Electroacupuncture Therapy for Change of Pain in Classical Trigeminal Neuralgia
Condition: Trigeminal Neuralgia
MeSH terms: Trigeminal Neuralgia; Neuralgia
Study type: Interventional

Summary: 
      The classical trigeminal neuralgia (CTN) is a common neuropathic pain in clinic by recurrent
      attacks of chronic sharp pain in the distribution of neuropathy branches of trigeminal
      neuralgia. With the lack of appropriate drug and surgery, acupuncture played a role in
      analgesia with its effective and few side effects. The study is designed to observe the
      therapeutic effect and safety of electroacupuncture (EA) in the treatment of CTN.
    

Detailed description: 
      A total of 120 subjects with CTN who met the inclusion criteria will be included in the
      study. The subjects will be randomly divided into EA+ Carbamazepine group, EA+placebo group,
      sham EA+Carbamazepine group and sham EA+placebo group. The indexes of main outcome evaluation
      are 1)Intensity of pain (Evaluation of the pain by VAS with 0-10 points) and 2)Brief
      introduction of 2-week pain. The indexes of secondary outcome evaluation are 1) Brief Pain
      Inventory-Facial scale(BPI-Facial); 2) Patient Global Impression of Change(PGIC); 3)
      Short-Form McGill Pain Questionnaire; 4) Short- Form 36 Questionnaire. This study will
      evaluate whether EA has the advantage over carbamazepine in the immediate effect, long-term
      effect and post effect of the analgesia in CTN. At the same time, the study also will
      demonstrate whether EA has a synergistic effect with carbamazepine on the treatment of CTN,
      or even whether EA has an alternative effect on carbamazepine. Furthermore, we will establish
      a standardized, effective and convenient therapy program of EA to promote according to the
      results.
    

Intervention name(s): EA+ Carbamazepine; EA+Placebo; sham EA+Carbamazepine; sham EA+Placebo
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Acupoints selection: Si-bai(ST2), Xia-guan(ST7), Di-cang(ST4), Quan-liao(SI18), Jia-che(ST6) and A-shi-xue of affected side. He-gu(LI4) and Wai-guan(TE5) of two sides.
Operation:The needles(0.18×25 mm) will be selected to stimulate the local points with shallow row needling according to the distribution of neuropathy branch of trigeminal neuralgia.The needles(0.25×40mm) will be selected to stimulate the distal acupoints. The Xia-guan(ST7) and Quan-liao(SL18) (or Jia-che(ST6)), He-gu(LI4) and Wai-guan(SJ5) acupoints will be received EA treatment by HuaTuo SDZ-ⅡB acupoint neural stimulator. The EA parameter is 2/100 Hz, 60 minutes and the current intensity is comfortable to subjects. Carbamazepine tablets should be took orally, 0.1g each time, thrice daily.; In this group, the selection, positioning and manipulation of acupoints, the frequency, duration and retaining needle time of treatment are same as EA + Carbamazepine Group; placebo, that appearance and specifications are the same as carbamazepine, are cooperated taken of dose 0.1g, thrice daily.; Selection of points and locations: the non-meridional points which are means to the points beside 5-10mm of the real acupoints (avoid the trigger point) in the EA group will be selected and needled with more shallow acupuncture (the depth of needling is about 1-2mm).
The operation of shame EA: The HuaTuo SDZ-ⅡB acupoint neural stimulator with damaged electrode wires will be selected to connect the points next to the Xia-guan(ST7) and Quan-liao (SI18) , He-gu (LI4) and Wai-guan(TE5).The frequency, intensity and retaining time will be same as EA group, The subjects can see the display screen and parameter settings of stimulator, however there is no electricity output in fact.
The dosage and frequency of oral carbamazepine tablets are same as above part.; The points selection, positioning and manipulation are same as Shame EA+ Carbamazepine group，placebo are cooperated taken of dose 0.1g, thrice daily.
Intervention MeSH terms: Carbamazepine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Classical trigeminal neuralgia; Electroacupuncture; Randomized controlled clinical trial