The Effectiveness of Pharmacopuncture in Patients with Lumbar Spinal Stenosis: A Protocol for a Multi-Centered, Pragmatic, Randomized, Controlled, Parallel Group Study

Jee Young Lee, Kyoung Sun Park, Suna Kim, Ji Yeon Seo, Hyun-Woo Cho, Dongwoo Nam, Yeoncheol Park, Eun-Jung Kim, Yoon Jae Lee, In-Hyuk Ha, Jee Young Lee, Kyoung Sun Park, Suna Kim, Ji Yeon Seo, Hyun-Woo Cho, Dongwoo Nam, Yeoncheol Park, Eun-Jung Kim, Yoon Jae Lee, In-Hyuk Ha

Abstract

Purpose: Lumbar spinal stenosis (LSS) is a chronic degenerative disease. Non-surgical intervention is recommended, considering the risks and benefits for the affected age group, as well as the characteristics of the disease. However, to date, no studies have compared various non-surgical interventions to ascertain the appropriate first-line non-surgical treatment for LSS. Therefore, the objective of this study will be to assess the efficacy of pharmacopuncture as a non-surgical, conservative treatment for LSS.

Patients and methods: A multi-centered, pragmatic, parallel-group study will be conducted. In total, 98 patients will be recruited at seven institutes; recruitment began in May 2022. After two treatment sessions per week over a period of 12 weeks, follow-up assessments will be held at weeks 13, 25, and 53.

Results: The efficacy of pharmacopuncture and conservative care will be pragmatically compared in patients radiologically diagnosed with LSS. Pain severity will be measured using the numeric rating scale and visual analog scale. Walking distance will also be evaluated. Patient-centered evaluations will include the Zurich Claudication Questionnaire, Short-Form 12 for Health-Related Quality of Life, EuroQoL 5 Dimension 5 Levels, and Patient Global Impression of Change.

Conclusion: The results of this study will confirm the efficacy of pharmacopuncture in comparison to conventional non-surgical treatment and will thus facilitate the prioritization of patient-centered interventions for LSS.

Trial registration: This study was registered at Clinicaltrials.gov (registration identifier: NCT05242497) and CRiS (registration identifier: KCT0007145).

Keywords: LSS; acupuncture; constriction; non-surgical intervention; pragmatic clinical trial; protocol.

Conflict of interest statement

The authors report no conflicts of interest in this work.

© 2022 Lee et al.

References

    1. Botwin K, Brown LA, Fishman M, Rao S. Fluoroscopically guided caudal epidural steroid injections in degenerative lumbar spine stenosis. Pain Physician. 2007;10(4):547–558.
    1. Katz JN, Zimmerman ZE, Mass H, Makhni MC. Diagnosis and management of lumbar spinal stenosis: a review. JAMA. 2022;327(17):1688–1699. doi:10.1001/jama.2022.5921
    1. Chad DA. Lumbar spinal stenosis. Neurol Clin. 2007;25(2):407–418. doi:10.1016/j.ncl.2007.01.003
    1. Bagley C, MacAllister M, Dosselman L, et al. Current concepts and recent advances in understanding and managing lumbar spine stenosis. F1000Res. 2019;8:F1000 Faculty Rev–137. doi:10.12688/f1000research.16082.1
    1. Deyo RA. Treatment of lumbar spinal stenosis: a balancing act. Spine J. 2010;10:625–627. doi:10.1016/j.spinee.2010.05.006
    1. Minamide A, Yoshida M, Maio K. The natural clinical course of lumbar spinal stenosis: a longitudinal cohort study over a minimum of 10 years. J Orthop Sci. 2013;18:693–698. doi:10.1007/s00776-013-0435-9
    1. Haig AJ, Tong HC, Yamakawa KSJ, et al. Predictors of pain and function in persons with spinal stenosis, low back pain, and no back pain. Spine. 2006;31:2950–2957. doi:10.1097/01.brs.0000247791.97032.1e
    1. Jacobi S, Beynon A, Dombrowski SU, Wdderkopp N, Witherspoon R, Hebert JJ. Effectiveness of conservative nonpharmacologic therapies for pain, disability, physical capacity, and physical activity behavior in patients with degenerative lumbar spinal stenosis: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2021;102(11):2247–2260. doi:10.1016/j.apmr.2021.03.033
    1. Weinstein IN, Lurie JD, Olson PR, et al. United States’ trends and regional variations in lumbar spine surgery: 1992–2003. Spine. 2006;31:2707–2714.
    1. Lurie J. Management of lumbar spinal stenosis. BMJ. 2016;352:h6234. doi:10.1136/bmj.h6234
    1. Kirker K, Masaracchio MF, Loghmani P, Torres-Panchame RE, Mattia M, States R. Management of lumbar spinal stenosis: a systematic review and meta-analysis of rehabilitation, surgical, injection, and medication interventions. Physhiother Theory Pract. 2022;1–46. doi:10.1080/09593985.2021.2012860
    1. Ammendolia C, Stuber KJ, Rok E, et al. Nonoperative treatment for lumbar spinal stenosis with neurogenic claudication. Cochrane Database Syst Rev. 2013;8:CD010712.
    1. Lee YJ, Shin JS, Lee J, et al. Usage report of pharmacopuncture in musculoskeletal patients visiting Korean medicine hospitals and clinics in Korea. BMC Complement Altern Med. 2016;16:292. doi:10.1186/s12906-016-1288-5
    1. Lee YJ, Shin J, Kim M, et al. Survey of integrative lumbar spinal stenosis treatment in Korean medicine doctors: preliminary data for clinical practice guidelines. BMC Complement Alternat Med. 2017;17:425. doi:10.1186/s12906-017-1942-6
    1. Kim MR, Shin JS, Lee J, et al. Safety of acupuncture and pharmacopuncture in 80,523 musculoskeletal disorder patients: a retrospective review of internal safety inspection and electronic medical records. Medicine. 2016;95(18):e3635. doi:10.1097/MD.0000000000003635
    1. Loudon K, Treweek S, Sullivan F, Donnan P, Thrope KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015;350:h2147. doi:10.1136/bmj.h2147
    1. Kim HJ, Lee YK, Kim DO, Chang BS, Lee CK, Yeom JS. Validation and cross-cultural adaptation of the Korean version of the Zurich claudication questionnaire in patients with lumbar spinal stenosis. Spine. 2018;43(2):E105–E110. doi:10.1097/BRS.0000000000002241
    1. Kim DY, Lee SH, Lee HY, et al. Validation of the Korean version of the Oswestry disability index. Spine. 2005;30(5):E123–E127. doi:10.1097/01.brs.0000157172.00635.3a
    1. Kim SH, Jo MW, Ahn J, Ock M, Shin S, Park J. Assessment of psychometric properties of the Korean SF-12 v2 in the general population. BMC Public Health. 2014;14:1086. doi:10.1186/1471-2458-14-1086
    1. Chuang-Stein C, Kirby S, Hirsch I, Atkinson G. The role of the minimum clinically important difference and its impact on designing a trial. Pharmaceut Statist. 2011;10:250–256. doi:10.1002/pst.459
    1. Minetama M, Kawakami M, Teraguchi M, et al. Supervised physical therapy vs home exercise for patients with lumbar spinal stenosis: a randomized controlled trial. Spine J. 2019;19:1310–1318. doi:10.1016/j.spinee.2019.04.009
    1. Zaina F, Tomkins-Lane C, Carragee E, Negrini S. Surgical versus non-surgical treatment for lumbar spinal stenosis. Cochrane Database Syst Rev. 2016;2016(1):CD010264.
    1. Sobottke R, Röllinghoff M, Siewe J, et al. Clinical outcomes and quality of life 1 year after open microsurgical decompression or implantation of an interspinous stand-alone spacer. Minim Invasive Neurosurg. 2010;53(4):179–183. doi:10.1055/s-0030-1263108
    1. Sobottke R, Aghayev E, Röder C, Eysel P, Delank SK, Zweig T. Predictors of surgical, general and follow-up complications in lumbar spinal stenosis relative to patient age as emerged from the Spine Tango Registry. Eur Spine J. 2012;21(3):411–417. doi:10.1007/s00586-011-2016-y
    1. Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG. Trends, major medical complications, and charge associated with surgery for lumbar spinal stenosis in older adults. JAMA. 2010;303(13):1259–1265. doi:10.1001/jama.2010.338
    1. Deyo RA, Mirza SK, Martin BI. Trends, major medical complications, and charge associated with surgery for lumbar spinal stenosis in older adults. JAMA. 2011;306(10):1088. doi:10.1001/jama.2011.1300
    1. Weinstein JN, Tosteson TD, Lurie JD, et al.; SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008;358(8):794–810. doi:10.1056/NEJMoa0707136
    1. Tosteson AN, Tosteson TD, Lurie JD, et al. Comparative effectiveness evidence from the spine patient outcomes research trial: surgical versus nonoperative care for spinal stenosis, degenerative spondylolisthesis, and intervertebral disc herniation. Spine. 2011;36(24):2061–2068. doi:10.1097/BRS.0b013e318235457b
    1. Malmivaara A, Slatis P, Heliovaara M, et al.; Finnish Lumbar Spinal Research Group. Surgical or nonoperative treatment for lumbar spinal stenosis? A randomized controlled trial. Spine. 2007;32(1):1‐8. doi:10.1097/01.brs.0000251014.81875.6d
    1. Slätis P, Malmivaara A, Heliövaara M, et al. Long‐term results of surgery for lumbar spinal stenosis: a randomised controlled trial. Eur Spine J. 2011;20(7):1174‐81. doi:10.1007/s00586-010-1652-y
    1. Amundsen T, Weber H, Nordal HJ, Magnaes B, Abdelnoor M, Lilleas F. Lumbar spinal stenosis: conservative or surgical management? A prospective 10‐year study. Spine. 2000;25(11):1424‐35. doi:10.1097/00007632-200006010-00016
    1. Minetama M, Kawakami M, Teraguchi M, et al. Therapeutic advantages of frequent physical therapy sessions for patients with lumbar spinal stenosis. Spine. 2020;45(11):E639–E646. doi:10.1097/BRS.0000000000003363
    1. Krebs EE, Gravely A, Nugent S, et al. Effect of opioid vs nonopioid medications on pain-related function in patients with chronic back pain or Hip or knee osteoarthritis pain; the SPACE randomized clinical trial. JAMA. 2018;319(9):872–882. doi:10.1001/jama.2018.0899
    1. Kim H, Kim JH, Park YS, et al. Comparative study of the efficacy of limaprost and pregabalin as single agents and in combination for the treatment of lumbar spinal stenosis: a prospective, double-blind, randomized controlled non-inferiority trial. Spine J. 2016;16(6):756–763. doi:10.1016/j.spinee.2016.02.049
    1. Takahasi J, Kobayashi H, Wakabayashi S, et al. The effect of a prostaglandin E1 derivative on the symptoms and quality of life of patients with lumbar spinal stenosis. J Orthop Sci. 2013;18(2):208–215. doi:10.1007/s00776-012-0342-5
    1. Ammendolia C, Stuber K, de Bruin LK, et al. Nonoperative treatment of lumbar spinal stenosis with neurogenic claudication: a systematic review. Spine. 2012;37:E609–E616. doi:10.1097/BRS.0b013e318240d57d
    1. Peng K, Chen L, Peng J, et al. Effects of calcitonin on lumbar spinal stenosis: a systematic review and meta-analysis. Int J Clin Exp Med. 2015;8:2536–2544.
    1. Kim D, Shin J, Moon Y, et al. Long-term follow up of spinal stenosis inpatients treated with integrative Korean medicine treatment. J Clin Med. 2021;10(1):74. doi:10.3390/jcm10010074
    1. Kim K, Jeong Y, Youn Y, et al. Nonoperative Korean medicine combination therapy for lumbar spinal stenosis: a retrospective case-series study. Evid Based Complement Alternat Med. 2015;2015:263898. doi:10.1155/2015/263898

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner