UnknownNot Applicable

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

Belgium200 participantsStarted 2022-05-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Back pain

Timeframe: 3 weeks

Leg pain

Timeframe: 3 weeks

Back pain

Timeframe: 6 months

Leg pain

Timeframe: 6 months

Back pain

Timeframe: 12 months

Leg pain

Timeframe: 12 months

Disability

Timeframe: 3 weeks

Disability

Timeframe: 6 months

Trial details

NCT IDNCT05349695

SponsorStudie- & Opleidingscentrum Neurochirurgie Virga Jesse

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-05

Contact for this trial

Mark Plazier, MD,PhD

+3211335511 mark.plazier@jessazh.be

View on ClinicalTrials.gov More Failed Back Surgery Syndrome trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.