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

Primary Purpose

Chronic Tension-Type Headache

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Fu's Subcutaneous Needling (FSN)
Sham acupuncture
Sponsored by
Jiang Xumei
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Tension-Type Headache focused on measuring Chronic tension-type headache, Acupuncture, Fu's subcutaneous needling(FSN), fMRI, Regional homogeneity (ReHo)

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Sham Comparator

    Arm Label

    Acupuncture

    Fu's subcutaneous needling (FSN)

    Sham acupuncture

    Arm Description

    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

    FSN at the points related with CTTH, twice 1 week for 4 weeks, fMRI will be used to detect the cerebral function changes.

    Streitberger placebo needles at nonacupoint for CTTH, twice 1 week for 4 weeks,fMRI will be used to detect the cerebral function changes.

    Outcomes

    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)
    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)
    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)
    It consists of six questions that assess the impact of headache on the ability to work, study, at home and in social situations.

    Full Information

    First Posted
    May 4, 2017
    Last Updated
    June 2, 2017
    Sponsor
    Jiang Xumei
    Collaborators
    Guangdong Provincial Hospital of Traditional Chinese Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03171337
    Brief Title
    The Efficacy of Acupuncture and Fu's Subcutaneous Needling (FSN ) in Treating Chronic Tension-type Headache by fMRI
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 10, 2017 (Anticipated)
    Primary Completion Date
    October 31, 2017 (Anticipated)
    Study Completion Date
    December 31, 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jiang Xumei
    Collaborators
    Guangdong Provincial Hospital of Traditional Chinese Medicine

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Tension-Type Headache
    Keywords
    Chronic tension-type headache, Acupuncture, Fu's subcutaneous needling(FSN), fMRI, Regional homogeneity (ReHo)

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Acupuncture
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Fu's subcutaneous needling (FSN)
    Arm Type
    Active Comparator
    Arm Description
    FSN at the points related with CTTH, twice 1 week for 4 weeks, fMRI will be used to detect the cerebral function changes.
    Arm Title
    Sham acupuncture
    Arm Type
    Sham Comparator
    Arm Description
    Streitberger placebo needles at nonacupoint for CTTH, twice 1 week for 4 weeks,fMRI will be used to detect the cerebral function changes.
    Intervention Type
    Device
    Intervention Name(s)
    Acupuncture
    Other Intervention Name(s)
    Filiform needle
    Intervention Description
    Acupuncture at acupoints for CTTH according to TCM theory using stainless filiform needle.
    Intervention Type
    Device
    Intervention Name(s)
    Fu's Subcutaneous Needling (FSN)
    Other Intervention Name(s)
    Fu's Acupuncture; Floating Needling; Fu Needling
    Intervention Description
    Fu's subcutaneous needling at specific points for CTTH using soft casing needle.
    Intervention Type
    Device
    Intervention Name(s)
    Sham acupuncture
    Other Intervention Name(s)
    Placebo Acupuncture
    Intervention Description
    Sham acupuncture at non-acupoints using Steinberger placebo needles
    Primary Outcome Measure Information:
    Title
    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)
    Description
    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.
    Time Frame
    5 months
    Secondary Outcome Measure Information:
    Title
    Pain Visual Analogue Scale (VAS)
    Description
    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).
    Time Frame
    4 months.
    Title
    Headache Impact Test (HIT-6)
    Description
    It consists of six questions that assess the impact of headache on the ability to work, study, at home and in social situations.
    Time Frame
    4 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xuemei Jiang, PhD
    Phone
    (86)13751847873
    Email
    jxmacu01@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhouyi Guo, Pro
    Phone
    (86)13503004488
    Email
    ann@scnu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhouyi Guo, Pro
    Organizational Affiliation
    SATCM Third Grade Laboratory of Chinese Medicine and Photonics Technology, College of Biophotonics and fMRI chamber, research resources center, South China Normal University.
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Jian Sun, PhD
    Organizational Affiliation
    Traditional therapy center, Guangdong Hospital of Traditional Chinese Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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