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      Journal of Pain Research (submit here)

      This international, peer-reviewed Open Access journal by Dove Medical Press focuses on reporting of high-quality laboratory and clinical findings in all fields of pain research and the prevention and management of pain. Sign up for email alerts here.

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      Effectiveness and Safety of Polydioxanone Thread Embedding Acupuncture Compared to Physical Therapy in the Treatment of Patients with Non-Specific Chronic Neck Pain: An Assessor-Blinded, Randomized, Controlled, Clinical Trial

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          Abstract

          Background

          Thread embedding acupuncture (TEA) has recently been used as a conservative treatment method for non-specific chronic neck pain (CNP). The objective of this study was to evaluate the effectiveness and safety of TEA compared to physical therapy (PT) for treating patients with CNP.

          Methods

          A total of 128 patients diagnosed with CNP were randomly assigned to a TEA group and a PT group at a 1:1 ratio. The TEA group received four sessions of TEA, while the PT group received eight sessions of PT over 4 weeks. Outcomes were assessed using Neck Pain and Disability Scale (NPDS), clinically important difference (CID), cervical spinal angle, Beck Depression Inventory II (BDI-II), Beck Anxiety Inventory (BAI), Patient Global Impression of Change (PGIC), and EuroQol Five-Dimension (EQ-5D) at baseline and 5, 9, and 13 weeks.

          Results

          The TEA group showed significant improvement in NPDS compared to the PT group at 5, 9, and 13 weeks. Proportions of patients with decreased NPDS scores of more than 11.5 points (minimal CID) were significantly higher in the TEA group at 5, 9, and 13 weeks. There were significant differences between the two groups at 5, 9, and 13 weeks for BDI-II, and at 5 and 9 weeks for BAI. For EQ-5D, the TEA group showed significant improvement at 5, 9, and 13 weeks. There was no significant difference in cervical spinal angle between the two groups. For PGIC, better improvement was observed at 9 and 13 weeks in the TEA group. Adverse events associated with interventions were mostly temporary and mild.

          Conclusion

          For patients with CNP, TEA treatment was found to be more effective than PT treatment for improving their pain and dysfunction, quality of life, and psychological distress. Despite some post-treatment discomfort, TEA treatment can be considered as a useful treatment method for patients with CNP.

          Trial Registration

          This trial has been registered 5 April 2019 in Clinical Research Information Service of South Korea (CRIS- KCT0003720).

          Most cited references57

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          An inventory for measuring clinical anxiety: Psychometric properties.

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            Measurement of health status. Ascertaining the minimal clinically important difference.

            In recent years quality of life instruments have been featured as primary outcomes in many randomized trials. One of the challenges facing the investigator using such measures is determining the significance of any differences observed, and communicating that significance to clinicians who will be applying the trial results. We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change. Using this approach we have established a plausible range within which the minimal clinically important difference (MCID) falls. In three studies in which instruments measuring dyspnea, fatigue, and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item, when responses were presented on a seven point Likert scale. Furthermore, we have established ranges for changes in questionnaire scores that correspond to moderate and large changes in the domains of interest. This information will be useful in interpreting questionnaire scores, both in individuals and in groups of patients participating in controlled trials, and in the planning of new trials.
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              Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations.

              A consensus meeting was convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to provide recommendations for interpreting clinical importance of treatment outcomes in clinical trials of the efficacy and effectiveness of chronic pain treatments. A group of 40 participants from universities, governmental agencies, a patient self-help organization, and the pharmaceutical industry considered methodologic issues and research results relevant to determining the clinical importance of changes in the specific outcome measures previously recommended by IMMPACT for 4 core chronic pain outcome domains: (1) Pain intensity, assessed by a 0 to 10 numerical rating scale; (2) physical functioning, assessed by the Multidimensional Pain Inventory and Brief Pain Inventory interference scales; (3) emotional functioning, assessed by the Beck Depression Inventory and Profile of Mood States; and (4) participant ratings of overall improvement, assessed by the Patient Global Impression of Change scale. It is recommended that 2 or more different methods be used to evaluate the clinical importance of improvement or worsening for chronic pain clinical trial outcome measures. Provisional benchmarks for identifying clinically important changes in specific outcome measures that can be used for outcome studies of treatments for chronic pain are proposed. Systematically collecting and reporting the recommended information needed to evaluate the clinical importance of treatment outcomes of chronic pain clinical trials will allow additional validation of proposed benchmarks and provide more meaningful comparisons of chronic pain treatments.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                jpr
                jpainres
                Journal of Pain Research
                Dove
                1178-7090
                28 January 2021
                2021
                : 14
                : 201-211
                Affiliations
                [1 ]Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daejeon University , Daejeon, Republic of Korea
                [2 ]Clinical Medicine Division, Korea Institute of Oriental Medicine , Daejeon, Republic of Korea
                [3 ]Korean Medicine Life Science, University of Science & Technology (UST), Campus of Korea Institute of Oriental Medicine , Daejeon, Republic of Korea
                [4 ]Department of Clinical Korean Medicine, Graduate School, Kyung Hee University , Seoul, Republic of Korea
                Author notes
                Correspondence: Young Il Kim Department of Acupuncture & Moxibustion Medicine, Daejeon University Daejeon Korean Medicine Hospital , 75, Daedeok-daero 176, Seo-gu, Daejeon, Republic of KoreaTel +82-42-470-9137Fax +82-42-477-9005 Email omdkim01@dju.kr
                Eunseok Kim Department of Acupuncture & Moxibustion Medicine, Daejeon University Seoul Korean Medicine Hospital , 32, Beobwon-ro 11, Songpa-gu, Seoul, Republic of KoreaTel +82-2-2222-8103Fax +82-2-2222-8111 Email mybestcando@naver.com
                [*]

                These authors contributed equally to this work

                Author information
                http://orcid.org/0000-0002-2262-1284
                http://orcid.org/0000-0003-4285-3063
                http://orcid.org/0000-0002-3043-1325
                http://orcid.org/0000-0002-7349-4596
                http://orcid.org/0000-0001-5730-6869
                http://orcid.org/0000-0003-1277-3329
                http://orcid.org/0000-0001-9221-3238
                Article
                276941
                10.2147/JPR.S276941
                7850897
                33536781
                029504c9-d4c2-4d9e-9328-f47905c6d715
                © 2021 Kim et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                : 13 August 2020
                : 24 December 2020
                Page count
                Figures: 5, Tables: 8, References: 58, Pages: 11
                Funding
                Funded by: KSN2013210 of the Korea Institute of Oriental Medicine (KIOM), Republic of Korea;
                This study was financially supported by grants from project KSN2021210 of the Korea Institute of Oriental Medicine (KIOM), Republic of Korea. The funding sources had no role in the experimental design, procedures, writing, and decision to submit the work for publication.
                Categories
                Original Research

                Anesthesiology & Pain management
                thread embedding acupuncture,physical therapy,non-specific chronic neck pain,randomized controlled trial

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