Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis
- Registration Number
- NCT00497913
- Lead Sponsor
- Tehran University of Medical Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B NaCl 0.9% - A Botulinum Toxin A -
- Primary Outcome Measures
Name Time Method Pain score on VAS at maximal grip, at maximal pinch, and during previous month at rest 4 months
- Secondary Outcome Measures
Name Time Method Patients subjective feeling of improvement. 4 months Tenderness on lateral epicondyle 4 months Pain sensation on resisted wrist extension, and passive wrist flexion 4 months Pain-free grip strength, and pinch strength 4 months Maximal grip strength, and pinch strength 4 months
Trial Locations
- Locations (1)
Imam Khomeini Hospital
🇮🇷Tehran, Iran, Islamic Republic of