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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Spinal Cord Injury Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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botulinum toxin A

Group Type ACTIVE_COMPARATOR

Botulinum toxin type A

Intervention Type DRUG

Subcutaneous injection of botulinum toxin type A

normal saline

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

Subcutaneous injection of normal saline

Interventions

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Botulinum toxin type A

Subcutaneous injection of botulinum toxin type A

Intervention Type DRUG

normal saline

Subcutaneous injection of normal saline

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No