Clinical trial NCT00110318: Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia
Official title: A Pragmatic, Randomised Controlled Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tennis Elbow
Musculoskeletal Diseases
Keywords: Tennis Elbow
Physical Therapy Techniques
Evidence-Based Medicine
Primary Health Care
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2005-05-06
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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.

Primary outcomes:
measure: General improvement
measure: Assessors assessment of severity
measure: Pain free grip strength
Secondary outcomes:
measure: Global perceived effect score
measure: Pain Visual Analogue Scale
measure: Function Visual Analogue Scale
measure: Impact on occupational and recreational activities
measure: Stratford pain free function questionnaire
measure: Patient rated evaluation questionnaire
measure: Pressure pain threshold
measure: Maximum grip strength
measure: Pain visual analogue scale with gripping
measure: Tests of motor control (reaction time, speed, accuracy, coordination)
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Musculoskeletal Pain & Injury Research Unit, Division of Physiotherapy, The University of Queensland
state: Queensland
Study officials:
affiliation: The University of Queensland
name: Dr Bill Vicenzino, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. doi: 10.1302/0301-620X.74B5.1388172.
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. doi: 10.1136/bmj.319.7215.964.