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Active, Not Recruiting

NCT Number: NCT04727216

Intermittent vs. Continuous Dorsal Root Ganglion Stimulation

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spine and Pain Institute NY

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dorsal Root Ganglion Stimulation (DRG-S)

Device

Dorsal Root Ganglion stimulation will be delivered with continuous dosing and 2 different ON/OFF periods to compare effects for each patient.

Primary outcomes

  1. Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:1 Intermittent Dosing

    Time frame: 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)

  2. Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:2 Intermittent Dosing

    Time frame: 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 outcomes

  1. Change in Quality of Life Between Continuous and 1:1 Intermittent Dosing

    Time frame: 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)

  2. Change in Quality of Life Between Continuous and 1:2 Intermittent Dosing

    Time frame: 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)

  3. Change in Disability Index Between Continuous and 1:1 Intermittent Dosing

    Time frame: 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)

  4. Change in Disability Index Between Continuous and 1:2 Intermittent Dosing

    Time frame: 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)

Other outcomes

  1. Stimulation Program Peference

    Time frame: 6 week follow up visit after completing all 3 stimulation programs

    Percentage of patients preferring each stimulation program

Sponsors and collaborators

Lead sponsor

Spine and Pain Institute of New York

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2021
Registry last updated
Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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