Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
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|ClinicalTrials.gov Identifier: NCT00241215|
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : June 21, 2016
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:
- inclusion of confounding conditions in the proband group, and
- 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).
|Condition or disease||Intervention/treatment||Phase|
|Cervicobrachial Neuralgia Myofascial Pain Syndromes||Drug: Botulinum toxin serotype A||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Probe Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome|
|Study Start Date :||June 2003|
|Primary Completion Date :||November 2005|
- Numerical pain rating
- Brief Pain Inventory
- Neck Disability Index
- Cervical range of motion
- Number of trigger points
- Postural exam
- Pain Diary and medications use
- Short Form (SF)-36
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241215
|United States, California|
|UCLA Pain Management Center|
|Santa Monica, California, United States, 90404|
|Principal Investigator:||F. Michael Ferrante, MD||University of California, Los Angeles|