Impact of the SCS With Different Waveforms Over the Quality of Life (SCS-Quality)

Study Overview
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Brief Summary
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Prospective, randomized, multicentre, parallel, controlled, and double-blind trial. It is a study with 2 groups with evaluation pre and post treatment with Spinal Cord Stimulation (SCS) implantation of patients with Failed Back Surgery Syndrome (FBSS). The study has been designed to assess primarily non-inferiority and secondarily superiority of SCS DTM therapy

Detailed Description
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Over 18 years old patients, with leg with or without low back neuropathic pain (DN4 ≥4), previously undergoing low back surgery that, after an Evidence-Based (EB) medical therapy, can be eligible to SCS therapy following the Good Clinical Practice (GCP) guidelines will be implanted of two leads in the epidural thoracic level with at least two poles (Medtronic Vectris) covering the T9-T10 interspace and, if the trial is positive, a Medtronic Intellis Internal Pulse Generators (IPG) will be implanted. The patients will be randomized to two groups to compare the improvement of pain control, the functional state and the quality of life of the patients by SCS Therapy across 12 months.

Official Title
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The Impact of Different Spinal Cord Stimulation Waveforms on Quality of Life in Patients With Chronic Pain (SCS-Quality)

Conditions
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Failed Back Surgery Syndrome, Spinal Cord Stimulation

Intervention / Treatment
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* Device: IPG with Conventional Stimulation
* Device: IPG with SCS DTM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Leg with/without Low back pain with neuropathic characteristics (VAS ≥ 5 and DN4≥4) during at least 6 months before the screening consultation. Stable medical therapy with Evidence Based Medicine (EBM) during at least one month before the screening Ready and able to accomplish the procedures of the study and use the activity monitor and the medication diary. Have 18 years old or older when the patient signs the informed consent Pain kept during at least the last 6 months with VAS ≥ 6 and functional limitation due to the pain Refractory to treatment (during at least 3 months), and/or Intolerable adverse effects that avoid an optimum medical treatment Previous lumbosacral surgery for treatment of the cause of his pain Pain attributable to a low back pathology Exclusion Criteria: Pregnant or with planned pregnancy Life expectancy <1 year. Polyneuropathy. Important Heart disease or peripheral vascular disease Degenerative disease that can decrease the functional capacity Alcoholism - Drug abuse Active infection Oncological active disease Haematological disorder with increased bleeding risk Patient unable to understand / follow the target of the study and the work flow When trial period has finished, the negative clinical response will be considered an exclusion criterion. The treatment could be completed, and the data collected but the patient will be excluded of the Randomized Clinical Trial (RCT) and the data analysed separately.

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, multicentre, parallel, controlled, and double-blind trial. It is a study with 2 groups with evaluation pre and post treatment with SCS implantation. The study has been designed to assess primarily non-inferiority and secondarily superiority of SCS DTM therapy
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCS with Conventional Stimulation<br>In this group, a conventional stimulation with low frequency will be tried. It will be programmed according to the usual clinical practice looking for one or more combinations of poles that allow a coverage of paraesthesia with a conventional stimulation of at least 80% of the painful area. This programming will be modified until getting not only 80% coverage but also a decrease of at least 50% of pain in that area. | Device: IPG with Conventional Stimulation<br>* In this group, a conventional stimulation with low frequency will be tried. It will be programmed according to the usual clinical practice looking for one or more combinations of poles that allow a coverage of paraesthesia with a conventional stimulation of at least 80% of the painful area. This programming will be modified until getting not only 80% coverage but also a decrease of at least 50% in that area. It can be reprogrammed as many times as necessary during the 14-21 days of margin.<br>|
| Experimental: SCS with SCS DTM Stimulation<br>IIn this group the SCS DTM™ workflow will be programmed. Each SCS DTM™ program group has at least two programs with different pulse rate in the 20 to 1,200 Hz range and each having a maximum pulse width of 1ms. | Device: IPG with SCS DTM<br>* In this group the SCS DTM™ workflow will be programmed. Each SCS DTM™ program group has at least two programs with different pulse rate in the 20 to 1,200 Hz range and each having a maximum pulse width of 1ms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority VAS | Non-inferiority of SCS DTM therapy compared with low frequency SCS in change of quantitative measure of pain with Visual Analogue Scale (VAS, 0-10 points, no pain to the worst pain imaginable). | 3, 6,12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superiority VAS | Superiority of SCS DTM therapy compared with low frequency SCS in the quantitative measure of pain with Visual Analogue Scale (VAS, 0-10, no pain to the worst pain imaginable). | 3, 6,12 months | 
| Correlation between VAS and functionality and quality of life scores | Correlation between the change of Visual Analogue Scale (VAS, 0-10, from no pain to the worst pain imaginable) and functionality (Oswestry Disability Index, ODI, from 0 to 100% of disability due to low back pain; Short form 36, SF-36, 0-100 points, from the worst health to the better) and quality of life scores (EuroQol-5D, EQ-5D, 0-1, from death to the best state of health) | 3, 6,12 months | 
| Objective measure of activity parameters | Difference between SCS DTM therapy compared with low frequency SCS in Objective measure of activity parameters (measured with an activity monitor) | 3, 6,12 months | 
| Qualitative measure of dream quality | Qualitative measure of dream quality Pittsburgh Sleep Quality Index (PSQI, 0 to 21, where lower scores denote a healthier sleep quality) | 3, 6,12 months | 
| Scores/Questionnaires of disability: ODI | Differences in Oswestry Disability Index versus control and between the arms (ODI, from 0 to 100% of disability due to low back pain) | 3, 6,12 months | 
| Scores/Questionnaires of quality of life: SF-36 | Differences in Short Form 36 versus control and between the arms (SF-36, 0-100 points, from the worst health to the better) | 3, 6,12 months | 
| Scores/Questionnaires of quality of life: EQ-5D | Differences in EQ-5D versus control and between the arms (EuroQol-5D, EQ-5D, 0-1, from death to the best state of health) | 3, 6,12 months | 
| Medication consumption | Medication consumption changes measured with Medication Quantification Scale III (MQSIII, from 0 points, no medication, according to the doses of each analgesic drug applying adjustment factors) | 3, 6,12 months | 
| Observational parameters: ratio of adverse effects | Observational parameters: ratio of adverse effects | 3, 6,12 months | 
| Observational parameters: time of battery charge | Observational parameters: time of battery charge | 3, 6,12 months | 
| Observational parameters: quality of battery charge | Observational parameters: quality of the battery recharge measured with the parameter provided by the IPG (Internal Pulse Generator), which classifies as bad, good or excellent | 3, 6,12 months | 
| Changes in quality of life assessed by wrist activity monitor accelerometer | To develop activity parameters measurables with an activity monitor and applicable clinically applying big data and complex mathematical calculations of position vectors and gyroscope data and activity monitor accelerometer, to predict changes early | 3, 6,12 months | 
| Changes in VAS assessed by wrist activity monitor accelerometer | To develop activity parameters measurables with an activity monitor and applicable clinically applying big data and complex mathematical calculations of position vectors and gyroscope data and activity monitor accelerometer, to predict changes early | 3, 6,12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, FBSS, SCS, HD, Quality of life, Activity monitoring