Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis (DCLE)

This study has been completed.

Sponsor:

Information provided by:

Tehran University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT00497913

First received: July 6, 2007

Last updated: April 22, 2008

Last verified: April 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

July 6, 2007

Last Updated Date

April 22, 2008

Start Date ^ICMJE

August 2007

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pain score on VAS at maximal grip, at maximal pinch, and during previous month at rest [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Pain score on VAS at maximal grip, at maximal pinch, at rest on VAS [ Time Frame: 4 months ]
Tenderness on lateral epicondyle [ Time Frame: 4 months ]
Pain sensation on resisted wrist extension, and passive wrist flexion [ Time Frame: 4 months ]
Grip strength, and Pinch strength on beginning of pain sensation [ Time Frame: 4 months ]
Maximal grip strength, and pinch strength [ Time Frame: 4 months ]

Change History

Complete list of historical versions of study NCT00497913 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Patients subjective feeling of improvement. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Tenderness on lateral epicondyle [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Pain sensation on resisted wrist extension, and passive wrist flexion [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Pain-free grip strength, and pinch strength [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Maximal grip strength, and pinch strength [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Patients subjective feeling of improvement. [ Time Frame: 4 months ]

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis

Official Title ^ICMJE

Brief Summary

The purpose of this study is to determine whether a single injection of Dysport with a new protocol at forearm is effective in the management of chronic lateral epicondylitis.

Detailed Description

Some studies valued the effectiveness of botulinum toxin. There is a great amount of controversy on the amount of botulinum toxin injected and the location of the injection. The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo at a new injection site at the forearm in the treatment of chronic tennis elbow unrelieved by corticosteroid injection and physiotherapy. It is a double blind randomized controlled trial.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Tennis Elbow

Intervention ^ICMJE

Drug: NaCl 0.9%
Drug: Botulinum Toxin A
Other Name: Dysport

Study Arm (s)

Active Comparator: A
Intervention: Drug: Botulinum Toxin A
Placebo Comparator: B
Intervention: Drug: NaCl 0.9%

Publications *

Espandar R, Heidari P, Rasouli MR, Saadat S, Farzan M, Rostami M, Yazdanian S, Mortazavi SM. Use of anatomic measurement to guide injection of botulinum toxin for the management of chronic lateral epicondylitis: a randomized controlled trial. CMAJ. 2010 May 18;182(8):768-73. Epub 2010 Apr 26.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

April 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Pain: pain will be assessed as the physician touches lateral epicondyle or passively flexing the patient's wrist and while the patient extends his/her wrist or 3rd finger against resistance. Individuals who fulfill two or more of above will be considered to have lateral epicondylitis.
Symptom duration: should be at least 6 months.
Previous trial of complete course of physiotherapy and corticosteroid injection.

Exclusion Criteria:

Rheumatoid arthritis
Generalized polyarthritis
Local elbow arthritis
Simultaneous medial epicondylalgia
Bilateral lateral epicondylitis
Neurologic deficits (abnormal light touch sensation, deep tendon reflexes abnormality, radicular pain, radial nerve entrapment, signs of nerve root compression, decreased muscle force, multiple sclerosis, seizures)
The use of corticosteroid in last 30 days
Simultaneous use of drugs other than acetaminophen or physical therapy in the course of study
Pregnancy
Breast-feeding
Previous hand surgery
Having a hobby or job that needs finger extension

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT00497913

Other Study ID Numbers ^ICMJE

85-02-53-4207

Has Data Monitoring Committee

Yes

Responsible Party

Study Sponsor ^ICMJE

Tehran University of Medical Sciences

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Seyed Mohammad J Mortazavi, M.D.

Tehran University of Medical Sciences

Information Provided By

Tehran University of Medical Sciences

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top