Intermittent Dorsal Root Ganglion Stimulation Dosing Comparison to Standard Continuous Dosing in Treating Chronic Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain, Intractable
- Sponsor
- Spine and Pain Institute of New York
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 1:1 Intermittent Dosing
- Last Updated
- 4 years ago
Overview
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.
Investigators
Kenneth Chapman
Principle Investigator
Spine and Pain Institute of New York
Eligibility Criteria
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
Outcomes
Primary Outcomes
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)
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
- 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)
- 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)
- 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)
- 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)