Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of California, Los Angeles
Collaborator:
Allergan
Treatments:
Botulinum Toxins
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