Pain, Chronic, Pain, Intractable
Conditions
Keywords
Dorsal Root Ganglion Stimulation, Intermittent Stimulation Dosing
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.
Interventions
DEVICEDorsal 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.
Sponsors
Spine and Pain Institute of New York
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants will be blinded to which stimulation program they are receiving during each 2 week cycle. The Investigator who is also the care provider will be blinded to both the stimulation they are receiving and the sequential order they are given in. The outcomes assessor will be blinded to the sequential order of the stimulation programs each participant receives.
Intervention model description
Subjects will undergo 3 sequential 2-week dosing stimulation programs \[1.) continuous, 2.) 1 minute on: 1 minute off, and 3.) 1 minute on: 2 minutes\] in randomized order and double blinded fashion for a total of 6 consecutive weeks.
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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) |
| 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 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stimulation Program Peference | 6 week follow up visit after completing all 3 stimulation programs | Percentage of patients preferring each stimulation program |
Countries
United States
Outcome results
None listed