Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia - Full Text View

Sponsors and Collaborators:	The University of Queensland National Health and Medical Research Council, Australia
Information provided by:	The University of Queensland
ClinicalTrials.gov Identifier:	NCT00110318

Purpose

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).

Condition	Intervention	Phase
Tennis Elbow Musculoskeletal Diseases	Procedure: Manual therapy and therapeutic exercise Procedure: Corticosteroid injections	Phase III

MedlinePlus related topics: Elbow Injuries and Disorders Exercise and Physical Fitness

Drug Information available for: Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Pragmatic, Randomised Controlled Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia

Further study details as provided by The University of Queensland:

Primary Outcome Measures:

General improvement
Assessors assessment of severity
Pain free grip strength

Secondary Outcome Measures:

Global perceived effect score
Pain Visual Analogue Scale
Function Visual Analogue Scale
Impact on occupational and recreational activities
Stratford pain free function questionnaire
Patient rated evaluation questionnaire
Pressure pain threshold
Maximum grip strength
Pain visual analogue scale with gripping
Tests of motor control (reaction time, speed, accuracy, coordination)

Estimated Enrollment:	198
Study Start Date:	March 2002
Estimated Study Completion Date:	June 2005

Detailed Description:

Musculoskeletal conditions account for the third leading cause of health systems expenditure in Australia. Lateral epicondylalgia (tennis elbow) is a painful musculoskeletal condition that is often treated in primary care. Seven out of every 1000 patients seeing their general medical practitioner do so for this condition, though most are not tennis related. On average 10-30% of sufferers take 12 weeks of absenteeism from work and the condition may last 6-48 months.

Two popular treatment options that are commonly prescribed for the management of lateral epicondylalgia are manual therapy/therapeutic exercise and corticosteroid injections. To date there is little evidence that supports manual therapy/therapeutic exercise. This lack of evidence is largely due to the small number of studies of physiotherapy treatments, most of which are of poor quality. The small number of studies of manual therapy contrasts with the larger number of studies of corticosteroid injections, which show that corticosteroid injections are beneficial in the short term (3-6 weeks), but they are associated with significantly greater recurrence rates and offer no advantage in the long term (12 months). The efficacy of a manual therapy and therapeutic exercise programme compared to that of corticosteroid injections is unknown at this stage.

This randomised controlled trial will evaluate the role of manual therapy and therapeutic exercise in the treatment of lateral epicondylalgia. The factors associated with success or failure of these common treatment options for lateral epicondylalgia will also be examined. A tangible outcome of this project will be the development of clinical guidelines for the most effective method of treating lateral epicondylalgia.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110318

Locations

Australia, Queensland
Musculoskeletal Pain & Injury Research Unit, Division of Physiotherapy, The University of Queensland
Brisbane, Queensland, Australia, 4072

Sponsors and Collaborators

The University of Queensland

National Health and Medical Research Council, Australia

Investigators

Principal Investigator:

Dr Bill Vicenzino, PhD

The University of Queensland

More Information

Publications:

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.

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.

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.

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.

Study ID Numbers:	H/355/PHYSIO/01/NHMRC, NHMRC#252710
Study First Received:	May 5, 2005
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00110318
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by The University of Queensland:

Tennis Elbow
Physical Therapy Techniques
Evidence-Based Medicine
Primary Health Care

Study placed in the following topic categories:

Musculoskeletal Diseases
Tennis Elbow
Wounds and Injuries
Disorders of Environmental Origin
Arm Injuries

ClinicalTrials.gov processed this record on January 16, 2009