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Treatment of Tennis Elbow With Botulinum Toxin

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00119704
Enrollment
60
Registered
2005-07-14
Start date
2002-09-30
Completion date
2005-03-31
Last updated
2006-05-09

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

Conditions

Epicondylitis, Lateral Humeral

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.

Interventions

DRUGBotulinum toxin A injection or normal saline

Sponsors

New World Development Company Limited
CollaboratorINDUSTRY
Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
100 mm visual analog scale (VAS)

Secondary

MeasureTime frame
Grip strength measured with a Jamar Hydraulic Hand Dynamometer with the elbow fully extended and the hand in middle position.

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026