Intermittent vs. Continuous Dorsal Root Ganglion Stimulation

Spine and Pain Institute of New York

Status: Unknown

Conditions: Pain, Intractable; Pain, Chronic

Treatments: Device: Dorsal Root Ganglion Stimulation (DRG-S)

Study type: Interventional

Funder types: Other

Identifiers

NCT04727216

Intermittent DRG-S Dosing

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

15 participants in 3 patient groups

Continuous DRG-S Dosing

Active Comparator group

Description:

2 week stimulation program using continuous DRG-S dosing at standard stimulation parameters

Treatment:

Device: Dorsal Root Ganglion Stimulation (DRG-S)

1 minute on: 1 minute off Intermittent DRG-S Dosing

Experimental group

Description:

2 week stimulation program using 1 minute on: 1 minute off intermittent DRG-S dosing at standard stimulation parameters

Treatment:

Device: Dorsal Root Ganglion Stimulation (DRG-S)

1 minute on: 2 minutes off Intermittent DRG-S Dosing

Experimental group

Description:

2 week stimulation program using 1 minute on: 2 minutes off intermittent DRG-S dosing at standard stimulation parameters

Treatment:

Device: Dorsal Root Ganglion Stimulation (DRG-S)