ClinicalTrials.gov
ClinicalTrials.gov Menu

Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Lateral Epicondylalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Tennis Elbow Procedure: Radiofrequency microtenotomy Other: Eccentric exercise Device: Arthrocare Topaz MicroDebrider Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Function. [ Time Frame: 12 month ]
    Function measured with the DASH (Disability of Arm-Shoulder-Hand) Questionnaire and Jamar dynamometer as static maximum grip strength.

  2. Pain. [ Time Frame: 12 month ]
    Pain estimated with Visual Analogue Scale (VAS 0-100 mm).


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Lena B Boman, PT, MSc +46858701637 lena.boman@capiostgoran.se

Locations
Sweden
Capio Sankt Göran Hospital Recruiting
Stockholm, Sweden, S-112 81
Contact: Tobias Wirén, MD, Director    +46858701161    tobias.wiren@capiostgoran.se   
Sponsors and Collaborators
Capio Sankt Görans Hospital
Karolinska Institutet
Investigators
Study Director: Annette Heijne, PT, PhD Karolinska Institutet

Responsible Party: Capio Sankt Görans Hospital
ClinicalTrials.gov Identifier: NCT02304952     History of Changes
Other Study ID Numbers: Lateral epicondylalgia
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016

Keywords provided by Capio Sankt Görans Hospital:
Lateral epicondylalgia
Pain
Function
Physiotherapy
Quality of Life

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries