Efficacy and safety of acupuncture for hand osteoarthritis: study protocol for a multi-center, randomized, sham-controlled clinical trial
Abstract Background Hand osteoarthritis (OA) is a prevalent disorder in the general population. Patients with hand OA often report symptoms of pain, stiffness, and functional limitations, which cause clinical burden and impact on quality of daily life. However, the efficacy of current therapies for...
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| Format: | Article |
| Language: | English |
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BMC
2023-02-01
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| Series: | Journal of Orthopaedic Surgery and Research |
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| Online Access: | https://doi.org/10.1186/s13018-023-03570-6 |
| _version_ | 1811165786889256960 |
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| author | Weiming Wang Hangyu Shi Yan Liu Yuanjie Sun Yu Chen Zhishun Liu |
| author_facet | Weiming Wang Hangyu Shi Yan Liu Yuanjie Sun Yu Chen Zhishun Liu |
| author_sort | Weiming Wang |
| collection | DOAJ |
| description | Abstract Background Hand osteoarthritis (OA) is a prevalent disorder in the general population. Patients with hand OA often report symptoms of pain, stiffness, and functional limitations, which cause clinical burden and impact on quality of daily life. However, the efficacy of current therapies for hand OA is limited. Other therapies with better effects and less adverse events are in urgent need. Acupuncture is well known for analgesia and has been proved effective in treating basal thumb joint arthritis. This study aims to clarify the efficacy and safety of acupuncture treatment for clinical symptomatic improvement of hand OA. Methods This will be a sham-controlled, randomized, multi-center clinical trial. A total of 340 participants will be recruited and randomly allocated to either traditional acupuncture group or sham acupuncture group. All participants will receive 12 treatment sessions over 4 weeks and 2 follow-up assessments in the following 3 months at week 8 and week 16. The primary outcome will be the proportion of responders at week 5. Secondary outcomes will include visual analog scale, Australian Canadian Osteoarthritis Hand Index, Functional Index for hand OA, the number of symptomatic joints, hand grip strength and pinch strength, global assessment, the World Health Organization Quality of Life abbreviated version and expectations. Safety will be evaluated during the whole process of the trial. All outcomes will be analyzed following the intention-to-treat principle. Discussion This prospective trial will provide high-quality evidence on evaluating the efficacy and safety of acupuncture treatment for hand OA. Results of this trial might contribute in offering a new option to clinical recommendations. Trial registration ClinicalTrials.gov Identifier: NCT05267093. Registered 23 February 2022. |
| first_indexed | 2024-04-10T15:42:48Z |
| format | Article |
| id | doaj.art-9ed4284f09aa43ecbea9457e251dd40c |
| institution | Directory Open Access Journal |
| issn | 1749-799X |
| language | English |
| last_indexed | 2024-04-10T15:42:48Z |
| publishDate | 2023-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Orthopaedic Surgery and Research |
| spelling | doaj.art-9ed4284f09aa43ecbea9457e251dd40c2023-02-12T12:18:00ZengBMCJournal of Orthopaedic Surgery and Research1749-799X2023-02-0118111110.1186/s13018-023-03570-6Efficacy and safety of acupuncture for hand osteoarthritis: study protocol for a multi-center, randomized, sham-controlled clinical trialWeiming Wang0Hangyu Shi1Yan Liu2Yuanjie Sun3Yu Chen4Zhishun Liu5Department of Acupuncture and Moxibustion, Guang’anmen Hospital, China Academy of Chinese Medical SciencesDepartment of Acupuncture and Moxibustion, Guang’anmen Hospital, China Academy of Chinese Medical SciencesKey Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese MedicineDepartment of Acupuncture and Moxibustion, Guang’anmen Hospital, China Academy of Chinese Medical SciencesNew Zealand College of Chinese MedicineDepartment of Acupuncture and Moxibustion, Guang’anmen Hospital, China Academy of Chinese Medical SciencesAbstract Background Hand osteoarthritis (OA) is a prevalent disorder in the general population. Patients with hand OA often report symptoms of pain, stiffness, and functional limitations, which cause clinical burden and impact on quality of daily life. However, the efficacy of current therapies for hand OA is limited. Other therapies with better effects and less adverse events are in urgent need. Acupuncture is well known for analgesia and has been proved effective in treating basal thumb joint arthritis. This study aims to clarify the efficacy and safety of acupuncture treatment for clinical symptomatic improvement of hand OA. Methods This will be a sham-controlled, randomized, multi-center clinical trial. A total of 340 participants will be recruited and randomly allocated to either traditional acupuncture group or sham acupuncture group. All participants will receive 12 treatment sessions over 4 weeks and 2 follow-up assessments in the following 3 months at week 8 and week 16. The primary outcome will be the proportion of responders at week 5. Secondary outcomes will include visual analog scale, Australian Canadian Osteoarthritis Hand Index, Functional Index for hand OA, the number of symptomatic joints, hand grip strength and pinch strength, global assessment, the World Health Organization Quality of Life abbreviated version and expectations. Safety will be evaluated during the whole process of the trial. All outcomes will be analyzed following the intention-to-treat principle. Discussion This prospective trial will provide high-quality evidence on evaluating the efficacy and safety of acupuncture treatment for hand OA. Results of this trial might contribute in offering a new option to clinical recommendations. Trial registration ClinicalTrials.gov Identifier: NCT05267093. Registered 23 February 2022.https://doi.org/10.1186/s13018-023-03570-6AcupunctureHand osteoarthritisClinical trialEfficacy and safety |
| spellingShingle | Weiming Wang Hangyu Shi Yan Liu Yuanjie Sun Yu Chen Zhishun Liu Efficacy and safety of acupuncture for hand osteoarthritis: study protocol for a multi-center, randomized, sham-controlled clinical trial Journal of Orthopaedic Surgery and Research Acupuncture Hand osteoarthritis Clinical trial Efficacy and safety |
| title | Efficacy and safety of acupuncture for hand osteoarthritis: study protocol for a multi-center, randomized, sham-controlled clinical trial |
| title_full | Efficacy and safety of acupuncture for hand osteoarthritis: study protocol for a multi-center, randomized, sham-controlled clinical trial |
| title_fullStr | Efficacy and safety of acupuncture for hand osteoarthritis: study protocol for a multi-center, randomized, sham-controlled clinical trial |
| title_full_unstemmed | Efficacy and safety of acupuncture for hand osteoarthritis: study protocol for a multi-center, randomized, sham-controlled clinical trial |
| title_short | Efficacy and safety of acupuncture for hand osteoarthritis: study protocol for a multi-center, randomized, sham-controlled clinical trial |
| title_sort | efficacy and safety of acupuncture for hand osteoarthritis study protocol for a multi center randomized sham controlled clinical trial |
| topic | Acupuncture Hand osteoarthritis Clinical trial Efficacy and safety |
| url | https://doi.org/10.1186/s13018-023-03570-6 |
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