Background of the study:
Functional constipation (FC) is common in children and poses a significant burden to patients, their families and the healthcare system. Pharmacological treatment mainly consists of oral osmotic laxatives. However, poor adherence to oral laxatives is known to be a common problem and patients often remain symptomatic despite pharmacological treatment. Many parents seek help in the form of complementary and integrative medicine. Acupuncture has been shown to relieve symptoms in adults with FC. However, published studies in children with FC are scarce and have important limitations.
Objective of the study:
To evaluate the feasibility, safety and potential efficacy of acupuncture in children with FC. The results of this study will be used to design a future randomized controlled trial (RCT).
Study design:
A prospective, non-randomized, multicenter, open-label pilot study.
Intervention: Children will receive 8 acupuncture sessions during 10 weeks (1 session per week during 6 weeks, followed by 1 session every other week during 4 weeks). Concurrent pharmacological treatment with polyethylene glycol ≥ 0.2 g/kg/day will be maintained as initiated prior to participation in the study.
Study population:
18 children (6-18 years old) with FC according to the Rome IV criteria.
6-18 years of age
Two or fewer spontaneous bowel movements (SBMs) per week (an SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use in the preceding 24 hours)
History of excessive stool retention
History of painful or hard bowel movements
children with FC not treated with PEG with a minimum dose of 0.2g/kg/day during at least one month at the time of potential inclusion.
Irritable bowel syndrome.
Organic causes of constipation; e.g. celiac disease, pediatric intestinal pseudo-obstruction, hypothyroidism, spina bifida, anorectal malformations, or Hirschsprung disease.
Significant chronic health conditions requiring specialty care (e.g. cardiac, pulmonary, hepatic, hematopoietic, renal, endocrine, or metabolic diseases, sickle cell disease, cerebral palsy) that could potentially impact the child's ability to participate or confound the results of the study.
Single group
Acupuncture treatment
Other interventionChildren will receive 8 acupuncture sessions during 10 weeks (1 session per week during 6 weeks, followed by 1 session every other week during 4 weeks). At each acupuncture session, the acupuncturist records the patient's bowel habits, gastrointestinal symptoms and the use of escape medication during the period between sessions. After 3, 6 and 8 acupuncture treatments respectively, patients will visit the research team after they receive acupuncture to evaluate adverse events. After completion of these 10 weeks, an acupuncture-free follow-up period of 4 weeks commences. The follow-up period will be used to investigate if and how long effects of the intervention will persist. During the intervention period and the follow-up period, escape medication (bisacodyl or enemas) is allowed under the same conditions as during the run-in period.
Primary outcome measure: feasibility
The primary endpoint is feasibility: a future RCT using this same intervention protocol will be deemed feasible if the pilot study renders an attrition rate ≥70% (i.e. ≥70% of patients completing the pilot study while attending ≥75% of scheduled acupuncture sessions).
Secondary outcome measure: Feasibility
Secondary endpoints to determine feasibility include consent rate, patient and parent satisfaction with acupuncture treatment (measured at t=6, t=10 and t=14 \[5-point-Likert scale\]) and assessment of required personnel capacity for a future RCT
Secondary Outcome Measure: Safety (assessment of adverse events)
The occurrence of adverse events (AE) is assessed at each research nurse visit (t=3, t=6, t=10, t=14). The occurrence of the following pre-determined adverse events are assessed: needle-related pain, local redness/irritation, hematomas, headache, fainting/syncope, sedation, neuropathy. For each patient-reported AE, severity (mild, moderate, or severe) and relation to acupuncture treatment (unrelated or possibly, probably, or definitely related) are determined.
Secondary Outcome Measure: Efficacy
The endpoint for efficacy is treatment success, based on the Rome IV criteria (Table 1): a child who fulfils the Rome IV criteria for FC prior to enrolment into the trial and no longer fulfils the Rome IV criteria at the end of the trial period is considered successfully treated. The endpoints, including quality of life and school absence, are based on a previously published core outcome set and include: * Defecation frequency (number of bowel movements/week, excluding fecal incontinence episodes) * Stool consistency (Bristol Stool Scale) * Painful defecation (yes/no) * Fecal incontinence frequency (episodes/week) * Withholding behavior (yes/no) * Abdominal pain (yes/no, VAS score) * Number of spontaneous bowel movements (\>24h after escape medication) * Time between acupuncture and defecation * Number of bowel movements \<24h after acupuncture * Frequency of use of escape medication * Time between escape medication and defecation * Number of bowel movements \<24h after escape med.
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