Neuropathic Pain, Spinal Cord Injury
Conditions
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.
Interventions
DRUGBotulinum toxin type A
Subcutaneous injection of botulinum toxin type A
DRUGnormal saline
Subcutaneous injection of normal saline
Sponsors
National Health Insurance Service Ilsan Hospital
Medy-Tox
Catholic University of Korea Saint Paul's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue scale | 4 weeks after intervention |
Countries
South Korea
Outcome results
None listed