NCT04384224

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

1.7 years

First QC Date

May 7, 2020

Last Update Submit

September 10, 2020

Conditions

Trigeminal Neuralgia

Outcome Measures

Primary Outcomes (1)

  • The change of Visual Analogue Scale

    Patients located their relative pain in a line marked in each extremity with 0 (0: no pain-on the left) and 10 (10: the worst pain imaginable-on the right)

    evaluated at the beginning of the treatment (day 0), the treatment day (3 session per week; just after treatment), and Day 21 (3 weeks) after the end of the treatment (follow-up)

Secondary Outcomes (1)

  • Short Form Health Survey-36

    evaluated at the beginning of the treatment (day 0) and Day 21 (3 weeks) after the end of the treatment (follow-up)

Study Arms (4)

sham acupuncture + placebo tablet group

PLACEBO COMPARATOR

sham acupuncture point + placebo tablet

Other: acupuncture

true acupuncture + placebo tablet group

EXPERIMENTAL

true acupuncture point + placebo tablet

Other: acupuncture

true acupuncture + antihistamine group

EXPERIMENTAL

true acupuncture point + Dexchlorpheniramine (4 mg)

Other: acupuncture

sham acupuncture + antihistamine group

SHAM COMPARATOR

sham acupuncture point + Dexchlorpheniramine (4 mg)

Other: acupuncture

Interventions

acupunctureOTHER

use disposable sterile steel needles to insert to the acupuncture point

sham acupuncture + antihistamine groupsham acupuncture + placebo tablet grouptrue acupuncture + antihistamine grouptrue acupuncture + placebo tablet group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Yu-Chen Lee

    China Medical University Hospital

    STUDY DIRECTOR

Central Study Contacts

Yu-Chen Lee

CONTACT

886-4-22052121d5167@mail.cmuh.org.tw

Chiu-Ming Chang

CONTACT

886-4-22052121asspiderman1982@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 12, 2020

Study Start

July 1, 2020

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

September 11, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)