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

Catholic University of Korea Saint Paul's Hospital

Status and phase

Completed

Phase 4

Conditions

Neuropathic Pain

Spinal Cord Injury

Treatments

Drug: normal saline

Drug: Botulinum toxin type A

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01579500

PC12MIMV0005

suyon 2011-131 (Other Identifier)

20120007154 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

20+ years old

Volunteers

No 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