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
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
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.
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
NCT ID
NCT03171337
First Posted
May 4, 2017
Last Updated
June 2, 2017
Sponsor
Jiang Xumei
Collaborators
Guangdong Provincial Hospital of Traditional Chinese Medicine
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
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The Efficacy of Acupuncture and Fu's Subcutaneous Needling (FSN ) in Treating Chronic Tension-type Headache by fMRI
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