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

This study has been completed.
Sponsor:
Collaborators:
The Craig H. Neilsen Foundation
Allergan
Information provided by (Responsible Party):
Cynthia Harrison-Felix, PhD, Craig Hospital
ClinicalTrials.gov Identifier:
NCT00320281
First received: April 28, 2006
Last updated: June 22, 2013
Last verified: June 2013
  Purpose

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.

Condition Intervention Phase
Spinal Cord Injury
Pain
Drug: botulinum toxin A
Other: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Botulinum Toxin A for the Treatment of Cervical/Shoulder Pain Following Acute Spinal Cord Injury.

Resource links provided by NLM:


Further study details as provided by Craig Hospital:

Primary Outcome Measures:
  • Numerical Rating Scale-NRS [ Time Frame: 6 weeks post-injection ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Short-Form McGill Pain Questionnaire [ Time Frame: 2 weeks, 6 weeks, and 6 months post-injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modified Leeds Neuropathic Symptoms and Signs Scale [ Time Frame: 2 weeks, 6 weeks, and 6 months post-injection ] [ Designated as safety issue: No ]
  • Beck Depression Inventory [ Time Frame: 2 weeks and 6 weeks post-injection ] [ Designated as safety issue: No ]
  • Cervical Range of Motion Measurements [ Time Frame: 2 weeks and 6 weeks post-injection ] [ Designated as safety issue: No ]
  • Patient Global Outcome Ratings [ Time Frame: 2 weeks, 6 weeks, and 6 months post-injection ] [ Designated as safety issue: No ]
  • Respiratory Function Measures [ Time Frame: 2 weeks and 6 weeks post-injection ] [ Designated as safety issue: No ]
  • Rehabilitation Interference Scale (RIS) [ Time Frame: 2 weeks and 6 weeks post-injection ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: April 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320281

Locations
United States, Colorado
Craig Hospital
Englewood, Colorado, United States, 80113
Sponsors and Collaborators
Craig Hospital
The Craig H. Neilsen Foundation
Allergan
Investigators
Principal Investigator: Gary Maerz, MD Craig Hospital
  More Information

No publications provided

Responsible Party: Cynthia Harrison-Felix, PhD, Department Director, Craig Hospital
ClinicalTrials.gov Identifier: NCT00320281     History of Changes
Other Study ID Numbers: 2691
Study First Received: April 28, 2006
Results First Received: March 1, 2013
Last Updated: June 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Craig Hospital:
Botox

Additional relevant MeSH terms:
Shoulder Pain
Spinal Cord Injuries
Arthralgia
Central Nervous System Diseases
Joint Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pain
Signs and Symptoms
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014