The Effects of Anodal Transcutaneous Spinal Direct Current Stimulation on Chronic Neuropathic Pain After Spinal Cord Injury: Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neuropathic Pain
- Sponsor
- Seoul National University Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Numeric rating scale (NRS) for neuropathic pain
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the analgesic effect of transcutaneous spinal direct current stimulation (tsDCS) applied on spinal cord in patients with spinal cord injury who have chronic neuropathic pain.
Detailed Description
Twenty patients with spinal cord injury and bilateral neuropathic pain received single sessions of both sham and anodal tsDCS (2 mA) over tenth thoracic vertebra for 20 min (reference electrodes on the head vertex). Treatment order was randomly assigned. A evaluator rated the pain using the visual analogue scale for pain, Patient Global Assessment and Present Pain Intensity.
Investigators
Hyung-ik Shin
Professor
Seoul National University Hospital
Eligibility Criteria
Inclusion Criteria
- •cervical or upper thoracic complete motor spinal cord injury, at least 6 months after SCI, 20\<=age\<90
- •neuropathic pain (LANSS score \>= 12), stable chronic pain for at least the three preceding months but not over 5 years
- •score higher than or equal to 4 cm (0 cm = 'no pain' and 10 cm = 'worst possible pain') on the visual ana- logue scale (VAS) for pain perception at the baseline/start of the treatment
- •refractoriness to drugs for pain relief - such as tricyclic antidepressants, antiepileptic drugs, and/or narcot- ics (pain resistant to at least two of these drugs supplied in ade- quate dosages for 6 months)
- •informed consent
Exclusion Criteria
- •patients with any clinically significant or unstable medical or progressive neurologic disorder
- •contraindication for electrial stimulation such as pacemaker implant
- •Women of childbearing age or pregnancy
- •significant cognitive deficit
- •Syringomyelia
- •neuropsychiatric comorbidity
- •depressive disorder (as indicated by a score of 10 greater on the Beck Depression Inventory)
- •history of substance abuse
- •skin defect under the electrodes
- •progressive neurological disease or other secondary conditions that could impact neuropathic pain
Outcomes
Primary Outcomes
Numeric rating scale (NRS) for neuropathic pain
Time Frame: Baseline NRS (average NRS over the preceding 24h), Change from Baseline NRS at 0, 60 and 120 minutes after the start of the stimulation
On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable
Secondary Outcomes
- Patient Global Assessment (PGA)(Baseline PGA (average PGA over the preceding 24h), Change from Baseline PGA at 0, 60 and 120 minutes after the start of the stimulation)
- Present Pain Intensity (PPI)(Baseline PPI (average PPI over the preceding 24h), Change from Baseline PPI at 0, 60 and 120 minutes after the start of the stimulation)