Status:
COMPLETED
Investigating Botulinum Toxin A to Treat Acute Neck/Upper Shoulder Pain Following a New Spinal Cord Injury.
Lead Sponsor:
Craig Hospital
Collaborating Sponsors:
The Craig H. Neilsen Foundation
Allergan
Conditions:
Spinal Cord Injury
Pain
Eligibility:
All Genders
15+ years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- Inpatient at Craig Hospital for initial rehabilitation following a traumatic spinal cord injury.
- Cervical Injury at C4-C8
- ASIA classification score of A,B,or C
- May still be in halo immobilization device and range of motion scores will therefore not be collected
- Report at least a 6/10 on the VAS for pain in the previous 24 hours prior to randomization
- Orthopedically stable
- Approval of attending physician
- Standard of care management with oral analgesic agents has not resulted in pain symptom resolution
- May not be enrolled in other clinical trial
Exclusion
- Pregnant
- Concurrent use of aminoglycoside antibiotics at the time of injection
- Diagnosis of myasthenia gravis or Eaton-Lambert Syndrome
- Known sensitivities to toxins
- Severe bradycardia (HR\<50 bpm) or hypotension (systolic blood pressure of \<80 mmHg)
- Deep vein thrombosis treatment doses of anticoagulants or coumadin
- History of recent dysphagia
- Ventilator dependent
- Unstable cervical fracture or not surgically stabilized
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00320281
Start Date
April 1 2006
End Date
August 1 2008
Last Update
October 14 2020
Active Locations (1)
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1
Craig Hospital
Englewood, Colorado, United States, 80113