Constipation - FunctionalNCT06618326
Acupuncture Versus Biofeedback Training on Bowel Motility in Children With Functional Constipation
A study testing Acupuncture and biofeedback in people with Constipation - Functional, run by Cairo University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Constipation - Functional
- What is being tested?
- Acupuncture and biofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ACUPUNCTURE VERSUS BIOFEEDBACK TRAINING ON BOWEL MOTILITY IN CHILDREN WITH FUNCTIONAL CONSTIPATION
: 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).
- Conditions
- Constipation - Functional
- Being tested
- Acupuncture, biofeedback
- Keywords
- CONSTIPATION, BIOFEEDBACK, ACUPUNCTURE
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Twenty patients were suffering from functional constipation. They ranged in age from 7-15 years. All children had reasonable cognitive functions, and a reasonable IQ so as were able to follow the instructions. All received acupuncture regardless of the number of acupuncture points, frequency, and courses of treatment in addition to non-pharmacological treatment advice from health care authorities such as the British Nutrition Foundation includes increasing fluid intake, physical activity and increasing dietary fiber consumption to a recommended daily intake of 30 g
biofeedbackDevice
Twenty patients were suffering from functional constipation. They ranged in age from 7-15 years. All children had reasonable cognitive functions, and a reasonable IQ so as were able to follow the instructions. All received biofeedback training in addition to non-pharmacological treatment advice from health care authorities such as the British Nutrition Foundation includes increasing fluid intake, physical activity and increasing dietary
| Study group | Role | What they receive |
|---|---|---|
| acupuncture | Experimental | Group (A): will receive acupuncture in addition to non-pharmacological treatment advice from health care authorities such as the British Nutrition Foundation includes increasing fluid intake, physical activity and increasing dietary fiber consumption to a recommended daily intake of 30 g. Receives: Device: Acupuncture |
| biofeedback training | Experimental | Group (B): will receive biofeedback training in addition to non-pharmacological treatment advice from health care authorities such as the British Nutrition Foundation includes increasing fluid intake, physical activity and increasing dietary fiber consumption to a recommended daily intake of 30 g. Receives: Device: biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
constipation
We limited the outcome measures to complete spontaneous bowel movement (CSBM), Bristol Stool Form Scale (BSFS), constipation symptoms scores (CSS), the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire, and Self-Rating Anxiety Scale (SAS) score. Before and after treatment, the result measurements were recorded (after 12 weeks).
Measured: after 12 session 3 session by week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Mar 2025
- Primary completion1 Apr 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed fekry ibrahim salman, Al-Ahliyya Amman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618326
- Sponsor's protocol ID
- acupuncture versus biofeedback
- Status last verified
- Feb 2025
- First submitted
- 17 Sep 2024
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACUPUNCTURE VERSUS BIOFEEDBACK TRAINING ON BOWEL MOTILITY IN CHILDREN WITH FUNCTIONAL CONSTIPATION
- ClinicalTrials.gov ID
- NCT06618326
- Acronym / sponsor ID
- acupuncture versus biofeedback
- Conditions
- Constipation - Functional
- Keywords
- CONSTIPATION, BIOFEEDBACK, ACUPUNCTURE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
: 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Experimental | Device: AcupunctureGroup (A): will receive acupuncture in addition to non-pharmacological treatment advice from health care authorities such as the British Nutrition Foundation includes increasing fluid intake, physical activity and increasing dietary fiber consumption to a recommended daily intake of 30 g. |
| biofeedback training | Experimental | Device: biofeedbackGroup (B): will receive biofeedback training in addition to non-pharmacological treatment advice from health care authorities such as the British Nutrition Foundation includes increasing fluid intake, physical activity and increasing dietary fiber consumption to a recommended daily intake of 30 g. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureTwenty patients were suffering from functional constipation. They ranged in age from 7-15 years. All children had reasonable cognitive functions, and a reasonable IQ so as were able to follow the instructions. All received acupuncture regardless of the number of acupuncture points, frequency, and courses of treatment in addition to non-pharmacological treatment advice from health care authorities such as the British Nutrition Foundation includes increasing fluid intake, physical activity and increasing dietary fiber consumption to a recommended daily intake of 30 g | Device | acupuncture |
| biofeedbackTwenty patients were suffering from functional constipation. They ranged in age from 7-15 years. All children had reasonable cognitive functions, and a reasonable IQ so as were able to follow the instructions. All received biofeedback training in addition to non-pharmacological treatment advice from health care authorities such as the British Nutrition Foundation includes increasing fluid intake, physical activity and increasing dietary | Device | biofeedback training |
Primary outcome
constipation
Time frame: after 12 session 3 session by week
We limited the outcome measures to complete spontaneous bowel movement (CSBM), Bristol Stool Form Scale (BSFS), constipation symptoms scores (CSS), the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire, and Self-Rating Anxiety Scale (SAS) score. Before and after treatment, the result measurements were recorded (after 12 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and biofeedback in people with Constipation - Functional, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
constipation (time frame: after 12 session 3 session by week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.