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Probe Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
This study is currently Recruiting
June 2005 By University of California, Los Angeles
First Recieved on October 17, 2005
Last Updated on April 18, 2007
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
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).
||Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
|Drug:Botulinum toxin serotype A|
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
1. Male or female patients aged 18-65 years.
2. Patients present with bilateral posterior neck/cervical muscle pain for greater than
3. Patients have numerical pain rating of 4 or greater
4. 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
5. Subjects willing to discontinue all pain medications except ibuprofen and a
non-opioid rescue medication for the duration of the study.
6. 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.
1. Subjects currently taking schedule II narcotics
2. No new non-pain medications or change in non-pain medications within 2 months of
screening or throughout the study
3. Pregnant or breastfeeding women
4. Use of investigational drugs within one month of study
5. Involvement in litigation surrounding neck pain
6. Significant medical or psychiatric disease
7. Patients with clinical depression (Beck?s Depression score)
8. Alcohol or drug abuse, in the opinion of the investigator
- Investigator: F. Michael Ferrante, MD - Principal Investigator - University of California, Los Angeles