- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00241215
Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
Probe Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
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).
Study Overview
Status
Intervention / Treatment
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 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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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California
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Santa Monica, California, United States, 90404
- UCLA Pain Management Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- Significant medical or psychiatric disease
- Patients with clinical depression (Beck's Depression score)
- Alcohol or drug abuse, in the opinion of the investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Neck Disability Index
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Brief Pain Inventory
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Numerical pain rating
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Cervical range of motion
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Number of trigger points
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Postural exam
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Secondary Outcome Measures
Outcome Measure |
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Pain Diary and medications use
|
Short Form (SF)-36
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: F. Michael Ferrante, MD, University of California, Los Angeles
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Disease
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Brachial Plexus Neuropathies
- Neuritis
- Syndrome
- Neuralgia
- Fibromyalgia
- Myofascial Pain Syndromes
- Brachial Plexus Neuritis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Botulinum Toxins
Other Study ID Numbers
- UCLA#03-03-061-03A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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