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Treatment of Post-Stroke Central Pain

13. mai 2026 oppdatert av: Nanchong Central Hospital

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

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Sichuan
      • Nanchong, Sichuan, Kina, 637000
        • Rekruttering
        • Nanchong Central Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)
Patients received conventional pharmacotherapy alone without any form of SCS.
Legemiddel: 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.
Eksperimentell: stSCS plus Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)
Patients received stSCS in addition to conventional pharmacotherapy.
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Numerical Rating Scale (NRS) score
Tidsramme: 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.
Six months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Sleep Quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: 6 months
The PSQI total score ranges from 0 to 21. Higher scores indicate worse sleep quality
6 months
Change in Physical Health assessed by the 36-Item Short Form Health Survey Physical Component Summary (SF-36 PCS)
Tidsramme: 6 months
The SF-36 PCS score ranges from 0 to 100. Higher scores indicate better physical health
6 months
Change in Mental Health assessed by the 36-Item Short Form Health Survey Mental Component Summary (SF-36 MCS)
Tidsramme: 6 months
The SF-36 MCS score ranges from 0 to 100. Higher scores indicate better mental health
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Nanchong Central Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2024

Primær fullføring (Antatt)

1. august 2026

Studiet fullført (Antatt)

1. august 2026

Datoer for studieregistrering

Først innsendt

26. april 2026

Først innsendt som oppfylte QC-kriteriene

13. mai 2026

Først lagt ut (Faktiske)

18. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2025030

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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