Treatment of Tennis Elbow With Botulinum Toxin

Epicondylitis, Lateral Humeral Clinical Trial

Official title:

Treatment of Lateral Epicondylitis With Botulinum Toxin: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00119704
• Other study ID #: CRE-2002.354-T
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2005
• Last updated: May 8, 2006
• Start date: September 2002
• Est. completion date: March 2005

Study information

• Verified date: June 2005
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epicondylitis, Lateral Humeral
• Tennis Elbow

Intervention

Drug:
• Botulinum toxin A injection or normal saline

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin, New Territories
Hong Kong	North District Hospital	Sheung Shui, New Territories

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	New World Development Company Limited

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	100 mm visual analog scale (VAS)
Secondary	Grip strength measured with a Jamar Hydraulic Hand Dynamometer with the elbow fully extended and the hand in middle position.