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

April 23, 2013 updated by: Myung Eun, Chung, Catholic University of Korea Saint Paul's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Catholic University Saint Paul's Hospital; National Health Insurance Corporation Ilsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual analogue scale
Time Frame: 4 weeks after intervention
4 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of Korea Saint Paul's Hospital

Collaborators

Medy-Tox
National Health Insurance Service Ilsan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

April 16, 2012

First Submitted That Met QC Criteria

April 16, 2012

First Posted (Estimate)

April 18, 2012

Study Record Updates

Last Update Posted (Estimate)

April 25, 2013

Last Update Submitted That Met QC Criteria

April 23, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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