Neuropathic Pain, Spinal Cord Injury
Conditions
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.
Interventions
DEVICEtsDCS
Both groups use the same DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany). In the tsDCS group, anode electrode is placed over tenth thoracic vertebra to target spinal cord with 2mA for 20 min, and the cathode (reference) electrode on the head vertex (in the Cz location according to the 10-20 EEG system) In sham tsDCS group, anode electrode is placed over tenth thoracic vertebra to target spinal cord with 2mA for 30s, and the cathode (reference) electrode on the head vertex (in the Cz location according to the 10-20 EEG system). The current was discontinued after 30 s while the power indicator remained on.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
tsDCS
Intervention model description
tsDCS
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. cervical or upper thoracic complete motor spinal cord injury, at least 6 months after SCI, 20\<=age\<90 2. neuropathic pain (LANSS score \>= 12), stable chronic pain for at least the three preceding months but not over 5 years 3. 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 4. 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) 5. informed consent
Exclusion criteria
1. patients with any clinically significant or unstable medical or progressive neurologic disorder 2. contraindication for electrial stimulation such as pacemaker implant 3. Women of childbearing age or pregnancy 4. significant cognitive deficit 5. Syringomyelia 6. neuropsychiatric comorbidity 7. depressive disorder (as indicated by a score of 10 greater on the Beck Depression Inventory) 8. history of substance abuse 9. skin defect under the electrodes 10. progressive neurological disease or other secondary conditions that could impact neuropathic pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric rating scale (NRS) for neuropathic pain | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | One of the most widely used patient reported outcomes (PROs) & PGA reflects the global impact of the disease from the patient's perspective 1. Markedly improved 2. Moderately improved 3. Mildly improved 4. No change 5. Mildly worse 6. Moderately worse 7. Markedly worse |
| 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 | Patient's subjective feeling of the intensity of pain right now 0: No pain 1. Mild 2. Discomforting 3. Distressing 4. Excruciating 5. Horrible |
Countries
South Korea
Outcome results
None listed