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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Failed Back Surgery Syndrome
• Intervention / Treatment: Device: Spinal cord stimulation

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Mark Plazier, MD,PhD; Phone Number: +3211335511; Email: mark.plazier@jessazh.be
• Study Contact Backup: Name: Vincent Raymaekers, MD; Phone Number: +3211335511; Email: vincent.raymaekers@gmail.com

Study Locations

• Belgium
  • Hasselt, Belgium
    • Recruiting
    • Jessa Hospital
    • Contact: Mark Plazier
  • Heusden-Zolder, Belgium
    • Recruiting
    • Sint-Franciscus ziekenhuis
  • Sint-Truiden, Belgium
    • Recruiting
    • St. Trudo Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Back pain	Visual analogue scale back (0-10)	3 weeks
Leg pain	Visual analogue scale back (0-10)	3 weeks
Back pain	Visual analogue scale back (0-10)	6 months
Leg pain	Visual analogue scale back (0-10)	6 months
Back pain	Visual analogue scale back (0-10)	12 months
Leg pain	Visual analogue scale back (0-10)	12 months
Disability	Oswestry Disability Index, ODI (0-100)	3 weeks
Disability	Oswestry Disability Index, ODI (0-100)	6 months
Disability	Oswestry Disability Index, ODI (0-100)	12 months
Health-related quality of life	EQ-5D-3L	3 weeks
Health-related quality of life	EQ-5D-3L	6 months
Health-related quality of life	EQ-5D-3L	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain medication	WHO classification and/or the use of neuropathic pain medication	3 weeks
Pain medication	WHO classification and/or the use of neuropathic pain medication	6 months
Pain medication	WHO classification and/or the use of neuropathic pain medication	12 months
Spinal cord stimulation type	Type of spinal cord stimulation amongst different patient clusters	3 weeks
Spinal cord stimulation type	Type of spinal cord stimulation amongst different patient clusters	6 months
Spinal cord stimulation type	Type of spinal cord stimulation amongst different patient clusters	12 months
Satisfied with current treatment	Yes/No question	3 weeks
Satisfied with current treatment	Yes/No question	6 months
Satisfied with current treatment	Yes/No question	12 months
Rate of return to work	% of patients returning to work or daily activities	3 weeks
Rate of return to work	% of patients returning to work or daily activities	6 months
Rate of return to work	% of patients returning to work or daily activities	12 months

Collaborators and Investigators

• Sponsor: Studie- & Opleidingscentrum Neurochirurgie Virga Jesse
• Collaborators: Medtronic
• Investigators: Principal Investigator: Mark Plazier, MD,PhD, Jessa Hospital Hasselt, Belgium

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2022
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): May 1, 2024

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (ACTUAL): April 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 22, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Spinal cord stimulation; Treatment pathways; Outcome assessment; Patient profiling; Medial pathway; Lateral pathway; Descending pain modulation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Back Pain; Chronic Pain; Failed Back Surgery Syndrome
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No