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

This study is currently Recruiting

June 2005 By University of California, Los Angeles

First Recieved on October 17, 2005

Last Updated on April 18, 2007

Sponsor: University of California, Los Angeles
Collaborators: Allergan
Information provided by: University of California, Los Angeles
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: 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).

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Eligibility

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

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

Investigators

  • Investigator: F. Michael Ferrante, MD - Principal Investigator - University of California, Los Angeles

Locations

  • UCLA Pain Management Center

    Santa Monica, California 90404 United States

Conditions related to this trial:

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