The Impact of Different Spinal Cord Stimulation Waveforms on Quality of Life in Patients With Chronic Pain (SCS-Quality)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Non-inferiority VAS
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Investigator)
Masking Description
The patient will not informed about the treatment arm, but the presence of paresthesia is a factor that break the masking.
The care provider and investigators will not know the treatment arm and only collect the information in the forms.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
SCS with Conventional Stimulation
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.
Intervention: IPG with Conventional Stimulation (Device)
SCS with SCS DTM Stimulation
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.
Intervention: IPG with SCS DTM (Device)
Outcomes
Primary Outcomes
Non-inferiority VAS
Time Frame: 3, 6,12 months
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).
Secondary Outcomes
- Scores/Questionnaires of disability: ODI(3, 6,12 months)
- Changes in VAS assessed by wrist activity monitor accelerometer(3, 6,12 months)
- Observational parameters: ratio of adverse effects(3, 6,12 months)
- Correlation between VAS and functionality and quality of life scores(3, 6,12 months)
- Objective measure of activity parameters(3, 6,12 months)
- Qualitative measure of dream quality(3, 6,12 months)
- Medication consumption(3, 6,12 months)
- Observational parameters: quality of battery charge(3, 6,12 months)
- Superiority VAS(3, 6,12 months)
- Changes in quality of life assessed by wrist activity monitor accelerometer(3, 6,12 months)
- Scores/Questionnaires of quality of life: SF-36(3, 6,12 months)
- Observational parameters: time of battery charge(3, 6,12 months)
- Scores/Questionnaires of quality of life: EQ-5D(3, 6,12 months)
Investigators
Pablo López Pais
Principal Investigator
Hospital Clinico Universitario de Santiago