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

NCT05349695 | Unknown

• 1 other identifier: 001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Failed Back Surgery Syndrome; Chronic Pain

Keywords

Spinal cord stimulation; Patient profiling; Treatment pathways; Outcome assessment; Medial pathway; Lateral pathway; Descending pain modulation

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (12)

• Pain medication

  3 weeks

• Pain medication

  6 months

• Pain medication

  12 months

• Spinal cord stimulation type

  3 weeks

• Spinal cord stimulation type

  6 months

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Studie- & Opleidingscentrum Neurochirurgie Virga Jesse: lead
• Medtronic: collaborator

Study Sites (3)

Jessa Hospital

Hasselt, Belgium

RECRUITING

Sint-Franciscus Ziekenhuis

Heusden-Zolder, Belgium

RECRUITING

St. Trudo Ziekenhuis

Sint-Truiden, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 38054386 DERIVED

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Chronic Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Mark Plazier, MD,PhD

  Jessa Hospital Hasselt, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Plazier, MD,PhD

CONTACT

+3211335511; mark.plazier@jessazh.be

Vincent Raymaekers, MD

CONTACT

+3211335511; vincent.raymaekers@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Plazier

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 27, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2024
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)