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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Failed Back Surgery Syndrome, Chronic Pain

Intervention / Treatment
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* Device: Spinal cord stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord stimulation, Patient profiling, Treatment pathways, Outcome assessment, Medial pathway, Lateral pathway, Descending pain modulation