Status:
COMPLETED
Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Allergan
Conditions:
Cervicobrachial Neuralgia
Myofascial Pain Syndromes
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00241215
Start Date
June 1 2003
Last Update
June 21 2016
Active Locations (1)
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1
UCLA Pain Management Center
Santa Monica, California, United States, 90404