PMID- 27779368
OWN - NLM
STAT- MEDLINE
DCOM- 20180123
LR  - 20181202
IS  - 1533-2500 (Electronic)
IS  - 1530-7085 (Linking)
VI  - 17
IP  - 5
DP  - 2017 Jun
TI  - Safety and Efficacy of Occipital Nerves Stimulation for the Treatment of Chronic 
      Migraines: Randomized, Double-blind, Controlled Single-center Experience.
PG  - 669-677
LID - 10.1111/papr.12504 [doi]
AB  - BACKGROUND: A recent multicenter study presented 52-week safety and efficacy 
      results from an open-label extension of a randomized, sham-controlled trial for 
      patients with chronic migraine (CM) undergoing peripheral nerve stimulation of 
      the occipital nerves. We present the data from a single center of 20 patients 
      enrolled at the Cleveland Clinic's Pain Management Department. METHODS: In this 
      single center, 20 patients were implanted with a neurostimulation system, 
      randomized to an active or control group for 12 weeks, and received open-label 
      treatment for an additional 40 weeks. Outcomes collected included number of 
      headache days, pain intensity, Migraine Disability Assessment (MIDAS), Zung Pain 
      and Distress (PAD), direct patient reports of headache pain relief, quality of 
      life, satisfaction, and adverse events (AEs). RESULTS: Headache days per month 
      were reduced by 8.51 (+/-9.81) days (P < 0.0001). The proportion of patients who 
      achieved a 30% and 50% reduction in headache days and/or pain intensity was 60% 
      and 35%, respectively. MIDAS and Zung PAD were reduced for all patients. Fifteen 
      (75%) of the 20 patients at the site reported at least one AE. A total of 20 AEs 
      were reported from the site. CONCLUSION: Our results support the 12-month 
      efficacy of 20 CM patients receiving peripheral nerve stimulation of the 
      occipital nerves in this single-center trial.
CI  - (c) 2016 World Institute of Pain.
FAU - Mekhail, Nagy A
AU  - Mekhail NA
AD  - Pain Management Department, Cleveland Clinic, Cleveland, Ohio, U.S.A.
FAU - Estemalik, Emad
AU  - Estemalik E
AD  - Center for Neurological Restoration, Cleveland Clinic, Cleveland, Ohio, U.S.A.
FAU - Azer, Gerges
AU  - Azer G
AD  - Evidence Based Pain Medicine Research, Cleveland Clinic, Cleveland, Ohio, U.S.A.
FAU - Davis, Kristina
AU  - Davis K
AD  - Center for Neurological Restoration, Cleveland Clinic, Cleveland, Ohio, U.S.A.
FAU - Tepper, Stuart J
AU  - Tepper SJ
AD  - Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio, U.S.A.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20161025
PL  - United States
TA  - Pain Pract
JT  - Pain practice : the official journal of World Institute of Pain
JID - 101130835
SB  - IM
MH  - Adult
MH  - Double-Blind Method
MH  - Electric Stimulation Therapy/*methods
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Migraine Disorders/*therapy
MH  - Pain Management/*methods
MH  - Peripheral Nerves/physiology
MH  - Quality of Life
MH  - Treatment Outcome
OTO - NOTNLM
OT  - causalgia
OT  - complex regional pain syndrome
OT  - neuromodulation
OT  - reflex sympathetic dystrophy
OT  - spinal cord stimulation
EDAT- 2016/10/26 06:00
MHDA- 2018/01/24 06:00
CRDT- 2016/10/26 06:00
PHST- 2016/02/15 00:00 [received]
PHST- 2016/06/22 00:00 [revised]
PHST- 2016/07/08 00:00 [accepted]
PHST- 2016/10/26 06:00 [pubmed]
PHST- 2018/01/24 06:00 [medline]
PHST- 2016/10/26 06:00 [entrez]
AID - 10.1111/papr.12504 [doi]
PST - ppublish
SO  - Pain Pract. 2017 Jun;17(5):669-677. doi: 10.1111/papr.12504. Epub 2016 Oct 25.