Clinical trial NCT06618326: Acupuncture Versus Biofeedback Training on Bowel Motility in Children With Functional Constipation
Official title: ACUPUNCTURE VERSUS BIOFEEDBACK TRAINING ON BOWEL MOTILITY IN CHILDREN WITH FUNCTIONAL CONSTIPATION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation - Functional
Keywords: CONSTIPATION
BIOFEEDBACK
ACUPUNCTURE
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: : Functional constipation is the most common gastrointestinal disorder affecting about 14 % of the global population and it negatively impacts the quality of life of those affected (Suares and Ford,2011). In addition, there is a substantial cost to health care systems and further out of pocket costs are incurred by those suffering from the condition. In the UK, costs of £168 million to the National Health Service have been reported by the Bowel Interest Group for just 1 year (2018-2019), with more than 175 000 patient days spent in hospital and numbers are increasing (Bowel Interest Group, 2020).

Traditional Chinese medicine believes that constipation is mostly caused by improper diet, emotional disorders, old age and physical weakness, and feelings of external evil; the disease is mainly in the intestine and is related to the spleen, stomach, lung, liver, kidney, and other visceral dysfunctions; the basic pathogenesis is the conduction dysfunction of the large intestine. Acupuncture and moxibustion treatment of constipation should start from the diseased part and the associated viscera, and the treatment principle is to clear the organs and lead the stagnation. The most used acupuncture points for the treatment of constipation in modern acupuncture are Tianshu (526 times), followed by Shangjuxu (366 times), Dachangshu (334 times), Zusanli (328 times), and Zhigou (306 times). Among them, Tianshu acupoint is the most used acupoint and it has a large gap with the value of Shangjuxu in the second place. The values of the acupoints in the 2nd to the 5th place are more balanced, and the value of Qihai in the sixth place is different from Zhigou in the fifth place. Also, the difference between the 6th and 15th positions is more balanced. From the frequency of acupuncture treatment of constipation, the top 5 acupoints are Tianshu, Shangjuxu, Dachangshu, Zusanli, and Zhigou (Fengzhi et al., 2023).

Biofeedback Therapy The goal of neuromuscular training using biofeedback techniques is to restore a normal pattern of defecation. Neuromuscular training or biofeedback therapy is an instrument-based learning process that is based on "operant conditioning" techniques. The governing principal is that any behaviour-be it a complex manoeuvre such as eating or a simple task such as muscle contraction-when reinforced its likelihood of being repeated and perfected increases several fold. In patients with dyssynergic defecation, the goal of neuromuscular training is two-fold. (Rao, 2008).


Eligibility criteria: Inclusion Criteria:

* children suffering from functional constipation using guidelines or the Rome IV/III/II criteria,
* Their ages ranged between 6 and 15 years.
* All children had reasonable cognitive functions, and a reasonable IQ so as were able to follow the instructions.

Exclusion Criteria:

* Exclusion Criteria were secondary constipation because of an underlying health issue or a side effect of medication use, medical conditions, psychiatric and/or neurological disorders that interfered with the gastrointestinal function and medications that influenced gastrointestinal function.

Primary outcomes:
measure: constipation
timeFrame: after 12 session 3 session by week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy Cairo University
Study officials:
References: