The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Chronic functional constipation is a common disease. To date there has not specific therapy
      on chronic functional constipation. Systematic reviews indicate that acupuncture is probably
      effective for the disease, but the evidence is limited. Recently, we have finished a
      multi-center clinical trial of individualized deep electro-acupuncture (EA) for chronic
      functional constipation (n=460, Registration ID: NCT00508482) which preliminarily showed EA
      was effective.

      This multi-center large-sample randomized controlled clinical trial of acupuncture for severe
      functional constipation is designed to confirm the efficacy and safety of EA.

      This project is conducted by Chinese experts, supported by the Chinese Government. The
      research result is expected to provide high quality evidence of EA for chronic functional
      constipation.
    

Intervention name(s): electro-acupuncture; sham electro-acupuncture
Intervention type(s): Device; Device
Intervention description(s): 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.
Other intervention name(s): SDZ-V electro-acupuncture apparatus (Huatuo, made in China); Sham SDZ-V electro-acupuncture apparatus (Huatuo, China)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic functional constipation; electro-acupuncture; multi-center randomized controlled trial; efficacy; safety