Functional Constipation, FC
Conditions
Interventions
Device Control Group:Gastroelectric pacing(GES)
Combined Intervention Group:Gastroelectric pacing (GES) and Novel Diaphragmatic-Pelvic-Abdominal Motion (DPAR) training
Drug Control Group:Conventional lactulose oral solution treatment
Sponsors
Jiangwan Hospital of Hongkou District,Shanghai
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Outpatients and inpatients who meet the Rome IV diagnostic criteria for functional constipation; 2.Aged 18 to 75 years,regardless of gender; 3.Disease duration of at least 6 months,with symptoms persisting for =3 months; 4.No organic or metabolic causes of constipation; 5.Willing to be randomly assigned to either the physical therapy group or the medication group,and able to comply with the intervention and complete follow-up assessments;
Exclusion criteria
Exclusion criteria: 1.Colorectal tumors, inflammatory bowel disease,or severe cardiopulmonary disease; 2.Use of laxatives or prokinetic agents within the past 2 weeks(a washout period of at least 2 weeks is required); 3.Pregnancy,lactation,or psychiatric/cognitive impairment; 4.Contraindications to electrical stimulation (such as implanted cardiac pacemaker); 5.Allergy or intolerance to lactulose or similar osmotic laxatives;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weekly changes in Complete Spontaneous Bowel Movements(CSBM) at Week 8;The response rate;Defecation Difficulty and Abdominal Bloating scores;At the end of the follow-up period(week 12),the reduction rate of CSBM compared to week 8, and the target maintenance rate.; | — |
Secondary
| Measure | Time frame |
|---|---|
| PAC-SYM score;Colonic transit time(SCTT);PAC-QOL score;Bristol Stool Form Scale score;Diaphragm mobility,abdominal muscle thickness(measured by ultrasound).;SAS/SDS scales score; | — |
Countries
China
Contacts
Public ContactLili Liu
Jiangwan Hospital of Hongkou District,Shanghai
Outcome results
None listed