Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000774628
Ethics application status
Approved
Date submitted
1/12/2005
Date registered
2/12/2005
Date last updated
4/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot investigation of the efficacy of botulinum toxin Type A injection as an adjunct to the non-surgical treatment of chronic tennis elbow.
Scientific title
A placebo controlled cross-over pilot investigation of the efficacy of Botulinum toxin Type A (Dysportÿ®) as an adjunct to the non-surgical treatment of chronic lateral epicondylitis.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic lateral epicondylitis 930 0
Condition category
Condition code
Musculoskeletal 999 999 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single occasion injection of Botulinum toxin Type A (100U Dysportÿ®, Ipsen Pty Ltd) to extensor carpi radialis brevis (extensor digitorum communis).
Intervention code [1] 783 0
Treatment: Drugs
Comparator / control treatment
A single occasion injection of placebo injection (100U sterile saline) to extensor carpi radialis brevis (extensor digitorum communis).
Control group
Placebo

Outcomes
Primary outcome [1] 1330 0
Mean change in pain free grip strength post-injection compared to average of three baseline measures.
Timepoint [1] 1330 0
At 12 weeks post-injection (Jamar hand held dynomometer)
Secondary outcome [1] 2373 0
Change in maximal wrist isometric (dynamometer) elbow related pain and disability (Disability of Arm, Shoulder and Hand Scale - DASH)
Timepoint [1] 2373 0
At 6, 12,18, 24 weeks compared to average of three baseline measures.
Secondary outcome [2] 2374 0
Change in signal intensity on T1 and T2 weighted MR images.
Timepoint [2] 2374 0
At 12 weeks compared to a baseline MRI.

Eligibility
Key inclusion criteria
Diagnosis of 'tennis elbow' (pain over lateral epicondyle, increased by forceful gripping, resisted wrist extension- Symptoms for >6 months duration, not responded to conservative management (physiotherapy, bracing, splinting, steroid injection)- Males and non pregnant females.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous BTXA injection within 3 months or any history of adverse reaction to BTXA- Disorders producing disturbed neuromuscular transmission (eg: myasthenia gravis)- Concurrent use of aminoglycosides [potential sensitiser to effect of BTXA]- Active Rheumatoid arthritis involving the upper extremity - Previous elbow surgery or nerve entrapment of the affected extremity- Workers Compensation or other compensable patients.

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)
Same volume colourless solution drawn up by admin assistant and provided to blinded physician for injection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number sequence to allocate first four subjects. Thereafter block randomisation to ensure approximately equal in trial numbers at each timepoint.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
12/07/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1096 0
University
Name [1] 1096 0
The University of Western Australia
Country [1] 1096 0
Australia
Funding source category [2] 1097 0
Commercial sector/Industry
Name [2] 1097 0
Ipsen Pty Ltd
Country [2] 1097 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Dr BJ Singer, School of Surgery and Pathology, The University of Western AustraliaMedical Research Foundation Building, Level 2, Rear 50 Murray Street, Perth, WA 6000
Address
School of Surgery, The University of Western Australia. Level 2 Medical Research Foundation Bldg, rear 50 Murray Street, Perth, Western Australia 6000
Country
Australia
Secondary sponsor category [1] 956 0
Individual
Name [1] 956 0
Professor KP Singer
Address [1] 956 0
School of Surgery and Pathology
The University of Western Australia
Country [1] 956 0
Australia
Secondary sponsor category [2] 957 0
Individual
Name [2] 957 0
Dr Peter Silbert
Address [2] 957 0
Department of Neurology
Royal Perth Hospital
Country [2] 957 0
Australia
Secondary sponsor category [3] 958 0
Individual
Name [3] 958 0
Dr John Dunne
Address [3] 958 0
Department of Neurology
Royal Perth Hospital
Country [3] 958 0
Australia
Secondary sponsor category [4] 959 0
Individual
Name [4] 959 0
Dr Swithin Song
Address [4] 959 0
Department of Radiology
Royal Perth Hospital
Country [4] 959 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2399 0
Royal Perth Hospital
Ethics committee address [1] 2399 0
Perth, Western Australia
Ethics committee country [1] 2399 0
Australia
Date submitted for ethics approval [1] 2399 0
Approval date [1] 2399 0
12/07/2004
Ethics approval number [1] 2399 0
EC2004/031

Summary
Brief summary
Lateral epicondylitis is a disabling condition that is associated with pain over the outside of the elbow joint and weakness during gripping activities. It is due to and abnormal repair response to repetitive microtrauma, most commonly involving the attachment of the Extensor Carpi Radialis Brevis (ECRB) tendon to the lateral epicondyle of the elbow.This pilot study is investigating the use of botulinum toxin injection to induce selective weakness of the ECRB muscle in order to provide an environment where normal healing of microscopic tears can take place, resulting in relief of pain and decreased disability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35391 0
Address 35391 0
Country 35391 0
Phone 35391 0
Fax 35391 0
Email 35391 0
Contact person for public queries
Name 9972 0
Dr Barbara Singer
Address 9972 0
School of Surgery and Pathology
The University of Western Australia
Level 2
Medical Research Foundation Building
Rear 50 Murray Street
Perth WA 6000
Country 9972 0
Australia
Phone 9972 0
+61 8 92240229
Fax 9972 0
+61 8 92240204
Email 9972 0
[email protected]
Contact person for scientific queries
Name 900 0
Dr Barbara Singer
Address 900 0
School of Surgery and Pathology
The University of Western Australia
Level 2
Medical Research Foundation Building
Rear 50 Murray Street
Perth WA 6000
Country 900 0
Australia
Phone 900 0
+61 8 92240229
Fax 900 0
+61 8 92240204
Email 900 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.