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Sponsors and Collaborators: |
Craig Hospital The Craig H. Neilsen Foundation Allergan |
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Information provided by: | Craig Hospital |
ClinicalTrials.gov Identifier: | NCT00320281 |
As clinicians, it is often a struggle to find effective pain control for a certain subgroup of patients with tetraplegia. These patients often have severe upper back, neck, and shoulder pain, limiting rehabilitation productivity and potential, and always limiting quality of life.
This pain appears to be primarily musculoskeletal. Muscles in the upper back and neck become shortened, rock hard, and extremely tender with even the slightest touch or stretch. Refractory to multiple classes of medications, modalities, and other treatments, patients truly suffer-not only from pain, but from fatigue, sedation, expense, and loss of useful rehabilitation time due to attempted remedies. Unfortunately, this subgroup of patients is not small and the problem is significant, as anyone who specializes in the treatment of spinal cord injury patients will recognize.
In search for another form of treatment, botulinum toxin A (BTXA) may be promising for pain control in that group of patients with tetraplegia whose pain has proven to be refractory to treatment. It did not take long searching the literature to find compelling evidence that BTXA may have another mechanism of action for direct pain control, apart from its well known mechanism for spasticity control. Clinically, it is increasingly being recommended and used for this purpose. In fact, one of the specific indications now recognized by most for BTXA treatment is for myogenic pain due to short, tight, strained muscles-just as we see with our population. Yet, it's application has not been studied in people with tetraplegia. Thus, the genesis of the project and the hope to help our patients evolved.
Study hypotheses:
Condition | Intervention |
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Spinal Cord Injury Pain |
Drug: botulinum toxin A |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Botulinum Toxin A for the Treatment of Cervical/Shoulder Pain Following Acute Spinal Cord Injury. |
Estimated Enrollment: | 20 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amy M Dannels-McClure, ND | 303-789-8562 | adannels-mcclure@craighospital.org |
United States, Colorado | |
Craig Hospital | Recruiting |
Englewood, Colorado, United States, 80113 |
Principal Investigator: | Gary Maerz, MD | Craig Hospital |
Responsible Party: | Craig Hospital ( Gary Maerz, MD ) |
Study ID Numbers: | 2691 |
Study First Received: | April 28, 2006 |
Last Updated: | June 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00320281 History of Changes |
Health Authority: | United States: Institutional Review Board |
Botox |
Spinal Cord Diseases Shoulder Pain Joint Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Pain |
Trauma, Nervous System Spinal Cord Injuries Signs and Symptoms Botulinum Toxins Musculoskeletal Diseases Botulinum Toxin Type A Arthralgia |
Spinal Cord Diseases Anti-Dyskinesia Agents Shoulder Pain Joint Diseases Nervous System Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Pain |
Trauma, Nervous System Pharmacologic Actions Spinal Cord Injuries Signs and Symptoms Botulinum Toxins Musculoskeletal Diseases Therapeutic Uses Central Nervous System Agents Arthralgia |