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A Comparative Study of a Deeply-inserted Acupotomy Applied to Hyeopcheok Points and Usual Korean Medicine Treatments for Lumbosacral Radiculopathy: Safety, Effectiveness, Cost-effectiveness: A Study Protocol

요천추신경병증에 대한 심부협척 도침술과 한의통상치료의 효과 비교: 안전성, 유효성, 경제성평가: 연구 프로토콜

  • Heo, In (Division of Clinical Medicine, School of Korean Medicine, Pusan National University) ;
  • Lee, Jin-Hyun (Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital) ;
  • Ko, Youn-Suk (Department of Rehabilitation Medicine of Korean Medicine, College of Korean Medicine, Woosuk University) ;
  • Jo, Dong Chan (Department of Rehabilitation Medicine of Korean Medicine, College of Korean Medicine, Woosuk University) ;
  • Kim, Young Il (Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Daejeon University) ;
  • Lee, Sang-Hyun (Division of Clinical Medicine, School of Korean Medicine, Pusan National University) ;
  • Hwang, Eui-Hyoung (Division of Clinical Medicine, School of Korean Medicine, Pusan National University) ;
  • Park, Tae-Yong (Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital) ;
  • Hwang, Man-Suk (Division of Clinical Medicine, School of Korean Medicine, Pusan National University)
  • 허인 (부산대학교한의학전문대학원 한방재활의학과) ;
  • 이진현 (가톨릭관동대학교 국제성모병원) ;
  • 고연석 (우석대학교 한의과대학 한방재활의학과) ;
  • 조동찬 (우석대학교 한의과대학 한방재활의학과) ;
  • 김영일 (대전대학교 한의과대학 침구의학과) ;
  • 이상현 (부산대학교한의학전문대학원 한방재활의학과) ;
  • 황의형 (부산대학교한의학전문대학원 한방재활의학과) ;
  • 박태용 (가톨릭관동대학교 국제성모병원) ;
  • 황만석 (부산대학교한의학전문대학원 한방재활의학과)
  • Received : 2021.11.26
  • Accepted : 2021.12.06
  • Published : 2021.12.30

Abstract

연구 배경 최근 한국 및 중국에서 근골격계 질환에 대한 도침술의 활용이 늘고 있다. 하지만 현재까지의 임상연구는 대부분 증례보고 형태에 그치거나, 충분한 근거가 확보되지는 않은 실정이다. 우리는 요천추신경병증환자의 치료에 있어 도침치료와 통상한의치료와의 비교를 통해 도침치료의 유효성, 안전성, 경제성 평가를 시행하기 위해 본 연구를 기획하게 되었다. 연구 방법 본 연구는 예비임상 연구로, 다기관에서 진행되며, 무작위대조군, 활성 대조군을 통한 2개군 병행집단 연구로 평가자 맹검을 시행하게 된다. 이 연구에서는 총 50명의 요천추신경병증 환자를 대상으로 2개군으로 균등하게 분배하여 도침술 또는 통상한의치료를 시행하게 된다(각군당 25명). 도침술 그룹의 경우 협척혈에 도침치료를 시행 받게 되며, 통상 한의치료군은 연구자 판단하에 도침술을 제외한 적절한 한의치료를 시행 받게 된다. 두 개의 그룹은 주당 2회씩 총 3주간 치료를 받게 된다. 일차 유효성 평가는 요통으로 인한 기능장애를 평가하기 위한 Oswestry disability index를 통해 시행한다. 이차 유효성 평가지표로는 numeric rating scale, European Quality of Life 5-Dimension 5-Level, short-form McGill Pain Questionnaire, Roland-Morris Disability Questionnaire scores를 시행하게 된다. 고찰 본 예비임상연구의 결과는 추후 있을 요천추신경병증에 대한 도침치료 및 한의통상치료 비교효과 연구의 유효성, 경제성평가 본 임상연구를 위한 기초 정보 및 가능성을 확인하고 적절한 대상자수 산정에 도움이 될 것이다.

Keywords

Acknowledgement

The authors would like to express appreciation for the contributions of patients with lumbosacral radiculopathy who will be participating in this trial.

References

  1. Alexander CE, Varacallo M. Lumbosacral radiculopathy. StatPearls [Internet] 2021 Jan [cited 2021 Apr 27]. Available from: URL:https://www.ncbi.nlm.nih.gov/books/NBK430837/
  2. Hoy D, Brooks P, Blyth F, Buchbinder R. The epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010;24:769-781. https://doi.org/10.1016/j.berh.2010.10.002
  3. Tarulli AW, Raynor EM. Lumbosacral radiculopathy. Neurol Clin. 2007;25:387-405. https://doi.org/10.1016/j.ncl.2007.01.008
  4. Lin JH, Chiang YH, Chen CC. Lumbar radiculopathy and its neurobiological basis. World J Anesthesiol. 2014;3:162-173. https://doi.org/10.5313/wja.v3.i2.162
  5. Lee JY, Whang PG, Lee JY, Phillips FM, Patel AA. Lumbar spinal stenosis. Instr Course Lect. 2013;62:383-396.
  6. Deyo RA, Gray DT, Kreuter W, Mirza S, Martin BI. United States trends in lumbar fusion surgery for degenerative conditions. Spine. 2005;30:1441-1445. https://doi.org/10.1097/01.brs.0000166503.37969.8a
  7. Imajo Y, Taguchi T, Neo M, Otani K, Ogata T, Ozawa H, Miyakoshi N, Murakami H, Iguchi T. Complications of spinal surgery for elderly patients with lumbar spinal stenosis in a super-aging country: An analysis of 8033 patients. J Orthop Sci. 2017;22:10-15. https://doi.org/10.1016/j.jos.2016.08.014
  8. Phan K, Mobbs RJ. Minimally invasive versus open laminectomy for lumbar stenosis: A systematic review and meta-analysis. Spine. 2016;41:E91-E100. https://doi.org/10.1097/brs.0000000000001161
  9. Li S, Shen T, Liang Y, Zhang Y, Bai B. Effects of miniscalpel-needle release on chronic neck pain: A retrospective analysis with 12-month follow-up. PLoS One. 2015;10:e0137033. https://doi.org/10.1371/journal.pone.0137033
  10. Yoon SH, Kim YS, Kwon MG, Kwon CY. Randomized controlled trials of miniscalpel acupuncture for lumbar spinal stenosis cited in the China national knowledge infrastructure database. J Acupunct Res. 2017;34:59-69. https://doi.org/10.13045/acupunct.2017093
  11. Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA. Cochrane handbook for systematic reviews of interventions. 2nd ed. Chichester:John Wiley & Sons. 2019:205-226.
  12. Fairbank JC, Pynsent PB. The Oswestry disability index. Spine. 2000;25:2940-2952. https://doi.org/10.1097/00007632-200011150-00017
  13. Jeon CH, Kim DJ, Kim SK, Kim DJ, Lee HM, Park HJ. Validation in the cross-cultural adaptation of the Korean version of the Oswestry disability index. J Korean Med Sci. 2006;21:1092-1097. https://doi.org/10.3346/jkms.2006.21.6.1092
  14. Shim SY, Park HJ, Lee JM, Lee HS. An overview of pain measurements. Korean J Acupunct. 2007;24:77-97.
  15. Dudgeon D, Raubertas RF, Rosenthal SN. The shortform McGill pain questionnaire in chronic cancer pain. Journal of Pain and Symptom Management. 1993;8:191-5. https://doi.org/10.1016/0885-3924(93)90126-g
  16. Lee JS, Lee DH, Suh KT, Kim JI, Lim JM, Goh TS. Validation of the Korean version of the Roland-Morris disability questionnaire. Eur Spine J. 2011;20:2115-2119. https://doi.org/10.1007/s00586-011-1788-4
  17. Kim SY, Kim E, Kwon O, Han CH, Kim YI. Effectiveness and safety of acupotomy for lumbar disc herniation: A randomized, assessor-blinded, controlled pilot study. Evid Based Complement Alternat Med. 2018;2018:5871657. https://doi.org/10.1155/2018/5871657
  18. Xilin C, Xinyi F, Zhichao L, Wenshan X, Quangui W, Mira L, Changqing G. Acupotomy treatment for lumbar disc herniation. J Acupunct Res. 2020;37:177-180. https://doi.org/10.13045/jar.2020.00094
  19. Yuk DI, Kim KM, Jeon JH, Kim YI, Kim JH. A review of trends for acupotomy. J Acupunct Res. 2014;31:35-43. https://doi.org/10.13045/acupunct.2014041
  20. Guideline Center for Korean Medicine. Guideline for lumbar herniated intervertebral disc; 2020 [cited 2021 Apr 27]. Available from: URL: https://nikom.or.kr/nckm/module/practiceGuide/viewPDF.do?guide_idx=151
  21. MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D, STRICTA Revision Group. Revised standards for reporting interventions in clinical trials of acupuncture (STRICTA): Extending the CONSORT statement. J Evid Based Med. 2010;3:140-155. https://doi.org/10.1111/j.1756-5391.2010.01086.x
  22. Moher D, Hopewell S, Schulz KF, Montorid V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10:28-55. https://doi.org/10.1016/j.ijsu.2011.10.001