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

  • STATUS
    Recruiting
  • End date
    Jul 26, 2023
  • participants needed
    120
  • sponsor
    Pablo López Pais
Updated on 26 January 2021

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

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.

Details
Condition Failed Back Surgery Syndrome, Spinal Cord Stimulation
Treatment IPG with Conventional Stimulation, IPG with SCS DTM
Clinical Study IdentifierNCT04244669
SponsorPablo López Pais
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Leg with/without Low back pain with neuropathic characteristics (VAS 5 and DN44) 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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