Failed Back Surgery SyndromeSCS-QualityNCT04244669
Impact of the SCS With Different Waveforms Over the Quality of Life (SCS-Quality)
A study testing IPG with Conventional Stimulation and IPG with SCS DTM in people with Failed Back Surgery Syndrome and Spinal Cord Stimulation, run by Pablo López Pais at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome, Spinal Cord Stimulation
- What is being tested?
- IPG with Conventional Stimulation and IPG with SCS DTM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 26 Nov 2020to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Pablo López Pais
Santiago de Compostela, A Coruña, 15706
Pablo López Pais, MD, EDPM, +34981950674, p.lopez@dolorsantiago.com
About this study
Official title: 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
Read the 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.
- Being tested
- IPG with Conventional Stimulation, IPG with SCS DTM
- Keywords
- FBSS, SCS, HD, Quality of life, Pain, Activity monitoring
- Medical subject headings
- Failed Back Surgery Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPG with Conventional StimulationDevice
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.
IPG with SCS DTMDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: IPG with SCS DTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3, 6,12 months
Secondary outcomes (13)
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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 3, 6,12 months
Observational parameters: ratio of adverse effects
Observational parameters: ratio of adverse effects
Measured: 3, 6,12 months
Observational parameters: time of battery charge
Observational parameters: time of battery charge
Measured: 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
Measured: 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
Measured: 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
Measured: 3, 6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start26 Nov 2020
- Primary completionJun 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pablo López Pais
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pablo López Pais, Hospital Clinico Universitario de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244669
- Sponsor's protocol ID
- SCS-Quality
- Acronym
- SCS-Quality
- Status last verified
- Dec 2020
- First submitted
- 24 Nov 2019
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Spinal Cord Stimulation Waveforms on Quality of Life in Patients With Chronic Pain (SCS-Quality)
- ClinicalTrials.gov ID
- NCT04244669
- Acronym / sponsor ID
- SCS-Quality / SCS-Quality
- Keywords
- FBSS, SCS, HD, Quality of life, Pain, Activity monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Pablo López PaisUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| SCS with Conventional Stimulation | Experimental | Device: IPG with Conventional StimulationIn 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. |
| SCS with SCS DTM Stimulation | Experimental | Device: IPG with SCS DTMIIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPG with Conventional StimulationIn 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. | Device | SCS with Conventional Stimulation |
| IPG with SCS DTMIn 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 | SCS with SCS DTM Stimulation |
Primary outcome
Non-inferiority VAS
Time frame: 3, 6,12 months
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).
13 secondary outcomes
Superiority VAS
Time frame: 3, 6,12 months
Correlation between VAS and functionality and quality of life scores
Time frame: 3, 6,12 months
Objective measure of activity parameters
Time frame: 3, 6,12 months
Qualitative measure of dream quality
Time frame: 3, 6,12 months
Scores/Questionnaires of disability: ODI
Time frame: 3, 6,12 months
Scores/Questionnaires of quality of life: SF-36
Time frame: 3, 6,12 months
Scores/Questionnaires of quality of life: EQ-5D
Time frame: 3, 6,12 months
Medication consumption
Time frame: 3, 6,12 months
Observational parameters: ratio of adverse effects
Time frame: 3, 6,12 months
Observational parameters: time of battery charge
Time frame: 3, 6,12 months
Observational parameters: quality of battery charge
Time frame: 3, 6,12 months
Changes in quality of life assessed by wrist activity monitor accelerometer
Time frame: 3, 6,12 months
Changes in VAS assessed by wrist activity monitor accelerometer
Time frame: 3, 6,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPG with Conventional Stimulation and IPG with SCS DTM in people with Failed Back Surgery Syndrome and Spinal Cord Stimulation, run by Pablo López Pais at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pablo López Pais, MD, EDPM (+34981950674, p.lopez@dolorsantiago.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority VAS (time frame: 3, 6,12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.