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

Study Overview
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Brief Summary
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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: inclusion of confounding conditions in the proband group, and 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
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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.

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

Conditions
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Cervicobrachial Neuralgia, Myofascial Pain Syndromes

Intervention / Treatment
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* Drug: Botulinum toxin serotype A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients aged 18-65 years. Patients present with bilateral posterior neck/cervical muscle pain for greater than 8 weeks Patients have numerical pain rating of 4 or greater 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 Subjects willing to discontinue all pain medications except ibuprofen and a non-opioid rescue medication for the duration of the study. 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: Subjects currently taking schedule II narcotics No new non-pain medications or change in non-pain medications within 2 months of screening or throughout the study Pregnant or breastfeeding women Use of investigational drugs within one month of study Involvement in litigation surrounding neck pain Significant medical or psychiatric disease Patients with clinical depression (Beck's Depression score) Alcohol or drug abuse, in the opinion of the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Botulinum toxin serotype A|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical pain rating |  |  | 
| Brief Pain Inventory |  |  | 
| Neck Disability Index |  |  | 
| Cervical range of motion |  |  | 
| Number of trigger points |  |  | 
| Postural exam |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Diary and medications use |  |  | 
| Short Form (SF)-36 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botulinum toxin serotype A, Cervicobrachial syndrome, Myofascial pain, Cervicothoracic myofascial pain, Propulsion, Postural abnormality