Efficacy and Safety of Electro-Thumbtack Needle Therapy for Patients With Chronic Neck Pain: Protocol for a Randomized, Sham-Controlled Trial
BackgroundChronic neck pain is a prevalent condition adversely impacting patients' wellbeing in both life and work experience. Electro-thumbtack needle (ETN) therapy, combining acupuncture with transcutaneous stimulation, might be one of the effective complementary and alternative medicine (CAM...
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| Format: | Article |
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Frontiers Media S.A.
2022-04-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2022.872362/full |
| _version_ | 1811303731126337536 |
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| author | Hangyu Shi Hangyu Shi Xinlu Wang Yan Yan Lili Zhu Yu Chen Shuai Gao Zhishun Liu |
| author_facet | Hangyu Shi Hangyu Shi Xinlu Wang Yan Yan Lili Zhu Yu Chen Shuai Gao Zhishun Liu |
| author_sort | Hangyu Shi |
| collection | DOAJ |
| description | BackgroundChronic neck pain is a prevalent condition adversely impacting patients' wellbeing in both life and work experience. Electro-thumbtack needle (ETN) therapy, combining acupuncture with transcutaneous stimulation, might be one of the effective complementary and alternative medicine (CAM) therapies in treating chronic neck pain, although the evidence is scarce. This study aims to estimate the efficacy and safety of ETN therapy for chronic neck pain.Methods and AnalysisThis is a sham-controlled, randomized clinical trial. A total of 180 subjects will be randomly allocated to either the ETN group or the sham ETN group. Treatment will be administrated three times a week for four consecutive weeks, with a 6-month follow-up. The primary outcome measure will be the Numerical Rating Scale for neck pain (NRS-NP) over a period of the 4 weeks. Secondary outcome measures include the Northwick Park Neck Pain Questionnaire (NPQ), Neck Disability Index (NDI), Patient Global Impression of Change (PGIC), patient expectation, and preference assessment. The chi-square test or Fisher's exact test will be used for proportions of participants having clinically meaningful improvement. Analysis of covariance or repeated-measures analysis of variance will be applied to examine changes in the outcome measures from baseline.DiscussionsThis prospective trial will contribute to evaluating the efficacy and safety of ETN in the treatment of chronic neck pain, with an intermediate-term follow-up. This study will provide further evidence for clinical neck pain management.Ethics and DisseminationThis trial has been approved by the Research Ethical Committee of Guang'anmen Hospital (ethical approval number: 2021-039-KY-01). Recruitment began in March 2022 and will continue until December 2023. Dissemination plans include posters, WeChat, websites, and bulletin boards in hospital and communities.Clinical Trial RegistrationThis trial is registered at ClinicalTrials.gov (identifier: NCT04981171). |
| first_indexed | 2024-04-13T07:53:14Z |
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| id | doaj.art-29d106579e0d441a83f5832d5a3894b5 |
| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-04-13T07:53:14Z |
| publishDate | 2022-04-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj.art-29d106579e0d441a83f5832d5a3894b52022-12-22T02:55:28ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2022-04-01910.3389/fmed.2022.872362872362Efficacy and Safety of Electro-Thumbtack Needle Therapy for Patients With Chronic Neck Pain: Protocol for a Randomized, Sham-Controlled TrialHangyu Shi0Hangyu Shi1Xinlu Wang2Yan Yan3Lili Zhu4Yu Chen5Shuai Gao6Zhishun Liu7Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaBeijing University of Chinese Medicine, Beijing, ChinaDepartment of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaDepartment of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaDepartment of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaNew Zealand College of Chinese Medicine, Auckland, New ZealandDepartment of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaDepartment of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, ChinaBackgroundChronic neck pain is a prevalent condition adversely impacting patients' wellbeing in both life and work experience. Electro-thumbtack needle (ETN) therapy, combining acupuncture with transcutaneous stimulation, might be one of the effective complementary and alternative medicine (CAM) therapies in treating chronic neck pain, although the evidence is scarce. This study aims to estimate the efficacy and safety of ETN therapy for chronic neck pain.Methods and AnalysisThis is a sham-controlled, randomized clinical trial. A total of 180 subjects will be randomly allocated to either the ETN group or the sham ETN group. Treatment will be administrated three times a week for four consecutive weeks, with a 6-month follow-up. The primary outcome measure will be the Numerical Rating Scale for neck pain (NRS-NP) over a period of the 4 weeks. Secondary outcome measures include the Northwick Park Neck Pain Questionnaire (NPQ), Neck Disability Index (NDI), Patient Global Impression of Change (PGIC), patient expectation, and preference assessment. The chi-square test or Fisher's exact test will be used for proportions of participants having clinically meaningful improvement. Analysis of covariance or repeated-measures analysis of variance will be applied to examine changes in the outcome measures from baseline.DiscussionsThis prospective trial will contribute to evaluating the efficacy and safety of ETN in the treatment of chronic neck pain, with an intermediate-term follow-up. This study will provide further evidence for clinical neck pain management.Ethics and DisseminationThis trial has been approved by the Research Ethical Committee of Guang'anmen Hospital (ethical approval number: 2021-039-KY-01). Recruitment began in March 2022 and will continue until December 2023. Dissemination plans include posters, WeChat, websites, and bulletin boards in hospital and communities.Clinical Trial RegistrationThis trial is registered at ClinicalTrials.gov (identifier: NCT04981171).https://www.frontiersin.org/articles/10.3389/fmed.2022.872362/fullacupuncturechronic neck painRCTelectro-thumbtack needleefficacy and safety |
| spellingShingle | Hangyu Shi Hangyu Shi Xinlu Wang Yan Yan Lili Zhu Yu Chen Shuai Gao Zhishun Liu Efficacy and Safety of Electro-Thumbtack Needle Therapy for Patients With Chronic Neck Pain: Protocol for a Randomized, Sham-Controlled Trial Frontiers in Medicine acupuncture chronic neck pain RCT electro-thumbtack needle efficacy and safety |
| title | Efficacy and Safety of Electro-Thumbtack Needle Therapy for Patients With Chronic Neck Pain: Protocol for a Randomized, Sham-Controlled Trial |
| title_full | Efficacy and Safety of Electro-Thumbtack Needle Therapy for Patients With Chronic Neck Pain: Protocol for a Randomized, Sham-Controlled Trial |
| title_fullStr | Efficacy and Safety of Electro-Thumbtack Needle Therapy for Patients With Chronic Neck Pain: Protocol for a Randomized, Sham-Controlled Trial |
| title_full_unstemmed | Efficacy and Safety of Electro-Thumbtack Needle Therapy for Patients With Chronic Neck Pain: Protocol for a Randomized, Sham-Controlled Trial |
| title_short | Efficacy and Safety of Electro-Thumbtack Needle Therapy for Patients With Chronic Neck Pain: Protocol for a Randomized, Sham-Controlled Trial |
| title_sort | efficacy and safety of electro thumbtack needle therapy for patients with chronic neck pain protocol for a randomized sham controlled trial |
| topic | acupuncture chronic neck pain RCT electro-thumbtack needle efficacy and safety |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2022.872362/full |
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