Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Lateral Epicondylalgia

Tennis Elbow Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02304952
• Other study ID #: Lateral epicondylalgia
• Status: Recruiting
• Phase: N/A
• First received: November 24, 2014
• Last updated: July 26, 2016
• Start date: September 2014
• Est. completion date: September 2018

Study information

• Verified date: July 2016
• Source: Capio Sankt Görans Hospital
• Contact: Lena B Boman, PT, MSc
• Phone: +46858701637
• Email: lena.boman[@]capiostgoran.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tennis Elbow

Intervention

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:
• 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.

Device:
• Arthrocare Topaz MicroDebrider

Locations

Country	Name	City	State
Sweden	Capio Sankt Göran Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Capio Sankt Görans Hospital	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Function.	Function measured with the DASH (Disability of Arm-Shoulder-Hand) Questionnaire and Jamar dynamometer as static maximum grip strength.	12 month	No
Primary	Pain.	Pain estimated with Visual Analogue Scale (VAS 0-100 mm).	12 month	No
Secondary	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	No