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Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia

Primary Purpose

Tennis Elbow, Musculoskeletal Diseases

Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Manual therapy and therapeutic exercise
Corticosteroid injections
Sponsored by
The University of Queensland
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring Tennis Elbow, Physical Therapy Techniques, Evidence-Based Medicine, Primary Health Care

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Outcomes

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)

Full Information

First Posted
May 5, 2005
Last Updated
December 9, 2013
Sponsor
The University of Queensland
Collaborators
National Health and Medical Research Council, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT00110318
Brief Title
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Queensland
Collaborators
National Health and Medical Research Council, Australia

4. Oversight

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow, Musculoskeletal Diseases
Keywords
Tennis Elbow, Physical Therapy Techniques, Evidence-Based Medicine, Primary Health Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
198 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Manual therapy and therapeutic exercise
Intervention Type
Procedure
Intervention Name(s)
Corticosteroid injections
Primary Outcome Measure Information:
Title
General improvement
Title
Assessors assessment of severity
Title
Pain free grip strength
Secondary Outcome Measure Information:
Title
Global perceived effect score
Title
Pain Visual Analogue Scale
Title
Function Visual Analogue Scale
Title
Impact on occupational and recreational activities
Title
Stratford pain free function questionnaire
Title
Patient rated evaluation questionnaire
Title
Pressure pain threshold
Title
Maximum grip strength
Title
Pain visual analogue scale with gripping
Title
Tests of motor control (reaction time, speed, accuracy, coordination)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Bill Vicenzino, PhD
Organizational Affiliation
The University of Queensland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Musculoskeletal Pain & Injury Research Unit, Division of Physiotherapy, The University of Queensland
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4072
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
8703521
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
1388172
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.
Results Reference
background
PubMed Identifier
10514160
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.
Results Reference
background

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Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia

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