Functional constipation
Conditions
Interventions
TEA treatment group:zusanli stimulation
Sham-TEA treatment group:sham electrical stimulation
Sponsors
Hainan Medical College First Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 to 75 years, regardless of gender; 2. Patients with functional constipation meeting the Rome IV criteria (fewer than 3 complete spontaneous bowel movements per week); 3. TEA treatment can be self-administered at home by the patients; 4. Voluntarily participate in this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of colorectal diseases (inflammatory bowel disease, toxic colitis, toxic megacolon, volvulus, Hirschsprung's disease, and idiopathic intestinal pseudo-obstruction); 2. Previous gastrointestinal surgery that altered the anatomical structure of the gastrointestinal tract; 3. Constipation caused by systemic diseases (e.g., diabetes mellitus, Parkinson's disease); 4. Inability to maintain a stable medication regimen during the study period; 5. Irritable Bowel Syndrome with Constipation; 6. Severe heart failure, liver failure, renal failure, acute stroke, uncontrolled diabetes mellitus, or hyperthyroidism; 7. Presence of implanted electrical stimulation devices, such as cardiac pacemakers, coronary artery stents, or other implants that may be affected by electrical stimulation; 8. Allergy to electrode patches; 9. Women who are currently pregnant or breastfeeding; 10. Inability to comply with the study protocol due to illness, severe cognitive impairment, psychiatric disorders, geographical distance, or other factors as determined by the research team; 11. Infection, bleeding, or scarring at the treatment site; 12. Familiar with acupuncture treatment, acupoints or meridians; 13. Participation in other interventional clinical trials within the past 90 days.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Patient Assessment of Constipation – Quality of Life Questionnaire(PAC-QOL);Upper gastrointestinal symptoms (GCSI);Hospital Anxiety and Depression Scale (HADS);Patient Assessment of Constipation – Symptoms Questionnaire(PAC-SYM);Weekly frequency of complete spontaneous bowel movements (CSBMs) and spontaneous bowel movements (SBMs);Bristol Stool Form Scale; | — |
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with 3 or more complete spontaneous bowel movements per week at week 4 of treatment.; | — |
Countries
China
Contacts
Public ContactYan Tan
Hainan Medical College First Affiliated Hospital
Outcome results
None listed