An interventional study of Dorsal Root Ganglion Stimulation (DRG-S) in Pain, Intractable and Pain, Chronic, sponsored by Spine and Pain Institute of New York. Status unknown at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-09-22.
Sponsored by Spine and Pain Institute of New York · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate and compare the therapeutic efficacy of intermittent Dorsal Root Ganglion Stimulation (DRG-S) to standard continuous stimulation in patients with chronic intractable pain
Intermittent Dorsal Root Ganglion Stimulation (DRG-S) dosing consists of preprogrammed cycles during which stimulation is delivered with standard DRG-S parameters alternated with periods during which no stimulation is being delivered.
In this study the investigators propose to evaluate therapeutic efficacy of Intermittent DRG-S at 1 minute on: 1 minute off and 1 minute on: 2 minute off dosing in comparison to standard continuous DRG-S dosing and determine if there is noninferiority between the intermittent and continuous paradigms in chronic pain patients with permanent DRG-S implants.
90 studies on the registry are indexed under Pain, Intractable; 16 are open to participants now.
This study's enrollment of 15 is below the median of 60 across 64 interventional studies indexed under Pain, Intractable.
Browse Pain, Intractable studies →This is the only study on the registry with Spine and Pain Institute of New York as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2 week stimulation program using continuous DRG-S dosing at standard stimulation parameters
Device: Dorsal Root Ganglion Stimulation (DRG-S)
2 week stimulation program using 1 minute on: 1 minute off intermittent DRG-S dosing at standard stimulation parameters
Device: Dorsal Root Ganglion Stimulation (DRG-S)
2 week stimulation program using 1 minute on: 2 minutes off intermittent DRG-S dosing at standard stimulation parameters
Device: Dorsal Root Ganglion Stimulation (DRG-S)
Dorsal Root Ganglion stimulation will be delivered with continuous dosing and 2 different ON/OFF periods to compare effects for each patient.
Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:1 Intermittent Dosing
Pain Questionnaire - (Scale is 0 to 10 with 0 being no pain and 10 being worst pain imaginable)
Time frame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing
Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:2 Intermittent Dosing
Pain Questionnaire - (Scale is 0 to 10 with 0 being no pain and 10 being worst pain imaginable)
Time frame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing
Change in Quality of Life Between Continuous and 1:1 Intermittent Dosing
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
Time frame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing
Change in Quality of Life Between Continuous and 1:2 Intermittent Dosing
Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)
Time frame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing
Change in Disability Index Between Continuous and 1:1 Intermittent Dosing
Questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Time frame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing
Change in Disability Index Between Continuous and 1:2 Intermittent Dosing
Questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)
Time frame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing
Stimulation Program Peference
Percentage of patients preferring each stimulation program
Time frame: 6 week follow up visit after completing all 3 stimulation programs
Plan to share: No
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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