Osteopathy in the treatment of irritable bowel syndrome symptoms in adults: study protocol for a randomized controlled trial

Florent Amsallem, Stéphane Sanchez, François Mion


Background: Osteopathy is chosen by patients as a treatment for irritable bowel syndrome (IBS) but evidence for its effectiveness is poor. The purpose of this study is to evaluate the effectiveness of osteopathy for IBS at 1 month follow-up in IBS adults.

Methods: Design: a multicenter, two-group parallel, randomized, double-blind, placebo-controlled trial. Inclusion criteria: adult IBS patients (Rome IV criteria) with similar baseline symptom severity, and comparable expectations of active and sham osteopathic treatment before. Treatment group included active osteopathic treatment. Control group included sham osteopathic treatment. Randomization was in allocation ratio 1:1. Assessment time was carried as inclusion and baseline assessment (day-1; initial visit V0), day 8, day 15 and follow-up (1 month and 3 months), treatments (day 0, day 8, day 15). Primary endpoint was effectiveness at 1 month (response to treatment defined as at least a 50-point reduction in IBS severity on the IBS-symptom severity score). Secondary endpoint was effectiveness at 3 months (response to treatment) and changes in total IBS quality of life scores up to 3 months. Sample size was 404 individuals to achieve 90% power to detect a 15% difference in treatment response at 1 month between the two groups (20% of patients lost to follow-up).

Conclusions: The two-group parallel, randomized, double-blind, placebo-controlled trial (sham therapy) in which the expectations and experiences of patients in the control group are comparable to the experimental group is the most accurate design for demonstrating the effectiveness of osteopathy on IBS symptoms. Future studies could use such a design to assert causality.

Trial registration: The trial has been registered in clinicalTrials.gov. Registration number: NCT05230277; registered on 7 February 2022.


Osteopathy, Sham therapy, IBS symptoms, Randomized controlled trial

Full Text:



Oka P, Parr H, Barberio B, Black CJ, Savarino EV, Ford AC. Global prevalence of irritable bowel syndrome according to Rome III or IV criteria: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2020;5(10):908‑17.

Hungin APS, Chang L, Locke GR, Dennis EH, Barghout V. Irritable bowel syndrome in the United States: prevalence, symptom patterns and impact. Aliment Pharmacol Ther. 2005;21(11):1365‑75.

Ringel Y, Williams RE, Kalilani L, Cook SF. Prevalence, Characteristics, and Impact of Bloating Symptoms in Patients With Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2009;7(1):68‑72.

Canavan C, West J, Card T. Review article: the economic impact of the irritable bowel syndrome. Aliment Pharmacol Ther. 2014;40(9):1023‑34.

McFarland LV. State-of-the-art of irritable bowel syndrome and inflammatory bowel disease research in 2008. World J Gastroenterol. 2008;14(17):2625.

De Ponti F. Drug Development for the irritable bowel syndrome: Current Challenges and Future Perspectives. Front Pharmacol. 2013. Available at: http://journal.frontiersin.org/article/10.3389/fphar.2013.00007/abstract. Accessed on 9 May 2021.

Amsallem F, Sanchez S, Armoiry X, Mion F. Effectiveness of Non-Pharmacological Interventions for Irritable Bowel Syndrome: A Systematic Review. Evid Based Complement Alternat Med. 2021;2021:4404185.

Attali T-V, Bouchoucha M, Benamouzig R. Treatment of refractory irritable bowel syndrome with visceral osteopathy: short-term and long-term results of a randomized trial. J Dig Dis. 2013;14(12):654‑61.

Florance B-M, Frin G, Dainese R, Nébot-Vivinus M-H, Marine Barjoan E, Marjoux S et al. Osteopathy improves the severity of irritable bowel syndrome: a pilot randomized sham-controlled study. Eur J Gastroenterol Hepatol. 2012;24(8):944‑9.

Vitton V, Benezech A, Honoré S, Sudour P, Lesavre N, Auquier P et al. CON-COUR study: Interferential therapy in the treatment of chronic constipation in adults: study protocol for a randomized controlled trial. Trials. 2015;16(1):234.

Billings W, Mathur K, Craven HJ, Xu H, Shin A. Potential Benefit with Complementary and Alternative Medicine in Irritable Bowel Syndrome: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2020;S1542356520312969.

Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K et al. SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials. Ann Intern Med. 2013;158(3):200.

Licciardone JC, Minotti DE, Gatchel RJ, Kearns CM, Singh KP. Osteopathic manual treatment and ultrasound therapy for chronic low back pain: a randomized controlled trial. Ann Fam Med. 2013;11(2):122‑9.

Nguyen C, Boutron I, Zegarra-Parodi R, Baron G, Alami S, Sanchez K et al. Effect of Osteopathic Manipulative Treatment vs Sham Treatment on Activity Limitations in Patients with Nonspecific Subacute and Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2021;181(5):620.

Passos MCF, Lembo AJ, Conboy LA, Kaptchuk TJ, Kelly JM, Quilty MT et al. Adequate relief in a treatment trial with IBS patients: a prospective assessment. Am J Gastroenterol. 2009;104(4):912-9.

Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997;11:395-402.

Miller LE. Study design considerations for irritable bowel syndrome clinical trials. Ann Gastroenterol. 2014;27(4):338‑45.

Patrick DL, Drossman DA, Frederick IO, DiCesare J, Puder KL. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Dig Dis Sci. 1998;43:400-11.

Pei L, Geng H, Guo J, Yang G, Wang L, Shen R. Effect of Acupuncture in Patients With Irritable Bowel Syndrome: A Randomized Controlled Trial. Mayo Clin Proc. 2020;95(8):1671-83.

Senna MK, Machaly SA. Does Maintained Spinal Manipulation Therapy for Chronic Nonspecific Low Back Pain Result in Better Long-Term Outcome? Spine. 2011;36(18):1427‑37.

Licciardone JC, Stoll ST, Fulda KG, Russo DP, Siu J, Winn W et al. Osteopathic Manipulative Treatment for Chronic Low Back Pain: A Randomized Controlled Trial. Spine. 2003;28(13):1355‑62.

Mujagic Z, Keszthelyi D, Aziz Q, Reinisch W, Quetglas EG, De Leonardis F et al. Systematic review: instruments to assess abdominal pain in irritable bowel syndrome. Aliment Pharmacol Ther. 2015;42(9):1064-81.

Hundscheid HW, Pepels MJ, Engels LG, Loffeld RJ. Treatment of irritable bowel syndrome with osteopathy: Results of a randomized controlled pilot study. J Gastroenterol Hepatol. 2007;22(9):1394‑8.