Comparison Between Steroid and Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia

Tennis Elbow Clinical Trial

Official title:

Comparison Between Steroid and Two Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized Double-blind Active Drug-controlled Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02767635
• Other study ID #: BR-100-108
• Status: Recruiting
• Phase: Phase 3
• First received: May 6, 2016
• Last updated: May 9, 2016
• Start date: January 2012
• Est. completion date: December 2016

Study information

• Verified date: May 2016
• Source: National Cheng-Kung University Hospital
• Contact: Yu-Ching Lin, MD, MSc
• Phone: 886-6-2353535
• Email: richelin[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to compare two different injection sites of low dose botulinum toxin type A with steroid in treating lateral epicondylalgia.

Description:

Lateral epicondylalgia or tennis elbow is a common painful elbow disorder with a prevalence of 1% to 3% in the general population and has a higher rate up to 14.5% in strenuous jobs. Botulinum toxin type A injection was an emerging option in treating lateral epicondylalgia. In this study, the patients were randomly assigned into three groups:

1. Botox-Epic group received 20 units of Botox injection into lateral epicondyle;

2. Botox-Tend group had 20 units of Botox injected into tender point of muscles;

3. Steroid group had 40mg of triamcinolone injected into lateral epicondyle.

The aim of this randomized controlled study was to compare the effects of injection with corticosteroid and botulinum toxin type A via two different sites in patients with lateral epicondylalgia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• spontaneous local pain over lateral epicondyle of the affected elbow for more than six months and failure to respond to previous physical therapy or oral medications,

• local tenderness around the lateral epicondyle, and

• pain elicited or aggravated by resisted contraction of the wrist or middle finger extensors.

Exclusion Criteria:

• local steroid injection within the past six months,

• coexisting elbow arthritis or arthralgia,

• previous trauma or surgery history over the lateral epicondyle,

• pregnancy or lactation, and

• other systemic, neuromuscular or bleeding disorders that are contraindicated to Botox injection.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tennis Elbow

Intervention

Drug:
• Botox-Epic
injected 20 units of Botox into lateral epicondyle in Botox-Epic group
• Botox-Tend
injected 20 units of Botox into tender point of muscles in Botox-Tend group
• triamcinolone acetonide (Steroid)
injected 40mg of triamcinolone acetonide into lateral epicondyle in Steroid group

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of pain assessed on the visual analogue scale		baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks	No
Secondary	Change of grip strength by dynamometer		baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks	No
Secondary	Change of self-assessment by Patient-Rated Tennis Elbow Evaluation		baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks	No