Clinical trial NCT00119704: Treatment of Tennis Elbow With Botulinum Toxin
Official title: Treatment of Lateral Epicondylitis With Botulinum Toxin: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epicondylitis, Lateral Humeral
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: New World Development Company Limited
First posted: 2005-07-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Botulinum A toxin is effective in the treatment of tennis elbow (lateral epicondylitis).

Detailed description: Tennis elbow (lateral epicondylitis) is a common cause of chronic elbow pain and wrist extensor dysfunction in adults, affecting 1% to 3% of the general population per year.

There is currently no consensus on its optimal treatment with wide-ranging options available. The best available scientific evidence suggests that only topical non-steroidal anti-inflammatory drugs and possibly, oral non-steroidal anti-inflammatory drugs may be useful for short term pain relief, while corticosteroid injections presented both benefits and harms as a short term measure.

Botulinum toxin has been reported in the treatment of lateral epicondylitis with promising results but these studies lack a control group bringing up the question whether recovery was a result of intervention or the natural history of the disease.

Method:

A twin-center, prospective, randomized, double-blind, placebo-controlled trial in which all patients received either a botulinum injection or a placebo saline injection.

Consecutive patients over 18 years old with tennis elbow referred to the outpatient clinic at the investigators' institution will be screened for this study. Eligible patients will be invited to participate in the study.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and up
* Pain at the lateral side of the elbow
* Pain at the lateral epicondyle during resisted dorsiflexion of the wrist with the elbow in full extension
* Pain for longer than 3 months

Exclusion Criteria:

* Previous operations (including previous steroid injections for the disorder)
* Nerve entrapment
* Pregnancy and while breast-feeding
* Presence of systemic neuromuscular disorders such as myasthenia gravis

Primary outcomes:
measure: 100 mm visual analog scale (VAS)
Secondary outcomes:
measure: Grip strength measured with a Jamar Hydraulic Hand Dynamometer with the elbow fully extended and the hand in middle position.
Other outcomes:
Locations:
city: Shatin, New Territories
country: Hong Kong
facility: Prince of Wales Hospital
city: Sheung Shui, New Territories
country: Hong Kong
facility: North District Hospital
Study officials:
affiliation: Department of Medicine & Therapeutics, Facutly of Medicine, The Chinese University of Hong Kong
name: Andrew CF Hui, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong SM, Hui AC, Tong PY, Poon DW, Yu E, Wong LK. Treatment of lateral epicondylitis with botulinum toxin: a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2005 Dec 6;143(11):793-7. doi: 10.7326/0003-4819-143-11-200512060-00007.