Electroacupuncture Therapy for Change of Pain in Classical Trigeminal Neuralgia

Zhejiang Chinese Medical University

Status: Completed

Conditions: Trigeminal Neuralgia

Treatments: Other: sham EA+Placebo; Other: EA+Placebo; Other: EA+ Carbamazepine; Other: sham EA+Carbamazepine

Study type: Interventional

Funder types: Other

Identifiers

NCT03580317

2018ZY008-CTN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients suffer from the pain with electric shock, shooting, stabbing occurs in one or more branches of the trigeminal nerve.
2. The visual analogue score(VAS) baseline score ≥5, have a attack more than 3 times a day, at least 4 days a week.
3. 18 years ≤ age ≤ 80 years.
4. Clear consciousness, have the ability of pain perception and resolution, can complete the basic communication.
5. Signed informed consent and volunteered to participate in this study.

Exclusion criteria

1. Those patients with epilepsy, head injury or other related neurological diseases.
2. Patients with serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders, or unable to cooperate with the treatment.
3. Combined with hypertension but poor control.
4. Severe depressive with definitive diagnosis recently.
5. Pregnant and lactating patients.
6. Installing pacemakers.
7. For any other reason that is not suitable for the treatment of EA.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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120 participants in 4 patient groups, including a placebo group

EA + Carbamazepine Group

Experimental group

Description:

The subjects in this group will receive 3 times per week, and 4 weeks of continuous intervention for a total of 12 times. The intervention including electroacupuncture(EA) treatment and combined with Carbamazepine (0.1g each time, thrice daily). The follow-up period is 6 months.

Treatment:

Other: EA+ Carbamazepine

EA + Placebo Group

Placebo Comparator group

Description:

The subjects in this group will receive 3 times per week, and 4 weeks of continuous intervention for a total of 12 times. The intervention including EA treatment and combined with placebo of carbamazepine. The follow-up period is 6 months.

Treatment:

Other: EA+Placebo

Sham EA+ Carbamazepine Group

Active Comparator group

Description:

The subjects in this group will receive 3 times per week, and 4 weeks of continuous intervention for a total of 12 times. The intervention including sham electroacupuncture(sham EA) intervention and combined with carbamazepine. The follow-up period is 6 months.

Treatment:

Other: sham EA+Carbamazepine

Sham EA+ Placebo Group

Sham Comparator group

Description:

The subjects in this group will receive 3 times per week, and 4 weeks of continuous intervention for a total of 12 times. The intervention including sham EA intervention and combined with placebo took orally. The follow-up period is 6 months.

Treatment:

Other: sham EA+Placebo