Intermittent vs. Continuous Dorsal Root Ganglion Stimulation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intermittent Dorsal Root Ganglion Stimulation Dosing Comparison to Standard Continuous Dosing in Treating Chronic Pain

Conditions
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Pain, Intractable, Pain, Chronic

Intervention / Treatment
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* Device: Dorsal Root Ganglion Stimulation (DRG-S)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous DRG-S Dosing<br>2 week stimulation program using continuous DRG-S dosing at standard stimulation parameters | Device: Dorsal Root Ganglion Stimulation (DRG-S)<br>* Dorsal Root Ganglion stimulation will be delivered with continuous dosing and 2 different ON/OFF periods to compare effects for each patient.<br>|
| Experimental: 1 minute on: 1 minute off Intermittent DRG-S Dosing<br>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)<br>* Dorsal Root Ganglion stimulation will be delivered with continuous dosing and 2 different ON/OFF periods to compare effects for each patient.<br>|
| Experimental: 1 minute on: 2 minutes off Intermittent DRG-S Dosing<br>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)<br>* Dorsal Root Ganglion stimulation will be delivered with continuous dosing and 2 different ON/OFF periods to compare effects for each patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dorsal Root Ganglion Stimulation, Intermittent Stimulation Dosing