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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tennis Elbow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Botox-Epic group

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

Group Type EXPERIMENTAL

Botox-Epic

Intervention Type DRUG

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

Botox-Tend group

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

Group Type EXPERIMENTAL

Botox-Tend

Intervention Type DRUG

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

Steroid group

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

Group Type ACTIVE_COMPARATOR

triamcinolone acetonide (Steroid)

Intervention Type DRUG

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

Interventions

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Botox-Epic

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

Intervention Type DRUG

Botox-Tend

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

Intervention Type DRUG

triamcinolone acetonide (Steroid)

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

Intervention Type DRUG

Other Intervention Names

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onabotulinumtoxinA onabotulinumtoxinA steroid

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No