The long-term effect of acupuncture for patients with chronic tension-type headache: study protocol for a randomized controlled trial

Lingyun Lu, Hui Zheng, Qianhua Zheng, Xinyu Hao, Siyuan Zhou, Shusen Zhang, Tao Wei, Tao Gao, Duoxi Duan, Ling Zhao, Ning Li, Ying Li, Lingyun Lu, Hui Zheng, Qianhua Zheng, Xinyu Hao, Siyuan Zhou, Shusen Zhang, Tao Wei, Tao Gao, Duoxi Duan, Ling Zhao, Ning Li, Ying Li

Abstract

Background: The effectiveness of acupuncture for patients with chronic tension-type headache (CTTH) is controversial. In this article, we report the protocol for a randomized controlled trial aiming to evaluate the long-term effect of acupuncture for CTTH, in comparison with superficial acupuncture.

Design: A two-armed, parallel-design, patient-assessor blind, randomized controlled trial is underway in China. A total of 218 participants with CTTH will be randomly assigned to the treatment group or the control group in a 1:1 ratio. Participants in the treatment group and control group will receive acupuncture or superficial acupuncture treatments in a fixed prescription of acupoints respectively, for a total of 20 sessions over 8 weeks. The posttreatment follow-up period will be 24 weeks. The primary outcome will be the proportion of responders assessed at week 16 after randomization. The secondary outcomes will include the number of headache days, the mean intensity of headache, the reduction of medication intake, results from the 36-item short form health survey, the Hamilton Depression Scale and the Hamilton Anxiety Scale, the number of participants with adverse events, the expectation value of acupuncture treatment, and the intensity of deqi sensation. The first five secondary outcomes will be assessed or calculated at baseline, and at 4, 8, 12, 16, 20, 24, 28, and 32 weeks after randomization. Moreover, the expectation value will be collected at baseline and at week 8 after randomization, the intensity of deqi sensation will be assessed at 5 minutes after each treatment and adverse events will be summarized at the end of the follow-up period.

Discussion: Results from this trial will provide evidence for the long-term effect of acupuncture for CTTH with a long follow-up period.

Trial registration: ClinicalTrial.gov NCT03133884 . Registered on 25 April 2017.

Keywords: Acupuncture; Chronic tension-type headache; Randomized controlled trial; Study protocol.

Conflict of interest statement

Ethics approval and consent to participate

The study is approved by Sichuan Regional Ethics Review Committee on Traditional Chinese Medicine (Approval No. 2016KL-007), and registered with ClinicalTrials.gov in the USA (NCT03133884). The implementation follows the principles of the Declaration of Helsinki (Version Edinburgh 2000). Only participants who provide written informed consent will be included in this study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of this trial
Fig. 2
Fig. 2
SPIRIT figure of enrolment, interventions, and assessments using the 36-item short form health survey (SF-36), Hamilton Depression Scale (HAMD) and Hamilton Anxiety Scale (HAMA). Deqi sensation will be assessed at 5 min after each treatment

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