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

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00178945
First received: September 12, 2005
Last updated: August 16, 2007
Last verified: August 2007
  Purpose

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
Refractory Cervicothoracic Myofascial Pain Syndrome (CMPS)
Cervical Dystonia
Drug: Botulinum Toxin Type A
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Score on the Pain Subscale of the TWSTRS

Secondary Outcome Measures:
  • Daily pain diary for 14 days post-injection
  • Safety profile at study exit

Estimated Enrollment: 20
Study Start Date: March 2004
Estimated Study Completion Date: March 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178945

Locations
United States, Tennessee
Vanderbilt Department of Neurology
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Thomas L Davis, MD Vanderbilt University Department of Neurology
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00178945     History of Changes
Other Study ID Numbers: 030797
Study First Received: September 12, 2005
Last Updated: August 16, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Fibromyalgia
Myofascial Pain Syndromes
Syndrome
Torticollis
Central Nervous System Diseases
Disease
Dyskinesias
Movement Disorders
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pathologic Processes
Rheumatic Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014