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

National Cheng-Kung University Hospital90 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Tennis Elbow

Interventions

Botox-EpicDRUG

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

Botox-TendDRUG

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

triamcinolone acetonide (Steroid)DRUG

injected 40mg of triamcinolone acetonide into lateral epicondyle in Steroid group

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital

Tainan, Taiwan, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Change of pain assessed on the visual analogue scale

Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks

Secondary Outcomes

Change of grip strength by dynamometer

Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks

Change of self-assessment by Patient-Rated Tennis Elbow Evaluation

Time frame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks

Central Contacts

Yu-Ching Lin, MD, MSc

CONTACT

886-6-2353535 richelin@mail.ncku.edu.tw

Data from ClinicalTrials.gov

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