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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00975442
Other study ID # 221/00
Secondary ID
Status Completed
Phase N/A
First received September 10, 2009
Last updated September 10, 2009
Start date February 2005
Est. completion date May 2005

Study information

Verified date September 2009
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate eccentric training as an intervention for lateral epicondylalgia (tennis elbow) in a clinical setting.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date May 2005
Est. primary completion date May 2005
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Positive diagnostic criteria according to Haker (1991): A history of pain around the lateral epicondyle for at least one month.

- Pain at palpation of the lateral epicondyle of humerus and positive results in two of the following three pain provocation tests: Middle finger test, resisted extension of the wrist, and Vigorimeter test. Each of these tests is described in detail by Haker (1991)

Exclusion Criteria:

- Subjects with rheumatoid arthritis

- Fibromyalgia

- Previous surgery in the elbow region

- Neck dysfunction suggesting possible cervical rhizopathy

- Entrapment of n.radialis

- Patients with ongoing treatment, or previous treatment less than three months before enrolled to the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Eccentric training
A home training program of eccentric training of the wrist extensors to be carried out daily with 3 sets of 15 repetitions. All subjects were instructed to use the forearm band (Epi Forsa 4061, Rehband, Sweden)
Device:
Forearm band
All subjects were instructed to use the forearm band during all daily activities.
Forearm band
All patients were instructed to use a forearm band during all daily activities.

Locations

Country Name City State
Sweden Karolinska Institutet Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Karolinska Institutet Rehband Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic criteria, whether or not the patient had recovered according to the diagnostic criteria for LE, Haker (1991) at follow up examinations 3 wk and 6 wk follow up No
Secondary Measurements of pain free functional grip strength using the Martin Vigorimeter test, and maximum pain free isometric extensor strength by using Nicholas Myometer 3 wk and 6 wk follow-up No
See also
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