Clinical trial NCT04727216: Intermittent vs. Continuous Dorsal Root Ganglion Stimulation
Official title: Intermittent Dorsal Root Ganglion Stimulation Dosing Comparison to Standard Continuous Dosing in Treating Chronic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Intractable
Pain, Chronic
Keywords: Dorsal Root Ganglion Stimulation
Intermittent Stimulation Dosing
Lead sponsor: Spine and Pain Institute of New York
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will undergo 3 sequential 2-week dosing stimulation programs \[1.) continuous, 2.) 1 minute on: 1 minute off, and 3.) 1 minute on: 2 minutes\] in randomized order and double blinded fashion for a total of 6 consecutive weeks.
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subject is able to provide informed consent to participate in the study;
* Subject is 21 years of age or older;
* Subject has been treated with DRG-S permanent implant device (Abbott, Plano, TX, USA) for a minimum of 3 months with sustained pain relief \>50% for chronic intractable pain;
* Subject's DRG-S parameters have remained unchanged for at least 30 days prior to the beginning of the study

Exclusion Criteria:

* Subject had a recent change in pain medication regimen resulting in increase in Morphine Milligram Equivalent dosing within 60 days prior to the beginning of the study
* Subject received an additional pain interventional procedure within 60 days prior to the beginning of the study

Primary outcomes:
measure: Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:1 Intermittent Dosing
timeFrame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing
measure: Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:2 Intermittent Dosing
timeFrame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing
Secondary outcomes:
measure: Change in Quality of Life Between Continuous and 1:1 Intermittent Dosing
timeFrame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing
measure: Change in Quality of Life Between Continuous and 1:2 Intermittent Dosing
timeFrame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing
measure: Change in Disability Index Between Continuous and 1:1 Intermittent Dosing
timeFrame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing
measure: Change in Disability Index Between Continuous and 1:2 Intermittent Dosing
timeFrame: After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing
Other outcomes:
measure: Stimulation Program Peference
timeFrame: 6 week follow up visit after completing all 3 stimulation programs
Locations:
city: New York
country: United States
facility: Spine and Pain Institute NY
state: New York
Study officials:
References:
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