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NCT00320281 · ClinicalTrials.gov registry record · Phase 4
Investigating Botulinum Toxin A to Treat Acute Neck/Upper Shoulder Pain Following a New Spinal Cord Injury.
A Phase 4 study of Pain and Spinal Cord Injury, sponsored by Craig Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT00320281 is a Phase 4 study of Pain and Spinal Cord Injury that has completed, run by Craig Hospital. The registered enrollment target is 19 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00320281, a Phase 4 study of Pain and Spinal Cord Injury, has completed, sponsored by Craig Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
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: * In addition to traditional treatments used for pain control, injection of BTXA into cervical and upper back muscles will effectively reduce cervical/shoulder pain severity reported by individuals with cervical spinal cord injuries, regardless of the etiology of pain. * Pain reduction secondary to the use of BTX
Conditions Studied
Interventions
- OTHER placebo
- DRUG botulinum toxin A
Study Locations (1)
Colorado
- Craig Hospital - Englewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2006-04 |
| Est. Completion | 2008-08 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00320281
The ClinicalTrials.gov registry entry for NCT00320281 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (94% lower). The listed sponsor is Craig Hospital, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00320281 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT00320281 about?
NCT00320281 is a clinical study titled "Investigating Botulinum Toxin A to Treat Acute Neck/Upper Shoulder Pain Following a New Spinal Cord Injury.". 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 ...
What is the current status of trial NCT00320281?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 19 participants. The study started on 2006-04. Estimated completion is 2008-08.
What conditions does trial NCT00320281 study?
This clinical trial studies the following conditions: Pain, Spinal Cord Injury.
What interventions are being tested in trial NCT00320281?
The interventions under investigation include: placebo (OTHER), botulinum toxin A (DRUG).
Who is sponsoring clinical trial NCT00320281?
This trial is sponsored by Craig Hospital, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00320281 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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