Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04429048 |
| Other study ID # |
202002094RIND |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 4, 2020 |
| Est. completion date |
July 8, 2021 |
Study information
| Verified date |
July 2022 |
| Source |
National Taiwan University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background :
Migraine is one of the most complex, prevalent, debilitating neurologic disorder in the
world. In clinical experience, there are limitation over western medicine for migraine,
especially some extra adverse effects. In traditional Chinese medicine(TCM), there are some
reviews and clinical practice point out acupressure at PC6 could relieve nausea/ vomiting and
pain while migraine. Recent researches also mention Calcitonin gene-related peptide (CGRP)
and Neurokinin A (NKA) in some degree correlated with the mechanism of migraine.
Objective:
CGRP and NKA play vital roles of migraine. In comparison with oral medication only and PC6
acupressure via oral medication, if there were better effect for migraine control. In
addition, investigators evaluate the plasma CGRP and NKA level before and after study to
figure out if any positive value and any correlation with acupressure.
Method:
By single-blinded, randomized, controlled clinical trial, total of 56 patients with migraine
were divided equally into acupressure group (modern routing standard therapy plus PC6
acupressure) and control group (modern routing standard therapy). Before intervention, the
participants needed to finish the Migraine Disability Assessment (MIDAS) questionnaire
evaluation. After 6 weeks, investigators will evaluate the severity, frequencies of headaches
and pain-killer consumption as primary outcome. In addition, investigators will investigate
if there were change of serum CGRP/NKA level after 6 weeks and the score changes of MOS
36-Item Short-Form Health Survey as secondary outcome.
Expected results:
The investigators predict that PC6 acupressure may not only reduce severity, frequencies and
duration of headaches but also reduce the dose of NSAIDs. In addition, the PC6 acupressure
also may reduce levels of serum CGRP and NKA, and improve the quality of life meanwhile.
Description:
Introduction:
Migraine is one of the most complex, prevalent, debilitating neurologic disorder and the
prevalence higher in female group. In general, there are many kinds of therapy for migraine
nowadays including of acute abortion oral drugs such as triptan, ergotamine, non-steroid
anti-inflammatory drugs, acetaminophen and preventive agents such as calcium channel blocker
(Flunarizine), anti-epileptic drugs (valproic acid, Topiramate, Pregabalin), beta
adrenergic-blocker (Propranolol), Selective Serotonin Reuptake Inhibitors(SSRI), anti-emetic
agents (Prochlorperazine) and other injection therapy such as Onabotulinum Toxin A or CGRP
(Calcitonin gene-related peptide) antagonist etc. The CGRP plays an important role of
trigemino-vascular responses in migraine. The serum CGRP levels elevated while migraine
attack and chronic migraine, therefore, CGRP is a potential biomarker. In recent studies,
higher plasma CGRP level during interictal phase of migraine or chronic migraine is indicated
the better response for Onabotulinum Toxin A and reduced plasma CGRP level can relieve the
discomfort of migraine. Neurokinin A (NKA) levels of venous blood are significantly higher in
responders than these nonresponse before the rizatriptan treatment, whereas reduced the
levels of both CGRP and NKA one hours after the treatment . The headache is associated with
nausea in about 80% of episodes, vomiting in about 30% in patients with migraine.
PC6 is belong to pericardium meridian locates the anterior aspect of forearm between the
tendons of the palmaris longus and the flexor carpi radialis, 2 cun proximal to the wrist
transverse stripes just on the median nerve . The antiemetic is lower for preventing
postoperative nausea and vomiting in the combination PC6 acupoint stimulation than these
patients with antiemetic only. Acupuncture at the PC6 is an effective alternative treatment
to conventional pharmacological treatment and resulted in almost immediate cessation of
intraoperative nausea and vomiting. Therefore, acupressure at PC6 is an effective and safety
method for nausea and vomiting. In addition, stimulation at PC6 can activate hypothalamic
orexin neurons, and that release orexins to induce analgesia. Taken together, PC6 stimulation
can produce effect of both analgesia and antiemetic effects. The present study suppose
stimulation at PC6 is beneficial for the treatment of migraine.
Therefore, the investigators designed a single-blinded, randomized, controlled trial to
evaluate the effect of acupressure at PC6 on headache in patients with migraine.
Method and study design:
(A) Participants The patients with migraine were enrolled from the outdoor patients (OPD) of
neurological department, Yunlin branch of National Taiwan University hospital. The basic
laboratory data including peripheral blood cells, Na/K/Ca/Mg, alanine aminotransferase (ALT),
creatinine, iron/total iron-binding capacity (TIBC)/ferritin to exclude extremely abnormal
metabolic disturbance or liver/renal functional impairment which may cause secondary
headache; and the awake electroencephalography (EEG) and brain image including computer
tomography (C-T) or magnetic resonance image (MRI) also were done to rule out any
intracranial structure lesion prior to the trial.
The migraine was diagnosed according to clinical manifestation and criteria from beta version
of the third edition of the International Classification of Headache Disorders (ICHD-3). In
addition, non-steroid anti-inflammatory drugs (NSAIDs) are used as episodic way while
migraine attack and Propranolol (Inderal R) is used as preventive way no matter when migraine
attack. In addition, the participants needed to finish the Migraine Disability Assessment
(MIDAS) questionnaire evaluation of 6 weeks.
(B) Study design: Single-blinded, randomized, controlled clinical trial. (C) Assessment time:
before PC6 acupressure (V1), two weeks after acupressure (V2), four weeks after acupressure
(V3) and six weeks after acupressure (D) Statistical analysis : Categorical data will be
displayed in numbers and percentages, whereas continuous variables will be given as means ±
standard deviations or median (Q1, Q3). Differences in categorical variables will be tested
using the chi-square test or Fisher exact test and differences in continuous variables will
be tested using the two sample independent t test or Mann-Whitney test between groups. The
generalized estimating equations (GEE) will be used to compare the change of primary outcomes
over time (the four time points (V1-V4)) between two groups. A p value of less than 0.05 will
be considered statistically significant. All statistical analyses will be performed using
SPSS Statistics 24or R version 3.4.4 .
Outcome :
The study of the present study predicts that PC6 acupressure may reduce severity of
headaches, the frequency of headache attacks and duration of headache, and also reduce the
dose of NSAID. In addition, the PC6 acupressure also may reduce levels of serum CGRP and NKA,
and also may improve the quality of life.
