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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.

      52,235 Monthly downloads/views I 2.832 Impact Factor I 4.5 CiteScore I 1.2 Source Normalized Impact per Paper (SNIP) I 0.655 Scimago Journal & Country Rank (SJR)

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      Is Open Access

      Effectiveness and Safety of Pharmacopuncture Therapy for Chronic Low Back Pain: A Protocol for a Pragmatic Randomized Controlled Trial

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          Abstract

          Purpose

          Chronic low back pain (LBP) is a common musculoskeletal disorder that affects everyday life; moreover, it occasionally causes disability and increases medical expenditure. This pragmatic randomized clinical trial aims to investigate the effects of pharmacopuncture on chronic LBP by comparing the effectiveness of pharmacopuncture and physiotherapy strategies.

          Patients and Methods

          In this two-armed, parallel, multi-center randomized controlled study, the participants will randomly undergo 10 sessions of pharmacopuncture therapy or physiotherapy over five weeks based on the randomization outcomes. The primary outcome will be the numeric rating scale (NRS) score of LBP. The secondary outcomes will include the NRS score of radiating leg pain, visual analog scale (VAS) score of LBP and radiating leg pain, Oswestry disability index, the Korean version of the Roland–Morris disability questionnaire, patient global impression of change (PGIC), short Form-12 health survey version 2, and 5-level EuroQol-5 dimension (EQ-5D-5L).

          Conclusion

          This protocol aims to examine the comparative effectiveness of pharmacopuncture, which is a widely used therapy in Korean medicine, with respect to the standard therapy through a pragmatic randomized controlled trial to present useful data to facilitate clinical or policy decision making.

          Trial Registration

          Clinicaltrials.gov (NCT04833309); Clinical Research Information Service (KCT0006088).

          Most cited references29

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          Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)

          M. Herdman, C. Gudex, S Lloyd … (2011)
          Purpose This article introduces the new 5-level EQ-5D (EQ-5D-5L) health status measure. Methods EQ-5D currently measures health using three levels of severity in five dimensions. A EuroQol Group task force was established to find ways of improving the instrument’s sensitivity and reducing ceiling effects by increasing the number of severity levels. The study was performed in the United Kingdom and Spain. Severity labels for 5 levels in each dimension were identified using response scaling. Focus groups were used to investigate the face and content validity of the new versions, including hypothetical health states generated from those versions. Results Selecting labels at approximately the 25th, 50th, and 75th centiles produced two alternative 5-level versions. Focus group work showed a slight preference for the wording ‘slight-moderate-severe’ problems, with anchors of ‘no problems’ and ‘unable to do’ in the EQ-5D functional dimensions. Similar wording was used in the Pain/Discomfort and Anxiety/Depression dimensions. Hypothetical health states were well understood though participants stressed the need for the internal coherence of health states. Conclusions A 5-level version of the EQ-5D has been developed by the EuroQol Group. Further testing is required to determine whether the new version improves sensitivity and reduces ceiling effects.
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            The PRECIS-2 tool: designing trials that are fit for purpose.

            Kirsty Loudon, Shaun Treweek, Frank Sullivan … (2015)
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              The Validity and Reproducibility of a Work Productivity and Activity Impairment Instrument

              Margaret C Reilly, Arthur Zbrozek, Ellen Dukes (1993)
              The construct validity of a quantitative work productivity and activity impairment (WPAI) measure of health outcomes was tested for use in clinical trials, along with its reproducibility when administered by 2 different methods. 106 employed individuals affected by a health problem were randomised to receive either 2 self-administered questionnaires (self administration) or one self-administered questionnaire followed by a telephone interview (interviewer administration). Construct validity of the WPAI measures of time missed from work, impairment of work and regular activities due to overall health and symptoms, were assessed relative to measures of general health perceptions, role (physical), role (emotional), pain, symptom severity and global measures of work and interference with regular activity. Multivariate linear regression models were used to explain the variance in work productivity and regular activity by validation measures. Data generated by interviewer-administration of the WPAI had higher construct validity and fewer omissions than that obtained by self-administration of the instrument. All measures of work productivity and activity impairment were positively correlated with measures which had proven construct validity. These validation measures explained 54 to 64% of variance (p less than 0.0001) in productivity and activity impairment variables of the WPAI. Overall work productivity (health and symptom) was significantly related to general health perceptions and the global measures of interference with regular activity. The self-administered questionnaire had adequate reproducibility but less construct validity than interviewer administration. Both administration methods of the WPAI warrant further evaluation as a measure of morbidity.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Pain Res
                Journal ID (iso-abbrev): J Pain Res
                Journal ID (publisher-id): jpr
                Title: Journal of Pain Research
                Publisher: Dove
                ISSN (Electronic): 1178-7090
                Publication date (Electronic): 01 September 2022
                Publication date Collection: 2022
                Volume: 15
                Pages: 2629-2639
                Affiliations
                [1 ]Jaseng Hospital of Korean Medicine , Seoul, Republic of Korea
                [2 ]Daejeon Jaseng Hospital of Korean Medicine , Daejeon, Republic of Korea
                [3 ]Bucheon Jaseng Hospital of Korean Medicine , Bucheon, Republic of Korea
                [4 ]Haeundae Jaseng Hospital of Korean Medicine , Busan, Republic of Korea
                [5 ]Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation , Seoul, Republic of Korea
                [6 ]Clinical Research Coordinating Team, Korea Institute of Oriental Medicine , Daejeon, Republic of Korea
                [7 ]KM Science Research Division, Korea Institute of Oriental Medicine , Daejeon, Republic of Korea
                [8 ] Korean Convergence Medicine, University of Science & Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon, Republic of Korea
                Author notes
                Correspondence: In-Hyuk Ha, Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation , 2F Vision Tower, 540 Gangnam-daero, Gangnam-gu, Seoul, 06110, Republic of Korea, Tel +82 2 2222 2740, Email hanihata@gmail.com
                [*]

                These authors contributed equally to this work

                Author information
                http://orcid.org/0000-0003-4390-7852
                http://orcid.org/0000-0002-1458-388X
                http://orcid.org/0000-0002-1532-0942
                http://orcid.org/0000-0003-1277-3329
                http://orcid.org/0000-0003-4285-3063
                http://orcid.org/0000-0002-5020-6723
                Article
                Publisher ID: 375231
                DOI: 10.2147/JPR.S375231
                PMC ID: 9443996
                PubMed ID: 36072909
                SO-VID: 4e8712b5-a0aa-4026-89fd-6f87343e5b32
                Copyright © © 2022 Park et al.
                License:

                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
                Date received : 23 May 2022
                Date accepted : 24 August 2022
                Page count
                Figures: 0, Tables: 2, References: 29, Pages: 11
                Funding
                Funded by: the Korea institute of oriental medicine (KIOM), republic of Korea;
                This research was funded by the Korea institute of oriental medicine (KIOM), republic of Korea (grant number KSN2022210).
                Categories
                Subject: Study Protocol

                ScienceOpen disciplines: Anesthesiology & Pain management
                Keywords: low back pain,pharmacopuncture,physical therapy,pragmatic randomized controlled trial,protocol,musculoskeletal disorder,korean medicine
                Data availability:
                ScienceOpen disciplines: Anesthesiology & Pain management
                Keywords: low back pain, pharmacopuncture, physical therapy, pragmatic randomized controlled trial, protocol, musculoskeletal disorder, korean medicine

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