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

Myofascial Pain Syndromes Clinical Trial

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

Status Completed

Clinical Trial 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).

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

• Cervicobrachial Neuralgia
• Fibromyalgia
• Myofascial Pain Syndromes
• Syndrome

• NCT number: NCT00241215
• Study type: Interventional
• Source: University of California, Los Angeles
• Status: Completed
• Phase: Phase 4
• Start date: June 2003