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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579500
• Other study ID #: PC12MIMV0005
• Secondary ID: 20120007154suyon
• Status: Completed
• Phase: Phase 4
• First received: April 16, 2012
• Last updated: April 23, 2013
• Start date: April 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Catholic University of Korea Saint Paul's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Drug:
• Botulinum toxin type A
Subcutaneous injection of botulinum toxin type A
• normal saline
Subcutaneous injection of normal saline

Locations

Country	Name	City	State
Korea, Republic of	Catholic University Saint Paul's Hospital; National Health Insurance Corporation Ilsan Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Catholic University of Korea Saint Paul's Hospital	Medy-Tox, National Health Insurance Service Ilsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale		4 weeks after intervention	No