PMID- 37589641
OWN - NLM
STAT- MEDLINE
DCOM- 20231009
LR  - 20231018
IS  - 1525-1403 (Electronic)
IS  - 1094-7159 (Linking)
VI  - 26
IP  - 7
DP  - 2023 Oct
TI  - Multiphase Spinal Cord Stimulation in Participants With Chronic Back or Leg Pain: 
      Results of the BENEFIT-02 Randomized Clinical Trial.
PG  - 1400-1411
LID - S1094-7159(23)00702-X [pii]
LID - 10.1016/j.neurom.2023.05.006 [doi]
AB  - OBJECTIVE: This study aimed to assess the safety and effectiveness of a new 
      charge-distributed multiphase stimulation paradigm during an extended spinal cord 
      stimulation (SCS) trial. MATERIALS AND METHODS: This prospective, multicenter, 
      randomized, single-blind, feasibility study included participants with chronic 
      low back and/or leg pain and baseline numerical rating scale (NRS) for overall 
      pain intensity >/=6. After a successful commercial SCS trial, participants were 
      randomized to multiphase SCS therapy A (approximately 600-1500 Hz) or B 
      (approximately 300-600 Hz), delivered via an investigational external pulse 
      generator and existing leads during an 11-to-12-day testing period. Primary end 
      points were mean NRS change from baseline to final in-office visit for each 
      multiphase therapy and between therapies. Secondary end points included mean NRS 
      change from end of commercial trial to final study visit and incidence of 
      device-related adverse events (AEs). Additional measures included 
      patient-reported outcomes collected at home through electronic watches and 
      written diaries. Power usage was compared between multiphase and commercial 
      therapies. RESULTS: A total of 122 participants initiated a commercial trial; 77 
      were randomized to a multiphase arm, and 65 completed the study. Reductions in 
      mean NRS scores from baseline to final study visit were significant for 
      multiphase therapy A and B (-4.3 and -4.7, respectively; both p < 0.0001). There 
      was no statistically significant difference in mean NRS reduction or percent pain 
      relief between multiphase therapies. In an additional analysis, 63.9% of 
      participants reported greater pain relief with multiphase than with commercial 
      SCS therapy in the at-home setting. On average, multiphase required less power 
      than did commercial devices. One non-serious device-related AE was reported, and 
      no infections occurred during the extended trial. CONCLUSIONS: Multiphase SCS 
      effectively reduced pain in participants with chronic low back and/or leg pain 
      during a trial, with no unanticipated device-related AEs reported. Future studies 
      should evaluate long-term effectiveness of multiphase stimulation. CLINICAL TRIAL 
      REGISTRATION: The Clinicaltrials.gov registration number for the study is 
      NCT03594266.
CI  - Copyright (c) 2023 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Kapural, Leonardo
AU  - Kapural L
AD  - Carolinas Pain Institute, Winston-Salem, NC, USA. Electronic address: 
      lkapuralmd@gmail.com.
FAU - Patterson, Denis G
AU  - Patterson DG
AD  - Nevada Advanced Pain Specialists, Reno, NV, USA.
FAU - Li, Sean
AU  - Li S
AD  - Premier Pain Centers, Shrewsbury, NJ, USA.
FAU - Hatheway, John
AU  - Hatheway J
AD  - Northwest Pain Care, PS, Spokane, WA, USA.
FAU - Hunter, Corey
AU  - Hunter C
AD  - Ainsworth Institute of Pain Management, New York, NY, USA.
FAU - Rosen, Steven
AU  - Rosen S
AD  - Delaware Valley Pain and Spine Institute, Trevose, PA, USA.
FAU - Fishman, Michael
AU  - Fishman M
AD  - Center for Interventional Pain and Spine, Lancaster, PA, USA.
FAU - Gupta, Mayank
AU  - Gupta M
AD  - Neuroscience Research Center DBA Kansas Pain Management, Overland Park, KS, USA.
FAU - Sayed, Dawood
AU  - Sayed D
AD  - The University of Kansas Health System, Kansas City, KS, USA.
FAU - Christopher, Anne
AU  - Christopher A
AD  - St Louis Pain Consultants, Chesterfield, MO, USA.
FAU - Burgher, Abram
AU  - Burgher A
AD  - Hope Research Institute, LLC, Phoenix, AZ, USA.
FAU - McJunkin, Tory
AU  - McJunkin T
AD  - Arizona Pain Specialists, Scottsdale, AZ, USA.
FAU - Ross, Edgar L
AU  - Ross EL
AD  - Brigham and Women's Hospital, Chestnut Hill, MA, USA.
FAU - Provenzano, David
AU  - Provenzano D
AD  - Pain Diagnostics and Interventional Care, Sewickley, PA, USA.
FAU - Amirdelfan, Kasra
AU  - Amirdelfan K
AD  - Boomerang Healthcare, Walnut Creek, CA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03594266
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20230816
PL  - United States
TA  - Neuromodulation
JT  - Neuromodulation : journal of the International Neuromodulation Society
JID - 9804159
SB  - IM
MH  - Humans
MH  - *Spinal Cord Stimulation/adverse effects/methods
MH  - *Chronic Pain/diagnosis/therapy
MH  - Leg
MH  - Prospective Studies
MH  - Single-Blind Method
MH  - Treatment Outcome
MH  - Spinal Cord
OTO - NOTNLM
OT  - Chronic pain
OT  - clinical trial
OT  - multiphase
OT  - remote monitoring
OT  - spinal cord stimulation
EDAT- 2023/08/17 12:41
MHDA- 2023/10/09 06:41
CRDT- 2023/08/17 10:34
PHST- 2023/03/16 00:00 [received]
PHST- 2023/05/05 00:00 [revised]
PHST- 2023/05/24 00:00 [accepted]
PHST- 2023/10/09 06:41 [medline]
PHST- 2023/08/17 12:41 [pubmed]
PHST- 2023/08/17 10:34 [entrez]
AID - S1094-7159(23)00702-X [pii]
AID - 10.1016/j.neurom.2023.05.006 [doi]
PST - ppublish
SO  - Neuromodulation. 2023 Oct;26(7):1400-1411. doi: 10.1016/j.neurom.2023.05.006. 
      Epub 2023 Aug 16.