Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
Completed · Phase 4
Conditions studied: Cervicobrachial Neuralgia, Myofascial Pain Syndromes
In brief
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).
Key facts
- Study ID
- NCT00241215
- Run by
- University of California, Los Angeles
- People needed
- 132
- Starts
- 2003-06-01
- Last updated by the study team
- 2016-06-21
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- UCLA Pain Management Center — Santa Monica, California, United States
Full record on ClinicalTrials.gov
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