Intermittent vs. Continuous Dorsal Root Ganglion Stimulation

Not Applicable

• Conditions: Pain, Intractable; Pain, Chronic
• Interventions: Device: Dorsal Root Ganglion Stimulation (DRG-S)

• Registration Number: NCT04727216
• Lead Sponsor: Spine and Pain Institute of New York

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.

Study Timeline

• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-27
• Study Start: 2021-03-23
• Primary Completion: 2021-08-01
• Status Verified: 2021-09
• Study Completion: 2021-09-15
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1 minute on: 1 minute off Intermittent DRG-S Dosing	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
1 minute on: 2 minutes off Intermittent DRG-S Dosing	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
Continuous DRG-S Dosing	Dorsal Root Ganglion Stimulation (DRG-S)	2 week stimulation program using continuous DRG-S dosing at standard stimulation parameters

Primary Outcome Measures

Name	Time	Method
Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:1 Intermittent Dosing	After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:1 intermittent dosing	Pain Questionnaire - (Scale is 0 to 10 with 0 being no pain and 10 being worst pain imaginable)
Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:2 Intermittent Dosing	After 2 weeks of continuous stimulation dosing and after 2 weeks of 1:2 intermittent dosing	Pain Questionnaire - (Scale is 0 to 10 with 0 being no pain and 10 being worst pain imaginable)

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life Between Continuous and 1:2 Intermittent Dosing	After 2 weeks of continuous stimulation dosing and after 2 weeks of 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)
Change in Quality of Life Between Continuous and 1:1 Intermittent Dosing	After 2 weeks of continuous stimulation dosing and after 2 weeks of 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)
Change in Disability Index Between Continuous and 1:1 Intermittent Dosing	After 2 weeks of continuous stimulation dosing and after 2 weeks of 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)
Change in Disability Index Between Continuous and 1:2 Intermittent Dosing	After 2 weeks of continuous stimulation dosing and after 2 weeks of 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)

Trial Locations

Locations (1)

Spine and Pain Institute NY; 🇺🇸 New York, New York, United States