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Investigating Botulinum Toxin A to Treat Acute Neck/Upper Shoulder Pain Following a New Spinal Cord Injury.

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ClinicalTrials.gov Identifier: NCT00320281
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : July 29, 2013
Last Update Posted : July 29, 2013
Sponsor:
Collaborators:
The Craig H. Neilsen Foundation
Allergan
Information provided by (Responsible Party):
Cynthia Harrison-Felix, PhD, Craig Hospital

April 28, 2006
May 3, 2006
March 1, 2013
July 29, 2013
July 29, 2013
April 2006
August 2008   (Final data collection date for primary outcome measure)
  • Numerical Rating Scale-NRS [ Time Frame: 6 weeks post-injection ]
    The Numerical Rating Scale (NRS) is a numerical scale from 0-10 used to rate pain. Participants were asked to assess the worst pain experienced in the past 5 days and rate it on a numerical scale from 0-10, with 10 being the "worst possible pain" they have experienced and 0 being "no pain."
  • Brief Pain Inventory-SF [ Time Frame: 2 weeks, 6 weeks, and 6 months post-injection ]
  • Short-Form McGill Pain Questionnaire [ Time Frame: 2 weeks, 6 weeks, and 6 months post-injection ]
  • Visual Analog Scale (pain scale)
  • Brief Pain Inventory-SF
  • Short-Form McGill Pain Questionnaire
Complete list of historical versions of study NCT00320281 on ClinicalTrials.gov Archive Site
  • Modified Leeds Neuropathic Symptoms and Signs Scale [ Time Frame: 2 weeks, 6 weeks, and 6 months post-injection ]
  • Beck Depression Inventory [ Time Frame: 2 weeks and 6 weeks post-injection ]
  • Cervical Range of Motion Measurements [ Time Frame: 2 weeks and 6 weeks post-injection ]
  • Patient Global Outcome Ratings [ Time Frame: 2 weeks, 6 weeks, and 6 months post-injection ]
  • Respiratory Function Measures [ Time Frame: 2 weeks and 6 weeks post-injection ]
  • Rehabilitation Interference Scale (RIS) [ Time Frame: 2 weeks and 6 weeks post-injection ]
  • Medication Quantification Scale-III
  • Modified Leeds Neuropathic Symptoms and Signs Scale
  • Beck Depression Inventory
  • Cervical Range of Motion Measurements
  • Patient Global Outcome Ratings
  • Respiratory Function Measures
  • Rehabilitation Interference Scale (RIS)
Not Provided
Not Provided
 
Investigating Botulinum Toxin A to Treat Acute Neck/Upper Shoulder Pain Following a New Spinal Cord Injury.
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Spinal Cord Injury
  • Pain
  • Drug: botulinum toxin A
    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.
    Other Name: Botox-A
  • Other: placebo
    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.
    Other Name: normal saline dose based on muscles to be injected, multiple injections may occur based on treatment plan. Injection occur at one single clinical visit.
  • Placebo Comparator: placebo
    Normal saline injections were used for placebo injections. Injections were based on treatment plan determined in clinical setting by study PI and physical therapist. 25 cc syringe was used and amount of saline injected was unit based on muscles to be injected according to the treatment plan.
    Intervention: Other: placebo
  • Active Comparator: Botulinum toxin A
    Botulism toxin A dosage was based on plan developed in clinical setting with study PI and physical therapist. Drug was dosed in 25 cc syringe,diluted with normal saline and injections occured based on treatment plan.
    Intervention: Drug: botulinum toxin A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
20
August 2008
August 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
15 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00320281
2691
Yes
Not Provided
Not Provided
Cynthia Harrison-Felix, PhD, Craig Hospital
Craig Hospital
  • The Craig H. Neilsen Foundation
  • Allergan
Principal Investigator: Gary Maerz, MD Craig Hospital
Craig Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP