Failed Back Surgery SyndromePROSTIMNCT05349695
Patient Profiling and Outcome Assessment in Spinal Cord Stimulation for Chronic Back and/or Leg Pain
An observational study of Failed Back Surgery Syndrome and Chronic Pain, run by Studie- & Opleidingscentrum Neurochirurgie Virga Jesse at 3 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome, Chronic Pain
- What is being tested?
- Spinal cord stimulation
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 3 sitesBelgium
- Study dates
- 1 May 2022to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients with chronic back and/or leg pain who have been approved by the multidisciplinary team for SCS treatment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites, 3 recruiting
- Recruiting
Jessa Hospital
Hasselt
Mark Plazier
- Recruiting
Sint-Franciscus Ziekenhuis
Heusden-Zolder
- Recruiting
St. Trudo Ziekenhuis
Sint-Truiden
About this study
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)
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.
- Conditions
- Failed Back Surgery Syndrome, Chronic Pain
- Being tested
- Spinal cord stimulation
- Keywords
- Spinal cord stimulation, Patient profiling, Treatment pathways, Outcome assessment, Medial pathway, Lateral pathway, Descending pain modulation
- Medical subject headings
- Failed Back Surgery Syndrome, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulationDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Back pain
Visual analogue scale back (0-10)
Measured: 3 weeks
Leg pain
Visual analogue scale back (0-10)
Measured: 3 weeks
Back pain
Visual analogue scale back (0-10)
Measured: 6 months
Leg pain
Visual analogue scale back (0-10)
Measured: 6 months
Back pain
Visual analogue scale back (0-10)
Measured: 12 months
Leg pain
Visual analogue scale back (0-10)
Measured: 12 months
Disability
Oswestry Disability Index, ODI (0-100)
Measured: 3 weeks
Disability
Oswestry Disability Index, ODI (0-100)
Measured: 6 months
Disability
Oswestry Disability Index, ODI (0-100)
Measured: 12 months
Health-related quality of life
EQ-5D-3L
Measured: 3 weeks
Health-related quality of life
EQ-5D-3L
Measured: 6 months
Health-related quality of life
EQ-5D-3L
Measured: 12 months
Secondary outcomes (12)
Pain medication
WHO classification and/or the use of neuropathic pain medication
Measured: 3 weeks
Pain medication
WHO classification and/or the use of neuropathic pain medication
Measured: 6 months
Pain medication
WHO classification and/or the use of neuropathic pain medication
Measured: 12 months
Spinal cord stimulation type
Type of spinal cord stimulation amongst different patient clusters
Measured: 3 weeks
Spinal cord stimulation type
Type of spinal cord stimulation amongst different patient clusters
Measured: 6 months
Spinal cord stimulation type
Type of spinal cord stimulation amongst different patient clusters
Measured: 12 months
Satisfied with current treatment
Yes/No question
Measured: 3 weeks
Satisfied with current treatment
Yes/No question
Measured: 6 months
Satisfied with current treatment
Yes/No question
Measured: 12 months
Rate of return to work
% of patients returning to work or daily activities
Measured: 3 weeks
Rate of return to work
% of patients returning to work or daily activities
Measured: 6 months
Rate of return to work
% of patients returning to work or daily activities
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Studie- & Opleidingscentrum Neurochirurgie Virga Jesse
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Mark Plazier, Studie- & Opleidingscentrum Neurochirurgie Virga Jesse
- Investigators
- Mark Plazier, MD,PhD, Principal investigator, Jessa Hospital Hasselt, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349695
- Sponsor's protocol ID
- 001
- Acronym
- PROSTIM
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raymaekers V, Meeuws S, Goudman L, der Steen GV, Moens M, Vanloon M, Ridder D, Menovsky T, Vesper J, Plazier M. Patient profiling and outcome assessment in spinal cord stimulation for chronic back and/or leg pain (the PROSTIM study): a study protocol. Pain Manag. 2023 Dec;13(12):677-687. doi: 10.2217/pmt-2023-0103. Epub 2023 Dec 6.
PubMed 38054386
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05349695
- Acronym / sponsor ID
- PROSTIM / 001
- Conditions
- Failed Back Surgery Syndrome, Chronic Pain
- Keywords
- Spinal cord stimulation, Patient profiling, Treatment pathways, Outcome assessment, Medial pathway, Lateral pathway, Descending pain modulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Studie- & Opleidingscentrum Neurochirurgie Virga JesseUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 May 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with chronic back and/or leg pain who have been approved by the multidisciplinary team for SCS treatment.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,..)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal cord stimulationEligible 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. | Device | – |
Primary outcome
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
12 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Derived from this study: PubMed 38054386Raymaekers V, Meeuws S, Goudman L, der Steen GV, Moens M, Vanloon M, Ridder D, Menovsky T, Vesper J, Plazier M. Patient profiling and outcome assessment in spinal cord stimulation for chronic back and/or leg pain (the PROSTIM study): a study protocol. Pain Manag. 2023 Dec;13(12):677-687. doi: 10.2217/pmt-2023-0103. Epub 2023 Dec 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Plazier, MD,PhD principal investigator
Jessa Hospital Hasselt, Belgium
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Failed Back Surgery Syndrome and Chronic Pain, run by Studie- & Opleidingscentrum Neurochirurgie Virga Jesse at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Plazier, MD,PhD (+3211335511, mark.plazier@jessazh.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Back pain (time frame: 3 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05349695, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.