Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Lateral Epicondylalgia
Primary Purpose
Tennis Elbow
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Radiofrequency microtenotomy
Eccentric exercise
Arthrocare Topaz MicroDebrider
Sponsored by
About this trial
This is an interventional treatment trial for Tennis Elbow focused on measuring Lateral epicondylalgia, Pain, Function, Physiotherapy, Quality of Life
Eligibility 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
Sites / Locations
- Capio Sankt Göran HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Eccentric exercise
Radiofrequency microtenotomy
Arm Description
Conservative treatment with eccentric exercise as self-training
A minimally invasive surgery (Topaz) and eccentric exercise as postoperative treatment
Outcomes
Primary Outcome Measures
Function.
Function measured with the DASH (Disability of Arm-Shoulder-Hand) Questionnaire and Jamar dynamometer as static maximum grip strength.
Pain.
Pain estimated with Visual Analogue Scale (VAS 0-100 mm).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02304952
First Posted
November 24, 2014
Last Updated
July 26, 2016
Sponsor
Capio Sankt Görans Hospital
Collaborators
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT02304952
Brief Title
Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Lateral Epicondylalgia
Official Title
Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Chronic Lateral Epicondylalgia - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Capio Sankt Görans Hospital
Collaborators
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow
Keywords
Lateral epicondylalgia, Pain, Function, Physiotherapy, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eccentric exercise
Arm Type
Active Comparator
Arm Description
Conservative treatment with eccentric exercise as self-training
Arm Title
Radiofrequency microtenotomy
Arm Type
Active Comparator
Arm Description
A minimally invasive surgery (Topaz) and eccentric exercise as postoperative treatment
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency microtenotomy
Other Intervention Name(s)
Minimally invasive surgery
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Eccentric exercise
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Arthrocare Topaz MicroDebrider
Primary Outcome Measure Information:
Title
Function.
Description
Function measured with the DASH (Disability of Arm-Shoulder-Hand) Questionnaire and Jamar dynamometer as static maximum grip strength.
Time Frame
12 month
Title
Pain.
Description
Pain estimated with Visual Analogue Scale (VAS 0-100 mm).
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Quality of life.
Description
The Short Form-12 (SF-12) is a questionnaire which measures Quality of Life (QoL), which are both physically and emotionally based.
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lena B Boman, PT, MSc
Phone
+46858701637
Email
lena.boman@capiostgoran.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annette Heijne, PT, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Director
Facility Information:
Facility Name
Capio Sankt Göran Hospital
City
Stockholm
ZIP/Postal Code
S-112 81
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Wirén, MD, Director
Phone
+46858701161
Email
tobias.wiren@capiostgoran.se
12. IPD Sharing Statement
Learn more about this trial
Eccentric Exercise or Radiofrequent Microtenotomy as Treatment of Lateral Epicondylalgia
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