Clinical trial NCT00320281: Investigating Botulinum Toxin A to Treat Acute Neck/Upper Shoulder Pain Following a New Spinal Cord Injury.
Official title: Botulinum Toxin A for the Treatment of Cervical/Shoulder Pain Following Acute Spinal Cord Injury.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Cord Injury
Pain
Keywords: Botox
Lead sponsor: Craig Hospital
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
name: Allergan
First posted: 2006-05-03
Enrollment: 19
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Numerical Rating Scale-NRS
timeFrame: 6 weeks post-injection
Secondary outcomes:
measure: Brief Pain Inventory-Short Form - Interference Score
timeFrame: 6 months post-injection
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
Study officials:
affiliation: Craig Hospital
name: Gary Maerz, MD
role: PRINCIPAL_INVESTIGATOR
References: