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

The Impact of Different Spinal Cord Stimulation Waveforms on Quality of Life in Patients With Chronic Pain (SCS-Quality)

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

Study Overview

• Status: Recruiting
• Conditions: Failed Back Surgery Syndrome; Spinal Cord Stimulation
• Intervention / Treatment: Device: IPG with Conventional Stimulation; Device: IPG with SCS DTM

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pablo López Pais, MD, EDPM; Phone Number: +34981950674; Email: p.lopez@dolorsantiago.com

Study Locations

• Spain
  • A Coruña
    • Santiago de compostela, A Coruña, Spain, 15706
      • Recruiting
      • Pablo López Pais
      • Contact: Pablo López Pais, MD, EDPM; Phone Number: +34981950674; Email: p.lopez@dolorsantiago.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCS with Conventional Stimulation; 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; 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.
Experimental: SCS with SCS DTM Stimulation; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superiority VAS	Superiority of SCS DTM therapy compared with low frequency SCS in the quantitative measure of pain with Visual Analogue Scale (VAS, 0-10, no pain to the worst pain imaginable).	3, 6,12 months
Correlation between VAS and functionality and quality of life scores	Correlation between the change of Visual Analogue Scale (VAS, 0-10, from no pain to the worst pain imaginable) and functionality (Oswestry Disability Index, ODI, from 0 to 100% of disability due to low back pain; Short form 36, SF-36, 0-100 points, from the worst health to the better) and quality of life scores (EuroQol-5D, EQ-5D, 0-1, from death to the best state of health)	3, 6,12 months
Objective measure of activity parameters	Difference between SCS DTM therapy compared with low frequency SCS in Objective measure of activity parameters (measured with an activity monitor)	3, 6,12 months
Qualitative measure of dream quality	Qualitative measure of dream quality Pittsburgh Sleep Quality Index (PSQI, 0 to 21, where lower scores denote a healthier sleep quality)	3, 6,12 months
Scores/Questionnaires of disability: ODI	Differences in Oswestry Disability Index versus control and between the arms (ODI, from 0 to 100% of disability due to low back pain)	3, 6,12 months
Scores/Questionnaires of quality of life: SF-36	Differences in Short Form 36 versus control and between the arms (SF-36, 0-100 points, from the worst health to the better)	3, 6,12 months
Scores/Questionnaires of quality of life: EQ-5D	Differences in EQ-5D versus control and between the arms (EuroQol-5D, EQ-5D, 0-1, from death to the best state of health)	3, 6,12 months
Medication consumption	Medication consumption changes measured with Medication Quantification Scale III (MQSIII, from 0 points, no medication, according to the doses of each analgesic drug applying adjustment factors)	3, 6,12 months
Observational parameters: ratio of adverse effects	Observational parameters: ratio of adverse effects	3, 6,12 months
Observational parameters: time of battery charge	Observational parameters: time of battery charge	3, 6,12 months
Observational parameters: quality of battery charge	Observational parameters: quality of the battery recharge measured with the parameter provided by the IPG (Internal Pulse Generator), which classifies as bad, good or excellent	3, 6,12 months
Changes in quality of life assessed by wrist activity monitor accelerometer	To develop activity parameters measurables with an activity monitor and applicable clinically applying big data and complex mathematical calculations of position vectors and gyroscope data and activity monitor accelerometer, to predict changes early	3, 6,12 months
Changes in VAS assessed by wrist activity monitor accelerometer	To develop activity parameters measurables with an activity monitor and applicable clinically applying big data and complex mathematical calculations of position vectors and gyroscope data and activity monitor accelerometer, to predict changes early	3, 6,12 months

Collaborators and Investigators

• Sponsor: Pablo López Pais

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2020
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: November 24, 2019
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 8, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Quality of life; HD; SCS; Activity monitoring; FBSS
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Back Pain; Failed Back Surgery Syndrome
• Other Study ID Numbers: SCS-Quality

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes