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Effect of acupuncture for functional constipation using resting-state functional magnetic resonance imaging: study protocol for a randomized controlled trial

Effect of acupuncture for functional constipation using resting-state functional magnetic resonance imaging: study protocol for a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005981
Enrollment
Unknown
Registered
2022-05-07
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional constipation

Interventions

Verum acupuncture group:Acupuncture at ST25
Sham acupuncture group:Shallow acupuncture at sham acupoint near ST25
Medication group:Macrogol 4000 Powder
Watchful waiting group:Watchful waiting and emergency treatment

Sponsors

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Right handedness. 2. Matching the diagnostic criteria of functional constipation according to the Rome IV criteria for functional gastrointestinal disorders. 3. No gender limitation and aged between 25 and 70 years. 4. No use of gastrointestinal drugs 2 weeks before treatment (except for emergency drugs), no acupuncture treatment for constipation in the previous 3 months, not participate in other ongoing clinical trials. 5. No use of psychotropic drugs before and during the study. 6. Participate voluntarily in the study and sign informed consent prior to treatment.

Exclusion criteria

Exclusion criteria: 1. Irritable bowel syndrome or constipation secondary to organic or endocrine or metabolic or postoperative diseases and adverse effect of medication. 2. With severe cardiovascular or liver or kidney insufficiency, abdominal aneurysms, hepatosplenomegaly, psychiatric diseases, cognitive impairment, aphasia and unable to cooperate with treatment. 3. Having any contraindications to fMRI scan and electroacupuncture, such as having a cardiac pacemaker, defibrillator, mechanical heart valve, electronic or magnetic device in the body, cochlear implant and metal denture, having claustrophobia. 4. With intracranial mass lesions or severe cranial anatomical asymmetry were found in MRI scan. 5. Cannot receive fMRI scan for other reasons. 6. blood coagulation disorders or requiring administration of anticoagulant agents, such as warfarin or heparin. 7. Severe fear of needles or allergic to metal needles.

Design outcomes

Primary

MeasureTime frame
Cerebral white matter microstructure by fMRI;Brain regions functional connectivity by fMRI;Number of spontaneous bowel movements per week;

Secondary

MeasureTime frame
Self-rating depression scale;Stool consistency score;Self-rating anxiety scale;

Countries

China

Contacts

Public ContactTao Zhang

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

zhangtao@bjzhongyi.com+86 13581901177

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026