doi: 10.1093/ecam/nem085. Epub 2007 Sep 13.
Blinding techniques in randomized controlled trials of laser therapy: an overview and possible solution
Affiliations
- PMID:18955233
- PMCID: PMC2586311
- DOI: 10.1093/ecam/nem085
Item in Clipboard
Blinding techniques in randomized controlled trials of laser therapy: an overview and possible solution
Ian Relf et al. Evid Based Complement Alternat Med.2008 Dec.
Display options
Format
Display options
Format
Abstract
Low-level laser therapy has evidence accumulating about its effectiveness in a variety of medical conditions. We reviewed 51 double blind randomized controlled trials (RCTs) of laser treatment. Analysis revealed 58% of trials showed benefit of laser over placebo. However, less than 5% of the trials had addressed beam disguise or allocation concealment in the laser machines used. Many of the trials used blinding methods that rely on staff cooperation and are therefore open to interference or bias. This indicates significant deficiencies in laser trial methodology. We report the development and preliminary testing of a novel laser machine that can blind both patient and operator to treatment allocation without staff participation. The new laser machine combines sealed preset and non-bypassable randomization codes, decoy lights and sound, and a conical perspex tip to overcome laser diode glow detection.
Figures
(A) DBL Laser machine in operation for a placebo treatment. Demonstration of laser probe applied to left hand whilst machine is activated. The dummy red light is visible on the skin and is shining out of the end of the probe. The probe is activated by pressing the tiny button visible on the central part of the probe. In this instance, the machine is in full operation, however the invisible infrared laser is switched off as would be the situation for a placebo treatment. The machine activation light on the laser front panel can be seen at the top left of the photograph. Aspect; DBL Laser machine is in the background sitting on carry case. (B) Front panel DBL laser machine. Four-digit patient entry code switch sited in upper right of panel. Indicator lights for machine operation in upper left. Laser probe (white) cord inserted into bottom right panel. Timer switch - central. Manual key lock and power on/off toggle in lower left of panel. Aspect; DBL Laser machine sitting on steel carry case.
DBL Laser machine specifications.
Similar articles
- The effect of low-level laser therapy on orthodontically induced root resorption: a pilot double blind randomized controlled trial.Ng D, Chan AK, Papadopoulou AK, Dalci O, Petocz P, Darendeliler MA.Ng D, et al.Eur J Orthod. 2018 May 25;40(3):317-325. doi: 10.1093/ejo/cjx065.Eur J Orthod. 2018.PMID:29016741Clinical Trial.
- An observational study found that authors of randomized controlled trials frequently use concealment of randomization and blinding, despite the failure to report these methods.Devereaux PJ, Choi PT, El-Dika S, Bhandari M, Montori VM, Schünemann HJ, Garg AX, Busse JW, Heels-Ansdell D, Ghali WA, Manns BJ, Guyatt GH.Devereaux PJ, et al.J Clin Epidemiol. 2004 Dec;57(12):1232-6. doi: 10.1016/j.jclinepi.2004.03.017.J Clin Epidemiol. 2004.PMID:15617948
- Is Scientific Medical Literature Related to Endometriosis Treatment Evidence-Based? A Systematic Review on Methodological Quality of Randomized Clinical Trials.Capraş RD, Urda-Cîmpean AE, Bolboacă SD.Capraş RD, et al.Medicina (Kaunas). 2019 Jul 15;55(7):372. doi: 10.3390/medicina55070372.Medicina (Kaunas). 2019.PMID:31311075Free PMC article.
- Trends in 'poor responder' research: lessons learned from RCTs in assisted conception.Papathanasiou A, Searle BJ, King NM, Bhattacharya S.Papathanasiou A, et al.Hum Reprod Update. 2016 Apr;22(3):306-19. doi: 10.1093/humupd/dmw001. Epub 2016 Feb 2.Hum Reprod Update. 2016.PMID:26843539Review.
- Assessment of risk of bias in quasi-randomized controlled trials and randomized controlled trials reported in theKorean Journal of Anesthesiology between 2010 and 2016.Kim JH, Kim TK, In J, Lee DK, Lee S, Kang H.Kim JH, et al.Korean J Anesthesiol. 2017 Oct;70(5):511-519. doi: 10.4097/kjae.2017.70.5.511. Epub 2017 Aug 14.Korean J Anesthesiol. 2017.PMID:29046770Free PMC article.Review.
Cited by
- Low-level laser therapy for chronic non-specific low back pain: a meta-analysis of randomised controlled trials.Glazov G, Yelland M, Emery J.Glazov G, et al.Acupunct Med. 2016 Oct;34(5):328-341. doi: 10.1136/acupmed-2015-011036. Epub 2016 May 20.Acupunct Med. 2016.PMID:27207675Free PMC article.Review.
- Is sham laser a valid control for acupuncture trials?Irnich D, Salih N, Offenbächer M, Fleckenstein J.Irnich D, et al.Evid Based Complement Alternat Med. 2011;2011:485945. doi: 10.1093/ecam/neq009. Epub 2011 Mar 10.Evid Based Complement Alternat Med. 2011.PMID:21772922Free PMC article.
- Combination Therapy of Infections Caused by Injection of Paint Using Medical Laser.Attarian S, Karami A, Ayatolahi F.Attarian S, et al.World J Plast Surg. 2017 Jan;6(1):120-122.World J Plast Surg. 2017.PMID:28289626Free PMC article.No abstract available.
- Low-dose laser acupuncture for non-specific chronic low back pain: a double-blind randomised controlled trial.Glazov G, Yelland M, Emery J.Glazov G, et al.Acupunct Med. 2014 Apr;32(2):116-23. doi: 10.1136/acupmed-2013-010456. Epub 2013 Nov 26.Acupunct Med. 2014.PMID:24280948Free PMC article.Clinical Trial.
- Short- and Long-Term Effectiveness of Low-Level Laser Therapy Combined with Strength Training in Knee Osteoarthritis: A Randomized Placebo-Controlled Trial.Stausholm MB, Naterstad IF, Alfredo PP, Couppé C, Fersum KV, Leal-Junior ECP, Lopes-Martins RÁB, Joensen J, Bjordal JM.Stausholm MB, et al.J Clin Med. 2022 Jun 15;11(12):3446. doi: 10.3390/jcm11123446.J Clin Med. 2022.PMID:35743513Free PMC article.
References
- Pirotta MV, Cohen MM, Kotsirilos V, Farish SJ. Complementary therapies: have they become accepted in general practice? Med J Aust. 2000;172:105–9. - PubMed
- Schlager A, Offer T, Baldissera I. Laser stimulation of acupuncture point P6 reduces postoperative vomiting in children undergoing strabismus surgery. Br J Anaesth. 1998;81:529–32. - PubMed
- Bjordal JM, Couppe C, Chow RT, Tuner J, Ljunggren EA. A systematic review of low level laser therapy with location-specific doses for pain from chronic joint disorders. Aust J Physiother. 2003;49:107–16. - PubMed
- Radmayr C, Schlager A, Studen M, Bartsch G. Prospective randomized trial using laser acupuncture versus desmopressin in the treatment of nocturnal enuresis. Eur Urol. 2001;40:201–05. - PubMed
Related information
LinkOut - more resources
Full Text Sources