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

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
F. Michael Ferrante, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00241215
First received: October 17, 2005
Last updated: June 19, 2016
Last verified: June 2016
  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).


Condition Intervention Phase
Cervicobrachial Neuralgia
Myofascial Pain Syndromes
Drug: Botulinum toxin serotype A
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Probe Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome

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

Enrollment: 132
Study Start Date: June 2003
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
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   (Adult)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

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

Locations
United States, California
UCLA Pain Management Center
Santa Monica, California, United States, 90404
Sponsors and Collaborators
University of California, Los Angeles
Allergan
Investigators
Principal Investigator: F. Michael Ferrante, MD University of California, Los Angeles
  More Information

Publications:
Responsible Party: F. Michael Ferrante, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00241215     History of Changes
Other Study ID Numbers: UCLA#03-03-061-03A 
Study First Received: October 17, 2005
Last Updated: June 19, 2016
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

Additional relevant MeSH terms:
Syndrome
Neuralgia
Myofascial Pain Syndromes
Fibromyalgia
Brachial Plexus Neuritis
Disease
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Brachial Plexus Neuropathies
Neuritis
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 23, 2016