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

This study is currently recruiting participants.

Verified by University of California, Los Angeles, June 2005

First Received: October 17, 2005 Last Updated: April 18, 2007 History of Changes

Sponsors and Collaborators:	University of California, Los Angeles Allergan
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00241215

Purpose

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	Intervention	Phase
Cervicobrachial Neuralgia Myofascial Pain Syndromes	Drug: Botulinum toxin serotype A	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Probe Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

Numerical pain rating
Brief Pain Inventory
Neck Disability Index
Cervical range of motion
Number of trigger points
Postural exam

Secondary Outcome Measures:

Pain Diary and medications use
Short Form (SF)-36

Estimated Enrollment:	150
Study Start Date:	June 2003

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241215

Contacts

Contact: F. Michael Ferrante, MD

310-319-2241

mferrante@mednet.ucla.edu

Locations

United States, California
UCLA Pain Management Center	Recruiting
Santa Monica, California, United States, 90404
Contact: F. Michael Ferrante, MD 310-319-2241 mferrante@mednet.ucla.edu
Principal Investigator: F. Michael Ferrante, MD

Sponsors and Collaborators

University of California, Los Angeles

Allergan

Investigators

Principal Investigator:

F. Michael Ferrante, MD

University of California, Los Angeles

More Information

No publications provided

Study ID Numbers:	UCLA#03-03-061-03A
Study First Received:	October 17, 2005
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00241215 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:

Botulinum toxin serotype A
Cervicobrachial syndrome
Myofascial pain

Cervicothoracic myofascial pain
Propulsion
Postural abnormality

Study placed in the following topic categories:

Neuralgia
Fibromyalgia
Myofascial Pain Syndromes
Pain
Rheumatic Diseases
Neuritis
Brachial Plexus Neuritis
Signs and Symptoms

Botulinum Toxins
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Peripheral Nervous System Diseases
Neurologic Manifestations
Congenital Abnormalities

Additional relevant MeSH terms:

Disease
Neuralgia
Anti-Dyskinesia Agents
Myofascial Pain Syndromes
Fibromyalgia
Brachial Plexus Neuropathies
Nervous System Diseases
Pain
Rheumatic Diseases
Pharmacologic Actions
Neuritis
Brachial Plexus Neuritis

Signs and Symptoms
Botulinum Toxins
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Therapeutic Uses
Syndrome
Peripheral Nervous System Diseases
Neurologic Manifestations
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009