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Sponsored by: |
Vanderbilt University |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00178945 |
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.
Condition | Intervention | Phase |
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Refractory Cervicothoracic Myofascial Pain Syndrome (CMPS) Cervical Dystonia |
Drug: Botulinum Toxin Type A |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Botulinum Toxin Type A (Botox) for the Treatment of Pain Associated With Cervical Dystonia and Refractory Cervicothoracic Myofascial Pain Syndrome |
Estimated Enrollment: | 20 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | March 2006 |
Cervical dystonia (CD) is a condition characterized by involuntary movements of the neck. Generally these movements are rotational and are frequently associated with significant pain. Treatment of CD with oral medications is usually unsuccessful and the current treatment of choice for the majority of patients consists of periodic injections of botulinum toxin into the offending muscles. Resistant cases are considered candidates for selective surgical denervation procedures.
Botulinum toxin type A (Botox®) is a FDA approved treatment for CD. Botox® has been safely used to treat CD in our clinic since 1989. In controlled trials, Botox® significantly improved pain in patients with CD.
Cervico-thoracic pain syndromes not associated with dystonia (refractory cervicothoracic myofascial pain syndrome or CMPS) is a chronic regional pain syndrome. It is a common component in acute and chronic pain syndromes, occurring in up to 14% of the U.S. population. This pain is often resistant to treatment and is characterized by a series of tender trigger points. These are often injected with local anesthetics that provide temporary relief of pain in some patients. Recent uncontrolled trials have suggested that Botox® may be helpful in patients with CMPS. Most attempts to use Botox® to treat these Patients have utilized smaller doses of Botox® than those used typically to treat CD. Also, most studies have used Botox® injection into tender trigger points rather than into the belly of the muscle as is commonly done to treat CD.
In this study we will use doses of Botox® that are typically used to treat CD. Injections of Botox® will be guided by EMG to determine areas of involuntarily firing muscle rather than solely into tender trigger points. The results in patients with CMPS will be compared to the pain relief experienced with those with CD. It is hoped that this trial will provide pilot data for planning a larger safety and efficacy trial of Botox® for chronic cervico-thoracic pain not associated with CD.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
Vanderbilt Department of Neurology | |
Nashville, Tennessee, United States, 37212 |
Principal Investigator: | Thomas L Davis, MD | Vanderbilt University Department of Neurology |
Study ID Numbers: | 030797 |
Study First Received: | September 12, 2005 |
Last Updated: | August 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00178945 |
Health Authority: | United States: Institutional Review Board |
Dystonic Disorders Fibromyalgia Myofascial Pain Syndromes Dystonia Central Nervous System Diseases Pain Rheumatic Diseases Dyskinesias Signs and Symptoms |
Torticollis Botulinum Toxins Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Movement Disorders Neurologic Manifestations Botulinum Toxin Type A |
Pathologic Processes Disease Anti-Dyskinesia Agents Therapeutic Uses Syndrome Physiological Effects of Drugs |
Nervous System Diseases Neuromuscular Agents Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions |