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

NCT04244669 | Unknown DMC FDA Device

• 1 other identifier: SCS-Quality
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Failed Back Surgery Syndrome; Spinal Cord Stimulation

Keywords

FBSS; SCS; HD; Quality of life; Pain; Activity monitoring

Outcome Measures

Primary Outcomes (1)

• Non-inferiority VAS

  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).

  3, 6,12 months

Secondary Outcomes (13)

• Superiority VAS

  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

• Scores/Questionnaires of disability: ODI

  3, 6,12 months

Study Arms (2)

SCS with Conventional Stimulation

EXPERIMENTAL

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.

Device: IPG with Conventional Stimulation

SCS with SCS DTM Stimulation

EXPERIMENTAL

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.

Device: IPG with SCS DTM

Interventions

IPG with Conventional Stimulation DEVICE

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% in that area. It can be reprogrammed as many times as necessary during the 14-21 days of margin.

SCS with Conventional Stimulation

IPG with SCS DTM DEVICE

In 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

SCS with SCS DTM Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pablo López Pais: lead

Study Sites (1)

Pablo López Pais

Santiago de Compostela, A Coruña, 15706, Spain

RECRUITING

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Pablo López Pais, MD, EDPM

CONTACT

+34981950674; p.lopez@dolorsantiago.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: January 28, 2020
• Study Start: November 26, 2020
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: December 10, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)