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Neuropathic Pain Study With Botulinum Toxin A in Spinal Cord Injury Patients

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ClinicalTrials.gov Identifier: NCT01579500
Recruitment Status : Completed
First Posted : April 18, 2012
Last Update Posted : April 25, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine whether botulinum toxin A is effective in the treatment of neuropathic pain in spinal cord injury patients.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Neuropathic Pain Drug: Botulinum toxin type A Drug: normal saline Phase 4

Detailed Description:
Neuropathic pain remains a significant cause of life quality deterioration. This study includes spinal cord injury patients with refractory chronic neuropathic pain and investigates whether injection with botulinum toxin A improves pain scores.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Botulinum Toxin A in Post Spinal Cord Injury Neuropathic Pain
Study Start Date : April 2012
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: botulinum toxin A Drug: Botulinum toxin type A
Subcutaneous injection of botulinum toxin type A
Placebo Comparator: normal saline Drug: normal saline
Subcutaneous injection of normal saline

Outcome Measures

Primary Outcome Measures :
  1. Visual analogue scale [ Time Frame: 4 weeks after intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • more than twenty years of age
  • paraplegic or tetraplegic due to cervical and thoracic spinal cord injury
  • more than 12 months since spinal cord injury and ASIA impairment scale unchanged for more than 6 months
  • persistence of neuropathic pain for more than three months or remission and recurrence of neuropathic pain for more than six months
  • a pain score of 40mm or more on the visual analogue scale

Exclusion Criteria:

  • neuropathic pain caused by confounding factors other than spinal cord injury
  • contraindicated for botulinum toxin type A
  • a change in pain medication one month prior to study enrollment
  • a condition involving neuromuscular junction (Ex. Eaton Lambert disease, myasthenia gravis)
  • person who received botulinum toxin type A within three months prior to study enrollment
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579500

Korea, Republic of
Catholic University Saint Paul's Hospital; National Health Insurance Corporation Ilsan Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Catholic University of Korea Saint Paul's Hospital
National Health Insurance Service Ilsan Hospital
More Information

Responsible Party: Myung Eun, Chung, clinical assistant proffessor, Catholic University of Korea Saint Paul's Hospital
ClinicalTrials.gov Identifier: NCT01579500     History of Changes
Other Study ID Numbers: PC12MIMV0005
20120007154 ( Other Identifier: Korea food and drug administration )
suyon 2011-131 ( Other Identifier: National Health Insurance Corporation Ilsan Hospital institutional review board )
First Posted: April 18, 2012    Key Record Dates
Last Update Posted: April 25, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents