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NCT Number: NCT00110318

Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Brisbane, Queensland, 4072, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual therapy and therapeutic exercise

Procedure

Corticosteroid injections

Procedure

Primary outcomes

  1. General improvement

  2. Assessors assessment of severity

  3. Pain free grip strength

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

The University of Queensland

Other

Collaborators

  • National Health and Medical Research Council, Australia

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
May 6, 2005
Registry last updated
Dec 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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