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J Pain. 2019 Sep 5. pii: S1526-5900(18)30681-3. doi: 10.1016/j.jpain.2019.08.005. [Epub ahead of print]

Therapy Habituation at 12 Months: Spinal Cord Stimulation Versus Dorsal Root Ganglion Stimulation for Complex Regional Pain Syndrome Type I and II.

Author information

1
Marcus Neuroscience Institute, Boca Raton, FL 33486, USA.
2
Cleveland Clinic, Cleveland, OH 44195, USA.
3
Volta Research and University of Illinois College of Medicine, Chicago, IL 60612, USA.
4
University of California at San Francisco CA 94115, USA.
5
IPM Medical Group, Inc., Walnut Creek CA 94598, USA.
6
Neurovations, Napa, CA 94558, USA.
7
Premier Pain Center, Shrewsbury Township NJ 07702, USA.
8
Abbott Neuromodulation, Plano, TX 75024, USA.
9
HOPE Research - TPC, Phoenix, AZ 85018, USA.
10
Pain Management Associates, Independence MO 64086, USA.
11
Florida Pain, Merritt Island, FL 32940, USA.
12
Carolinas Pain Institute, Winston-Salem NC 27103, USA.
13
Newport Beach Headache and Pain, Newport Beach CA 92660, USA.
14
Evolve Restorative Center, Santa Rosa, CA 95403, USA.
15
Holy Cross Hospital, Ft. Lauderdale FL 33308, USA.
16
Drug Studies America, Marietta GA 30060, USA.
17
Abbott Neuromodulation, Plano, TX 75024, USA. Electronic address: alex.kent@abbott.com.
18
Center for Pain Relief, Charleston WV 25301, USA.

Abstract

The ACCURATE randomized, controlled trial compared outcomes of dorsal root ganglion (DRG) stimulation versus tonic spinal cord stimulation (SCS) in 152 subjects with chronic lower extremity pain due to complex regional pain syndrome (CRPS) type I or II. This ACCURATE sub-study was designed to evaluate whether therapy habituation occurs with DRG stimulation as compared to SCS through 12-months. A modified intention-to-treat analysis was performed to assess percentage pain relief (PPR) and responder rates at follow-up visits (end-of-trial, 1, 3, 6, 9, 12-months post-permanent implant) for all subjects that completed trial stimulation (DRG:N=73, SCS:N=72). For both groups, mean PPR was significantly greater at end-of-trial (DRG:82.2%, SCS:77.0%) than all other follow-ups. Following permanent DRG system implantation, none of the time points were significantly different from one another in PPR (range:69.3-73.9%). For the SCS group, PPR at 9-months (58.3%) and 12-months (57.9%) was significantly less than at 1-month (66.9%). The responder rate also decreased for the SCS group from 1-month (68.1%) to 12-months (61.1%). After stratifying by diagnosis, it was found that only the CRPS-I population had diminishing pain relief with SCS. DRG stimulation resulted in more stable pain relief through 12-months, while tonic SCS demonstrated therapy habituation at 9- and 12-months. Trial Registration: The ACCURATE study was registered at ClinicalTrials.gov with Identifier NCT01923285. Perspective: This article reports on an ACCURATE sub-study, which found that long-term therapy habituation occurred at 12-months with SCS, but not DRG stimulation, in patients with CRPS. The underlying mechanisms of action for these results remain unclear, although several lines of inquiry are proposed.

KEYWORDS:

complex regional pain syndrome; dorsal root ganglion stimulation; habituation; spinal cord stimulation; tolerance

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