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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
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.
the Third affiliated hospital of Zhejiang Chinese Medical university
Hangzhou, Zhejiang, China
Change from Baseline Intensity of Pain to 28 weeks
Evaluation of the pain by VAS with 0-10 points which that 0 means painless and 10 means very painful.
Time frame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
Brief Pain Inventory-Facial scale(BPI-Facial)
This instrument is composed of 18 items on a 1-point scale (0-10). 4 questions center on pain intensity, 7 questions deal with the interference of pain with general life activities and the remaining 7 questions deal with the interference of pain with face-specific activities.
Time frame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
Patient Global Impression of Change(PGIC)
This index will record the general change impression of pain for CTN.
Time frame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
Short-Form McGill Pain Questionnaire
The pain rating index has 2 subscales: these words or items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe. There's also one item for present pain intensity and one item for a 10cm visual analogue scale for average pain. This version includes 7 additional symptoms related to neuropathic pain, for a total of 22 items with 0-10 numerical response options.
Time frame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
Short-Form 36 Questionnaire
The scale includes: 1.Physical Functioning (PF).2.Physical function (RP).3.Body Pain (BP).4.General Health (GH).5.Vitality.6.Social Functioning (SF)7.Role-emotional (RE).8.Mental Health (MH).
Time frame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
The proportion of patients using rescue analgesics
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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.
The proportion of patients using rescue analgesics
Time frame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks
The frequency of CTN attacks
Calculated from the pain diary
Time frame: Baseline, 2 weeks, 4 weeks, 16 weeks, 28 weeks