---
title: Patient Profiling and Outcome Assessment in Spinal Cord Stimulation for Chronic Back and/or Leg Pain
nct_id: NCT05349695
overall_status: UNKNOWN
sponsor: Studie- & Opleidingscentrum Neurochirurgie Virga Jesse
study_type: OBSERVATIONAL
primary_condition: Failed Back Surgery Syndrome
countries: Belgium
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05349695.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05349695"
ct_last_update_post_date: 2022-04-27
last_seen_at: "2026-05-12T06:26:47.413Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Patient Profiling and Outcome Assessment in Spinal Cord Stimulation for Chronic Back and/or Leg Pain

**Official Title:** Patient Profiling and Outcome Assessment in Spinal Cord Stimulation for Chronic Back and/or Leg Pain: Study Protocol for a Prospective, Multicentric Observational Study (the PROSTIM Study)

**NCT ID:** [NCT05349695](https://clinicaltrials.gov/study/NCT05349695)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 200
- **Lead Sponsor:** Studie- & Opleidingscentrum Neurochirurgie Virga Jesse
- **Collaborators:** Medtronic
- **Conditions:** Failed Back Surgery Syndrome, Chronic Pain
- **Start Date:** 2022-05-01
- **Completion Date:** 2024-05
- **CT.gov Last Update:** 2022-04-27

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Interventions

- **Spinal cord stimulation** (DEVICE) — Eligible patients will undergo a SCS trial period for three weeks (as legally defined by the reimbursement authorities). The leads can be placed both surgically of percutaneously with an external trial stimulator. Surgical implantation of an implanted pulse generator (IPG) is performed if the patient achieves at least 50% pain reduction and a reduced pain medication use (reimbursement requirements) during the trial period. Subsequently, the implanted devices are programmed to the optimal parameters in collaboration with a nurse specialized in SCS treatment. The patients are educated on the use of the patient programmer.

## Primary Outcomes

- **Back pain** _(time frame: 3 weeks)_ — Visual analogue scale back (0-10)
- **Leg pain** _(time frame: 3 weeks)_ — Visual analogue scale back (0-10)
- **Back pain** _(time frame: 6 months)_ — Visual analogue scale back (0-10)
- **Leg pain** _(time frame: 6 months)_ — Visual analogue scale back (0-10)
- **Back pain** _(time frame: 12 months)_ — Visual analogue scale back (0-10)
- **Leg pain** _(time frame: 12 months)_ — Visual analogue scale back (0-10)
- **Disability** _(time frame: 3 weeks)_ — Oswestry Disability Index, ODI (0-100)
- **Disability** _(time frame: 6 months)_ — Oswestry Disability Index, ODI (0-100)
- **Disability** _(time frame: 12 months)_ — Oswestry Disability Index, ODI (0-100)
- **Health-related quality of life** _(time frame: 3 weeks)_ — EQ-5D-3L
- **Health-related quality of life** _(time frame: 6 months)_ — EQ-5D-3L
- **Health-related quality of life** _(time frame: 12 months)_ — EQ-5D-3L

## Secondary Outcomes

- **Pain medication** _(time frame: 3 weeks)_
- **Pain medication** _(time frame: 6 months)_
- **Pain medication** _(time frame: 12 months)_
- **Spinal cord stimulation type** _(time frame: 3 weeks)_
- **Spinal cord stimulation type** _(time frame: 6 months)_
- **Spinal cord stimulation type** _(time frame: 12 months)_
- **Satisfied with current treatment** _(time frame: 3 weeks)_
- **Satisfied with current treatment** _(time frame: 6 months)_
- **Satisfied with current treatment** _(time frame: 12 months)_
- **Rate of return to work** _(time frame: 3 weeks)_
- **Rate of return to work** _(time frame: 6 months)_
- **Rate of return to work** _(time frame: 12 months)_

## Locations (3)

- Jessa Hospital, Hasselt, Belgium — _RECRUITING_
- Sint-Franciscus Ziekenhuis, Heusden-Zolder, Belgium — _RECRUITING_
- St. Trudo Ziekenhuis, Sint-Truiden, Belgium — _RECRUITING_

## Recent Field Changes (last 30 days)

- `results.hasResults` — added _(2026-05-12)_
- `locations.jessa hospital|hasselt||belgium` — added _(2026-05-12)_
- `locations.sint-franciscus ziekenhuis|heusden-zolder||belgium` — added _(2026-05-12)_
- `locations.st. trudo ziekenhuis|sint-truiden||belgium` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05349695.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05349695*  
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