Clinical trial NCT04244669: Impact of the SCS With Different Waveforms Over the Quality of Life (SCS-Quality)
Official title: The Impact of Different Spinal Cord Stimulation Waveforms on Quality of Life in Patients With Chronic Pain (SCS-Quality)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Failed Back Surgery Syndrome
Spinal Cord Stimulation
Keywords: FBSS
SCS
HD
Quality of life
Pain
Activity monitoring
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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
* 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.

Primary outcomes:
measure: Non-inferiority VAS
timeFrame: 3, 6,12 months
Secondary outcomes:
measure: Superiority VAS
timeFrame: 3, 6,12 months
measure: Correlation between VAS and functionality and quality of life scores
timeFrame: 3, 6,12 months
measure: Objective measure of activity parameters
timeFrame: 3, 6,12 months
measure: Qualitative measure of dream quality
timeFrame: 3, 6,12 months
measure: Scores/Questionnaires of disability: ODI
timeFrame: 3, 6,12 months
measure: Scores/Questionnaires of quality of life: SF-36
timeFrame: 3, 6,12 months
measure: Scores/Questionnaires of quality of life: EQ-5D
timeFrame: 3, 6,12 months
measure: Medication consumption
timeFrame: 3, 6,12 months
measure: Observational parameters: ratio of adverse effects
timeFrame: 3, 6,12 months
measure: Observational parameters: time of battery charge
timeFrame: 3, 6,12 months
measure: Observational parameters: quality of battery charge
timeFrame: 3, 6,12 months
measure: Changes in quality of life assessed by wrist activity monitor accelerometer
timeFrame: 3, 6,12 months
measure: Changes in VAS assessed by wrist activity monitor accelerometer
timeFrame: 3, 6,12 months
Other outcomes:
Locations:
city: Santiago de compostela
country: Spain
facility: Pablo López Pais
state: A Coruña
Study officials:
References: