Functional constipation
Conditions
Interventions
TEA group (experimental group):The stimulation site is the bilateral ST36 acupoints, on the anterior and lateral side of the calf, 3 inches below the Dubi point, and one finger width above the anterio
Sham-TEA group (control group):The stimulation sites were bilateral non-acupoints, 6–10 cm below and to the sides of ST36 (not on any meridian line).
Sponsors
The Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who can fully understand and are willing to comply with the study process, voluntarily participate in this study and sign the informed consent form, and are 18<= aged <=75 years old. 2. Meet the diagnostic criteria for functional constipation (FC) in Rome IV: 1. Must include 2 or more of the following: more than 1/4 (25%) of the bowel movements feel laborious More than 1/4 (25%) of the bowel movements are dry bulb or hard stools (Bristol Stool Characteristics Scale Type 1~2) More than 1/4 (25%) have a feeling of incomplete bowel movement More than 1/4 (25%) of the bowel movements have anorectal obstruction/blockage More than 1/4 (25%) of the bowel movements require manual assistance (e.g., using fingers to assist in defecation, pelvic floor support) spontaneous bowel movement (SBM) less than 3 times per week; 2. Loose feces rarely appear when laxatives are not used; 3. Does not meet the diagnostic criteria for irritable bowel syndrome. Symptoms appeared for at least 6 months before diagnosis, and the above diagnostic criteria were met in the last 3 months. 3. Consistent with the London classification of rectal hyposensitivity (RH) diagnostic criteria: when at least 1 of the following 3 sensory thresholds is abnormally elevated: initial sensory threshold [FCSV], defecation threshold [DDV], and maximum tolerability threshold [MTV]. 4. Normal colonoscopy results within five years or abnormal results that are considered clinically significant by the investigator.
Exclusion criteria
Exclusion criteria: 1. Organic diseases of the digestive system, such as inflammatory bowel disease, intestinal tumor, tuberculous peritonitis, chronic pancreatitis, etc., or those who still have peptic ulcer and infectious diarrhea; 2. Drug-induced constipation; 3. Irritable bowel syndrome; 4. Diseases affecting the function of the digestive system, such as uncontrolled hyperthyroidism or hypothyroidism, diabetes, autoimmune diseases, neurological (such as anorexia nervosa, etc.) or severe psychiatric diseases (such as severe depression or severe anxiety), etc.; 5. Severe heart, liver, kidney disease, cerebrovascular disease, hematopoietic system disease or tumor; 6. History of gastrointestinal surgery; 7. Suspected or confirmed history of tobacco, alcohol or drug abuse; 8. During the study period, drugs that affect gastrointestinal motility and function cannot be stopped or planned, such as prokinetic drugs, anticholinergics, calcium channel blockers, 5-HT3 receptor antagonists, antidiarrheal agents, antacids, antidepressants, anxiolytics, intestinal flora modulators, and antibiotics; 9. Females who are pregnant, breastfeeding, or planning to become pregnant during the study; 10. Implantation of electronic devices, such as pacemakers; 11. Subjects who have participated in any clinical trial and received treatment in the past 3 months; 12. Familiar with acupuncture treatment, acupuncture points or meridians; 13. In the opinion of the investigator, the subject has other conditions that are not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anorectal manometry (ARM);Heart rate variability (HRV); | — |
Secondary
| Measure | Time frame |
|---|---|
| Bowel habit diary;Hamilton Anxiety/Depression Scale (HAMA/D);The Patient Assessment of Constipation Quality of Life (PAC-QoL) questionnaires;The Patient Assessment of Constipation Symptom (PAC-SYM) questionnaires;Defecation Satisfaction Visual Analogue Scale; | — |
Countries
China
Contacts
Public ContactDai Fei
The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed