The long-term effect of acupuncture for patients with chronic tension-type headache: study protocol for a randomized controlled trial
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 acup...
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doaj-e49ac81e73a047d2a108b9c292af12202020-11-25T02:28:29ZengBMCTrials1745-62152017-10-011811810.1186/s13063-017-2188-9The long-term effect of acupuncture for patients with chronic tension-type headache: study protocol for a randomized controlled trialLingyun Lu0Hui Zheng1Qianhua Zheng2Xinyu Hao3Siyuan Zhou4Shusen Zhang5Tao Wei6Tao Gao7Duoxi Duan8Ling Zhao9Ning Li10Ying Li11Chengdu University of Traditional Chinese MedicineChengdu University of Traditional Chinese MedicineChengdu University of Traditional Chinese MedicineChengdu University of Traditional Chinese MedicineChengdu University of Traditional Chinese MedicineChengdu University of Traditional Chinese MedicineChengdu University of Traditional Chinese MedicineChengdu University of Traditional Chinese MedicineChengdu University of Traditional Chinese MedicineChengdu University of Traditional Chinese MedicineWest China School of Medicine/West China Hospital of Sichuan UniversityChengdu University of Traditional Chinese MedicineAbstract 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.http://link.springer.com/article/10.1186/s13063-017-2188-9AcupunctureChronic tension-type headacheRandomized controlled trialStudy protocol |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Lingyun Lu Hui Zheng Qianhua Zheng Xinyu Hao Siyuan Zhou Shusen Zhang Tao Wei Tao Gao Duoxi Duan Ling Zhao Ning Li Ying Li |
spellingShingle |
Lingyun Lu Hui Zheng Qianhua Zheng Xinyu Hao Siyuan Zhou Shusen Zhang Tao Wei Tao Gao Duoxi Duan Ling Zhao Ning Li Ying Li The long-term effect of acupuncture for patients with chronic tension-type headache: study protocol for a randomized controlled trial Trials Acupuncture Chronic tension-type headache Randomized controlled trial Study protocol |
author_facet |
Lingyun Lu Hui Zheng Qianhua Zheng Xinyu Hao Siyuan Zhou Shusen Zhang Tao Wei Tao Gao Duoxi Duan Ling Zhao Ning Li Ying Li |
author_sort |
Lingyun Lu |
title |
The long-term effect of acupuncture for patients with chronic tension-type headache: study protocol for a randomized controlled trial |
title_short |
The long-term effect of acupuncture for patients with chronic tension-type headache: study protocol for a randomized controlled trial |
title_full |
The long-term effect of acupuncture for patients with chronic tension-type headache: study protocol for a randomized controlled trial |
title_fullStr |
The long-term effect of acupuncture for patients with chronic tension-type headache: study protocol for a randomized controlled trial |
title_full_unstemmed |
The long-term effect of acupuncture for patients with chronic tension-type headache: study protocol for a randomized controlled trial |
title_sort |
long-term effect of acupuncture for patients with chronic tension-type headache: study protocol for a randomized controlled trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2017-10-01 |
description |
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. |
topic |
Acupuncture Chronic tension-type headache Randomized controlled trial Study protocol |
url |
http://link.springer.com/article/10.1186/s13063-017-2188-9 |
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