PMID- 29244235
OWN - NLM
STAT- MEDLINE
DCOM- 20180727
LR  - 20220210
IS  - 1525-1403 (Electronic)
IS  - 1094-7159 (Print)
IS  - 1094-7159 (Linking)
VI  - 21
IP  - 1
DP  - 2018 Jan
TI  - New Therapy for Refractory Chronic Mechanical Low Back Pain-Restorative 
      Neurostimulation to Activate the Lumbar Multifidus: One Year Results of a 
      Prospective Multicenter Clinical Trial.
PG  - 48-55
LID - 10.1111/ner.12741 [doi]
AB  - OBJECTIVES: The purpose of the international multicenter prospective single arm 
      clinical trial was to evaluate restorative neurostimulation eliciting episodic 
      contraction of the lumbar multifidus for treatment of chronic mechanical low back 
      pain (CMLBP) in patients who have failed conventional therapy and are not 
      candidates for surgery or spinal cord stimulation (SCS). MATERIALS AND METHODS: 
      Fifty-three subjects were implanted with a neurostimulator (ReActiv8, Mainstay 
      Medical Limited, Dublin, Ireland). Leads were positioned bilaterally with 
      electrodes close to the medial branch of the L2 dorsal ramus nerve. The primary 
      outcome measure was low back pain evaluated on a 10-Point Numerical Rating Scale 
      (NRS). Responders were defined as subjects with an improvement of at least the 
      Minimal Clinically Important Difference (MCID) of >/=2-point in low back pain NRS 
      without a clinically meaningful increase in LBP medications at 90 days. Secondary 
      outcome measures included Oswestry Disability Index (ODI) and Quality of Life 
      (QoL; EQ-5D). RESULTS: For 53 subjects with an average duration of CLBP of 14 
      years and average NRS of 7 and for whom no other therapies had provided 
      satisfactory pain relief, the responder rate was 58%. The percentage of subjects 
      at 90 days, six months, and one year with >/=MCID improvement in single day NRS was 
      63%, 61%, and 57%, respectively. Percentage of subjects with >/=MCID improvement in 
      ODI was 52%, 57%, and 60% while those with >/=MCID improvement in EQ-5D was 88%, 
      82%, and 81%. There were no unanticipated adverse events (AEs) or serious AEs 
      related to the device, procedure, or therapy. The initial surgical approach led 
      to a risk of lead fracture, which was mitigated by a modification to the surgical 
      approach. CONCLUSIONS: Electrical stimulation to elicit episodic lumbar 
      multifidus contraction is a new treatment option for CMLBP. Results demonstrate 
      clinically important, statistically significant, and lasting improvement in pain, 
      disability, and QoL.
CI  - (c) 2017 The Authors. Neuromodulation: Technology at the Neural Interface published 
      by Wiley Periodicals, Inc. on behalf of International Neuromodulation Society.
FAU - Deckers, Kristiaan
AU  - Deckers K
AD  - GZA Hospitals, Wilrijk, Belgium.
FAU - De Smedt, Kris
AU  - De Smedt K
AD  - GZA Hospitals, Wilrijk, Belgium.
FAU - Mitchell, Bruce
AU  - Mitchell B
AD  - Monash Clinical Research Pty Ltd, Clayton, VIC, Australia.
FAU - Vivian, David
AU  - Vivian D
AD  - Monash Clinical Research Pty Ltd, Clayton, VIC, Australia.
FAU - Russo, Marc
AU  - Russo M
AD  - Hunter Pain Clinic, Broadmeadow, NSW, Australia.
FAU - Georgius, Peter
AU  - Georgius P
AD  - Sunshine Coast Clinical Research, Noosa Heads, QLD, Australia.
FAU - Green, Matthew
AU  - Green M
AD  - Pain Medicine of South Australia, Welland, SA, Australia.
FAU - Vieceli, John
AU  - Vieceli J
AD  - Pain Medicine of South Australia, Welland, SA, Australia.
FAU - Eldabe, Sam
AU  - Eldabe S
AD  - The James Cook University Hospital, Middlesbrough, UK.
FAU - Gulve, Ashish
AU  - Gulve A
AD  - The James Cook University Hospital, Middlesbrough, UK.
FAU - van Buyten, Jean-Pierre
AU  - van Buyten JP
AD  - Algemeen Ziekenhuis Nikolaas, Sint-Niklaas, Belgium.
FAU - Smet, Iris
AU  - Smet I
AD  - Algemeen Ziekenhuis Nikolaas, Sint-Niklaas, Belgium.
FAU - Mehta, Vivek
AU  - Mehta V
AD  - St. Bartholomew's Hospital, London, UK.
FAU - Ramaswamy, Shankar
AU  - Ramaswamy S
AD  - St. Bartholomew's Hospital, London, UK.
FAU - Baranidharan, Ganesan
AU  - Baranidharan G
AD  - Leeds Teaching Hospitals NHS Trust, Leeds, UK.
FAU - Sullivan, Richard
AU  - Sullivan R
AD  - Precision Neurosurgery, Kew, VIC, Australia.
FAU - Gassin, Robert
AU  - Gassin R
AD  - Precision Neurosurgery, Kew, VIC, Australia.
FAU - Rathmell, James
AU  - Rathmell J
AD  - Brigham and Women's Healthcare, Harvard Medical School, Boston, MA, USA.
FAU - Gilligan, Chris
AU  - Gilligan C
AD  - Brigham and Women's Healthcare, Harvard Medical School, Boston, MA, USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20171215
PL  - United States
TA  - Neuromodulation
JT  - Neuromodulation : journal of the International Neuromodulation Society
JID - 9804159
SB  - IM
MH  - Adult
MH  - Chronic Pain/therapy
MH  - Disability Evaluation
MH  - Disabled Persons
MH  - Electrodes, Implanted
MH  - Female
MH  - Humans
MH  - International Cooperation
MH  - Low Back Pain/psychology/*therapy
MH  - Lumbosacral Region/*physiology
MH  - Male
MH  - Middle Aged
MH  - Pain Measurement
MH  - Prospective Studies
MH  - Quality of Life/psychology
MH  - Spinal Cord Stimulation/*methods
MH  - Time Factors
MH  - *Treatment Outcome
MH  - Young Adult
PMC - PMC5814827
OTO - NOTNLM
OT  - Arthrogenic muscle inhibition
OT  - chronic nonspecific low back pain
OT  - electrical stimulation
OT  - lumbar multifidus
OT  - motor control
EDAT- 2017/12/16 06:00
MHDA- 2018/07/28 06:00
PMCR- 2018/02/16
CRDT- 2017/12/16 06:00
PHST- 2017/08/27 00:00 [received]
PHST- 2017/10/06 00:00 [revised]
PHST- 2017/11/02 00:00 [accepted]
PHST- 2017/12/16 06:00 [pubmed]
PHST- 2018/07/28 06:00 [medline]
PHST- 2017/12/16 06:00 [entrez]
PHST- 2018/02/16 00:00 [pmc-release]
AID - S1094-7159(21)02176-0 [pii]
AID - NER12741 [pii]
AID - 10.1111/ner.12741 [doi]
PST - ppublish
SO  - Neuromodulation. 2018 Jan;21(1):48-55. doi: 10.1111/ner.12741. Epub 2017 Dec 15.