Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia

This study has been completed.
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Dr Bill Vicenzino, The University of Queensland
ClinicalTrials.gov Identifier:
NCT00110318
First received: May 5, 2005
Last updated: December 9, 2013
Last verified: December 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Pragmatic, Randomised Controlled Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia

Resource links provided by NLM:


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
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Dr Bill Vicenzino, Chair of Sports Physiotherapy, The University of Queensland
ClinicalTrials.gov Identifier: NCT00110318     History of Changes
Other Study ID Numbers: H/355/PHYSIO/01/NHMRC, NHMRC#252710
Study First Received: May 5, 2005
Last Updated: December 9, 2013
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

Additional relevant MeSH terms:
Musculoskeletal Diseases
Tennis Elbow
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014