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

NCT ID: NCT04384224

Last Updated: 2020-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-02-28

Brief 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.

Detailed 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.

Conditions

Trigeminal Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

sham acupuncture + placebo tablet group

sham acupuncture point + placebo tablet

Group Type: PLACEBO_COMPARATOR

acupuncture

Intervention Type: OTHER

use disposable sterile steel needles to insert to the acupuncture point

true acupuncture + placebo tablet group

true acupuncture point + placebo tablet

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: OTHER

use disposable sterile steel needles to insert to the acupuncture point

true acupuncture + antihistamine group

true acupuncture point + Dexchlorpheniramine (4 mg)

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: OTHER

use disposable sterile steel needles to insert to the acupuncture point

sham acupuncture + antihistamine group

sham acupuncture point + Dexchlorpheniramine (4 mg)

Group Type: SHAM_COMPARATOR

acupuncture

Intervention Type: OTHER

use disposable sterile steel needles to insert to the acupuncture point

Interventions

acupuncture

use disposable sterile steel needles to insert to the acupuncture point

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Multiple sclerosis
• Temporomandibular joint disorders
• Neoplasias 6. Altered neurologic profile
• Hypoesthesia
• Dysesthesia
• Anesthesia
• Paresis 7. Association with other cranial nerve neuralgias (eg, glossopharyngeal neuralgia) 8. Imagiologic alterations 9. Proposed surgical intervention
• Compression of the Gasser ganglion
• Micro vascular decompression
• Radiofrequency rhizotomy

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Chen Lee

Role: STUDY_DIRECTOR

China Medical University Hospital

Locations

China Medical University Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yu-Chen Lee

Role: CONTACT

d5167@mail.cmuh.org.tw

886-4-22052121 ext. 1670

Chiu-Ming Chang

Role: CONTACT

asspiderman1982@gmail.com

886-4-22052121 ext. 1670

Facility Contacts

Yu-Chen Lee, Doctor

Role: primary

d5167@mail.cmuh.org.tw

0975-682023

Other Identifiers

CMUH109-REC3-007

Identifier Type: -

Identifier Source: org_study_id