NCT00975442

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
Last Updated

September 11, 2009

Status Verified

September 1, 2009

Enrollment Period

3 months

First QC Date

September 10, 2009

Last Update Submit

September 10, 2009

Conditions

Keywords

ElbowTendinitisSports MedicineAthletic injuries

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (2)

Eccentric training

EXPERIMENTAL
Other: Eccentric trainingDevice: Forearm band

Forearm band

PLACEBO COMPARATOR
Device: Forearm band

Interventions

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)

Eccentric training

All subjects were instructed to use the forearm band during all daily activities.

Also known as: Epi Forsa 4061, Rehband, Sweden
Forearm band

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 17177, Sweden

Location

MeSH Terms

Conditions

Tennis ElbowTendinopathyAthletic Injuries

Condition Hierarchy (Ancestors)

Elbow TendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Study Officials

  • Johan Söderberg, P.T.

    Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Huddinge, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2009

First Posted

September 11, 2009

Study Start

February 1, 2005

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

September 11, 2009

Record last verified: 2009-09

Locations