BACKGROUND: The prevalence of chronic @entity1142 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 @entity1142 in @entity1 and encouraging results in adults. The primary objective of this study is to assess the efficacy of interferential therapy during 8 weeks in adult @entity1 . 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, @entity1 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 @entity1 with a history of chronic @entity1142 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 ( @entity1 Assessment of Constipation Symptoms questionnaire), colonic transit time, anorectal manometry, @entity1 satisfaction (analogical visual scale), @entity1 QoL ( @entity1 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 @entity1 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).

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

@entity1 :: ('9606', 'Species') :: ['children', 'patients', 'patient', 'Patient'] @entity1142 :: ('MESH:D003248', 'Disease') :: ['constipation']
@entity1142 :: (MESH:D003248,Disease) :: ['constipation']
