High-density in Spinal Cord Stimulation: Virtual Expert Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 272
- Locations
- 1
- Primary Endpoint
- Pain relief by pain medication
Study Overview
Brief Summary
This is a prospective, multi-center, observational follow-up study observing the effectiveness of high density spinal cord stimulation in patients with failed back surgery syndrome patients with back and leg pain.
Detailed Description
DISCOVER will measure the effectiveness of high-density spinal cord stimulation for treatment of chronic back and leg pain. Identification of clinical effective parameters concerning location of active electrodes, frequency, pulse duration, amplitude and battery consumption are, besides safety, the major outcome parameters of this study.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Failed Back Surgery Syndrome patients (FBSS) with insufficient pain reduction with conventional SCS or FBSS patients suitable for SCS
- •Age > 18 years
- •Chronic pain as a result of FBSS that exists for at least 6 months with a pain intensity 5 or higher measured on numeric rating scale (NRS)
- •Patient has been informed of the study procedures and has given written informed consent
- •Patient willing to comply with study protocol including attending the study visits
Exclusion Criteria
- •Expected inability of patients to receive or properly operate the spinal cord stimulation system
- •History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
- •Active malignancy
- •Addiction to any of the following drugs, alcohol (5E/day) and/or medication
- •Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
- •Immune deficiency (HIV positive, immunosuppressiva, etc.)
- •Life expectancy < 1 year
- •Local infection or other skin disorder at site of incision
- •Pregnancy
- •Other implanted active medical device
Outcomes
Primary Outcomes
Pain relief by pain medication
Time Frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Questionnaire regarding the amount of pain relief by pain medication
The current health status
Time Frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
The health status will be observed with the Euroqol (EQ-5D-5L) questionnaire.
Pain intensity with the Numeric Rating Scale (NRS)
Time Frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
The abilities in daily living
Time Frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
The functional abilities will be assessed with the Oswestry Low Back Pain Questionnaire.
Patient's satisfaction
Time Frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Patient's satisfaction with the stimulation will be assessed with a 5 item Likert scale
Subjective sleep quality
Time Frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).
Secondary Outcomes
- Battery efficiency of the neurostimulator(The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.)
- Pain area coverage(The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.)
- HD stim parameters(The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.)
- AdaptiveStim use (in case of Restore Sensor)(The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.)
- Paresthesia threshold(The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.)
- MRI need(The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.)
Investigators
Moens Maarten
Prof. dr.
Universitair Ziekenhuis Brussel