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Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis

NCT ID: NCT00497913

Last Updated: 2008-04-23

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-04-30

Brief Summary

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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

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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.

Conditions

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Tennis Elbow

Keywords

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Tennis Elbow Botulinum Toxin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Botulinum Toxin A

Intervention Type DRUG

B

Group Type PLACEBO_COMPARATOR

NaCl 0.9%

Intervention Type DRUG

Interventions

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NaCl 0.9%

Intervention Type DRUG

Botulinum Toxin A

Intervention Type DRUG

Other Intervention Names

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Dysport

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Seyed Mohammad J Mortazavi, M.D.

Role: STUDY_DIRECTOR

Tehran University of Medical Sciences

Locations

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Imam Khomeini Hospital

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

References

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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. doi: 10.1503/cmaj.090906. Epub 2010 Apr 26.

Reference Type DERIVED
PMID: 20421357 (View on PubMed)

Other Identifiers

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85-02-53-4207

Identifier Type: -

Identifier Source: org_study_id