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View Clinical Trial (Medical Research Study)
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Investigating Botulinum Toxin A to Treat Acute Neck/Upper Shoulder Pain Following a New Spinal Cord Injury. - NCT00320281-80113 (Clinical Trial 141332)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy141332.aspx
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| City: |
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Englewood |
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State:
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CO |
| Zip Code: |
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80113 |
| Conditions: |
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Spinal Cord Injury - Pain |
| Purpose: |
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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 BTXA will be associated with a decrease in total
analgesic medication use among SCI patients during acute inpatient rehabilitation.
- BTXA to treat cervical/shoulder pain will increase active participation in the
rehabilitation program for individuals with tetraplegia during inpatient
rehabilitation.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- 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 Criteria:
- 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 |
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| Study is available at: |
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Craig Hospital
Englewood, CO 80113
United States
Primary Contact:
Amy M Dannels-McClure, ND
Email: adannels-mcclure@craighospital.org
Phone: 303-789-8562 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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