Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Fibromyalgia, Neurology, Pain |
| Therapuetic Areas: | Musculoskeletal, Neurology, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | June 2003 |
| Contact: | F. Michael Ferrante, MD |
| Email: | mferrante@mednet.ucla.edu |
| Phone: | 310-319-2241 |
Probe Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
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).
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).
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.
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.
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
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