Efficacy of acupuncture versus sham acupuncture or waitlist control for patients with chronic plantar fasciitis: study protocol for a two-centre randomised controlled trial
Introduction Plantar fasciitis (PF) is reported to be the most common cause of plantar heel pain. Acupuncture has been used for patients experiencing PF, but evidence of the efficacy of acupuncture on PF is limited. The primary objective of this trial is to compare combined acupuncture and sham acup...
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BMJ Publishing Group
2020-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e036773.full |
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| author | Yan Liu Weiming Wang Zhishun Liu Liang Li Sixing Liu Zhiwei Zang Weina Zhang |
| author_facet | Yan Liu Weiming Wang Zhishun Liu Liang Li Sixing Liu Zhiwei Zang Weina Zhang |
| author_sort | Yan Liu |
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| description | Introduction Plantar fasciitis (PF) is reported to be the most common cause of plantar heel pain. Acupuncture has been used for patients experiencing PF, but evidence of the efficacy of acupuncture on PF is limited. The primary objective of this trial is to compare combined acupuncture and sham acupuncture (SA) versus waitlist control for improving the level of pain experienced by patients suffering from chronic PF.Methods and analysis This will be a two-centre, parallel-group, sham and no-treatment controlled, assessor-blinded randomised trial. We will randomly allocate 120 participants with chronic PF to acupuncture, SA and waitlist control groups at a ratio of 2:1:1. Participants in the acupuncture and SA groups will receive a 30 min acupuncture or SA treatment for a total of 12 sessions over 4 weeks, with a 12-week follow-up. Participants in the waitlist control group will not undergo treatment for a period of 16 weeks but instead will have the option of 4 weeks (12 sessions) of acupuncture free of charge at the end of the follow-up period. The primary outcome will be the treatment response rate 4 weeks after randomisation, assessed as a minimum of 50% improvement in the worst pain intensity during the first steps in the morning compared with the baseline. All analyses will be performed with a two-sided p value of <0.05 considered significant following the intention-to-treat principle.Ethics and dissemination The study has been approved by the Ethical Committee of the Guang’anmen Hospital, China Academy of Chinese Medical Sciences (approval no. 2019-210-KY). The results will be disseminated through presentation at a peer-reviewed medical journal, the relevant conferences and scientific meetings.Trial registration NCT04185259. |
| format | Article |
| id | doaj-art-431eb0e9fc6847b681370a5c059c2428 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-431eb0e9fc6847b681370a5c059c24282025-01-08T18:30:09ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-036773Efficacy of acupuncture versus sham acupuncture or waitlist control for patients with chronic plantar fasciitis: study protocol for a two-centre randomised controlled trialYan Liu0Weiming Wang1Zhishun Liu2Liang Li3Sixing Liu4Zhiwei Zang5Weina Zhang62 Gastroenterology and Hepatology, Baylor College of Medicine, Houston, Texas, USA1 Department of Acupuncture, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaDepartment of Acupuncture, Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China1 Department of Psychiatry, National Clinical Research Center for Mental Disorders, and National Center for Mental Disorders, The Second Xiangya Hospital of Central South University, Changsha, Hunan, ChinaSchool of Acupuncture–Moxibustion and Tuina, Guizhou University of Traditional Chinese Medicine, Guiyang City, Guizhou, ChinaDepartment of Acupuncture, Yantai Hospital of Traditional Chinese Medicine, Yantai, ChinaAcupuncture and Moxibustion Department, China Academy of Traditional Chinese Medicine Guang’anmen Hospital, Xicheng District, ChinaIntroduction Plantar fasciitis (PF) is reported to be the most common cause of plantar heel pain. Acupuncture has been used for patients experiencing PF, but evidence of the efficacy of acupuncture on PF is limited. The primary objective of this trial is to compare combined acupuncture and sham acupuncture (SA) versus waitlist control for improving the level of pain experienced by patients suffering from chronic PF.Methods and analysis This will be a two-centre, parallel-group, sham and no-treatment controlled, assessor-blinded randomised trial. We will randomly allocate 120 participants with chronic PF to acupuncture, SA and waitlist control groups at a ratio of 2:1:1. Participants in the acupuncture and SA groups will receive a 30 min acupuncture or SA treatment for a total of 12 sessions over 4 weeks, with a 12-week follow-up. Participants in the waitlist control group will not undergo treatment for a period of 16 weeks but instead will have the option of 4 weeks (12 sessions) of acupuncture free of charge at the end of the follow-up period. The primary outcome will be the treatment response rate 4 weeks after randomisation, assessed as a minimum of 50% improvement in the worst pain intensity during the first steps in the morning compared with the baseline. All analyses will be performed with a two-sided p value of <0.05 considered significant following the intention-to-treat principle.Ethics and dissemination The study has been approved by the Ethical Committee of the Guang’anmen Hospital, China Academy of Chinese Medical Sciences (approval no. 2019-210-KY). The results will be disseminated through presentation at a peer-reviewed medical journal, the relevant conferences and scientific meetings.Trial registration NCT04185259.https://bmjopen.bmj.com/content/10/9/e036773.full |
| spellingShingle | Yan Liu Weiming Wang Zhishun Liu Liang Li Sixing Liu Zhiwei Zang Weina Zhang Efficacy of acupuncture versus sham acupuncture or waitlist control for patients with chronic plantar fasciitis: study protocol for a two-centre randomised controlled trial BMJ Open |
| title | Efficacy of acupuncture versus sham acupuncture or waitlist control for patients with chronic plantar fasciitis: study protocol for a two-centre randomised controlled trial |
| title_full | Efficacy of acupuncture versus sham acupuncture or waitlist control for patients with chronic plantar fasciitis: study protocol for a two-centre randomised controlled trial |
| title_fullStr | Efficacy of acupuncture versus sham acupuncture or waitlist control for patients with chronic plantar fasciitis: study protocol for a two-centre randomised controlled trial |
| title_full_unstemmed | Efficacy of acupuncture versus sham acupuncture or waitlist control for patients with chronic plantar fasciitis: study protocol for a two-centre randomised controlled trial |
| title_short | Efficacy of acupuncture versus sham acupuncture or waitlist control for patients with chronic plantar fasciitis: study protocol for a two-centre randomised controlled trial |
| title_sort | efficacy of acupuncture versus sham acupuncture or waitlist control for patients with chronic plantar fasciitis study protocol for a two centre randomised controlled trial |
| url | https://bmjopen.bmj.com/content/10/9/e036773.full |
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