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Effects of Eccentric Training for Patients With Lateral Epicondylalgia

Primary Purpose

Tennis Elbow, Epicondylitis, Lateral Humeral

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Eccentric training
Forearm band
Forearm band
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring Elbow, Tendinitis, Sports Medicine, Athletic injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Eccentric training

Forearm band

Arm Description

Outcomes

Primary Outcome Measures

Diagnostic criteria, whether or not the patient had recovered according to the diagnostic criteria for LE, Haker (1991) at follow up examinations

Secondary Outcome Measures

Measurements of pain free functional grip strength using the Martin Vigorimeter test, and maximum pain free isometric extensor strength by using Nicholas Myometer

Full Information

First Posted
September 10, 2009
Last Updated
September 10, 2009
Sponsor
Karolinska Institutet
Collaborators
Rehband Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT00975442
Brief Title
Effects of Eccentric Training for Patients With Lateral Epicondylalgia
Official Title
Effects of Eccentric Training for Patients With Lateral Epicondylalgia - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Karolinska Institutet
Collaborators
Rehband Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow, Epicondylitis, Lateral Humeral
Keywords
Elbow, Tendinitis, Sports Medicine, Athletic injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eccentric training
Arm Type
Experimental
Arm Title
Forearm band
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Eccentric training
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
Forearm band
Other Intervention Name(s)
Epi Forsa 4061, Rehband, Sweden
Intervention Description
All subjects were instructed to use the forearm band during all daily activities.
Intervention Type
Device
Intervention Name(s)
Forearm band
Other Intervention Name(s)
Epi Forsa 4061, Rehband, Sweden
Intervention Description
All patients were instructed to use a forearm band during all daily activities.
Primary Outcome Measure Information:
Title
Diagnostic criteria, whether or not the patient had recovered according to the diagnostic criteria for LE, Haker (1991) at follow up examinations
Time Frame
3 wk and 6 wk follow up
Secondary Outcome Measure Information:
Title
Measurements of pain free functional grip strength using the Martin Vigorimeter test, and maximum pain free isometric extensor strength by using Nicholas Myometer
Time Frame
3 wk and 6 wk follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Söderberg, P.T.
Organizational Affiliation
Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Huddinge, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
17177
Country
Sweden

12. IPD Sharing Statement

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Effects of Eccentric Training for Patients With Lateral Epicondylalgia

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