Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of Eccentric Training for Patients With Lateral Epicondylalgia

This study has been completed.
Sponsor:
Collaborator:
Rehband Sweden
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00975442
First received: September 10, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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


Condition Intervention
Tennis Elbow
Epicondylitis, Lateral Humeral
Other: Eccentric training
Device: Forearm band

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Eccentric Training for Patients With Lateral Epicondylalgia - a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

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 [ Time Frame: 3 wk and 6 wk follow up ] [ Designated as safety issue: No ]

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 [ Time Frame: 3 wk and 6 wk follow-up ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: February 2005
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eccentric training 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 patients were instructed to use a forearm band during all daily activities.
Other Name: Epi Forsa 4061, Rehband, Sweden
Placebo Comparator: Forearm band Device: Forearm band
All subjects were instructed to use the forearm band during all daily activities.
Other Name: Epi Forsa 4061, Rehband, Sweden

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975442

Locations
Sweden
Karolinska Institutet
Stockholm, Sweden, 17177
Sponsors and Collaborators
Karolinska Institutet
Rehband Sweden
Investigators
Principal Investigator: Johan Söderberg, P.T. Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Huddinge, Sweden
  More Information

No publications provided

Responsible Party: Johan Söderberg P.T., Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Huddinge, Sweden
ClinicalTrials.gov Identifier: NCT00975442     History of Changes
Other Study ID Numbers: 221/00
Study First Received: September 10, 2009
Last Updated: September 10, 2009
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Elbow
Tendinitis
Sports Medicine
Athletic injuries

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

ClinicalTrials.gov processed this record on November 24, 2014