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Completed

NCT Number: NCT01579500

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

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Catholic University Saint Paul's Hospital; National Health Insurance Corporation Ilsan Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A

Drug

Subcutaneous injection of botulinum toxin type A

normal saline

Drug

Subcutaneous injection of normal saline

Primary outcomes

  1. Visual analogue scale

    Time frame: 4 weeks after intervention

Sponsors and collaborators

Lead sponsor

Catholic University of Korea Saint Paul's Hospital

Other

Collaborators

  • Medy-Tox
  • National Health Insurance Service Ilsan Hospital

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 18, 2012
Registry last updated
Apr 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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