Health TrialsbyHealthPanel

Treatment of Post-Stroke Central Pain

ConditionCentral Post-Stroke Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanchong Central Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)Experimental treatment 1 intervention
Group B: stSCS plus Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Numerical Rating Scale (NRS) score

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.

Time frame
Six months

Secondary outcomes

1

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

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

Time frame
6 months
2

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

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

Time frame
6 months
3

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

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

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanchong Central Hospital

Lead sponsor

Source ClinicalTrials.gov
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