Comparison Between Type A Botulinum Toxin Injection and Corticosteroid Injection in the Treatment of Tennis Elbow

Tennis Elbow Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00395616
• Other study ID #: e120537192
• Status: Recruiting
• Phase: N/A
• First received: November 2, 2006
• Last updated: November 2, 2006
• Start date: November 2006

Study information

• Verified date: November 2006
• Source: E-DA Hospital
• Contact: Yu-Ching Lin, MD
• Phone: 886-7-6150011
• Email: yuchinglin2003[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

Humeral lateral epicondylitis or tennis elbow is a common painful elbow disorder. The cause of tennis elbow is the chronic overload of bone-tendon junction. High prevalence of tennis elbow has a direct impact on the workplace productivity and quality of life. Steroid injection is the very few methods proved to have short-term efficacy in tennis elbow treatment, but it has potential adverse effects like tendon rupture. Temporary paralysis of muscle after botulinum toxin injection may reduce the physical demands and facilitate the normal repair mechanism during recovery. Preliminary studies suggested that botulinum toxin injection is effective in treating tennis elbow. The objective of this study is to compare the effects of botulinum toxin injection with corticosteroid injection in tennis elbow treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Pain at the lateral epicondyle of the elbow

• Tenderness at the lateral epicondyle of the elbow

• Pain on resisted extension of the wrist

Exclusion Criteria:

• Local injection of steroid within 3 months

• Previous elbow trauma or operations

• Pregnancy

• 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

• Tennis Elbow
• Type A Botulinum Toxin

Intervention

Drug:
• Botox (drug)

Locations

Country	Name	City	State
Taiwan	E-Dah Hospital	Kaohsiung,

Sponsors (1)

Lead Sponsor	Collaborator
E-DA Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WHOQOL-BREF
Primary	visual analogue scale for pain
Primary	grip strength