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

This study is not yet open for participant recruitment.
Verified May 2017 by Jiang Xumei, South China Normal University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03171337
First Posted: May 31, 2017
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Jiang Xumei, South China Normal University
  Purpose

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


Condition Intervention
Chronic Tension-Type Headache Device: Acupuncture Device: Fu's Subcutaneous Needling (FSN) Device: Sham acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Jiang Xumei, South China Normal University:

Primary Outcome Measures:
  • 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) [ Time Frame: 5 months ]
    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.


Secondary Outcome Measures:
  • Pain Visual Analogue Scale (VAS) [ Time Frame: 4 months. ]
    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).

  • Headache Impact Test (HIT-6) [ Time Frame: 4 months. ]
    It consists of six questions that assess the impact of headache on the ability to work, study, at home and in social situations.


Estimated Enrollment: 45
Anticipated Study Start Date: June 10, 2017
Estimated Study Completion Date: December 31, 2017
Estimated Primary Completion Date: October 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Placebo 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171337


Contacts
Contact: Xuemei Jiang, PhD (86)13751847873 jxmacu01@126.com
Contact: Zhouyi Guo, Pro (86)13503004488 ann@scnu.edu.cn

Sponsors and Collaborators
Jiang Xumei
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
  More Information

Responsible Party: Jiang Xumei, Postdoctor;Lecturer, South China Normal University
ClinicalTrials.gov Identifier: NCT03171337     History of Changes
Other Study ID Numbers: SouthSNU
First Submitted: May 4, 2017
First Posted: May 31, 2017
Last Update Posted: June 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Jiang Xumei, South China Normal University:
Chronic tension-type headache
Acupuncture
Fu's subcutaneous needling(FSN)
fMRI
Regional homogeneity (ReHo)

Additional relevant MeSH terms:
Headache
Tension-Type Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases