Clinical trial NCT00241215: Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
Official title: Probe Study to Evaluate the Efficacy of Botulinum Toxin Serotype A Injections for Cervicobrachial Myofascial Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cervicobrachial Neuralgia
Myofascial Pain Syndromes
Keywords: Botulinum toxin serotype A
Cervicobrachial syndrome
Myofascial pain
Cervicothoracic myofascial pain
Propulsion
Postural abnormality
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2005-10-18
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Numerical pain rating
measure: Brief Pain Inventory
measure: Neck Disability Index
measure: Cervical range of motion
measure: Number of trigger points
measure: Postural exam
Secondary outcomes:
measure: Pain Diary and medications use
measure: Short Form (SF)-36
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: UCLA Pain Management Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: F. Michael Ferrante, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferrante FM, Bearn L, Rothrock R, King L. Evidence against trigger point injection technique for the treatment of cervicothoracic myofascial pain with botulinum toxin type A. Anesthesiology. 2005 Aug;103(2):377-83. doi: 10.1097/00000542-200508000-00021.