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

Pablo López Pais

Status: Unknown

Conditions: Spinal Cord Stimulation; Failed Back Surgery Syndrome

Treatments: Device: IPG with SCS DTM; Device: IPG with Conventional Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04244669

SCS-Quality

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

SCS with Conventional Stimulation

Experimental group

Description:

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.

Treatment:

Device: IPG with Conventional Stimulation

SCS with SCS DTM Stimulation

Experimental group

Description:

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.

Treatment:

Device: IPG with SCS DTM