Condition category
Nervous System Diseases
Date applied
27/10/2016
Date assigned
05/04/2017
Last edited
11/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Migraine is a debilitating headache condition which affects 15% of the population at least once in the course of a lifetime. Its causes are not well understood, but imbalances in blood flow in the brain are suspected to play a role. Acupuncture, originating from traditional Chinese medicine, is the practice of stimulating various points of the body, usually with needles, and has been found to be work well as part of preventive care for migraine and for pain relief from migraine attack. It has also been found to stimulate response from the brain, which has been observed by several measures, including changes in the blood flow. However, the connection with migraine is not yet well understood. To address this gap, this study is investigating whether pain relief from acupuncture is reflected in the flow of oxygenated blood in the brain and muscles. With a novel tool to record real-time changes in blood flow, namely by near-infrared spectroscopy (NIRS), it may be possible to see how successful the treatment is while the effect is being felt, as well as provide further clues into the causes of migraine.

Who can participate?
Adults aged 20-65 diagnosed with migraine

What does the study involve?
Participants are randomly allocated to one of three groups. Those in group 1 receive “true” (verum) acupuncture, meaning needling at specified points to achieve a specific feeling and effect. Those in group 2 receive “placebo” acupuncture, where the needling is applied more shallowly and at points not believed to have an effect. Participants in group 3 are not given acupuncture. The acupuncture treatments (groups 1 and 2) are compared by examining changes in the blood flow in the brain while receiving acupuncture, by using NIRS. There is also comparison among all three groups to assess the effect on migraine symptoms.

What are the possible benefits and risks of participating?
Participants may possibly benefit from an improvement of their migraine symptoms. Acupuncture is considered safe for most patients, but some may have adverse reaction to contact with the (hypo-allergenic) needles, such as redness of the skin. Some participants may observe a worsening of their symptoms, before they see improvement.

Where is the study run from?
The study is run with the cooperation of China Medical University and Taiwan National University
Hospital (Taiwan)

When is the study starting and how long is it expected to run for?
August 2014 to July 2017

Who is funding the study
National Research Institute of Chinese Medicine (Taiwan)

Who is the main contact?
Dr Wei-Zen Sun
wzsun@ntu.edu.tw

Trial website

Contact information

Type

Scientific

Primary contact

Dr Wei-Zen Sun

ORCID ID

Contact details

Department of Anesthesiology
4F
No.7
Chung Shan S. Rd.(Zhongshan S. Rd.)
Zhongzheng Dist
Taipei
10002
Taiwan
+886 2 2312 3456 ext. 65522
wzsun@ntu.edu.tw

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

201402077RINA, version 17-Mar-2016; MOHW104-NRICM-C-114-000-005

Study information

Scientific title

The analgesic modulation of standardized acupuncture and the cerebral and muscular hemodynamic response in migraine patients: a randomized, placebo-controlled trial

Acronym

Study hypothesis

The analgesic effect of verum acupuncture is greater than that of placebo acupuncture, and that of placebo acupuncture exceeds that of no acupuncture. Furthermore, near-infrared spectroscopy (NIRS) of the brain can provide sufficient detail to distinguish various clinical responses to needling of the scalp in real time, while the readings in the upper trapezius muscle are expected to behave as a control.

Ethics approval

1. National Taiwan University Hospital Research Ethics Committee, 29/09/2014, ref: 201402077RINA (Version 05-Aug-2014)
2. The National Taiwan University Hospital Research Ethics Committee, 05/05/2016, ref: 201402077RINA (Version 17-Mar-2016)

Study design

Interventional randomized parallel placebo-controlled quasi double-blind multi-center study

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Migraine (with or without aura)

Intervention

Participants are randomly allocated to one of the three groups below:

1. Verum acupuncture (de-qi-inducing needling at specified points)
2. Placebo acupuncture (shallow needle stimulation a specified distance away from specified points, no induction of de qi)
3. No acupuncture (patients receive no acupuncture in the study period)

In all arms, patients have access to medication prescribed prior to, including rescue medicine for headache. Acupuncture (verum or placebo) is administered three times a week for four weeks, with sessions lasting 30 minutes each.

Blood flow in the brain are compared for groups 2 and 3 using near-infrared spectroscopy.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Primary clinical measures:
1. Headache duration (headache hours/day)
2. Headache frequency (headache days/month) 3. Headache intensity (VAS score)

These are recorded in headache diaries covering the 12-week duration of the study and apply to all treatment arms

Primary hemodynamic measures:
1. Regional oxygenation of the cerebral cortex (Oxy/Deoxy-Hb ratio)
2. Regional oxygenation of the upper trapezius (Oxy/Deoxy-Hb ratio)

These are measured by near-infrared spectroscopy (NIRS) during each acupuncture treatment session and apply only to the two acupuncture arms, verum and placebo

Secondary outcome measures

1. Medications (name, type, usage), recorded in headache diary
2. Presence of migraine aura (Yes/No), noted by attending physician during treatment session
3. Headache intensity (VAS score), noted by attending physician during treatment session
4. Headache site (Left/Right), noted by attending physician during treatment session
5. Body movement (duration of movement per 10-min interval), recorded by video of treatment session

Except the measure for medications (#1), the above apply only to the acupuncture arms, verum and placebo.

Overall trial start date

01/08/2014

Overall trial end date

31/07/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosed with migraine (with or without aura, according to ICHD-II criteria)
2. Patient has given consent to receive acupuncture treatment
3. Age (20-65)
4. Patient has provided informed consent to participate (informed about possibility of receiving placebo treatment or no acupuncture treatment, informed about the use of NIRS during acupuncture sessions)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Patient refuses acupuncture treatment
2. Patient has contra-indications for acupuncture
3. Patient suffers from hemophilia, skin infections or has other conditions that preclude the use of acupuncture
4. Suffers mental illness
5. Pregnant or lactating
6. Patient is currently participating in another clinical study or has participated in another clinical trial within 3 months to enrolling in the study
7. Patient opts or drops out of study
8. Patient has received acupuncture treatment within the past 3 months
9. Patient fails to follow the parameters of the study, such as number of acupuncture treatments per week

Recruitment start date

01/08/2014

Recruitment end date

31/07/2017

Locations

Countries of recruitment

Taiwan

Trial participating centre

China Medical University
No.91, Hsueh-Shih Road
Taichung
40402
Taiwan

Trial participating centre

National Taiwan University Hospital
No.7, Chung Shan S. Rd.(Zhongshan S. Rd) Zhongzheng Dist
Taipei
10002
Taiwan

Sponsor information

Organisation

National Research Institute of Chinese Medicine, Ministry of Health and Welfare

Sponsor details

No. 155-1
Sec. 2
Linong St.
Beitou District
Taipei
11221
Taiwan
+886 2 28201999
wzsun@ntu.edu.tw

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Research Institute of Chinese Medicine, Ministry of Health and Welfare

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Wei-Zen Sun (wzsun@ntu.edu.tw).

Intention to publish date

31/07/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/08/2017: Internal review. 12/07/2017: Internal edit.