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Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00241215
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : June 21, 2016
Information provided by (Responsible Party):
F. Michael Ferrante, University of California, Los Angeles

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 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).

Condition or disease Intervention/treatment Phase
Cervicobrachial Neuralgia Myofascial Pain Syndromes Drug: Botulinum toxin serotype A Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Probe Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
Study Start Date : June 2003
Actual Primary Completion Date : November 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Numerical pain rating
  2. Brief Pain Inventory
  3. Neck Disability Index
  4. Cervical range of motion
  5. Number of trigger points
  6. Postural exam

Secondary Outcome Measures :
  1. Pain Diary and medications use
  2. Short Form (SF)-36

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female patients aged 18-65 years.
  2. Patients present with bilateral posterior neck/cervical muscle pain for greater than 8 weeks
  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.

Exclusion Criteria:

  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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00241215

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United States, California
UCLA Pain Management Center
Santa Monica, California, United States, 90404
Sponsors and Collaborators
University of California, Los Angeles
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Principal Investigator: F. Michael Ferrante, MD University of California, Los Angeles
Publications of Results:
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Responsible Party: F. Michael Ferrante, Principal Investigator, University of California, Los Angeles Identifier: NCT00241215    
Other Study ID Numbers: UCLA#03-03-061-03A
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Keywords provided by F. Michael Ferrante, University of California, Los Angeles:
Botulinum toxin serotype A
Cervicobrachial syndrome
Myofascial pain
Cervicothoracic myofascial pain
Postural abnormality
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Brachial Plexus Neuritis
Pathologic Processes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Brachial Plexus Neuropathies
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs