Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofa… (NCT00241215) | Clinical Trial Compass
CompletedPhase 4
Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
United States132 participantsStarted 2003-06
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
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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