PMID- 28324697
OWN - NLM
STAT- MEDLINE
DCOM- 20181023
LR  - 20181023
IS  - 2468-7812 (Electronic)
IS  - 2468-7812 (Linking)
VI  - 29
DP  - 2017 Jun
TI  - Adverse events in a chiropractic spinal manipulative therapy single-blinded, 
      placebo, randomized controlled trial for migraineurs.
PG  - 66-71
LID - S2468-7812(17)30054-1 [pii]
LID - 10.1016/j.msksp.2017.03.003 [doi]
AB  - BACKGROUND: Unlike pharmacological randomized controlled trials (RCTs), 
      manual-therapy RCTs do not always report adverse events (AEs). The few 
      manual-therapy RCTs that provide information on AEs are frequently without 
      details, such as the type and-, severity of the AE and reason for withdrawal. 
      OBJECTIVE: To prospectively report all AEs in a chiropractic spinal manipulative 
      therapy (CSMT) RCT. DESIGN: A prospective 3-armed, single-blinded, placebo, RCT. 
      METHODS: Seventy migraineurs were randomized to the CSMT or a placebo, with 12 
      intervention sessions over three months. The recommendations by CONSORT and the 
      International Headache Society's Task Force on AEs in migraine RCTs were 
      followed. A standardized reporting scheme designed for pharmacological RCTs was 
      used, and the AEs were described as frequencies and percentages within each 
      group. The 95% confidence intervals (CIs) for the percentages (absolute risk) of 
      AEs in each group were calculated when possible. Attributable risk (%) and 
      relative risk were calculated with the corresponding 95% CIs. RESULTS: AEs were 
      assessed in 703 sessions, with 355 in the CSMT group and 348 in the placebo 
      group. Local tenderness was the most common AE, reported by 11.3% and 6.9% of the 
      CSMT group and the placebo group, respectively, and tiredness on the intervention 
      day was reported by 8.5% and 1.4% of CSMT group and the placebo group, 
      respectively. The highest attributable risk was for tiredness on the treatment 
      day, 7.0% (CI 3.9-10.2%) which presented a relative risk of 5.9 (CI 2.3-15.0). 
      CONCLUSIONS: AEs were mild and transient, and severe or serious AEs were not 
      observed.
CI  - Copyright (c) 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Chaibi, Aleksander
AU  - Chaibi A
AD  - Head and Neck Research Group, Research Centre, Akershus University Hospital, 
      1478, Lorenskog, Oslo, Norway; Institute of Clinical Medicine, Campus Akershus 
      University Hospital, University of Oslo, 1474, Nordbyhagen, Oslo, Norway. 
      Electronic address: aleksander.chaibi@medisin.uio.no.
FAU - Benth, Jurate Saltyte
AU  - Benth JS
AD  - Institute of Clinical Medicine, Campus Akershus University Hospital, University 
      of Oslo, 1474, Nordbyhagen, Oslo, Norway; HOKH, Research Centre, Akershus 
      University Hospital, 1478, Lorenskog, Oslo, Norway. Electronic address: 
      jurate.saltyte-benth@medisin.uio.no.
FAU - Tuchin, Peter J
AU  - Tuchin PJ
AD  - Department of Chiropractic, Macquarie University, NSW, 2109, Australia. 
      Electronic address: peter.tuchin@mq.edu.au.
FAU - Russell, Michael Bjorn
AU  - Russell MB
AD  - Head and Neck Research Group, Research Centre, Akershus University Hospital, 
      1478, Lorenskog, Oslo, Norway; Institute of Clinical Medicine, Campus Akershus 
      University Hospital, University of Oslo, 1474, Nordbyhagen, Oslo, Norway. 
      Electronic address: m.b.russell@medisin.uio.no.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20170314
PL  - Netherlands
TA  - Musculoskelet Sci Pract
JT  - Musculoskeletal science & practice
JID - 101692753
SB  - IM
EIN - Musculoskelet Sci Pract. 2017 Oct;31:21. PMID: 28628805
CIN - J Am Osteopath Assoc. 2018 Jul 1;118(7):482-483. PMID: 29946667
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Female
MH  - Humans
MH  - Male
MH  - Manipulation, Chiropractic/*adverse effects/*methods
MH  - Manipulation, Spinal/*adverse effects/*methods
MH  - Middle Aged
MH  - Migraine Disorders/*therapy
MH  - Norway
MH  - Pain/*etiology
MH  - Placebo Effect
MH  - Single-Blind Method
MH  - Young Adult
OTO - NOTNLM
OT  - Adverse events
OT  - Chiropractic
OT  - Migraine
OT  - RCT
OT  - Randomized controlled trial
OT  - Side effects
OT  - Spinal manipulative therapy
EDAT- 2017/03/23 06:00
MHDA- 2018/10/24 06:00
CRDT- 2017/03/22 06:00
PHST- 2016/12/15 00:00 [received]
PHST- 2017/02/27 00:00 [revised]
PHST- 2017/03/11 00:00 [accepted]
PHST- 2017/03/23 06:00 [pubmed]
PHST- 2018/10/24 06:00 [medline]
PHST- 2017/03/22 06:00 [entrez]
AID - S2468-7812(17)30054-1 [pii]
AID - 10.1016/j.msksp.2017.03.003 [doi]
PST - ppublish
SO  - Musculoskelet Sci Pract. 2017 Jun;29:66-71. doi: 10.1016/j.msksp.2017.03.003. 
      Epub 2017 Mar 14.