Patient Profiling and Outcome Assessment in Spinal Cord Stimulation for Chronic Back and/or Leg Pain

• Conditions: Chronic Pain; Failed Back Surgery Syndrome

• Registration Number: NCT05349695
• Lead Sponsor: Studie- & Opleidingscentrum Neurochirurgie Virga Jesse

Brief Summary

The PROSTIM study is an ongoing prospective, multicentric and observational clinical study. Patients are recruited in three different centers in Eastern Belgium from May 2018 onwards. This real-world data collection approaches the outcome assessment of daily medical practice. A hierarchical cluster analysis is used to identify significant patient clusters based on the Visual Analogue Scale (VAS), Oswestry disability index (ODI), Pain Vigilance and Awareness Questionnaire (PVAQ), Pain Catastrophizing Scale (PCS) and EuroQol with five dimensions for health-related quality of life (EQ-5D). Patient clusters will be assessed on the change in biopsychosocial variables after six weeks, three and twelve months. Secondary outcomes include the comparison of pain medication use, SCS parameters, treatment satisfaction and return to work.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-22
• Last Update Submitted: 2022-04-22
• Study First Posted: 2022-04-27
• Last Update Posted: 2022-04-27
• Study Start: 2022-05-01
• Primary Completion: 2023-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Male/female over 18 years old.
• Chronic intractable back and/or leg pain (PSPS T2), refractory to conservative treatment measures.
• Positive recommendation after multidisciplinary assessment including psychiatric assessment.
• Patients are capable of giving written informed consent.

Exclusion Criteria

• Negative recommendation after multidisciplinary assessment (ex. psychiatric disorders).
• Insufficient improvement during trial period.
• Previous SCS implantation.
• Removal due to complication (infection, loss of function,...)
• Surgical contraindication (infection of surgical site, coagulation disorders,..)
• Pregnancy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Back pain	12 months	Visual analogue scale back (0-10)
Disability	12 months	Oswestry Disability Index, ODI (0-100)
Leg pain	12 months	Visual analogue scale back (0-10)
Health-related quality of life	12 months	EQ-5D-3L

Secondary Outcome Measures

Name	Time	Method
Spinal cord stimulation type	12 months	Type of spinal cord stimulation amongst different patient clusters
Satisfied with current treatment	12 months	Yes/No question
Rate of return to work	12 months	% of patients returning to work or daily activities
Pain medication	12 months	WHO classification and/or the use of neuropathic pain medication

Trial Locations

Locations (3)

Sint-Franciscus Ziekenhuis; 🇧🇪 Heusden-Zolder, Belgium

St. Trudo Ziekenhuis; 🇧🇪 Sint-Truiden, Belgium

Jessa Hospital; 🇧🇪 Hasselt, Belgium