Electroacupuncture vs topical diclofenac sodium gel for patients with hand osteoarthritis: study protocol for a randomized controlled trial
Abstract Background Hand osteoarthritis (OA) is a prevalent joint disorder and a great burden to both patients and society. While electroacupuncture (EA) and topical diclofenac sodium gel (DSG) are both currently used to treat OA, no head-to-head study of EA and topical DSG for hand OA exists. Thus,...
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| Format: | Article |
| Language: | English |
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BMC
2022-04-01
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| Series: | Journal of Orthopaedic Surgery and Research |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13018-022-03125-1 |
| _version_ | 1811303602450333696 |
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| author | Weiming Wang Shudan Yu Zilin Long Yan Liu Yan Yan Tianheng Sun Zhishun Liu |
| author_facet | Weiming Wang Shudan Yu Zilin Long Yan Liu Yan Yan Tianheng Sun Zhishun Liu |
| author_sort | Weiming Wang |
| collection | DOAJ |
| description | Abstract Background Hand osteoarthritis (OA) is a prevalent joint disorder and a great burden to both patients and society. While electroacupuncture (EA) and topical diclofenac sodium gel (DSG) are both currently used to treat OA, no head-to-head study of EA and topical DSG for hand OA exists. Thus, it remains unknown whether one intervention offers improved outcomes over the other. This study aims to compare the effects of EA and topical DSG in patients with hand OA. Methods A total of 108 participants with hand OA according to the American College of Rheumatology criteria will be recruited and randomly assigned to the EA group or topical DSG group with a 1:1 allocation ratio. Participants in the EA group will receive EA treatment thrice weekly for 4 weeks, followed by a 12-week follow-up. In the topical DSG group, topical DSG at a dose of 2 g over the affected joints per hand will be applied four times per day for 4 weeks. The outcomes will be measured at weeks 4, 8, and 16. The primary outcome will be the change in average overall finger joint pain intensity in the dominant hand from baseline to week 4. All outcome variables will be analyzed on an intention-to-treat principle. All statistical tests will be two-sided. Discussion This study will help determine which of the two treatment protocols, EA or topical DSG, is more effective for the clinical treatment of hand OA. Trial registration ClinicalTrials.gov identifier: NCT04402047. Registered 16 May 2020, https://clinicaltrials.gov/ct2/show/NCT04402047 |
| first_indexed | 2024-04-13T07:50:56Z |
| format | Article |
| id | doaj.art-189bd0ad81cc46008577d155e920e918 |
| institution | Directory Open Access Journal |
| issn | 1749-799X |
| language | English |
| last_indexed | 2024-04-13T07:50:56Z |
| publishDate | 2022-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Orthopaedic Surgery and Research |
| spelling | doaj.art-189bd0ad81cc46008577d155e920e9182022-12-22T02:55:32ZengBMCJournal of Orthopaedic Surgery and Research1749-799X2022-04-011711910.1186/s13018-022-03125-1Electroacupuncture vs topical diclofenac sodium gel for patients with hand osteoarthritis: study protocol for a randomized controlled trialWeiming Wang0Shudan Yu1Zilin Long2Yan Liu3Yan Yan4Tianheng Sun5Zhishun Liu6Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang’anmen HospitalDepartment of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang’anmen HospitalBeijing University of Chinese MedicineKey Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese MedicineDepartment of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang’anmen HospitalBeijing University of Chinese MedicineDepartment of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang’anmen HospitalAbstract Background Hand osteoarthritis (OA) is a prevalent joint disorder and a great burden to both patients and society. While electroacupuncture (EA) and topical diclofenac sodium gel (DSG) are both currently used to treat OA, no head-to-head study of EA and topical DSG for hand OA exists. Thus, it remains unknown whether one intervention offers improved outcomes over the other. This study aims to compare the effects of EA and topical DSG in patients with hand OA. Methods A total of 108 participants with hand OA according to the American College of Rheumatology criteria will be recruited and randomly assigned to the EA group or topical DSG group with a 1:1 allocation ratio. Participants in the EA group will receive EA treatment thrice weekly for 4 weeks, followed by a 12-week follow-up. In the topical DSG group, topical DSG at a dose of 2 g over the affected joints per hand will be applied four times per day for 4 weeks. The outcomes will be measured at weeks 4, 8, and 16. The primary outcome will be the change in average overall finger joint pain intensity in the dominant hand from baseline to week 4. All outcome variables will be analyzed on an intention-to-treat principle. All statistical tests will be two-sided. Discussion This study will help determine which of the two treatment protocols, EA or topical DSG, is more effective for the clinical treatment of hand OA. Trial registration ClinicalTrials.gov identifier: NCT04402047. Registered 16 May 2020, https://clinicaltrials.gov/ct2/show/NCT04402047https://doi.org/10.1186/s13018-022-03125-1ElectroacupunctureDiclofenac sodium gelHand osteoarthritisClinical trial |
| spellingShingle | Weiming Wang Shudan Yu Zilin Long Yan Liu Yan Yan Tianheng Sun Zhishun Liu Electroacupuncture vs topical diclofenac sodium gel for patients with hand osteoarthritis: study protocol for a randomized controlled trial Journal of Orthopaedic Surgery and Research Electroacupuncture Diclofenac sodium gel Hand osteoarthritis Clinical trial |
| title | Electroacupuncture vs topical diclofenac sodium gel for patients with hand osteoarthritis: study protocol for a randomized controlled trial |
| title_full | Electroacupuncture vs topical diclofenac sodium gel for patients with hand osteoarthritis: study protocol for a randomized controlled trial |
| title_fullStr | Electroacupuncture vs topical diclofenac sodium gel for patients with hand osteoarthritis: study protocol for a randomized controlled trial |
| title_full_unstemmed | Electroacupuncture vs topical diclofenac sodium gel for patients with hand osteoarthritis: study protocol for a randomized controlled trial |
| title_short | Electroacupuncture vs topical diclofenac sodium gel for patients with hand osteoarthritis: study protocol for a randomized controlled trial |
| title_sort | electroacupuncture vs topical diclofenac sodium gel for patients with hand osteoarthritis study protocol for a randomized controlled trial |
| topic | Electroacupuncture Diclofenac sodium gel Hand osteoarthritis Clinical trial |
| url | https://doi.org/10.1186/s13018-022-03125-1 |
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