Intermittent vs. Continuous Dorsal Root Ganglion Stimulation

September 21, 2021 updated by: Kenneth Chapman, Spine and Pain Institute of New York

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Spine and Pain Institute NY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stimulation Program Peference
Time Frame: 6 week follow up visit after completing all 3 stimulation programs
Percentage of patients preferring each stimulation program
6 week follow up visit after completing all 3 stimulation programs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spine and Pain Institute of New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 23, 2021

Primary Completion (ACTUAL)

August 1, 2021

Study Completion (ANTICIPATED)

September 15, 2021

Study Registration Dates

First Submitted

January 22, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (ACTUAL)

January 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Intermittent DRG-S Dosing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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