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Completed

NCT Number: NCT03391635

Efficacy of Electroacupuncture Compared With Transcutaneous Electric Nerve Stimulation for Functional Constipation

The objective of this trial is to compare the efficacy of electroacupuncture versus transcutaneous electric nerve stimulation for functional constipation

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Key information

Conditions

Functional Constipation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, 100053, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Conforming to the criteria for the diagnosis of functional constipation in Rome III standard;
  • Aged of 18 to 75 years;
  • 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

  • Constipation caused by irritable bowel syndrome and organically or medicated; secondary to endocrine, metabolic, neurogenic, or surgical constipation;
  • Subjects with serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders, or the inability to cooperate with the examination and treatment.
  • Pregnant or lactation patients;
  • Subjects with abdominal aortic aneurysm, abnormal enlargement of liver and spleen and so on.
  • Subjects with coagulation dysfunction or anticoagulants such as warfarin and heparin have been used all the time.
  • Subjects installed with the cardiac pacemaker.

Treatment and study plan

Electroacupuncture

Device

Participants will receive electroacupuncture at bilateral ST25, SP14 and ST37 for 30 minutes each time，3 times a week for 8 weeks.

Other names: EA

TranscutaneousElectricNerveStimulation

Device

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.

Other names: TENS

Primary outcomes

  1. The proportion of participants with an average increasing of one or more complete spontaneous bowel movements from baseline at week 8.

    Time frame: 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 outcomes

  1. The proportion of participants with an average increasing of one or more complete spontaneous bowel movements

    Time frame: 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.

  2. Change number in CSBMS

    Time frame: Baseline，week 4，week 8, week 20 and week 32

    The change in the number of CSBMs at weeks 4 , 8 , 20 and 32.

  3. Change number in SBMS

    Time frame: Baseline，week 4，week 8, week 20 and week 32

    The change in the number of SBMs at weeks 4 , 8 , 20 and 32.

  4. The proportion of participants with type3 or type 4 stool character

    Time frame: 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

  5. Change number of average score in defecation difficulty

    Time frame: 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

  6. Change number of PAC-QOL score

    Time frame: 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.

  7. The proportion and average amount of using cathartics

    Time frame: weeks -1 , 4 , 8 , 20 and 32.

    The proportion and average amount of using cathartics at weeks -1 , 4 , 8 , 20 and 32.

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

Efficacy of Electroacupuncture Compared With Transcutaneous Electric Nerve Stimulation for Functional Constipation:a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 5, 2018
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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