Effect of Acupressure in Migraine: Single-blinded, Randomized, Controlled 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.

Conditions

• Migraine; Status

Interventions

DEVICE

Acupressure elastic band (Sea-Band)

The PC6 acupressure was done via Sea-Band in persistent compressive state for 3 minutes per time and three times a day , then at least 5 days in one week for 6 weeks continuously except modern routine standard therapy

DEVICE

General elastic band (no bud)

general elastic band was put over bilateral PC6 acupoints

Sponsors & Collaborators

• China Medical University, Taiwan

  collaborator OTHER

• National Taiwan University Hospital

  lead OTHER

Principal Investigators

• Chih-hung Tsai, MD · National Taiwan University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-07-04

Primary Completion

2021-06-25

Completion

2021-07-08

Countries

• Taiwan

Study Locations