Clinical trial NCT03171337: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Tension-Type Headache
Keywords: Chronic tension-type headache
Acupuncture
Fu's subcutaneous needling(FSN)
fMRI
Regional homogeneity (ReHo)
Lead sponsor: South China Normal University
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial Hospital of Traditional Chinese Medicine
First posted: 2017-05-31
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: 5 months
Secondary outcomes:
measure: Pain Visual Analogue Scale (VAS）
timeFrame: 4 months.
measure: Headache Impact Test (HIT-6)
timeFrame: 4 months.
Other outcomes:
Locations:
Study officials:
affiliation: SATCM Third Grade Laboratory of Chinese Medicine and Photonics Technology, College of Biophotonics and fMRI chamber, research resources center, South China Normal University.
name: Zhouyi Guo, Pro
role: STUDY_CHAIR
affiliation: Traditional therapy center, Guangdong Hospital of Traditional Chinese Medicine
name: Jian Sun, PhD
role: PRINCIPAL_INVESTIGATOR
References: