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Trial registered on ANZCTR


Registration number
ACTRN12605000574640
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
4/10/2005
Date last updated
2/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia
Scientific title
A randomised control trial of physiotherapy (exercise and manual therapy), corticosteroid injection and a control no-treatment condition in the treatment of lateral epicondylalgia to determine clinical efficacy.
Secondary ID [1] 183 0
National Health and Medical Research Council (NHMRC): NHMRC # 252710
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lateral Epicondylalgia or Tennis Elbow 701 0
Condition category
Condition code
Musculoskeletal 778 778 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 779 779 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single blinded, randomized controlled trial of 198 participants. Three groups: 1) Manual Therapy and therapeutic exercise consisting of eight 30 minute treatment sessions over 6 weeks of Mulligan's mobilisations with movement, taping and customised therapeutic exercise programme. Participants also instructed on a home programme of exercise and self-mobilisation. 2) One Corticosteroid injection. All groups were given written and verbal advice on self-management.
Intervention code [1] 383 0
Treatment: Other
Comparator / control treatment
3) A one session no treatment control group
Control group
Active

Outcomes
Primary outcome [1] 987 0
1) General Improvement
Timepoint [1] 987 0
Measured at baseline, 3,6,12,26 & 52 weeks after enrollment into study.
Primary outcome [2] 988 0
2) Assessors assesssment of severity
Timepoint [2] 988 0
Measured at baseline, 3,6,12,26 & 52 weeks after enrollment into study.
Primary outcome [3] 989 0
3) Pain free grip strength
Timepoint [3] 989 0
Measured at baseline, 3,6,12,26 & 52 weeks after enrollment into study.
Secondary outcome [1] 1864 0
Global perceived effect score
Timepoint [1] 1864 0
Measured at baseline, 3,6,12,26 & 52 weeks after enrollment into study.
Secondary outcome [2] 1865 0
Pain Visual Analogue Scale
Timepoint [2] 1865 0
Measured at baseline, 3,6,12,26 & 52 weeks after enrollment into study.
Secondary outcome [3] 1866 0
Function Visual Analogue Scale
Timepoint [3] 1866 0
Measured at baseline, 3,6,12,26 & 52 weeks after enrollment into study.
Secondary outcome [4] 1867 0
Impact on occupational and recreational activities
Timepoint [4] 1867 0
Measured at baseline, 3,6,12,26 & 52 weeks after enrollment into study.
Secondary outcome [5] 1868 0
Stratford pain free function questionnaire
Timepoint [5] 1868 0
Measured at baseline, 3,6,12,26 & 52 weeks after enrollment into study.
Secondary outcome [6] 1869 0
Patient rated elbow evaluation
Timepoint [6] 1869 0
Measured at baseline, 3,6,12,26 & 52 weeks after enrollment into study.
Secondary outcome [7] 1870 0
Pressure pain threshold
Timepoint [7] 1870 0
Measured at baseline, 3,6,12,26 & 52 weeks after enrollment into study.
Secondary outcome [8] 1871 0
Maximum grip Strength
Timepoint [8] 1871 0
Measured at baseline, 3,6,12,26 & 52 weeks after enrollment into study.
Secondary outcome [9] 1872 0
Pain Visual analogue scale with gripping
Timepoint [9] 1872 0
Measured at baseline, 3,6,12,26 & 52 weeks after enrollment into study.
Secondary outcome [10] 1873 0
Tests of motor control.
Timepoint [10] 1873 0
Measured at baseline, 3,6,12,26 & 52 weeks after enrollment into study.

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
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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)
Concealed allocation by randomisation over the phone from a central trial unit (Queensland Clinical Trial Centre).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation schedule with no restriction.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 857 0
Government body
Name [1] 857 0
NHMRC # 252710
Address [1] 857 0
Country [1] 857 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 726 0
Government body
Name [1] 726 0
NHMRC
Address [1] 726 0
Country [1] 726 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35982 0
Address 35982 0
Country 35982 0
Phone 35982 0
Fax 35982 0
Email 35982 0
Contact person for public queries
Name 9572 0
Ms Leanne Bisset
Address 9572 0
Musculoskeletal Pain And Injury Research Unit
Division of Physiotherapy
School of Health and Rehabilitation Sciences
University of Queensland
St Lucia QLD 4072
Country 9572 0
Australia
Phone 9572 0
+61 7 33654587
Fax 9572 0
Email 9572 0
l.bisset@shrs.uq.edu.au
Contact person for scientific queries
Name 500 0
Dr Bill Vicenzino
Address 500 0
Musculoskeletal Pain And Injury Research Unit
Division of Physiotherapy
School of Health and Rehabilitation Sciences
University of Queensland
St Lucia QLD 4072
Country 500 0
Australia
Phone 500 0
+61 7 33654587
Fax 500 0
Email 500 0
b.vicenzino@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary