Impact of the SCS With Different Waveforms Over the Quality of Life (SCS-Quality)
NCT ID: NCT04244669
Last Updated: 2020-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2020-11-26
2023-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
The care provider and investigators will not know the treatment arm and only collect the information in the forms.
Study Groups
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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.
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.
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.
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Pablo López Pais
OTHER
Responsible Party
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Pablo López Pais
Principal Investigator
Locations
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Pablo López Pais
Santiago de Compostela, A Coruña, Spain
Countries
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Central Contacts
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Facility Contacts
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Pablo López Pais, MD, EDPM
Role: primary
Other Identifiers
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SCS-Quality
Identifier Type: -
Identifier Source: org_study_id