Menu
Recruiting NCT07593313

Treatment of Post-Stroke Central Pain

No phase Interventional Central Post-Stroke Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: stSCS+Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline), Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline).
Who it may be relevant to
Registry conditions: Central Post-Stroke Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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-
  • 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 amitripty

Primary outcome measures

  • Numerical Rating Scale (NRS) score [Time frame: Six months]
Secondary outcome measures (3)
  • Change in Sleep Quality assessed by the Pittsburgh Sleep Quality Index (PSQI) [Time frame: 6 months]
  • Change in Physical Health assessed by the 36-Item Short Form Health Survey Physical Component Summary (SF-36 PCS) [Time frame: 6 months]
  • Change in Mental Health assessed by the 36-Item Short Form Health Survey Mental Component Summary (SF-36 MCS) [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Nanchong Central Hospital — Nanchong

Identifiers

NCT: NCT07593313 · 2025030

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗