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Clinical Trials/NCT07593313
NCT07593313RecruitingNot Applicable

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

Nanchong Central Hospital1 site in 1 country80 target enrollmentStarted: January 1, 2024Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
80
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor
Nanchong Central Hospital
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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