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:

  1. inclusion of confounding conditions in the proband group, and
  2. 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