Pain Clinical Trial
Official title:
Botulinum Toxin A for the Treatment of Cervical/Shoulder Pain Following Acute 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 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.
n/a
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