Botulinum Toxin Type A (Botox) for the Treatment of Cervical Dystonia and Upper Thoracic Muscular Pain

Completed · Phase 1/Phase 2

Conditions studied: Refractory Cervicothoracic Myofascial Pain Syndrome (CMPS), Cervical Dystonia

In brief

The purpose of this study is to investigate the use of injections of Botox (botulinum toxin type A) for the treatment of chronic neck pain. Botox is an approved treatment for patients with cervical dystonia. Cervical dystonia is a chronic condition characterized by involuntary movements of the neck that are often painful. In this study, the response from Botox in patients with neck pain not associated with cervical dystonia will be compared to the pain response in patients with cervical dystonia.

Key facts

Study ID

NCT00178945

Run by

Vanderbilt University

People needed

20

Starts

2004-03-01

Expected to finish

2006-03-01

Last updated by the study team

2016-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Outpatient, male and female subjects, of any race, between 18 years of age and older. Female subjects of childbearing potential must have a negative urine pregnancy test result at the Screening/Baseline Visit. (A female is considered of childbearing potential unless she is postmenopausal or without a uterus and/or both ovaries.)
• Subjects suffering from cervicothoracic muscle pain with or without cervical dystonia. The pain must be of at least 3 months duration and characterized by a numerical pain rating score of at least 5 on the pain subscale of the TWSTR scale.
• Subjects who are able to understand the requirements of the study and sign an Informed Consent Form.

You may not qualify if…

• Female subjects who are pregnant (positive urine pregnancy test) or who have an infant they are breast-feeding or who are of childbearing potential and not practicing a reliable method of birth control (OCP or barrier).
• Subjects who have had standard trigger point injections with local anesthetics in the last 3 months.
• Subjects who have had chiropractic manipulation of the neck or upper thoracic region in the last 3 months or plan on having such manipulations during the study.
• Subjects, who by clinical evaluation and / or MRI study, are considered to have symptomatic cervical and/or thoracic disc pathology as primary etiology of their pain.
• Subjects whose cervical spine ROM is restricted in the setting of arthritic conditions (advanced osteoporosis, degenerative arthritis, ankylosing spondylitis).
• Significant medical or psychiatric comorbid disease, as deemed by the investigators
• Litigation involving the existence or cause for neck pain and/or headache
• Pending disability assessment
• Subjects with a diagnosis of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.
• Subjects currently using aminoglycoside antibiotics or agents that interfere with neuromuscular function.
• Subjects with profound atrophy or excessive weakness of the muscles in the target area(s) of injection.
• Subjects with an infection at the injection site or systemic infection (in this case, postpone study entry until one week following recovery).
• Subjects with an allergy or sensitivity to any component of the test medication.
• Subjects with a history of poor cooperation, non-compliance with medical treatment, or unreliability.
• Subjects currently participating in an investigational drug study or who have participated in an investigational drug study within 30 days of the Baseline Visit.

Where it is running

• Vanderbilt Department of Neurology — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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