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      Efficacy and safety of acupuncture for hand osteoarthritis: study protocol for a multi-center, randomized, sham-controlled clinical trial

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          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.

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          Most cited references42

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          Development of the World Health Organization WHOQOL-BREF Quality of Life Assessment

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            2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee

            To develop an evidence-based guideline for the comprehensive management of osteoarthritis (OA) as a collaboration between the American College of Rheumatology (ACR) and the Arthritis Foundation, updating the 2012 ACR recommendations for the management of hand, hip, and knee OA.
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              Pain: a review of three commonly used pain rating scales.

              This review aims to explore the research available relating to three commonly used pain rating scales, the Visual Analogue Scale, the Verbal Rating Scale and the Numerical Rating Scale. The review provides information needed to understand the main properties of the scales. Data generated from pain-rating scales can be easily misunderstood. This review can help clinicians to understand the main features of these tools and thus use them effectively. A MedLine review via PubMed was carried out with no restriction of age of papers retrieved. Papers were examined for methodological soundness before being included. The search terms initially included pain rating scales, pain measurement, Visual Analogue Scale, VAS, Verbal Rating Scale, VRS, Numerical/numeric Rating Scale, NRS. The reference lists of retrieved articles were used to generate more papers and search terms. Only English Language papers were examined. All three pain-rating scales are valid, reliable and appropriate for use in clinical practice, although the Visual Analogue Scale has more practical difficulties than the Verbal Rating Scale or the Numerical Rating Scale. For general purposes the Numerical Rating Scale has good sensitivity and generates data that can be statistically analysed for audit purposes. Patients who seek a sensitive pain-rating scale would probably choose this one. For simplicity patients prefer the Verbal Rating Scale, but it lacks sensitivity and the data it produces can be misunderstood. In order to use pain-rating scales well clinicians need to appreciate the potential for error within the tools, and the potential they have to provide the required information. Interpretation of the data from a pain-rating scale is not as straightforward as it might first appear.
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                Author and article information

                Contributors
                zhishunjournal@163.com
                Journal
                J Orthop Surg Res
                J Orthop Surg Res
                Journal of Orthopaedic Surgery and Research
                BioMed Central (London )
                1749-799X
                6 February 2023
                6 February 2023
                2023
                : 18
                : 89
                Affiliations
                [1 ]GRID grid.410318.f, ISNI 0000 0004 0632 3409, Department of Acupuncture and Moxibustion, Guang’anmen Hospital, , China Academy of Chinese Medical Sciences, ; Beijing, China
                [2 ]GRID grid.24695.3c, ISNI 0000 0001 1431 9176, Beijing University of Chinese Medicine, ; Beijing, China
                [3 ]GRID grid.24695.3c, ISNI 0000 0001 1431 9176, Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, , Beijing University of Chinese Medicine, ; Beijing, China
                [4 ]New Zealand College of Chinese Medicine, Auckland, New Zealand
                Article
                3570
                10.1186/s13018-023-03570-6
                9901154
                571a06eb-4995-4757-baf7-d71f0651a7d9
                © The Author(s) 2023

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 23 August 2022
                : 31 January 2023
                Funding
                Funded by: the China Academy of Chinese Medical Sciences Innovation Fund
                Award ID: NO. CI2021A03517
                Award Recipient :
                Funded by: “Capital’s Funds for Health Improvement and Research
                Award ID: NO. CFH2022-4-4157
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2023

                Surgery
                acupuncture,hand osteoarthritis,clinical trial,efficacy and safety
                Surgery
                acupuncture, hand osteoarthritis, clinical trial, efficacy and safety

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