lateral Epicondylalgia
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|ClinicalTrials.gov Identifier: NCT02304952|
Recruitment Status : Unknown
Verified July 2016 by Capio Sankt Görans Hospital.
Recruitment status was: Recruiting
First Posted : December 2, 2014
Last Update Posted : July 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Tennis Elbow||Procedure: Radiofrequency microtenotomy Other: Eccentric exercise Device: Arthrocare Topaz MicroDebrider||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Chronic Lateral Epicondylalgia - a Randomized Controlled Trial|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
Active Comparator: Eccentric exercise
Conservative treatment with eccentric exercise as self-training
Other: Eccentric exercise
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.
Active Comparator: Radiofrequency microtenotomy
A minimally invasive surgery (Topaz) and eccentric exercise as postoperative treatment
Procedure: Radiofrequency microtenotomy
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.
Other Name: Minimally invasive surgery
Device: Arthrocare Topaz MicroDebrider
- Function. [ Time Frame: 12 month ]Function measured with the DASH (Disability of Arm-Shoulder-Hand) Questionnaire and Jamar dynamometer as static maximum grip strength.
- Pain. [ Time Frame: 12 month ]Pain estimated with Visual Analogue Scale (VAS 0-100 mm).
- Quality of life. [ Time Frame: 12 month ]The Short Form-12 (SF-12) is a questionnaire which measures Quality of Life (QoL), which are both physically and emotionally based.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304952
|Contact: Lena B Boman, PT, MScemail@example.com|
|Capio Sankt Göran Hospital||Recruiting|
|Stockholm, Sweden, S-112 81|
|Contact: Tobias Wirén, MD, Director +46858701161 firstname.lastname@example.org|
|Study Director:||Annette Heijne, PT, PhD||Karolinska Institutet|