Botulinum Toxin Type A (Botox) for the Treatment of Cervical Dystonia and Upper Thoracic Muscular Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00178945|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : June 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Refractory Cervicothoracic Myofascial Pain Syndrome (CMPS) Cervical Dystonia||Drug: Botulinum Toxin Type A||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|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|
|Study Start Date :||March 2004|
|Estimated Study Completion Date :||March 2006|
U.S. FDA Resources
- Score on the Pain Subscale of the TWSTRS
- Daily pain diary for 14 days post-injection
- Safety profile at study exit
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178945
|United States, Tennessee|
|Vanderbilt Department of Neurology|
|Nashville, Tennessee, United States, 37212|
|Principal Investigator:||Thomas L Davis, MD||Vanderbilt University Department of Neurology|