Trigeminal NeuralgiaNCT04384224
The Clinical Benefits of the Combination Use of Acupuncture and Antihistamine on Trigeminal Neuralgia
A study testing acupuncture in people with Trigeminal Neuralgia, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- acupuncture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2020to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404
Yu-Chen Lee, Doctor, 0975-682023, d5167@mail.cmuh.org.tw
About this study
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.
Read the 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
- Being tested
- acupuncture
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
use disposable sterile steel needles to insert to the acupuncture point
| Study group | Role | What they receive |
|---|---|---|
| sham acupuncture + placebo tablet group | Placebo comparator | sham acupuncture point + placebo tablet Receives: Other: acupuncture |
| true acupuncture + placebo tablet group | Experimental | true acupuncture point + placebo tablet Receives: Other: acupuncture |
| true acupuncture + antihistamine group | Experimental | true acupuncture point + Dexchlorpheniramine (4 mg) Receives: Other: acupuncture |
| sham acupuncture + antihistamine group | Sham comparator | sham acupuncture point + Dexchlorpheniramine (4 mg) Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
a 36-item questionnaire assessing functional health and well-being during the previous month. Testing of the Taiwanese version has demonstrated validity similar to that of other language versions. The SF-36 evaluates quality of life in 8 domains: physical functioning (PF), role limitations due to physical problems (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and general mental health (MH). Five of the scales (PF, RP, BP, SF and RE) indicate the absence of limitations or disability. The remaining 3 scales (GH, VT and MH) indicate a positive state of well-being, with mid-range scores indicating no reported limitations or disabilities. In this study, items in each domain will be aggregated and transformed into a scale from 0 to 100, with higher scores indicating better health status.
Measured: evaluated at the beginning of the treatment (day 0) and Day 21 (3 weeks) after the end of the treatment (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Jul 2020
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chen Lee, Study director, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384224
- Sponsor's protocol ID
- CMUH109-REC3-007
- Status last verified
- Sep 2020
- First submitted
- 7 May 2020
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Benefits of the Combination Use of Acupuncture and Antihistamine on Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT04384224
- Acronym / sponsor ID
- CMUH109-REC3-007
- Conditions
- Trigeminal Neuralgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sham acupuncture + placebo tablet group | Placebo comparator | Other: acupuncturesham acupuncture point + placebo tablet |
| true acupuncture + placebo tablet group | Experimental | Other: acupuncturetrue acupuncture point + placebo tablet |
| true acupuncture + antihistamine group | Experimental | Other: acupuncturetrue acupuncture point + Dexchlorpheniramine (4 mg) |
| sham acupuncture + antihistamine group | Sham comparator | Other: acupuncturesham acupuncture point + Dexchlorpheniramine (4 mg) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (11 listed)
- 1. Patient refuse to participate 2. Psychologic instability 3. Atypical pain location (eg, no specific trigger points) 4. Anticlotting therapy 5. Secondary trigeminal neuralgia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureuse disposable sterile steel needles to insert to the acupuncture point | Other | sham acupuncture + antihistamine group, sham acupuncture + placebo tablet group, true acupuncture + antihistamine group, true acupuncture + placebo tablet group |
Primary outcome
The change of Visual Analogue Scale
Time frame: 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)
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)
1 secondary outcome
Short Form Health Survey-36
Time frame: evaluated at the beginning of the treatment (day 0) and Day 21 (3 weeks) after the end of the treatment (follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Chen Lee study director
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Trigeminal Neuralgia, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Chen Lee (886-4-22052121 ext. 1670, d5167@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of Visual Analogue Scale (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.