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

Primary Purpose

Spinal Cord Injury, Neuropathic Pain

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Botulinum toxin type A
normal saline
Sponsored by
Catholic University of Korea Saint Paul's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Catholic University Saint Paul's Hospital; National Health Insurance Corporation Ilsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

botulinum toxin A

normal saline

Arm Description

Outcomes

Primary Outcome Measures

Visual analogue scale

Secondary Outcome Measures

Full Information

First Posted
April 16, 2012
Last Updated
April 23, 2013
Sponsor
Catholic University of Korea Saint Paul's Hospital
Collaborators
National Health Insurance Service Ilsan Hospital, Medy-Tox
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1. Study Identification

Unique Protocol Identification Number
NCT01579500
Brief Title
Neuropathic Pain Study With Botulinum Toxin A in Spinal Cord Injury Patients
Official Title
The Effect of Botulinum Toxin A in Post Spinal Cord Injury Neuropathic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of Korea Saint Paul's Hospital
Collaborators
National Health Insurance Service Ilsan Hospital, Medy-Tox

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Neuropathic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
botulinum toxin A
Arm Type
Active Comparator
Arm Title
normal saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Intervention Description
Subcutaneous injection of botulinum toxin type A
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
Subcutaneous injection of normal saline
Primary Outcome Measure Information:
Title
Visual analogue scale
Time Frame
4 weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Catholic University Saint Paul's Hospital; National Health Insurance Corporation Ilsan Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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