The long-term effect of acupuncture for patients with chronic tension-type headache: study protocol for a randomized controlled trial
Lu et al. Trials
The long-term effect of acupuncture for patients with chronic tension-type headache: study protocol for a randomized controlled trial
Lingyun Lu 0 2
Hui Zheng 0 2
Qianhua Zheng 0 2
Xinyu Hao 0 2
Siyuan Zhou 0 2
Shusen Zhang 0 2
Tao Wei 0 2
Tao Gao 0 2
Duoxi Duan 0 2
Ling Zhao 0 2
Ning Li 1
Ying Li 0 2
0 Chengdu University of Traditional Chinese Medicine , 37 Shi'er Qiao Road, Jinniu District, Chengdu, Sichuan 610075 , People's Republic of China
1 West China School of Medicine/West China Hospital of Sichuan University , 37 Guoxue Lane, Wuhou District, Chengdu, Sichuan 610041 , People's Republic of China
2 Chengdu University of Traditional Chinese Medicine , 37 Shi'er Qiao Road, Jinniu District, Chengdu, Sichuan 610075 , People's Republic of China
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 longterm 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.
Acupuncture; Chronic tension-type headache; Randomized controlled trial; Study protocol
Background
Chronic tension-type headache (CTTH) is a disorder
evolving from frequent episodic tension-type headache
(TTH), typically bilateral, pressing or tightening in
quality, mild to moderate in intensity, lasting hours to days,
or unremitting [
1
]. In April 2016, the World Health
Organization reported that chronic headache, occurring
on 15 or more days every month affected 1.7–4% of the
world’s adult population, among which CTTH, as the
most common chronic primary headache disorder,
affected 1–3% of adults [
2
].
According to the guidelines developed by the European
Federation of Neurological Societies, prophylactic
treatment should be considered in patients with CTTH, and
the recommended prophylactic drugs include
amitriptyline, mirtazapine, venlafaxine, and muscle relaxants [
3
].
However, some unpleasant side effects of the
recommended drugs have been reported, including sexual
dysfunction, body weight changes, gastrointestinal
discomfort, unusual bleeding, and bruising [
4–6
]. In addition
to the serious adverse effects associated with the use of
muscle relaxants, its evidence for application to CTTH
patients is limited [
7
]. More importantly, issues such as
medication overuse and how to prevent CTTH sufferers
from developing medication overuse headache require
greater attention.
Acupuncture, one of the most important components
in traditional Chinese medicine (TCM), is widely used to
relieve tension-type headache [
3, 8
]. Several trials of
good quality have drawn the conclusion that
acupuncture was superior to sham acupuncture in TTH
treatment [
9, 10
]; some studies, however, have indicated no
significant differences [
11–13
]. According to the
National Institute for Health and Clinical Excellence
clinical guidelines [
8
] and Cochrane Library systematic
reviews [
14, 15
], acupuncture is recommended for
CTTH management. Nevertheless, its scientific basis is
still relatively limited owing to a lack of adequate
statistical power, insufficient reports, or relevant
methodological shortcomings in previous studies [
16, 17
].
CTTH is a chronic disorder characterized by
persistent or recurrent attacks of headaches, thus the
long-term effect of acupuncture is of particula (...truncated)