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

Phase 4

Completed

• Conditions: Cervicobrachial Neuralgia; Myofascial Pain Syndromes

• Registration Number: NCT00241215
• Lead Sponsor: University of California, Los Angeles

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 Timeline

• Study Start: 2003-06
• Study First Submitted: 2005-10-17
• Study First Submitted QC: 2005-10-17
• Study First Posted: 2005-10-18
• Primary Completion: 2005-11
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-19
• Last Update Posted: 2016-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UCLA Pain Management Center; 🇺🇸 Santa Monica, California, United States