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

Primary Purpose

Failed Back Surgery Syndrome, Spinal Cord Stimulation

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
IPG with Conventional Stimulation
IPG with SCS DTM
Sponsored by
Pablo López Pais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Failed Back Surgery Syndrome focused on measuring FBSS, SCS, HD, Quality of life, Pain, Activity monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Pablo López PaisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SCS with Conventional Stimulation

SCS with SCS DTM Stimulation

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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)
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)
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)
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)
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)
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)
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)
Observational parameters: ratio of adverse effects
Observational parameters: ratio of adverse effects
Observational parameters: time of battery charge
Observational parameters: time of battery charge
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
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
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

Full Information

First Posted
November 24, 2019
Last Updated
December 8, 2020
Sponsor
Pablo López Pais
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1. Study Identification

Unique Protocol Identification Number
NCT04244669
Brief Title
Impact of the SCS With Different Waveforms Over the Quality of Life (SCS-Quality)
Acronym
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 26, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pablo López Pais

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Back Surgery Syndrome, Spinal Cord Stimulation
Keywords
FBSS, SCS, HD, Quality of life, Pain, Activity monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
Care ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SCS with Conventional Stimulation
Arm Type
Experimental
Arm 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.
Arm Title
SCS with SCS DTM Stimulation
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
IPG with Conventional Stimulation
Intervention 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% in that area. It can be reprogrammed as many times as necessary during the 14-21 days of margin.
Intervention Type
Device
Intervention Name(s)
IPG with SCS DTM
Intervention Description
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
Primary Outcome Measure Information:
Title
Non-inferiority VAS
Description
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).
Time Frame
3, 6,12 months
Secondary Outcome Measure Information:
Title
Superiority VAS
Description
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).
Time Frame
3, 6,12 months
Title
Correlation between VAS and functionality and quality of life scores
Description
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)
Time Frame
3, 6,12 months
Title
Objective measure of activity parameters
Description
Difference between SCS DTM therapy compared with low frequency SCS in Objective measure of activity parameters (measured with an activity monitor)
Time Frame
3, 6,12 months
Title
Qualitative measure of dream quality
Description
Qualitative measure of dream quality Pittsburgh Sleep Quality Index (PSQI, 0 to 21, where lower scores denote a healthier sleep quality)
Time Frame
3, 6,12 months
Title
Scores/Questionnaires of disability: ODI
Description
Differences in Oswestry Disability Index versus control and between the arms (ODI, from 0 to 100% of disability due to low back pain)
Time Frame
3, 6,12 months
Title
Scores/Questionnaires of quality of life: SF-36
Description
Differences in Short Form 36 versus control and between the arms (SF-36, 0-100 points, from the worst health to the better)
Time Frame
3, 6,12 months
Title
Scores/Questionnaires of quality of life: EQ-5D
Description
Differences in EQ-5D versus control and between the arms (EuroQol-5D, EQ-5D, 0-1, from death to the best state of health)
Time Frame
3, 6,12 months
Title
Medication consumption
Description
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)
Time Frame
3, 6,12 months
Title
Observational parameters: ratio of adverse effects
Description
Observational parameters: ratio of adverse effects
Time Frame
3, 6,12 months
Title
Observational parameters: time of battery charge
Description
Observational parameters: time of battery charge
Time Frame
3, 6,12 months
Title
Observational parameters: quality of battery charge
Description
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
Time Frame
3, 6,12 months
Title
Changes in quality of life assessed by wrist activity monitor accelerometer
Description
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
Time Frame
3, 6,12 months
Title
Changes in VAS assessed by wrist activity monitor accelerometer
Description
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
Time Frame
3, 6,12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pablo López Pais, MD, EDPM
Phone
+34981950674
Email
p.lopez@dolorsantiago.com
Facility Information:
Facility Name
Pablo López Pais
City
Santiago de compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo López Pais, MD, EDPM
Phone
+34981950674
Email
p.lopez@dolorsantiago.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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