Cervicobrachial Neuralgia, Myofascial Pain Syndromes
Conditions
Keywords
Botulinum toxin serotype A, Cervicobrachial syndrome, Myofascial pain, Cervicothoracic myofascial pain, Propulsion, Postural abnormality
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.
Interventions
DRUGBotulinum toxin serotype A
Sponsors
Allergan
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postural exam | — |
| Cervical range of motion | — |
| Number of trigger points | — |
| Numerical pain rating | — |
| Brief Pain Inventory | — |
| Neck Disability Index | — |
Secondary
| Measure | Time frame |
|---|---|
| Short Form (SF)-36 | — |
| Pain Diary and medications use | — |
Countries
United States
Outcome results
None listed