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

National Cheng-Kung University

Status and phase: Unknown; Phase 3

Conditions: Tennis Elbow

Treatments: Drug: Botox-Tend; Drug: triamcinolone acetonide (Steroid); Drug: Botox-Epic

Study type: Interventional

Funder types: Other

Identifiers

NCT02767635

BR-100-108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Botox-Epic group

Experimental group

Description:

20 units of Botox injection into lateral epicondyle in Botox-Epic group

Treatment:

Drug: Botox-Epic

Botox-Tend group

Experimental group

Description:

20 units of Botox injected into tender point of muscles in Botox-Tend group

Treatment:

Drug: Botox-Tend

Steroid group

Active Comparator group

Description:

40mg of triamcinolone acetonide but not Botox injected into lateral epicondyle in Steroid group

Treatment:

Drug: triamcinolone acetonide (Steroid)