NCT03171337

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

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Jiang Xumei · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Tension-Type Headache

Interventions

Type	Name	Description
DEVICE	Acupuncture	Acupuncture at acupoints for CTTH according to TCM theory using stainless filiform needle.
DEVICE	Fu's Subcutaneous Needling (FSN)	Fu's subcutaneous needling at specific points for CTTH using soft casing needle.
DEVICE	Sham acupuncture	Sham acupuncture at non-acupoints using Steinberger placebo needles

Timeline

• Start date: 2017-06-10
• Primary completion: 2017-10-31
• Completion: 2017-12-31
• First posted: 2017-05-31
• Last updated: 2017-06-05