Functional Constipation
Conditions
Keywords
acupuncture, functional constipation, transcutaneous electric nerve stimulation, randomized controlled trial
Brief summary
The objective of this trial is to compare the efficacy of electroacupuncture versus transcutaneous electric nerve stimulation for functional constipation
Detailed description
Both electroacupuncture(EA) therapy and transcutaneous electric nerve stimulation(TENS) are safe and effective for functional constipation, but no head to head comparing trial was conducted. Methods：102 participants with functional constipation will be recruited and randomly allocated into the EA group and the TENS group.Participants in both groups will receive EA or TENS treatment at Tianshu(ST 25), Fujie(SP 14) and Shangju xu(ST 37) 3 times a week for 8 weeks.
Interventions
DEVICEElectroacupuncture
Participants will receive electroacupuncture at bilateral ST25, SP14 and ST37 for 30 minutes each time，3 times a week for 8 weeks.
DEVICETranscutaneousElectricNerveStimulation
Participants will receive transcutaneous electric nerve stimulation at bilateral ST25, SP14 and ST37 for 30 minutes each time，3 times a week for 8 weeks.
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Conforming to the criteria for the diagnosis of functional constipation in Rome III standard; 2. Aged of 18 to 75 years; 3. No medication for constipation has been used for at least 2 weeks before treatment. Except for emergency treatment, it has not received acupuncture treatment for constipation in the past 3 months, and has not participated in other ongoing clinical research.
Exclusion criteria
1. Constipation caused by irritable bowel syndrome and organically or medicated; secondary to endocrine, metabolic, neurogenic, or surgical constipation; 2. Subjects with serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders, or the inability to cooperate with the examination and treatment. 3. Pregnant or lactation patients; 4. Subjects with abdominal aortic aneurysm, abnormal enlargement of liver and spleen and so on. 5. Subjects with coagulation dysfunction or anticoagulants such as warfarin and heparin have been used all the time. 6. Subjects installed with the cardiac pacemaker.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of participants with an average increasing of one or more complete spontaneous bowel movements from baseline at week 8. | Baseline，week 8 | The proportion of participants with an average increasing of one or more complete spontaneous bowel movements from baseline at week 8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change number in CSBMS | Baseline，week 4，week 8, week 20 and week 32 | The change in the number of CSBMs at weeks 4 , 8 , 20 and 32. |
| Change number in SBMS | Baseline，week 4，week 8, week 20 and week 32 | The change in the number of SBMs at weeks 4 , 8 , 20 and 32. |
| The proportion of participants with type3 or type 4 stool character | Baseline，week 4，week 8, week 20 and week 32 | According to the BRISTOL stool form scale, the proportion of participants with type3 or type 4 at weeks 4 , 8 , 20 and 32 |
| The proportion of participants with an average increasing of one or more complete spontaneous bowel movements | Baseline，week 4，week 20 and week 32 | The proportion of participants with an average increasing of one or more complete spontaneous bowel movements from baseline at weeks 4 , 20 and 32. |
| Change number of PAC-QOL score | Baseline，week 8 | The change in total score on the patients assessment of constipation quality of life questionnaire(PAC-QOL) total score at the end of week 8, compared with baseline. |
| The proportion and average amount of using cathartics | weeks -1 , 4 , 8 , 20 and 32. | The proportion and average amount of using cathartics at weeks -1 , 4 , 8 , 20 and 32. |
| Change number of average score in defecation difficulty | Baseline，week 4，week 8, week 20 and week 32 | The change in average score of difficulty in defecation at weeks 4 , 8 , 20 and 32 |
Countries
China
Outcome results
None listed