Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis

Tennis Elbow Clinical Trial

— DCLE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497913
• Other study ID #: 85-02-53-4207
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2007
• Last updated: April 22, 2008
• Start date: August 2007
• Est. completion date: April 2008

Study information

• Verified date: April 2008
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Tennis Elbow

Intervention

Drug:
• NaCl 0.9%

• Botulinum Toxin A

Locations

Country	Name	City	State
Iran, Islamic Republic of	Imam Khomeini Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score on VAS at maximal grip, at maximal pinch, and during previous month at rest		4 months	No
Secondary	Patients subjective feeling of improvement.		4 months	No
Secondary	Tenderness on lateral epicondyle		4 months	No
Secondary	Pain sensation on resisted wrist extension, and passive wrist flexion		4 months	No
Secondary	Pain-free grip strength, and pinch strength		4 months	No
Secondary	Maximal grip strength, and pinch strength		4 months	No