Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia

Musculoskeletal Diseases Clinical Trial

Official title:

A Pragmatic, Randomised Controlled Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00110318
• Other study ID #: H/355/PHYSIO/01/NHMRC
• Secondary ID: NHMRC#252710
• Status: Completed
• Phase: Phase 3
• First received: May 5, 2005
• Last updated: December 9, 2013
• Start date: March 2002
• Est. completion date: September 2006

Study information

• Verified date: December 2013
• Source: The University of Queensland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Tennis Elbow

Intervention

Procedure:
• Manual therapy and therapeutic exercise

• Corticosteroid injections

Locations

Country	Name	City	State
Australia	Musculoskeletal Pain & Injury Research Unit, Division of Physiotherapy, The University of Queensland	Brisbane	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
The University of Queensland	National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General improvement
Primary	Assessors assessment of severity
Primary	Pain free grip strength
Secondary	Global perceived effect score
Secondary	Pain Visual Analogue Scale
Secondary	Function Visual Analogue Scale
Secondary	Impact on occupational and recreational activities
Secondary	Stratford pain free function questionnaire
Secondary	Patient rated evaluation questionnaire
Secondary	Pressure pain threshold
Secondary	Maximum grip strength
Secondary	Pain visual analogue scale with gripping
Secondary	Tests of motor control (reaction time, speed, accuracy, coordination)