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

Chronic Pain Clinical Trial

— PROSTIM  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05349695
• Other study ID #: 001
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: May 2024

Study information

• Verified date: April 2022
• Source: Studie- & Opleidingscentrum Neurochirurgie Virga Jesse
• Contact: Mark Plazier, MD,PhD
• Phone: +3211335511
• Email: mark.plazier[@]jessazh.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2024
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Failed Back Surgery Syndrome

Intervention

Device:
• Spinal cord stimulation
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.

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt
Belgium	Sint-Franciscus Ziekenhuis	Heusden-Zolder
Belgium	St. Trudo Ziekenhuis	Sint-Truiden

Sponsors (2)

Lead Sponsor	Collaborator
Studie- & Opleidingscentrum Neurochirurgie Virga Jesse	Medtronic

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Back pain	Visual analogue scale back (0-10)	3 weeks
Primary	Leg pain	Visual analogue scale back (0-10)	3 weeks
Primary	Back pain	Visual analogue scale back (0-10)	6 months
Primary	Leg pain	Visual analogue scale back (0-10)	6 months
Primary	Back pain	Visual analogue scale back (0-10)	12 months
Primary	Leg pain	Visual analogue scale back (0-10)	12 months
Primary	Disability	Oswestry Disability Index, ODI (0-100)	3 weeks
Primary	Disability	Oswestry Disability Index, ODI (0-100)	6 months
Primary	Disability	Oswestry Disability Index, ODI (0-100)	12 months
Primary	Health-related quality of life	EQ-5D-3L	3 weeks
Primary	Health-related quality of life	EQ-5D-3L	6 months
Primary	Health-related quality of life	EQ-5D-3L	12 months
Secondary	Pain medication	WHO classification and/or the use of neuropathic pain medication	3 weeks
Secondary	Pain medication	WHO classification and/or the use of neuropathic pain medication	6 months
Secondary	Pain medication	WHO classification and/or the use of neuropathic pain medication	12 months
Secondary	Spinal cord stimulation type	Type of spinal cord stimulation amongst different patient clusters	3 weeks
Secondary	Spinal cord stimulation type	Type of spinal cord stimulation amongst different patient clusters	6 months
Secondary	Spinal cord stimulation type	Type of spinal cord stimulation amongst different patient clusters	12 months
Secondary	Satisfied with current treatment	Yes/No question	3 weeks
Secondary	Satisfied with current treatment	Yes/No question	6 months
Secondary	Satisfied with current treatment	Yes/No question	12 months
Secondary	Rate of return to work	% of patients returning to work or daily activities	3 weeks
Secondary	Rate of return to work	% of patients returning to work or daily activities	6 months
Secondary	Rate of return to work	% of patients returning to work or daily activities	12 months