The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation
Condition: Constipation
MeSH terms: Constipation
Intervention: electro-acupuncture; sham electro-acupuncture
Intervention description: Procedure: electro-acupuncture; Points:Tianshu (ST25) Fujie(SP14), Shangjuxu (ST37).Pierced the skin, needles are inserted 30to70mm into bilateral ST25 and SP14 vertically until piercing the abdominal muscle layer.Electric stimulator is applied to bilateral ST25 and SP14 with dilatational wave, 10/50 Hz and electric current 0.1-1.0mA. The participant's abdominal muscle twitching mildly is the appropriate dose. Bilateral ST37 are inserted 25-30mm and then twirling lifting and thrusting for 3 times.Local sour and heavy feeling is appropriate dose. Steady small twirling lifting and thrusting 3 times in all. 30 min/per day/per session.During the 8 weeks treatment, the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total.; Procedure:sham electro-acupuncture;Points:Sham Tianshu(ST25),sham Fujie(SP14),sham Shangjuxu (ST37).Sham points location:20mm away from ST25,middle of Spleen and Stomach Channel;30mm from SP14,middle of Spleen and Stomach Channel; one point beside ST37,middle of Stomach and Gallbladder Channel; Performance:The needle is inserted with needle of 0.30×25mm by 3-5mm. No twirling lifting and thrusting. The electric stimulator is applied to bilateral sham ST25 and sham SP14 with dilatational wave,10/50 Hz and electric current 0.5mA.The mental wire has been cut off with a same outlook as the treatment group.The electric stimulator is looked normal but with no current output. Length of Treatment and the treatment sessions are the same as treatment group.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1075.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: chronic functional constipation; electro-acupuncture; multi-center randomized controlled trial; efficacy; safety

Summary:

      The main purpose of this study is to evaluate efficacy of electro-acupuncture for severe
      functional constipation compared with sham acupuncture, used as placebo; the secondary
      purpose is to evaluate the safety and post-treatment effect of electro-acupuncture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  meeting the diagnosis of Rome III criteria for chronic functional constipation;

          -  severe chronic constipation: two or fewer spontaneous complete bowel movements per
             week for more than 3 months;

          -  18-75 years old;

          -  no use of medicine for constipation during the two weeks before enrollment (except
             rescue medication);

          -  no acupuncture treatment for constipation in recent 3 months;

          -  never joined any other trial in process in 3 months;

          -  volunteered to join this research and signed the informed consent.

        Exclusion Criteria:

          -  Irritable bowel syndrome (IBS) and constipation caused by endocrine, metabolic,
             nervous or postoperative diseases or drugs;

          -  constipation accompanied by serious cardiovascular, hepatic, renal, or psychiatric
             disease, cognitive dysfunction or aphasia, or severe dystrophy affecting the
             cooperation for examination or treatment;

          -  pregnant women or women in lactation period

          -  constipation accompanied by abdominal aneurysm, hepatosplenomegaly, etcetera;

          -  bleeding disorders, or regular anticoagulant drug users, such as warfarin and heparin,
             etcetera;

          -  cardiac pacemaker carrier.