Effect of acupuncture for functional constipation using resting-state functional magnetic resonance imaging: study protocol for a randomized controlled trial
- Conditions
- Functional constipation
- Registration Number
- ITMCTR2200005981
- Lead Sponsor
- Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cerebral white matter microstructure by fMRI;Brain regions functional connectivity by fMRI;Number of spontaneous bowel movements per week;
- Secondary Outcome Measures
Name Time Method Self-rating depression scale;Stool consistency score;Self-rating anxiety scale;