Clinical Trial: Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Probe Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
Brief Summary:
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).
Detailed Summary:
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.
Sponsor: University of California, Los Angeles
Current Primary Outcome:
- Numerical pain rating
- Brief Pain Inventory
- Neck Disability Index
- Cervical range of motion
- Number of trigger points
- Postural exam
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pain Diary and medications use
- Short Form (SF)-36
Original Secondary Outcome:
- Pain Diary and medications use
- SF-36
Information By: University of California, Los Angeles
Dates:
Date Received: October 17, 2005
Date Started: June 2003
Date Completion:
Last Updated: June 19, 2016
Last Verified: June 2016