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

NCT03171337 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2017-06-05

No results posted yet for this study

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

Conditions

  • Chronic Tension-Type Headache

Interventions

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

Sponsors & Collaborators

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • Jiang Xumei

    lead OTHER

Principal Investigators

  • 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.

  • Jian Sun, PhD · Traditional therapy center, Guangdong Hospital of Traditional Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-10
Primary Completion
2017-10-31
Completion
2017-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03171337 on ClinicalTrials.gov