Investigating Botulinum Toxin A to Treat Acute Neck/Upper Shoulder Pain Following a New Spinal Cord Injury.
Condition: Spinal Cord Injury; Pain
MeSH terms: Shoulder Pain; Spinal Cord Injuries; Wounds and Injuries
Intervention: botulinum toxin A; placebo
Intervention description: Injection of BTXA into cervical and upper back muscles based on treatment plan prescribed for each participant individually based on muscle soreness and tightness. Injections occured on one single clinic visit.Both the saline and BTXA were dosed in 25 cc syringes and looked the same for the physician performing the injections to ensure both participant and study physician remained blinded.; Injection of normal saline into cervical and upper back muscles was also based on treatment plan prescribed for each participant individually based on muscle soreness and tightness. Injections occured on one single clinic visit. Both the saline and BTXA were dosed in 25 cc syringes and looked the same for the physician performing the injections to ensure both participant and study physician remained blinded.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Botox

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