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Clinical Trials/NCT01579500
NCT01579500
Completed
Phase 4

The Effect of Botulinum Toxin A in Post Spinal Cord Injury Neuropathic Pain

Catholic University of Korea Saint Paul's Hospital1 site in 1 country40 target enrollmentApril 2012

Overview

Phase
Phase 4
Intervention
Botulinum toxin type A
Conditions
Spinal Cord Injury
Sponsor
Catholic University of Korea Saint Paul's Hospital
Enrollment
40
Locations
1
Primary Endpoint
Visual analogue scale
Status
Completed
Last Updated
13 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
April 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Catholic University of Korea Saint Paul's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Myung Eun, Chung

clinical assistant proffessor

Catholic University of Korea Saint Paul's Hospital

Eligibility 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

Arms & Interventions

botulinum toxin A

Intervention: Botulinum toxin type A

normal saline

Intervention: normal saline

Outcomes

Primary Outcomes

Visual analogue scale

Time Frame: 4 weeks after intervention

Study Sites (1)

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