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NCT Number: NCT07593313

Treatment of Post-Stroke Central Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanchong Central Hospital

Nanchong, Sichuan, 637000, China

Location status: Recruiting

Location contact

Zhenhong 高

CONTACT

[email protected]

18404999336

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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.

Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)

Drug

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.

Primary outcomes

  1. Numerical Rating Scale (NRS) score

    Time frame: Six months

    The primary outcome was pain intensity measured by the NRS(0-10) recorded at baseline, immediately after stimulation termination (study group)/at the corresponding time point after treatment (control group), and at 1, 3, and 6 months post-treatment. The proportions of patients with an NRS reduction of ≥30% and ≥50% from baseline were also recorded, with the latter defined as treatment response.

    NRS ranges from 0 (no pain) to 10 (worst possible pain). Higher scores indicate worse pain.

Secondary outcomes

  1. Change in Sleep Quality assessed by the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 6 months

    The PSQI total score ranges from 0 to 21. Higher scores indicate worse sleep quality

  2. Change in Physical Health assessed by the 36-Item Short Form Health Survey Physical Component Summary (SF-36 PCS)

    Time frame: 6 months

    The SF-36 PCS score ranges from 0 to 100. Higher scores indicate better physical health

  3. Change in Mental Health assessed by the 36-Item Short Form Health Survey Mental Component Summary (SF-36 MCS)

    Time frame: 6 months

    The SF-36 MCS score ranges from 0 to 100. Higher scores indicate better mental health

Study contacts

Contact information is provided by the study sponsor or research team.

Zhenguo Gao

CONTACT

[email protected]

18404999336

Sponsors and collaborators

Lead sponsor

Nanchong Central Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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