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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous DRG-S Dosing | Active Comparator | 2 week stimulation program using continuous DRG-S dosing at standard stimulation parameters |
|
| 1 minute on: 1 minute off Intermittent DRG-S Dosing | Experimental | 2 week stimulation program using 1 minute on: 1 minute off intermittent DRG-S dosing at standard stimulation parameters |
|
| 1 minute on: 2 minutes off Intermittent DRG-S Dosing | Experimental | 2 week stimulation program using 1 minute on: 2 minutes off intermittent DRG-S dosing at standard stimulation parameters |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Numerical Rating Scale (NRS) Pain Scores Between Continuous and 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life Between Continuous and 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Stimulation Program Peference | Percentage of patients preferring each stimulation program | 6 week follow up visit after completing all 3 stimulation programs |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spine and Pain Institute NY | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28030470 | Background | Deer TR, Levy RM, Kramer J, Poree L, Amirdelfan K, Grigsby E, Staats P, Burton AW, Burgher AH, Obray J, Scowcroft J, Golovac S, Kapural L, Paicius R, Kim C, Pope J, Yearwood T, Samuel S, McRoberts WP, Cassim H, Netherton M, Miller N, Schaufele M, Tavel E, Davis T, Davis K, Johnson L, Mekhail N. Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial. Pain. 2017 Apr;158(4):669-681. doi: 10.1097/j.pain.0000000000000814. | |
| 27150431 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 8, 2025 | Jul 24, 2025 | 3 |
| ID | Term |
|---|---|
| D010148 | Pain, Intractable |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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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.
| Change in Quality of Life Between Continuous and 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 | 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 | 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 |
| Background |
| Miller JP, Eldabe S, Buchser E, Johanek LM, Guan Y, Linderoth B. Parameters of Spinal Cord Stimulation and Their Role in Electrical Charge Delivery: A Review. Neuromodulation. 2016 Jun;19(4):373-84. doi: 10.1111/ner.12438. Epub 2016 May 6. |
| 33236811 | Background | Chapman KB, Yousef TA, Foster A, D Stanton-Hicks M, van Helmond N. Mechanisms for the Clinical Utility of Low-Frequency Stimulation in Neuromodulation of the Dorsal Root Ganglion. Neuromodulation. 2021 Jun;24(4):738-745. doi: 10.1111/ner.13323. Epub 2020 Nov 25. |
| 33227827 | Background | Chapman KB, Yousef TA, Vissers KC, van Helmond N, D Stanton-Hicks M. Very Low Frequencies Maintain Pain Relief From Dorsal Root Ganglion Stimulation: An Evaluation of Dorsal Root Ganglion Neurostimulation Frequency Tapering. Neuromodulation. 2021 Jun;24(4):746-752. doi: 10.1111/ner.13322. Epub 2020 Nov 23. |
| 31152179 | Background | Esposito MF, Malayil R, Hanes M, Deer T. Unique Characteristics of the Dorsal Root Ganglion as a Target for Neuromodulation. Pain Med. 2019 Jun 1;20(Suppl 1):S23-S30. doi: 10.1093/pm/pnz012. |
| 23421796 | Background | Koopmeiners AS, Mueller S, Kramer J, Hogan QH. Effect of electrical field stimulation on dorsal root ganglion neuronal function. Neuromodulation. 2013 Jul-Aug;16(4):304-11; discussion 310-1. doi: 10.1111/ner.12028. Epub 2013 Feb 19. |
| 27989460 | Background | Arcourt A, Gorham L, Dhandapani R, Prato V, Taberner FJ, Wende H, Gangadharan V, Birchmeier C, Heppenstall PA, Lechner SG. Touch Receptor-Derived Sensory Information Alleviates Acute Pain Signaling and Fine-Tunes Nociceptive Reflex Coordination. Neuron. 2017 Jan 4;93(1):179-193. doi: 10.1016/j.neuron.2016.11.027. Epub 2016 Dec 15. |
| 31524325 | Background | Koetsier E, Franken G, Debets J, van Kuijk SMJ, Linderoth B, Joosten EA, Maino P. Dorsal Root Ganglion Stimulation in Experimental Painful Diabetic Polyneuropathy: Delayed Wash-Out of Pain Relief After Low-Frequency (1Hz) Stimulation. Neuromodulation. 2020 Feb;23(2):177-184. doi: 10.1111/ner.13048. Epub 2019 Sep 16. |
| 30456795 | Background | Vesper J, Slotty P, Schu S, Poeggel-Kraemer K, Littges H, Van Looy P, Agnesi F, Venkatesan L, Van Havenbergh T. Burst SCS Microdosing Is as Efficacious as Standard Burst SCS in Treating Chronic Back and Leg Pain: Results From a Randomized Controlled Trial. Neuromodulation. 2019 Feb;22(2):190-193. doi: 10.1111/ner.12883. Epub 2018 Nov 19. |
| 32202044 | Background | Deer TR, Patterson DG, Baksh J, Pope JE, Mehta P, Raza A, Agnesi F, Chakravarthy KV. Novel Intermittent Dosing Burst Paradigm in Spinal Cord Stimulation. Neuromodulation. 2021 Apr;24(3):566-573. doi: 10.1111/ner.13143. Epub 2020 Mar 23. |