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

Phase 3

• Conditions: Tennis Elbow
• Interventions: Drug: triamcinolone acetonide (Steroid); Drug: Botox-Tend; Drug: Botox-Epic

• Registration Number: NCT02767635
• Lead Sponsor: National Cheng-Kung University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-01
• Status Verified: 2016-05
• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-09
• Last Update Submitted: 2016-05-09
• Study First Posted: 2016-05-10
• Last Update Posted: 2016-05-10
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Steroid group	triamcinolone acetonide (Steroid)	40mg of triamcinolone acetonide but not Botox injected into lateral epicondyle in Steroid group
Botox-Tend group	Botox-Tend	20 units of Botox injected into tender point of muscles in Botox-Tend group
Botox-Epic group	Botox-Epic	20 units of Botox injection into lateral epicondyle in Botox-Epic group

Primary Outcome Measures

Name	Time	Method
Change of pain assessed on the visual analogue scale	baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks

Secondary Outcome Measures

Name	Time	Method
Change of grip strength by dynamometer	baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Change of self-assessment by Patient-Rated Tennis Elbow Evaluation	baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan