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

This study has been completed.
Sponsor:
Collaborators:
National Health Insurance Corporation Ilsan Hospital
Medy-Tox
Information provided by (Responsible Party):
Myung Eun, Chung, Catholic University of Korea Saint Paul's Hospital
ClinicalTrials.gov Identifier:
NCT01579500
First received: April 16, 2012
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Spinal Cord Injury
Neuropathic Pain
 Drug: Botulinum toxin type A
Drug: normal saline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Botulinum Toxin A in Post Spinal Cord Injury Neuropathic Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Catholic University of Korea Saint Paul's Hospital:

Primary Outcome Measures:
  • Visual analogue scale [ Time Frame: 4 weeks after intervention ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579500

Locations
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 Corporation Ilsan Hospital
Medy-Tox
  More Information

No publications provided

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, suyon 2011-131
Study First Received: April 16, 2012
Last Updated: April 23, 2013
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board

Additional relevant MeSH terms:
Neuralgia
Spinal Cord Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Spinal Cord Diseases
Central 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 May 23, 2013