

Placebo use and participant blinding in osteopathic clinical studies
https://doi.org/10.32885/2220-0975-2025-2-127-142
Abstract
Currently, Russia continues to actively integrate osteopathy into the scientific framework, which includes adherence to evidence-based medicine principles. The gold standard for confirming the efficacy of therapeutic interventions is double-blind placebo-controlled randomized trials, originally designed for testing new pharmaceutical drugs. However, there are no precise guidelines on how to conduct such studies in osteopathy. This lecture describes types of placebo interventions and blinding techniques, as well as protocol variations for double-blind placebo-controlled trials employed in osteopathic research, which can be utilized when planning scientific projects.
About the Authors
D. A. LeskovskayaRussian Federation
Darya A. Leskovskaya, doctor of physical and rehabilitation medicine
bld. 27 Kolomyazhskiy pr., Saint-Petersburg, Russia 197341
Yu. P. Potekhina
Russian Federation
Yulia P. Potekhina, Dr. Sci. (Med.), Professor, Professor at the N. Yu. Belenkov Department of Normal Physiology; Deputy Director for Scientific and Methodological Work
Scopus Author ID: 55318321700
bld. 1 lit. A ul. Degtyarnaya, Saint-Petersburg, Russia 191024
bld. 10/1 Minin and Pozharskiy sq., Nizhniy Novgorod, Russia 603005
References
1. Koterov A. N. Historical stages of the invention and use of placebo. Farmakoekonomika. Sovremennaya farmakoekonomika i farmakoepidemiologiya. 2022; 15 (4): 502–522. https://doi.org/10.17749/2070-4909/farmakoekonomika.2022.118 (in russ.).
2. A dictionary of epidemiology / Ed. M. Porta. New York: Oxford University Press; 2014.
3. Epidemiological dictionary / Ed. J. M. Last. M.: Otkryty institut zdorovya v ramkakh proekta «Globus»; 2009 (in russ.).
4. Shapiro A. K. Semantics of the placebo. Psychiat. Quarterly. 1968; 42 (4): 653–695. https://doi.org/10.1007/BF01564309
5. Pepper O. H. P. A note to the placebo. Amer. J. Pharm. 1945; 117: 409–412.
6. ВVasilenko V. V. Prehistory of the dummy. Rus. med. zhurn. 2012; 20: 1058–1061. https://www.rmj.ru/articles/istoriya_meditsiny/Predystoriya_pustyshki/ (in russ.).
7. Louhiala P. Placebo effects: the meaning of care in medicine. Springer; 2020. https://doi.org/10.1007/978-3-030-27329-3
8. Gaddum J. H. Therapeutic trials on man (chapter). Pharmacology. London: Oxford University Press; 1940: 378–383.
9. Shapiro A. K. L., Morris A. The placebo effect in medical and psychological therapies // In: Handbook of psychotherapy and behavior change / Ed. S. L. Garfi eld et al. New York: Wiley; 1978: 369–410.
10. Yabluchanskiy N. I., Vasilyeva L. G., Volyanskiy Yu. L. The principle of disease optimality. Kharkiv: Osnova; 1992 (in russ.).
11. Benedetti F., Carlino E., Pollo A. How placebos change the patient′s brain. Nevropsikhofarmakologiya. 2011; 36 (1): 339–354. https://doi.org/10.1038/npp.2010.81
12. Geuter S., Koban L., Wager T. D. The cognitive neuroscience of placebo effects: Concepts, predictions, and physiology. Ann. Rev. Neurosci. 2017; 40: 167–188. https://doi.org/10.1146/annurev-neuro-072116-031132
13. Khailov P. M. Placebo and evidence-based medicine. Med. tekhnol. Otsenka i vybor. 2012; 1: 10–16 (in russ.).
14. Waber R. L., Shiv B., Ariely D. Commercial features of placebo and therapeutic effi cacy. J.A.M.A. 2008; 299 (9): 1016–1017. https://doi.org/10.1001/jama.299.9.1016
15. Schaefer M., Sahin T., Berstecher B. Why do open-label placebos work? A randomized controlled trial of an open-label placebo induction with and without extended information about the placebo effect in allergic rhinitis. PLOS ONE. 2018; 13 (3): e0192758. https://doi.org/10.1371/journal.pone.0192758
16. Finniss D. G., Kaptchuk T. J., Miller F., Benedetti F. Biological, clinical, and ethical advances of placebo effects. Lancet. 2010; 9715 (375): 686–695. https://doi.org/10.1016/S0140-6736 (09)61706-2
17. Varlamov A. A., Portnova G. V., McGlone F. F. C-tactile system and neurobiological mechanisms of «emotional» tactile perception: history of discovery and current research. Zhurn. vyssh. nerv. deyatelnosti. 2019; 69 (3): 280–293. https://doi.org/10.1134/S0044467719030158 (in russ.).
18. Zhukov D. A. Stop, who leads? The biology of human and animal behavior (in 2 vol.). Vol. 1. M.: Alpina non-fi kshn; 2014 (in russ.).
19. Johansson R. S., Trulsson M., Olsson K. Å., Westberg K.-G. Mechanoreceptor activity from the human face and oral mucosa. Exp. Brain Res. 1988; 72 (1): 204–208. https://doi.org/10.1007/BF00248518
20. Nordin M. Low-threshold mechanoreceptive and nociceptive units with unmyelinated (C) fi bres in the human supraorbital nerve. J. Physiol. 1990; 426: 229–240.
21. Vallbo A. B., Olausson H., Wessberg J. Unmyelinated afferents constitute a second system coding tactile stimuli of the human hairy skin. J. Neurophysiol. 1999; 81 (6): 2753–2763.
22. McGlone F., Wessberg J., Olausson H. Discriminative and affective touch: Sensing and feeling. Neuron. 2014; 82 (4): 737–755. https://doi.org/10.1016/j.neuron.2014.05.001
23. Yosipovitch G., Ishiuji Y., Patel T. S. et al. The brain processing of scratching. J. Investig. Dermatol. 2008; 128 (7): 1806–1811. https://doi.org/10.1038/jid.2008.3
24. Meijer L. L., Ruis C., van der Smagt M. J. et al. Neural basis of affective touch and pain: A novel model suggests possible targets for pain amelioration. J. Neuropsychol. 2022; 16 (1): 38–53. https://doi.org/10.1111/jnp.12250
25. Meijer L. L., Hasenack B., Kamps J. C. C. et al. Affective touch perception and longing for touch during the COVID-19 pandemic. Scientif. Reports. 2022; 12 (1): 3887. https://doi.org/10.1038/s41598-022-07213-4
26. Mokhov D. E., Maryanovich A. T. Osteopathy as evidence-based medicine. Russ. Osteopath. J. 2013; 1–2: 138–154 (in russ.).
27. Cerritelli F., Verzella M., Cicchitti L. et al. The paradox of sham therapy and placebo effect in osteopathy: A systematic review. Medicine (Baltimore). 2016; 95 (35): e4728. https://doi.org/10.1097/MD.0000000000004728
28. Minakova A. L., Ustinov A. V. Study of the effectiveness of osteopathic correction of hallux valgus deformity of the first toe grades I–II. Russ. Osteopath. J. 2022; 3: 75–90. https://doi.org/10.32885/2220-0975-2022-3-75-90 (in russ.).
29. Kolyshnitsyn N. Yu., Mokhov D. E., Smirnova L. M. et al. Results of osteopathic correction according to stabilography data in patients with lower limb amputation at the shin level. Russ. Osteopath. J. 2023; 1: 67–78. https://doi.org/10.32885/2220-0975-2023-1-67-78 (in russ.).
30. Ferreira-Faria M. A., Bautista-Aguirre F. The effect of pressure release technique on latent myofascial trigger points in the upper trapezius muscle: A randomized controlled clinical trial. Russ. Osteopath. J. 2021; 1: 138–150. https://doi.org/10.32885/2220-0975-2021-1-138-150 (in russ.).
31. Potekhina Yu. P., Tregubova E. S., Mokhov D. E. Effects of osteopathic correction and possibilities of their study. Russ. Osteopath. J. 2022; 4: 8–29. https://doi.org/10.32885/2220-0975-2022-4-8-29 (in russ.).
32. Antonova Yu. V., Iskandarov A. M., Mizonova I. B. Results of osteopathic correction in patients with post-traumatic coccygodynia. Russ. Osteopath. J. 2019; 1–2: 19–27. https://doi.org/10.32885/2220-0975-2019-1-2-19-27 (in russ.).
33. Petrishchev A. A., Mokhov D. E., Shakirov A. M. Osteopathic treatment of patients with cervicalgia. Russ. Osteopath. J. 2016; 1–2: 36–43. https://doi.org/10.32885/2220-0975-2016-1-2-36-43 (in russ.).
34. Belova O. G., Borovskaya V. G., Vetrova M. V. et al. Anatomy and physiology of clinical research. MEDACH.PRO Guidelines. Web version as of 03.06.2021. https://medach.pro/post/2635 (in russ.).
35. Noll D. R., Degenhardt B. F., Fossum C., Hensel K. Clinical and research protocol for osteopathic manipulative treatment of elderly patients with pneumonia. J. Amer. Osteopath. Ass. 2008; 108 (9): 508–516.
36. Noll D. R., Degenhardt B. F., Johnson J. C. Multicenter Osteopathic pneumonia study in the elderly: Subgroup analysis on hospital length of stay, ventilator-dependent respiratory failure rate, and in-hospital mortality rate. J. Amer. Osteopath. Ass. 2016; 116 (9): 574–587.
37. Kesada B. M. Effects of osteopathic methods of balancing the sphenobasilar synchondrosis and separation of the anterior ethmoidal suture in children with narrow palate. Russ. Osteopath. J. 2022; 1: 121–133. https://doi.org/10.32885/2220-0975-2022-1-121-133 (in russ.).
38. Shenone L. E. The effect of osteopathic balanced ligamentous tension (BLT) technique on LV in lumbalgia. Russ. Osteopath. J. 2022; 3: 157–166. https://doi.org/10.32885/2220-0975-2022-3-157-166 (in russ.).
39. Chaibi A., Šaltytė Benth J., Bjørn Russell M. Validation of placebo in a manual therapy randomized controlled trial. Scientif. Reports. 2015; 5: 11774. https://doi.org/10.1038/srep11774
40. Favier N., Guinet A., Nageleisen M. et al. Side effects and quality of life in patients undergoing chemotherapy: Assessment of the impact of osteopathic correction (multicenter randomized clinical trial). Russ. Osteopath. J. 2019; 3–4: 174–185. https://doi.org/10.32885/2220-0975-2019-3-4-174-185 (in russ.).
Review
For citations:
Leskovskaya D.A., Potekhina Yu.P. Placebo use and participant blinding in osteopathic clinical studies. Russian Osteopathic Journal. 2025;(2):127-142. (In Russ.) https://doi.org/10.32885/2220-0975-2025-2-127-142