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A pilot investigation of the efficacy of botulinum toxin Type A injection as an adjunct to the non-surgical treatment of chronic tennis elbow.

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.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000774628
Enrollment
24
Registered
2005-12-02
Start date
2004-07-12
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

A single occasion injection of Botulinum toxin Type A (100U Dysportÿ®, Ipsen Pty Ltd) to extensor carpi radialis brevis (extensor digitorum communis).

Sponsors

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
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026