The Impact of Different Spinal Cord Stimulation Waveforms on Quality of Life in Patients With Chronic Pain (SCS-Quality)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Failed Back Surgery Syndrome
- Sponsor
- Pablo López Pais
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Non-inferiority VAS
- Last Updated
- 5 years ago
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.
Investigators
Pablo López Pais
Principal Investigator
Hospital Clinico Universitario de Santiago
Eligibility Criteria
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
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
- 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)
- Scores/Questionnaires of disability: ODI(3, 6,12 months)
- Superiority VAS(3, 6,12 months)
- Observational parameters: ratio of adverse effects(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)
- Changes in VAS assessed by wrist activity monitor accelerometer(3, 6,12 months)