Stop the pain: study protocol for a randomized-controlled trial

Abstract

BackgroundFunctional abdominal pain (FAP) is not only a highly prevalent disease but also poses a considerable burden on children and their families. Untreated, FAP is highly persistent until adulthood, also leading to an increased risk of psychiatric disorders. Intervention studies underscore the efficacy of cognitive behavioral treatment approaches but are limited in terms of sample size, long-term follow-up data, controls and inclusion of psychosocial outcome data.Methods/DesignIn a multicenter randomized controlled trial, 112 children aged 7 to 12 years who fulfill the Rome III criteria for FAP will be allocated to an established cognitive behavioral training program for children with FAP (n = 56) or to an active control group (focusing on age-appropriate information delivery; n = 56). Randomization occurs centrally, blockwise and is stratified by center. This study is performed in five pediatric gastroenterology outpatient departments. Observer-blind assessments of outcome variables take place four times: pre-, post-, 3- and 12-months post-treatment. Primary outcome is the course of pain intensity and frequency. Secondary endpoints are health-related quality of life, pain-related coping and cognitions, as well as selfefficacy.DiscussionThis confirmatory randomized controlled clinical trial evaluates the efficacy of a cognitive behavioral intervention for children with FAP. By applying an active control group, time and attention processes can be controlled, and long-term follow-up data over the course of one year can be explored.Trial registrationDRKS00005038 (date: 25 July 2013); NCT02030392 (date: 7 January 2014)Electronic supplementary materialThe online version of this article (doi:10.1186/1745-6215-15-357) contains supplementary material, which is available to authorized users.

Roles of Lactose and Fructose Malabsorption and Dietary Outcomes in Children Presenting with Chronic Abdominal Pain

“…We found a high prevalence of abnormal fructose and lactose hydrogen breath tests among a treatment-seeking patient cohort with unexplained CAP [17]. Interestingly, abdominal pain symptoms still persisted during an elimination diet and after follow-up in more than three-quarters of patients.…”

“…From March 2014 until March 2016, a total of 253 eligible patients, aged 7-12 years, presenting with unexplained CAP in five pediatric German gastroenterology centers were investigated to select patients for a randomized controlled group interventional cognitive behavioral training program for functional abdominal pain disorders (FAPD) (NCT02030392) [17]. This study was approved by the institutional review board in Potsdam, Germany and the local ethics committees.…”

“…Across the study centers, a systematic, stepwise medical screening approach based on current recommendations [19] was followed to identify the organic causes of CAP such as inflammatory bowel disease, celiac disease, or food intolerance, according to the trial protocol [17]. After informed consent, the standardized medical histories of all 253 patients (e.g., pain history, related symptoms, alarm signs like fever, bloody stools, involuntary weight loss, persistent vomiting; see Supplementary Figure S1), thorough physical examination (skin, ear, nose, throat, cardiac, pulmonic, and abdominal examination, body weight, length, blood pressure), and laboratory (complete blood count, erythrocyte sedimentation rate, blood glucose, basal thyroid stimulating hormone, creatinine, urea, gamma glutamyl transferase, glutamate pyruvate transaminase, glutamate oxalate transaminase, alkaline phosphatase, lipase, IgA, C-reactive protein, anti-transglutaminase IgA antibodies, anti-deamidated gliadin IgG antibodies), multistix urine test, and stool tests (including calprotectin, occult blood testing, stool ova, and parasite test) were investigated (Supplementary Tables S1 and S2).…”

“…In light of the high prevalence of carbohydrate malabsorption in children presenting with CAP [7][8][9][10][11], diagnostics should include the investigation of lactose or fructose intolerance if a diet-related cause is assumed. We investigated children referred with CAP within the framework of a randomized controlled trial for the evaluation of a cognitive behavioral training program for FAPD (NCT02030392) [17]. In this study, we aimed to prospectively analyze whether lactose or fructose malabsorption is a major cause of CAP by the symptomatic hydrogen breath test (H 2 BT) or diagnostic elimination diet with noticeable improvement at follow-up.…”

Do Mothers Benefit from a Child-Focused Cognitive Behavioral Treatment (CBT) for Childhood Functional Abdominal Pain? A Randomized Controlled Pilot Trial

“…In addition, interpretation and generalizability of results may be constrained due to the selectivity of the non-treatment-seeking sample with a high rate of decliners for further examination and single-site conduction of this trial. Replication of results, including a multi-site approach with a one-year follow-up and active control group, is currently ongoing [ 65 ].…”