Effect of Fu’s subcutaneous needling for cancer pain management: protocol for a pragmatic randomised controlled trial
Introduction Pain is a common symptom in patients with cancer, and pain management is crucial for these patients. Fu’s subcutaneous needling (FSN) is a modern acupuncture therapy based on basic medicine commonly used in patients with pain. However, evidence of its effectiveness in treating cancer pa...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2023-04-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/4/e068232.full |
| _version_ | 1797838038719528960 |
|---|---|
| author | Yang Cao Yihan He Jian Sun Danghan Xu Zhanbo Yu Ximin Cai Jietao Lin Tengjiao Lin Zhaoxi Liu |
| author_facet | Yang Cao Yihan He Jian Sun Danghan Xu Zhanbo Yu Ximin Cai Jietao Lin Tengjiao Lin Zhaoxi Liu |
| author_sort | Yang Cao |
| collection | DOAJ |
| description | Introduction Pain is a common symptom in patients with cancer, and pain management is crucial for these patients. Fu’s subcutaneous needling (FSN) is a modern acupuncture therapy based on basic medicine commonly used in patients with pain. However, evidence of its effectiveness in treating cancer pain has not been systematically proven. Therefore, this pragmatic randomised controlled trial aims to evaluate the effectiveness and safety of FSN for cancer pain management.Methods and analysis Overall, 120 eligible patients will be recruited and randomly assigned into two groups using block randomisation. Both groups will be administered analgesic drugs according to the National Comprehensive Cancer Network guidelines. The treatment group will receive FSN therapy one time a day for 6 days. Additionally, we will assess analgesic consumption as the primary outcome and the Numerical Rating Scale, outbreak pain, symptom assessment and adverse events as secondary outcomes to evaluate the effect and safety of FSN in treating cancer pain. The incidence of adverse events will be monitored to assess the safety of FSN.Ethics and dissemination Ethics approval was obtained from the Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine (approval No: K(2021)096). The results will be published in a peer-reviewed journal, and trial participants will be informed via email and/or phone calls.Trial registration number ChiCTR2200056348. |
| first_indexed | 2024-04-09T15:35:25Z |
| format | Article |
| id | doaj.art-5bf3ed440080408e8f33fe15c2e3ad7d |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-09T15:35:25Z |
| publishDate | 2023-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-5bf3ed440080408e8f33fe15c2e3ad7d2023-04-27T19:30:07ZengBMJ Publishing GroupBMJ Open2044-60552023-04-0113410.1136/bmjopen-2022-068232Effect of Fu’s subcutaneous needling for cancer pain management: protocol for a pragmatic randomised controlled trialYang Cao0Yihan He1Jian Sun2Danghan Xu3Zhanbo Yu4Ximin Cai5Jietao Lin6Tengjiao Lin7Zhaoxi Liu8Clinical Epidemiology and Biostatistics, School of Medical Sciences, Orebro University, Orebro, Sweden3 The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China2 Department of Pathology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Beijing, ChinaRehabilitation Center, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, ChinaGuangzhou University of Chinese Medicine, Guangzhou, Guangdong, ChinaGuangzhou University of Chinese Medicine, Guangzhou, Guangdong, ChinaOncology Center, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, ChinaRadiotherapy Department, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, ChinaGuangzhou University of Chinese Medicine, Guangzhou, Guangdong, ChinaIntroduction Pain is a common symptom in patients with cancer, and pain management is crucial for these patients. Fu’s subcutaneous needling (FSN) is a modern acupuncture therapy based on basic medicine commonly used in patients with pain. However, evidence of its effectiveness in treating cancer pain has not been systematically proven. Therefore, this pragmatic randomised controlled trial aims to evaluate the effectiveness and safety of FSN for cancer pain management.Methods and analysis Overall, 120 eligible patients will be recruited and randomly assigned into two groups using block randomisation. Both groups will be administered analgesic drugs according to the National Comprehensive Cancer Network guidelines. The treatment group will receive FSN therapy one time a day for 6 days. Additionally, we will assess analgesic consumption as the primary outcome and the Numerical Rating Scale, outbreak pain, symptom assessment and adverse events as secondary outcomes to evaluate the effect and safety of FSN in treating cancer pain. The incidence of adverse events will be monitored to assess the safety of FSN.Ethics and dissemination Ethics approval was obtained from the Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine (approval No: K(2021)096). The results will be published in a peer-reviewed journal, and trial participants will be informed via email and/or phone calls.Trial registration number ChiCTR2200056348.https://bmjopen.bmj.com/content/13/4/e068232.full |
| spellingShingle | Yang Cao Yihan He Jian Sun Danghan Xu Zhanbo Yu Ximin Cai Jietao Lin Tengjiao Lin Zhaoxi Liu Effect of Fu’s subcutaneous needling for cancer pain management: protocol for a pragmatic randomised controlled trial BMJ Open |
| title | Effect of Fu’s subcutaneous needling for cancer pain management: protocol for a pragmatic randomised controlled trial |
| title_full | Effect of Fu’s subcutaneous needling for cancer pain management: protocol for a pragmatic randomised controlled trial |
| title_fullStr | Effect of Fu’s subcutaneous needling for cancer pain management: protocol for a pragmatic randomised controlled trial |
| title_full_unstemmed | Effect of Fu’s subcutaneous needling for cancer pain management: protocol for a pragmatic randomised controlled trial |
| title_short | Effect of Fu’s subcutaneous needling for cancer pain management: protocol for a pragmatic randomised controlled trial |
| title_sort | effect of fu s subcutaneous needling for cancer pain management protocol for a pragmatic randomised controlled trial |
| url | https://bmjopen.bmj.com/content/13/4/e068232.full |
| work_keys_str_mv | AT yangcao effectoffussubcutaneousneedlingforcancerpainmanagementprotocolforapragmaticrandomisedcontrolledtrial AT yihanhe effectoffussubcutaneousneedlingforcancerpainmanagementprotocolforapragmaticrandomisedcontrolledtrial AT jiansun effectoffussubcutaneousneedlingforcancerpainmanagementprotocolforapragmaticrandomisedcontrolledtrial AT danghanxu effectoffussubcutaneousneedlingforcancerpainmanagementprotocolforapragmaticrandomisedcontrolledtrial AT zhanboyu effectoffussubcutaneousneedlingforcancerpainmanagementprotocolforapragmaticrandomisedcontrolledtrial AT ximincai effectoffussubcutaneousneedlingforcancerpainmanagementprotocolforapragmaticrandomisedcontrolledtrial AT jietaolin effectoffussubcutaneousneedlingforcancerpainmanagementprotocolforapragmaticrandomisedcontrolledtrial AT tengjiaolin effectoffussubcutaneousneedlingforcancerpainmanagementprotocolforapragmaticrandomisedcontrolledtrial AT zhaoxiliu effectoffussubcutaneousneedlingforcancerpainmanagementprotocolforapragmaticrandomisedcontrolledtrial |