search
Back to results

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

Primary Purpose

Cervicobrachial Neuralgia, Myofascial Pain Syndromes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Botulinum toxin serotype A
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicobrachial Neuralgia focused on measuring Botulinum toxin serotype A, Cervicobrachial syndrome, Myofascial pain, Cervicothoracic myofascial pain, Propulsion, Postural abnormality

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA Pain Management Center

Outcomes

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

Full Information

First Posted
October 17, 2005
Last Updated
June 19, 2016
Sponsor
University of California, Los Angeles
Collaborators
Allergan
search

1. Study Identification

Unique Protocol Identification Number
NCT00241215
Brief Title
Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
Official Title
Probe Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Allergan

4. Oversight

5. Study Description

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: 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicobrachial Neuralgia, Myofascial Pain Syndromes
Keywords
Botulinum toxin serotype A, Cervicobrachial syndrome, Myofascial pain, Cervicothoracic myofascial pain, Propulsion, Postural abnormality

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Botulinum toxin serotype A
Primary Outcome Measure Information:
Title
Numerical pain rating
Title
Brief Pain Inventory
Title
Neck Disability Index
Title
Cervical range of motion
Title
Number of trigger points
Title
Postural exam
Secondary Outcome Measure Information:
Title
Pain Diary and medications use
Title
Short Form (SF)-36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
F. Michael Ferrante, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Pain Management Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16052120
Citation
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. doi: 10.1097/00000542-200508000-00021.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs