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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.
 
ClinicalTrials.gov Identifier: NCT00241215
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : June 21, 2016
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
F. Michael Ferrante, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE October 17, 2005
First Posted Date  ICMJE October 18, 2005
Last Update Posted Date June 21, 2016
Study Start Date  ICMJE June 2003
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2005)
  • Numerical pain rating
  • Brief Pain Inventory
  • Neck Disability Index
  • Cervical range of motion
  • Number of trigger points
  • Postural exam
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2006)
  • Pain Diary and medications use
  • Short Form (SF)-36
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2005)
  • Pain Diary and medications use
  • SF-36
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
Official Title  ICMJE Probe Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
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).

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Cervicobrachial Neuralgia
  • Myofascial Pain Syndromes
Intervention  ICMJE Drug: Botulinum toxin serotype A
Study Arms  ICMJE Not Provided
Publications * Ferrante FM, Bearn L, Rothrock R, King L. Evidence against trigger point injection technique for the treatment of cervicothoracic myofascial pain with botulinum toxin type A. Anesthesiology. 2005 Aug;103(2):377-83.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2016)
132
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00241215
Other Study ID Numbers  ICMJE UCLA#03-03-061-03A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party F. Michael Ferrante, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Allergan
Investigators  ICMJE
Principal Investigator: F. Michael Ferrante, MD University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP