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Comparison Between Type A Botulinum Toxin Injection and Corticosteroid Injection in the Treatment of Tennis Elbow

Primary Purpose

Type A Botulinum Toxin, Tennis Elbow

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Botox (drug)

About this trial

This is an interventional treatment trial for Type A Botulinum Toxin

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pain at the lateral epicondyle of the elbow
Tenderness at the lateral epicondyle of the elbow
Pain on resisted extension of the wrist

Exclusion Criteria:

Local injection of steroid within 3 months
Previous elbow trauma or operations
Pregnancy
Systemic neuromuscular disorders such as myasthenia gravis

Sites / Locations

E-Dah HospitalRecruiting

Outcomes

Primary Outcome Measures

WHOQOL-BREF

visual analogue scale for pain

grip strength

Secondary Outcome Measures

Full Information

NCT ID

NCT00395616

First Posted

November 2, 2006

Last Updated

November 2, 2006

Sponsor

E-DA Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00395616

Brief Title

Comparison Between Type A Botulinum Toxin Injection and Corticosteroid Injection in the Treatment of Tennis Elbow

Study Type

Interventional

2. Study Status

Record Verification Date

November 2006

Overall Recruitment Status

Unknown status

Study Start Date

November 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

E-DA Hospital

4. Oversight

5. Study Description

Brief Summary

Humeral lateral epicondylitis or tennis elbow is a common painful elbow disorder. The cause of tennis elbow is the chronic overload of bone-tendon junction. High prevalence of tennis elbow has a direct impact on the workplace productivity and quality of life. Steroid injection is the very few methods proved to have short-term efficacy in tennis elbow treatment, but it has potential adverse effects like tendon rupture. Temporary paralysis of muscle after botulinum toxin injection may reduce the physical demands and facilitate the normal repair mechanism during recovery. Preliminary studies suggested that botulinum toxin injection is effective in treating tennis elbow. The objective of this study is to compare the effects of botulinum toxin injection with corticosteroid injection in tennis elbow treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type A Botulinum Toxin, Tennis Elbow

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Botox (drug)

Primary Outcome Measure Information:

Title

WHOQOL-BREF

Title

visual analogue scale for pain

Title

grip strength

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pain at the lateral epicondyle of the elbow Tenderness at the lateral epicondyle of the elbow Pain on resisted extension of the wrist Exclusion Criteria: Local injection of steroid within 3 months Previous elbow trauma or operations Pregnancy Systemic neuromuscular disorders such as myasthenia gravis

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yu-Ching Lin, MD

Phone

886-7-6150011

Ext

2367

yuchinglin2003@yahoo.com.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yu-Ching Lin, MD

Organizational Affiliation

E-Dah Hospital, Kaohsiung, Taiwan

Official's Role

Study Chair

Facility Information:

Facility Name

E-Dah Hospital

City

Kaohsiung,

ZIP/Postal Code

833

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yu-Ching Lin, MD

Phone

886-7-6150011

Ext

2367

yuchinglin2003@yahoo.com.tw

12. IPD Sharing Statement

Learn more about this trial

Comparison Between Type A Botulinum Toxin Injection and Corticosteroid Injection in the Treatment of Tennis Elbow

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