The Clinical Benefits of the Combination Use of Acupuncture and Antihistamine on Trigeminal Neuralgia

Last updated: September 10, 2020
Sponsor: China Medical University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Trigeminal Neuralgia

Headaches

Pain

Treatment

N/A

Clinical Study ID

NCT04384224
CMUH109-REC3-007
  • Ages > 20
  • All Genders

Study Summary

Trigeminal neuralgia is a paroxysmal extreme pain and is an unmet clinical need, we hope that our discovery about the antihistamine and acupuncture can be used in the treatment trigeminal neuralgia. This present study aims to further investigate whether antihistamine dexchlorpheniramine can facilitate the analgesic effect of acupuncture in patients with trigeminal neuralgia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Age ≥ 20 2. Occurrence of episodes of intense facial paroxysmal pain in territoryinnervated by the trigeminal nerve (VAS score ≥ 6) 3. Presence of a normal neurologicexamination 4. Neurologist confirm- Normal neuroimaging analysis 5. Duration of eachpain episode < 15 minutes

Exclusion

Exclusion Criteria:

    1. Patient refuse to participate 2. Psychologic instability 3. Atypical pain location (eg, no specific trigger points) 4. Anticlotting therapy 5. Secondary trigeminalneuralgia

  • Multiple sclerosis

  • Temporomandibular joint disorders

  • Neoplasias 6. Altered neurologic profile

  • Hypoesthesia

  • Dysesthesia

  • Anesthesia

  • Paresis 7. Association with other cranial nerve neuralgias (eg, glossopharyngealneuralgia) 8. Imagiologic alterations 9. Proposed surgical intervention

  • Compression of the Gasser ganglion

  • Micro vascular decompression

  • Radiofrequency rhizotomy

Study Design

Total Participants: 40
Study Start date:
July 01, 2020
Estimated Completion Date:
February 28, 2022

Study Description

Trigeminal neuralgia is a paroxysmal extreme pain that occurs in the region dominated by facial trigeminal nerve. It is characterized by repetition and irregularity. Once the disease occurs, the pain is generally unbearable. Carbamazepine or other drugs is the main treatment methods. However, most patients will experience side effects so that drug treatments for trigeminal neuralgia has its limitation limitation. Surgical treatments have better efficacy but with greater risk.

The efficacy of acupuncture for pain treatment has been widely demonstrated by many clinical trials. A recent meta analysis has demonstrated that significant differences of efficacy between true and sham acupuncture indicate that acupuncture is more than a placebo. However, there are few clinical randomized controlled trials reporting the efficacy of acupuncture on trigeminal neuralgia.

Histamine H1 receptor antagonists are commonly used for treating allergy. Recently, we found that histamine H1 receptor antagonists at relatively low doses facilitate electroacupuncture (EA) analgesia in the acetic acid-induced abdominal writhing test. We have also conducted a clinical trial to demonstrate that H1 receptor antagonists facilitate EA analgesia in healthy volunteers. The study recruited 40 healthy normal subjects we found that EA at bilateral ST36 and GB34 plus high-dose dexchlorpheniramine (4 mg) produced greater pain threshold increases as than EA alone groups, suggesting the combination use of H1 antihistamine can facilitate acupuncture analgesia in humans.

This study aims to investigate whether antihistamine dexchlorpheniramine can also facilitate the analgesic effect of acupuncture in patients with trigeminal neuralgia. The experimental design is as follows: This experiment will recruit 40 healthy subjects, randomly divided into 4 groups, each group of 10 patients (1) sham acupuncture + placebo tablet group, (2) true acupuncture + placebo tablet group , (3) true acupuncture + antihistamine group and (4) sham acupuncture + antihistamine group. The treatment duration is one week for 3 acupuncture/sham acupuncture treatment. Dexchlorpheniramine (4 mg) or placebo tablets will be administered at the sleeping time the day before acupuncture treatment.

Connect with a study center

  • China Medical University Hospital

    Taichung, 404
    Taiwan

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.