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Investigating Botulinum Toxin A to Treat Acute Neck/Upper Shoulder Pain Following a New Spinal Cord Injury.
This study has been completed.

First Received on April 28, 2006.   Last Updated on June 27, 2011   History of Changes
Sponsor: Craig Hospital
Collaborators: The Craig H. Neilsen Foundation
Allergan
Information provided by: Craig Hospital
ClinicalTrials.gov Identifier: NCT00320281
  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
Spinal Cord Injury
Pain
 Drug: botulinum toxin A

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:

MedlinePlus related topics: Botox Rehabilitation Spinal Cord Injuries
Drug Information available for: Botulinum toxin A Clostridium botulinum toxin
U.S. FDA Resources

Further study details as provided by Craig Hospital:

Primary Outcome Measures:
  • Visual Analog Scale (pain scale) [ Time Frame: 2 weeks, 6 weeks, and 6 months post injection ] [ Designated as safety issue: No ]
  • 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 ]

Estimated Enrollment: 20
Study Start Date: April 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: botulinum toxin A
    Injection of BTXA into cervical and upper back muscles
  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
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: Gary Maerz, MD, Craig Hospital
ClinicalTrials.gov Identifier: NCT00320281     History of Changes
Other Study ID Numbers: 2691
Study First Received: April 28, 2006
Last Updated: June 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Craig Hospital:
Botox

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

ClinicalTrials.gov processed this record on February 09, 2012



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