Treatment of Post-Stroke Central Pain
Efficacy and Safety of Short-Term Spinal Cord Stimulation Combined With Pharmacotherapy for Central Post-Stroke Pain: A Single-Center, Randomized, Controlled Trial
Nanchong Central Hospital
80 participants
Jan 1, 2024
INTERVENTIONAL
Conditions
Summary
To evaluate the short-term analgesic efficacy of stSCS combined with pharmacotherapy compared with pharmacotherapy alone in patients with CPSP, measured by Numerical Rating Scale (NRS) score immediately after treatment.
Eligibility
Inclusion Criteria9
- Diagnosis of central post-stroke pain (CPSP) according to the International Association for the Study of Pain (IASP) criteria
- Clear history of stroke confirmed by cranial CT or MRI
- Pain occurring after stroke and distributed in body parts corresponding to central nervous system injury
- Pain with neuropathic characteristics (e.g., burning sensation, electric shock sensation, needle prick sensation)
- Pain not explained by other causes
- Age ≥ 18 years
- Pain duration ≥ 3 months
- Baseline pain Numerical Rating Scale (NRS) score ≥ 4 points
- Complete clinical data with follow-up time ≥ 6 months
Exclusion Criteria4
- History of chronic pain before stroke
- Severe cognitive impairment that prevents cooperation with pain assessment (Mini-Mental State Examination, MMSE < 15 points)
- Contraindications to spinal cord stimulation (SCS), such as coagulation disorders, active infections, or mental diseases that prevent cooperation
- Malignant tumors or other severe organic diseases with expected survival < 1 year
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Interventions
Patients received stSCS in addition to conventional pharmacotherapy. stSCS Procedure: Under digital subtraction angiography (DSA) guidance, a temporary electrode (typically an 8-contact electrode) was percutaneously placed into the corresponding spinal cord segment (cervical C2-C4 or thoracic T8-T10, depending on the pain distribution area). The electrode was connected to an external stimulator to deliver continuous stimulation for 7-14 days. Stimulation parameters were as follows: frequency 40-60 Hz (conventional mode) or BurstDR mode, pulse width 210-450 μs, and amplitude individually adjusted based on the patient's sensory threshold (targeting a comfortable paresthesia covering the painful area). After the test period, the electrode was removed without a second-stage implantation. Postoperatively, patients continued receiving baseline pharmacotherapy, which could be reduced as appropriate.
Patients received conventional pharmacotherapy alone without any form of SCS. The medication regimen followed the 2025 International Association for the Study of Pain (IASP) recommendations, with gabapentin (starting at 300 mg/d, gradually titrated to 900-1800 mg/d based on tolerability, administered in 2-3 divided doses) or pregabalin (starting at 75 mg/d, gradually titrated to 150-300 mg/d in 2-3 divided doses) as the foundation, and could be combined with duloxetine (60-120 mg/d) or amitriptyline (25-75 mg at bedtime). Drug doses were individually adjusted by the attending physician according to patient response and tolerability.
Locations(1)
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NCT07593313