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

Phase 4

Completed

• Conditions: Spinal Cord Injury; Neuropathic Pain
• Interventions: Drug: normal saline; Drug: Botulinum toxin type A

• Registration Number: NCT01579500
• Lead Sponsor: Catholic University of Korea Saint Paul's Hospital

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-16
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-18
• Status Verified: 2013-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-23
• Last Update Posted: 2013-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline	normal saline	-
botulinum toxin A	Botulinum toxin type A	-

Primary Outcome Measures

Name	Time	Method
Visual analogue scale	4 weeks after intervention

Trial Locations

Locations (1)

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