Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
Several studies have previously examined the use of botulinum toxin serotype A for myofascial pain of the neck and shoulders (cervicobrachial syndrome). These studies have suffered from:
- inclusion of confounding conditions in the proband group, and
- inability to identify predictors of response.
This study attempts to define the characteristics of responders to botulinum serotype A for myofascial pain of the neck and shoulders (cervicobrachial syndrome).
|Cervicobrachial Neuralgia Myofascial Pain Syndromes||Drug: Botulinum toxin serotype A||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Probe Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome|
- Numerical pain rating
- Brief Pain Inventory
- Neck Disability Index
- Cervical range of motion
- Number of trigger points
- Postural exam
- Pain Diary and medications use
- Short Form (SF)-36
|Study Start Date:||June 2003|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
Design: Single-center, double-blind, placebo-controlled, enriched trial.
Subjects will wash-out of their existing pain medications at least 2 weeks prior to baseline visit. At baseline, patients with a Numerical Pain Rating of 4 or greater will be injected with Botulinum Toxin Serotype A. At 14 weeks postinjection, those who at the 6 weeks post-injection visit had at least a 50% decrease in their pain outcome measures will be randomized into one of two treatment groups. Group 1 will receive a second BTX injection while group 2 will receive an injection of saline and both groups will be followed for an additional 6 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241215
|United States, California|
|UCLA Pain Management Center|
|Santa Monica, California, United States, 90404|
|Principal Investigator:||F. Michael Ferrante, MD||University of California, Los Angeles|