PMID- 23294685
OWN - NLM
STAT- MEDLINE
DCOM- 20130801
LR  - 20161125
IS  - 1532-9283 (Electronic)
IS  - 1360-8592 (Linking)
VI  - 17
IP  - 1
DP  - 2013 Jan
TI  - The suitability of sham treatments for use as placebo controls in trials of 
      spinal manipulative therapy: a pilot study.
PG  - 59-68
LID - S1360-8592(12)00166-0 [pii]
LID - 10.1016/j.jbmt.2012.06.005 [doi]
AB  - Despite the augmented use and dependence on manual therapy (MT), there are still 
      calls from both within and outside the MT professions to provide robust evidence 
      that spinal manipulative therapy (SMT) induces therapeutic effects beyond 
      placebo. To facilitate this, placebo or 'sham' treatments, the development of 
      which is notoriously difficult, must be used in rigorously controlled trials. The 
      aim of this study was to investigate the suitability of different shams as 
      controls in SMT trials. A repeated measures, single-blind, randomised trial was 
      conducted on 10 asymptomatic subjects. Pain pressure thresholds (PPTs) were 
      measured at 2 sites, local and systemic, before and after the application of 
      either high-velocity low-amplitude thrust (HVLAT), sham functional technique 
      (SFT), sham ultrasound (SUS) or no intervention control (NIC) to the 
      cervico-thoracic (CT) junctional area. Treatment credibility was then assessed 
      using a 4-point Likert Scale in response to 4 statements. Results demonstrated no 
      significant change in PPT following any of the interventions, irrespective of 
      site tested. The effect sizes for all interventions were considered small 
      (d = <0.2). There were significant differences in Likert Scale responses for each 
      statement (P < 0.001), with SUS eliciting significantly different responses as 
      compared to SFT and NIC but not, predominantly, with HVLAT. SUS is implicated as 
      being the most effective sham, having high fidelity to subjects' perceptions of a 
      'real' treatment, whilst being therapeutically inert i.e. results in no 
      significant change in clinical status.
CI  - Copyright (c) 2012 Elsevier Ltd. All rights reserved.
FAU - Lougee, Hannah
AU  - Lougee H
AD  - Research Department, The British College of Osteopathic Medicine, London, United 
      Kingdom.
FAU - Johnston, Ross G
AU  - Johnston RG
FAU - Thomson, Oliver P
AU  - Thomson OP
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20120706
PL  - United States
TA  - J Bodyw Mov Ther
JT  - Journal of bodywork and movement therapies
JID - 9700068
RN  - 0 (Placebos)
SB  - IM
MH  - Adult
MH  - Analysis of Variance
MH  - Anthropometry
MH  - Cervical Vertebrae/diagnostic imaging
MH  - Confidence Intervals
MH  - Female
MH  - Humans
MH  - Male
MH  - Manipulation, Spinal/*methods
MH  - Pain Measurement/methods
MH  - Pain Threshold/*physiology
MH  - Pilot Projects
MH  - Placebos
MH  - Prone Position
MH  - Reference Values
MH  - Single-Blind Method
MH  - Spine/*diagnostic imaging
MH  - Thoracic Vertebrae/diagnostic imaging
MH  - Ultrasonography, Doppler/methods
MH  - Young Adult
EDAT- 2013/01/09 06:00
MHDA- 2013/08/02 06:00
CRDT- 2013/01/09 06:00
PHST- 2012/03/22 00:00 [received]
PHST- 2012/06/07 00:00 [revised]
PHST- 2012/06/12 00:00 [accepted]
PHST- 2013/01/09 06:00 [entrez]
PHST- 2013/01/09 06:00 [pubmed]
PHST- 2013/08/02 06:00 [medline]
AID - S1360-8592(12)00166-0 [pii]
AID - 10.1016/j.jbmt.2012.06.005 [doi]
PST - ppublish
SO  - J Bodyw Mov Ther. 2013 Jan;17(1):59-68. doi: 10.1016/j.jbmt.2012.06.005. Epub 
      2012 Jul 6.