Clinical trial NCT00497913: Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tennis Elbow
Keywords: Tennis Elbow
Botulinum Toxin
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-07-09
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score on VAS at maximal grip, at maximal pinch, and during previous month at rest
timeFrame: 4 months
Secondary outcomes:
measure: Patients subjective feeling of improvement.
timeFrame: 4 months
measure: Tenderness on lateral epicondyle
timeFrame: 4 months
measure: Pain sensation on resisted wrist extension, and passive wrist flexion
timeFrame: 4 months
measure: Pain-free grip strength, and pinch strength
timeFrame: 4 months
measure: Maximal grip strength, and pinch strength
timeFrame: 4 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Imam Khomeini Hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: Seyed Mohammad J Mortazavi, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.