The Efficacy of Acupuncture and Fu's Subcutaneous Needling (FSN ) in Treating Chronic Tension-type Headache by fMRI

To Explore the Cerebral Function Efficacy of Acupuncture and Fu's Subcutaneous Needling (FSN) in the Treatment of Chronic Tension-type Headache by Means of fMRI: a Single-blinded, Randomized Controlled Trials.

Epidemiological studies show a one-year prevalence of 30%-60% for episodic tension-type headache (TTH) and 2%-3% for chronic TTH (CTTH). Many TTH patients seek acupuncture treatment worldwide, and CTTH is one of the most commonly treated. FSN has been used to treat CTTH recently; the curative effect of it was especially good for CTTH accompanying pericranial tenderness. Nonetheless, the effectiveness of acupuncture and FSN for CTTH remains controversial. Several research results showed that symptoms of TTH improve after acupuncture treatment, but these improvements were more subjective than objective measures. So, the aim of this study is to determine the cerebral function efficacy of acupuncture and FSN in the treatment of CTTH, using Headache impact test questionnaire (HIT-6), VAS to evaluate the subjective symptom and fMRI to detect the objective cerebral function changes.

Intervention: device: acupuncture; Fu's subcutaneous; placebo sham acupuncture

Study Overview

• Status: Unknown
• Conditions: Chronic Tension-Type Headache
• Intervention / Treatment: Device: Acupuncture; Device: Fu's Subcutaneous Needling (FSN); Device: Sham acupuncture

Detailed Description

Tension-type headache (TTH) is the most prevalent type of primary headache. Unlike migraine, however, there have been no significant treatment advances for chronic TTH in the past few decades, probably due to the limited understanding of its pathophysiology compared with that of migraine. The objective of the present study is to investigate the cerebral function imaging changes in patients with chronic tension headache trough comparing that in healthy people, focus on the regional homogeneity (ReHo) of ROIs of brain. In addition, the effect of acupuncture and Fu's subcutaneous needing (FSN) on the cerebral function will also be studied. This is a clinical trial study, randomized, in parallel, single-blinded assessor, and with a sham placebo control.

The study will be carried out in the （Traditional therapy center, Guangdong Hospital of Traditional Chinese Medicine）. Patients will be collected according to the inclusion criteria (conform to diagnose criterion for headache ICHD-3), with age between 18 and 45 years old. Healthy people will be collected too according to the inclusion criteria for healthy people, with age matching with the patients. The participants will respond to questionnaires at the beginning and end of the first, fifth and last therapeutic intervention and their fMRI of brain will be acquired. The therapeutic intervention will include: 8 acupuncture sessions, 8 FSN sessions and 8 placebo sham acupuncture sessions (twice per week for 4 weeks). The measurements taken will be: impact of headache on daily life, severity of headache, emotional problem of headache, the cerebral function of ROIs (by means of fMRI) of headache and so on.

Through these interventions it is hoped that patients will present an improvement in their pain presentation, quality of life and emotional problem, as well as cerebral function imaging in certain region of brain. Evidence for these hypotheses will provide the cerebral function effect mechanism of acupuncture and FSN to CTTH, and some evidence in the research will perhaps support that acupuncture and FSN are two type minimally-invasive treatment methods, with few side-effects and low cost.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xuemei Jiang, PhD; Phone Number: （86）13751847873; Email: jxmacu01@126.com
• Study Contact Backup: Name: Zhouyi Guo, Pro; Phone Number: （86）13503004488; Email: ann@scnu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Conforms to clinical diagnostic criteria of CTTH associated with pericranial tenderness（ICHD-3 beta version）, Han nationality.
2. Aged between 18 and 45 years old men or women with right-handed.
3. No history of cognitive dysfunction.
4. Seeking medical advice for TTH for the first time.
5. Providing informed consent to participate in the study.

Exclusion Criteria:

1. Taking analgesics or other drugs may affect the resting state fMRI scans of brain within two weeks.
2. Have hypertension, diabetes, anxiety, depression and other systemic diseases, other chronic pain etc. Psychiatric or neurologic disorder that unable patient to consent and follow study protocol.
3. Combined with other type headache.
4. Intracranial lesions are found in MRI or CT scans.
5. Headache breaks out within 24h after fMRI scan.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Acupuncture; Acupuncture at acupoints for CTTH according to TCM theory, twice 1 week for 4 weeks，fMRI will be used to detect the cerebral function changes	Device: Acupuncture; Acupuncture at acupoints for CTTH according to TCM theory using stainless filiform needle.; Other Names: Filiform needle
ACTIVE_COMPARATOR: Fu's subcutaneous needling (FSN); FSN at the points related with CTTH, twice 1 week for 4 weeks, fMRI will be used to detect the cerebral function changes.	Device: Fu's Subcutaneous Needling (FSN); Fu's subcutaneous needling at specific points for CTTH using soft casing needle.; Other Names: Fu's Acupuncture; Floating Needling; Fu Needling
SHAM_COMPARATOR: Sham acupuncture; Streitberger placebo needles at nonacupoint for CTTH, twice 1 week for 4 weeks,fMRI will be used to detect the cerebral function changes.	Device: Sham acupuncture; Sham acupuncture at non-acupoints using Steinberger placebo needles; Other Names: Placebo Acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Regional homogeneity data (ReHo) (using Kendall's coefficient of concordance as index) of Resting state fMRI of the whole brain (from the Vertex to Basicranial)	ReHo data before and after the first/last, as well as after the fourth acupuncture, FSN and sham acupuncture treatment, Changes of ReHo data from baseline to after the first, fourth, last treatment will be calculated in each treatment group and will be compared with each other.	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Visual Analogue Scale (VAS）	The intensity of pain was measured by a 10 cm VAS. The scores range from no pain (zero) to the worst possible pain (10 cm).	4 months.
Headache Impact Test (HIT-6)	It consists of six questions that assess the impact of headache on the ability to work, study, at home and in social situations.	4 months.

Collaborators and Investigators

• Sponsor: Jiang Xumei
• Collaborators: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Investigators: Study Chair: Zhouyi Guo, Pro, SATCM Third Grade Laboratory of Chinese Medicine and Photonics Technology, College of Biophotonics and fMRI chamber, research resources center, South China Normal University.; Principal Investigator: Jian Sun, PhD, Traditional therapy center, Guangdong Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 10, 2017
• Primary Completion (ANTICIPATED): October 31, 2017
• Study Completion (ANTICIPATED): December 31, 2017

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 26, 2017
• First Posted (ACTUAL): May 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 5, 2017
• Last Update Submitted That Met QC Criteria: June 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Acupuncture; fMRI; Chronic tension-type headache; Fu's subcutaneous needling(FSN); Regional homogeneity (ReHo)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache
• Other Study ID Numbers: SouthSNU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No