Journal of Pain Research (Sep 2022)

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

  • Park KS,
  • Kim S,
  • Seo JY,
  • Cho H,
  • Lee JY,
  • Lee YJ,
  • Lee J,
  • Kim MJ,
  • Choi YE,
  • Yang CS,
  • Han CH,
  • Ha IH

Journal volume & issue
Vol. Volume 15
pp. 2629 – 2639

Abstract

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Kyoung Sun Park,1 Suna Kim,2 Ji Yeon Seo,3 HyunWoo Cho,4 Jee Young Lee,5 Yoon Jae Lee,5 Jinho Lee,1 Min Ji Kim,6 Young Eun Choi,6 Chang Sop Yang,7 Chang-Hyun Han,7,8,* In-Hyuk Ha5,* 1Jaseng Hospital of Korean Medicine, Seoul, Republic of Korea; 2Daejeon Jaseng Hospital of Korean Medicine, Daejeon, Republic of Korea; 3Bucheon Jaseng Hospital of Korean Medicine, Bucheon, Republic of Korea; 4Haeundae Jaseng Hospital of Korean Medicine, Busan, Republic of Korea; 5Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea; 6Clinical Research Coordinating Team, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea; 7KM 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*These authors contributed equally to this workCorrespondence: 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 [email protected]: 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).Keywords: low back pain, pharmacopuncture, physical therapy, pragmatic randomized controlled trial, protocol, musculoskeletal disorder, Korean medicine

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