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

NCT03171337 | Unknown DMC

• 1 other identifier: SouthSNU
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Tension-Type Headache

Keywords

Chronic tension-type headache; Acupuncture; Fu's subcutaneous needling(FSN); fMRI; Regional homogeneity (ReHo)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain Visual Analogue Scale (VAS）

  4 months.

• Headache Impact Test (HIT-6)

  4 months.

Study Arms (3)

Acupuncture

EXPERIMENTAL

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

Fu's subcutaneous needling (FSN)

ACTIVE COMPARATOR

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)

Sham acupuncture

SHAM COMPARATOR

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

Interventions

Acupuncture DEVICE

Acupuncture at acupoints for CTTH according to TCM theory using stainless filiform needle.

Also known as: Filiform needle

Acupuncture

Fu's Subcutaneous Needling (FSN) DEVICE

Fu's subcutaneous needling at specific points for CTTH using soft casing needle.

Also known as: Fu's Acupuncture; Floating Needling; Fu Needling

Fu's subcutaneous needling (FSN)

Sham acupuncture DEVICE

Sham acupuncture at non-acupoints using Steinberger placebo needles

Also known as: Placebo Acupuncture

Sham acupuncture

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Taking analgesics or other drugs may affect the resting state fMRI scans of brain within two weeks.
• 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.
• Combined with other type headache.
• Intracranial lesions are found in MRI or CT scans.
• Headache breaks out within 24h after fMRI scan.

Sponsors & Collaborators

• Jiang Xumei: lead
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• 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.

  STUDY CHAIR

• Jian Sun, PhD

  Traditional therapy center, Guangdong Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuemei Jiang, PhD

CONTACT

（86）13751847873; jxmacu01@126.com

Zhouyi Guo, Pro

CONTACT

（86）13503004488; ann@scnu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postdoctor;Lecturer

Model Details: The parallel group includes the positive and negative controls, the positive control is Fu's Subcutaneous Needling group and the negative is Sham acupuncture group. And the other parallel control is the fMRI of patients with CTTH VS fMRI of healthy people.

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 31, 2017
• Study Start: June 10, 2017
• Primary Completion: October 31, 2017
• Study Completion: December 31, 2017
• Last Updated: June 5, 2017

Record last verified: 2017-05