Chronic Constipation
Conditions
Keywords
constipation
Brief summary
The worldwide prevalence of chronic constipation (CC) is 15%, and women are more likely to develop the disease than men. CC have a significant impact on quality of life and increase the burden of national health insurance. The conventional medication treatments are primarily symptom-specific and have limited efficacy. Previous small sample study had shown the therapeutic potential of transcutaneous auricular vagus nerve stimulation (taVNS) for irritable bowel syndrome with constipation (IBS-C). The aim of this study was to investigate whether taVNS could improve defecation condition and constipation symptoms in patients with CC.
Interventions
DEVICEtaVNS
Patients will receive taVNS (device produced by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s on periods and 30s off periods; frequency: 25 Hz; amplitude of 0-2 mA at the maximum level that the patient could tolerate; pulse width: 0.5ms)
DRUGLaxative Agent
Bisacodyl or glycerin enemas can be used in patients who do not have a bowel movement for more than 3 days.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. FC or IBS-C patients aged 18-75 years who meet the diagnostic criteria for Rome IV; 2. Complete spontaneous bowel movements (CSBMs) per week \< 3; 3. No constipation medication used for at least 2 weeks prior to enrollment, not participated in clinical trials in the past three months, and no abnormal colonoscopy within the past 12 months in those with alarm symptoms.
Exclusion criteria
1. Have cognitive impairment, psychiatric disorders, or conditions that may affect patient cooperation; 2. Have a cardiac pacemaker implantation or other electronically implanted devices; 3. Prior taVNS treatment; 4. History of colorectal surgery, except for simple appendectomy; 5. Severe cardiovascular, hepatic, or renal disease; 6. Known malignancy; 7. Secondary constipation caused by medications and other diseases; 8. Pregnant or lactating women; 9. Refusal to sign an informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate | 4 weeks | Proportion of patients with an average of 3 or more complete spontaneous bowel movements (CSBMs) per week from 1 to 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CSBMs | 12 weeks | Changes from baseline by time point in the CSBMs |
| Spontaneous bowel movements (SBMs) | 12 weeks | Changes from baseline by time point in the SBMs |
| Abdominal symptoms | 12 weeks | Changes from baseline by time point in abdominal symptoms scores (abdominal bloating, abdominal fullness, abdominal discomfort, abdominal pain, abdominal cramping). |
| Bristol stool form scale (BFSF) | 12 weeks | Changes from baseline by time point in the BFSF |
| Laxative agents using | 12 weeks | Proportion of patients using laxative agents and/or other adjunctive bowel measures at 1-12 weeks and the average number of times per week |
| Responder rate at the time of the follow-up visit | 8 weeks | Proportion of patients with an average of 3 or more CSBMs per week from 5 to 12 weeks |
| Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL) | 12 weeks | Changes from baseline by time point in the PAC-QOL score |
| Self-Rating Depression Scale (SDS) | 12 weeks | Changes from baseline by time point in SDS scores |
| Self-Rating Anxiety Scale (SAS) | 12 weeks | Changes from baseline by time point in SAS scores |
| Adverse events | 12 weeks | Adverse events |
| Patient Assessment of Constipation symptom (PAC-SYM) | 12 weeks | Changes from baseline by time point in the PAC-SYM score |
Countries
China
Outcome results
None listed