Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome

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.

Inclusion criteria

• Male or female patients aged 18-65 years.
• Patients present with bilateral posterior neck/cervical muscle pain for greater than 8 weeks
• Patients have numerical pain rating of 4 or greater
• Patients willing to adhere to a physical therapy program of 2-3 visits for myofascial release and also home stretching exercises for the length of the study
• Subjects willing to discontinue all pain medications except ibuprofen and a non-opioid rescue medication for the duration of the study.
• Women of child-bearing potential must be using a reliable means of contraception and have a negative urine pregnancy test prior to injection of BOTOX.

Exclusion criteria

• Subjects currently taking schedule II narcotics
• No new non-pain medications or change in non-pain medications within 2 months of screening or throughout the study
• Pregnant or breastfeeding women
• Use of investigational drugs within one month of study
• Involvement in litigation surrounding neck pain
• Significant medical or psychiatric disease
• Patients with clinical depression (Beck's Depression score)
• Alcohol or drug abuse, in the opinion of the investigator