Journal Article

CON-COUR study: Interferential therapy in the treatment of chronic constipation in adults: study protocol for a randomized controlled trial

Vitton, Véronique, Baumstarck, Karine, Honoré, Stéphane, Benezech, Alban, Lesavre, Nathalie, Auquier, Pascal, Sudour, Patrick

2015

Overview

Background The prevalence of chronic constipation is about 15 % in Western countries with a significant impact on quality of life and health care costs. The first-line therapy, based on medical treatment combined with laxatives and dietary rules, is often disappointing. Interferential therapy is a new treatment that has demonstrated its efficiency in the treatment of chronic constipation in children and encouraging results in adults. The primary objective of this study is to assess the efficacy of interferential therapy during 8 weeks in adult patients. The secondary objectives are to assess this new and noninvasive therapy in terms of persistence of the clinical efficacy, colonic transit time, ano-rectal manometry, patient satisfaction and quality of life (QoL), and tolerance. Methods/Design Design: multicenter, prospective, randomized, placebo-controlled, double blind, two-parallel groups study. Setting: nine French adult gastroenterology centers. Inclusion criteria: adult patients with a history of chronic constipation refractory to medical treatment for at least 3 months. Treatment groups: (1) interferential-experimental group (effective stimulation); (2) placebo-control group (sham stimulation). Randomization: 1:1 allocation ratio. Evaluation times: inclusion (T0, randomization), baseline assessment (T1), start of stimulation (T2), intermediary assessment (T3, 4 weeks), end of stimulation (T4, 8 weeks), follow-up (T5 and T6, 1- and 6-month). Endpoints: (1) primary: short-term efficacy at T4 (treatment response defined as three or more spontaneous, complete bowel movements per week); (2) secondary: efficacy at T5 and T6, symptoms (Patient Assessment of Constipation Symptoms questionnaire), colonic transit time, anorectal manometry, patient satisfaction (analogical visual scale), patient QoL (Patient Assessment of Constipation Quality of Life Questionnaire), side/unexpected effects. Sample size: 200 individuals to obtain 80 % power to detect a 20 % difference in treatment response at T4 between the two groups (15 % of lost to follow-up patients expected). Discussion The randomized, double-blind, placebo-controlled design is the most appropriate to demonstrate the efficacy of a new experimental therapeutic (Evidence-Based Medicine Working Group classification). National and international recommendations could be updated based on the findings of this study. Trial registration Current controlled trials NCT02381665 (registration date: February 13, 2015).

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V
• Subject: Adult / Adults / Biomedicine / Care and treatment / Chronic Disease / Clinical Protocols / Clinical trials / Colon - physiopathology / Constipation / Constipation - diagnosis / Constipation - physiopathology / Constipation - psychology / Constipation - therapy / Defecation / Double-Blind Method / Electric Stimulation Therapy - adverse effects / Electrodes / Evidence-based medicine / Female / France / Gastrointestinal agents / Gastrointestinal Transit / Health Sciences / Human health and pathology / Humans / Hépatology and Gastroenterology / Laxatives / Life Sciences / Male / Manometry / Medical care, Cost of / Medical equipment / Medicine / Medicine & Public Health / Metabolic disorders / Patient Satisfaction / Pelvis / Prospective Studies / Quality of Life / Recovery of Function / Research Design / Statistics for Life Sciences / Study Protocol / Surveys and Questionnaires / Teaching hospitals / Time Factors / Treatment Outcome