Effectiveness and Cost-utility Analysis of Spinal Cord Stimulation for Chronic Intractable Pain in Thailand

Completed

• Conditions: Patients undergoing SCS implants due to intractable pain at Siriraj Hospital; spinal cord stimulation; effectiveness; quality-adjusted life year; incremental cost-utility ratios; cost-utility analysis; willingness to pay; Thailand

• Registration Number: TCTR20210923001
• Lead Sponsor: Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-03-31
• Study Start: 2021-09-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

CMM group
1) The patients were more than 7 years old
2) The patients suffered from chronic intractable pain from FBSS, PVD or neuropathic pain
3) The patients reported no satisfactory response to previous treatment defined by a pain score (numeric rating scale or NRS) of at least 5 out of 10 for at least 2 years, despite physical therapy, appropriate regimen of pain medication (gabapentin dose of more than 900 mg/day or pregabalin more than 150 mg/day and two or more other pain medications), other pain interventions or surgery.

SCS+CMM group
Any patients who underwent a successful SCS trial and subsequent implantation.

Exclusion Criteria

1. Refusal to participate in the study
2. Pain due to cancer 3. Difficulty of communication or poor literacy of Thai language

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cost-utility Post-treatment (3 years time points) incremental cost-utility ratio

Secondary Outcome Measures

Name	Time	Method
Pain score Post-treatment (1-6 months time points) Numeric rating pain score range: 0-10,Overall pain-related interference Post-treatment (1-6 months time points) Brief Pain Inventory questionnaire (range: 0-70),Utility Post-treatment (1-6 months time points) EQ-5D-5L health questionnaires21(Thai version)