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RECRUITING
NCT07593313
NA

Treatment of Post-Stroke Central Pain

Sponsor: Nanchong Central Hospital

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of Short-Term Spinal Cord Stimulation Combined With Pharmacotherapy for Central Post-Stroke Pain: A Single-Center, Randomized, Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2024-01-01

Completion Date

2026-08-01

Last Updated

2026-05-18

Healthy Volunteers

No

Interventions

PROCEDURE

stSCS+Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)

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.

DRUG

Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)

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)

Nanchong Central Hospital

Nanchong, Sichuan, China