NCT00110318

Brief Summary

This randomised controlled trial will evaluate the role of manual therapy and therapeutic exercise and corticosteroid injections in the treatment of lateral epicondylalgia (tennis elbow).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2002

Typical duration for phase_3

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

March 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

4.5 years

First QC Date

May 5, 2005

Last Update Submit

December 9, 2013

Conditions

Tennis ElbowMusculoskeletal Diseases

Keywords

Tennis ElbowPhysical Therapy TechniquesEvidence-Based MedicinePrimary Health Care

Outcome Measures

Primary Outcomes (3)

  • General improvement

  • Assessors assessment of severity

  • Pain free grip strength

Secondary Outcomes (10)

  • Global perceived effect score

  • Pain Visual Analogue Scale

  • Function Visual Analogue Scale

  • Impact on occupational and recreational activities

  • Stratford pain free function questionnaire

  • +5 more secondary outcomes

Interventions

Manual therapy and therapeutic exercisePROCEDURE
Corticosteroid injectionsPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Elbow pain for at least 6 weeks and satisfy the widely accepted diagnostic criteria of lateral epicondylalgia
  • Diagnostic criteria are pain over the lateral humeral epicondyle that is provoked by gripping activities
  • Reduced grip strength and increased sensitivity to manual palpation over the lateral epicondyle
  • Reproduction of pain with stretching of the forearm extensor muscles or with specific resisted static contraction of extensor carpi radialis brevis is also usually present.

You may not qualify if:

  • In the preceding 6 months, had consulted a health care practitioner for neck or arm pain or injury, other than lateral epicondylalgia, which has prevented participation in usual work or recreational activities
  • Had treatment with physiotherapy or corticosteroid injections for lateral epicondylalgia in the preceding 6 months
  • Upper limb fractures
  • Diseases of the bone, muscle and nervous systems that preclude treatment by any of the treatments being evaluated in the project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Musculoskeletal Pain & Injury Research Unit, Division of Physiotherapy, The University of Queensland

Brisbane, Queensland, 4072, Australia

Location

Related Publications (4)

  • Assendelft WJ, Hay EM, Adshead R, Bouter LM. Corticosteroid injections for lateral epicondylitis: a systematic overview. Br J Gen Pract. 1996 Apr;46(405):209-16.

    PMID: 8703521BACKGROUND

  • Mathers C, Penm R. Health systems costs of injury, poisoning and musculskeletal disorders in Australia 1993-94. Australian Institute of Health and Welfare (Health and Welfare Expenditure Series no. 6): Canberra. p 77, 1999.

    BACKGROUND

  • Labelle H, Guibert R, Joncas J, Newman N, Fallaha M, Rivard CH. Lack of scientific evidence for the treatment of lateral epicondylitis of the elbow. An attempted meta-analysis. J Bone Joint Surg Br. 1992 Sep;74(5):646-51. doi: 10.1302/0301-620X.74B5.1388172.

    PMID: 1388172BACKGROUND

  • Hay EM, Paterson SM, Lewis M, Hosie G, Croft P. Pragmatic randomised controlled trial of local corticosteroid injection and naproxen for treatment of lateral epicondylitis of elbow in primary care. BMJ. 1999 Oct 9;319(7215):964-8. doi: 10.1136/bmj.319.7215.964.

    PMID: 10514160BACKGROUND

MeSH Terms

Conditions

Tennis ElbowMusculoskeletal Diseases

Interventions

Musculoskeletal ManipulationsExercise Therapy

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationAftercareContinuity of Patient CarePatient Care

Study Officials

  • Dr Bill Vicenzino, PhD

    The University of Queensland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Sports Physiotherapy

Study Record Dates

First Submitted

May 5, 2005

First Posted

May 6, 2005

Study Start

March 1, 2002

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

AU(1)