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

May 9, 2016 updated by: Yu-Ching Lin, National Cheng-Kung University Hospital

Comparison Between Steroid and Two Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized Double-blind Active Drug-controlled Pilot Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Tainan, Taiwan, 138
        • Recruiting
        • Department of physical Medicine and Rehabilitation, National Cheng Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Botox-Epic group
20 units of Botox injection into lateral epicondyle in Botox-Epic group
Drug: Botox-Epic
injected 20 units of Botox into lateral epicondyle in Botox-Epic group
Other Names:
  • onabotulinumtoxinA
Experimental: Botox-Tend group
20 units of Botox injected into tender point of muscles in Botox-Tend group
Drug: Botox-Tend
injected 20 units of Botox into tender point of muscles in Botox-Tend group
Other Names:
  • onabotulinumtoxinA
Active Comparator: Steroid group
40mg of triamcinolone acetonide but not Botox injected into lateral epicondyle in Steroid group
Drug: triamcinolone acetonide (Steroid)
injected 40mg of triamcinolone acetonide into lateral epicondyle in Steroid group
Other Names:
  • steroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of pain assessed on the visual analogue scale
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of grip strength by dynamometer
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
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
baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Investigators

  • Principal Investigator: Yu-Ching Lin, MD, MSc, National Cheng-Kung University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 6, 2016

First Submitted That Met QC Criteria

May 9, 2016

First Posted (Estimate)

May 10, 2016

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 9, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-100-108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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