Treatment of Post-Stroke Central Pain

Nanchong Central Hospital

Status: Enrolling

Conditions: Central Post-Stroke Pain

Treatments: Drug: Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline); Procedure: stSCS+Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)

Study type: Interventional

Funder types: Other

Identifiers

NCT07593313

2025030

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)

Experimental group

Description:

Patients received conventional pharmacotherapy alone without any form of SCS.

Treatment:

Drug: Gabapentin or Pregabalin (with optional Duloxetine or Amitriptyline)

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

Experimental group

Description:

Patients received stSCS in addition to conventional pharmacotherapy.

Treatment:

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