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

N

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

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)

Trial contacts and locations

1

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Central trial contact

Yu-Ching Lin, MD, MSc

Data sourced from clinicaltrials.gov

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