Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia

• ClinicalTrials.gov Identifier: NCT00110318
• Recruitment Status: Completed
• First Posted: May 6, 2005
• Last Update Posted: December 11, 2013
• Sponsor: The University of Queensland
• Collaborator: National Health and Medical Research Council, Australia
• Information provided by (Responsible Party): Dr Bill Vicenzino, The University of Queensland

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Tennis Elbow; Musculoskeletal Diseases	Procedure: Manual therapy and therapeutic exercise; Procedure: Corticosteroid injections	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 198 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: A Pragmatic, Randomised Controlled Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia
• Study Start Date: March 2002
• Actual Primary Completion Date: September 2006
• Actual Study Completion Date: September 2006

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. General improvement
2. Assessors assessment of severity
3. Pain free grip strength

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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.

• Responsible Party: Dr Bill Vicenzino, Chair of Sports Physiotherapy, The University of Queensland
• ClinicalTrials.gov Identifier: NCT00110318
• Other Study ID Numbers: H/355/PHYSIO/01/NHMRC; NHMRC#252710
• First Posted: May 6, 2005
• Last Update Posted: December 11, 2013
• Last Verified: December 2013

Keywords provided by Dr Bill Vicenzino, The University of Queensland:

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

Additional relevant MeSH terms:

Musculoskeletal Diseases; Tennis Elbow; Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Arm Injuries; Wounds and Injuries; Tendon Injuries