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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00110318




Registration number
NCT00110318
Ethics application status
Date submitted
5/05/2005
Date registered
6/05/2005
Date last updated
11/12/2013

Titles & IDs
Public title
Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia
Scientific title
A Pragmatic, Randomised Controlled Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia
Secondary ID [1] 0 0
NHMRC#252710
Secondary ID [2] 0 0
H/355/PHYSIO/01/NHMRC
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tennis Elbow 0 0
Musculoskeletal Diseases 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
General improvement
Timepoint [1] 0 0
Primary outcome [2] 0 0
Assessors assessment of severity
Timepoint [2] 0 0
Primary outcome [3] 0 0
Pain free grip strength
Timepoint [3] 0 0
Secondary outcome [1] 0 0
Global perceived effect score
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Pain Visual Analogue Scale
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Function Visual Analogue Scale
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Impact on occupational and recreational activities
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Stratford pain free function questionnaire
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Patient rated evaluation questionnaire
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Pressure pain threshold
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Maximum grip strength
Timepoint [8] 0 0
Secondary outcome [9] 0 0
Pain visual analogue scale with gripping
Timepoint [9] 0 0
Secondary outcome [10] 0 0
Tests of motor control (reaction time, speed, accuracy, coordination)
Timepoint [10] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Musculoskeletal Pain & Injury Research Unit, Division of Physiotherapy, The University of Queensland - Brisbane
Recruitment postcode(s) [1] 0 0
4072 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT00110318
Trial related presentations / 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. doi: 10.1302/0301-620X.74B5.1388172.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Dr Bill Vicenzino, PhD
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00110318