{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T04:50:52Z","timestamp":1787028652832,"version":"build-2736575974"},"reference-count":42,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2025,2,12]],"date-time":"2025-02-12T00:00:00Z","timestamp":1739318400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003718","name":"Korea Institute of Oriental Medicine (KIOM), Republic of Korea","doi-asserted-by":"publisher","award":["KSN2121211"],"award-info":[{"award-number":["KSN2121211"]}],"id":[{"id":"10.13039\/501100003718","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background\/Objectives: We aimed to compare non-pharmacological (non-PHM) and pharmacological (PHM) treatment for patients with non-acute lumbar disc herniation (LDH) and determine the feasibility of a large-scale study. Methods: This was a two-armed, parallel, multicenter, pragmatic controlled trial performed in South Korea. All patients underwent magnetic resonance imaging (MRI) scans both at the screening stage and the last follow-up. Patients with LDH findings on MRI were randomly assigned to non-PHM and PHM groups. Treatment was administered twice a week for a total of 8 weeks, and follow-up assessments were performed at weeks 9, 13, and 27 post-randomization. The primary outcome was the Oswestry Disability Index (ODI) score. A linear mixed model was used for primary analysis from intention-to-treat perspectives. The incremental cost-effectiveness ratio (ICER) was calculated for economic evaluation. Results: Thirty-six patients were enrolled, and thirty-five were included in the final analysis. At Week 9, the difference in ODI scores between the two groups was 5.17 (95% CI: \u22124.00 to 14.35, p = 0.262), and the numeric rating scale scores for lower back and leg pains were 1.89 (95% CI: 0.68 to 3.10, p = 0.003) and 1.52 (95% CI: 0.27 to 2.77, p = 0.018), respectively, confirming greater improvement in the non-PHM group than in the PHM group. The non-PHM group showed lower costs and higher quality-adjusted life years than the PHM group. The ICER calculated using the EuroQoL-5 Dimension (EQ-5D) was USD 20,926. Conclusions: We confirm the possibility that a non-PHM strategy could be a more effective and cost-effective treatment option than PHM for patients with non-acute lumbar disc herniation. Furthermore, this pilot study confirmed the feasibility of the main study in terms of design and patient compliance.<\/jats:p>","DOI":"10.3390\/jcm14041204","type":"journal-article","created":{"date-parts":[[2025,2,12]],"date-time":"2025-02-12T06:06:06Z","timestamp":1739340366000},"page":"1204","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Comparative Effectiveness of Non-Pharmacological and Pharmacological Treatments for Non-Acute Lumbar Disc Herniation: A Multicenter, Pragmatic, Randomized Controlled, Parallel-Grouped Pilot Study"],"prefix":"10.3390","volume":"14","author":[{"given":"Doori","family":"Kim","sequence":"first","affiliation":[{"name":"Jaseng Hospital of Korean Medicine, 536 Gangnam-daero, Gangnam-gu, Seoul 06110, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jee Young","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Korean Internal Medicine, Integrative Cancer Center, Cha Ilsan Medical Center, 1205, Jungang-ro, Ilsandong-gu, Goyang-si 10414, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1532-0942","authenticated-orcid":false,"given":"Yoon Jae","family":"Lee","sequence":"additional","affiliation":[{"name":"Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 540 Gangnam-daero, Gangnam-gu, Seoul 06110, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1277-3329","authenticated-orcid":false,"given":"Chang Sop","family":"Yang","sequence":"additional","affiliation":[{"name":"KM Science Research Division, Korea Institute of Oriental Medicine, 1672, Yuseong-daero, Yuseong-gu, Daejeon 34054, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4285-3063","authenticated-orcid":false,"given":"Chang-Hyun","family":"Han","sequence":"additional","affiliation":[{"name":"KM Science Research Division, Korea Institute of Oriental Medicine, 1672, Yuseong-daero, Yuseong-gu, Daejeon 34054, Republic of Korea"},{"name":"School of Korea Institute of Oriental Medicine, Korean Convergence Medical Science, University of Science & Technology, Daejeon 34054, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5020-6723","authenticated-orcid":false,"given":"In-Hyuk","family":"Ha","sequence":"additional","affiliation":[{"name":"Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 540 Gangnam-daero, Gangnam-gu, Seoul 06110, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,2,12]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"2356","DOI":"10.1016\/S0140-6736(18)30480-X","article-title":"What low back pain is and why we need to pay attention","volume":"391","author":"Hartvigsen","year":"2018","journal-title":"Lancet"},{"key":"ref_2","first-page":"646","article-title":"Burden of major musculoskeletal conditions","volume":"81","author":"Woolf","year":"2003","journal-title":"Bull. World Health Organ."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"2163","DOI":"10.1016\/S0140-6736(12)61729-2","article-title":"Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990\u20132010: A systematic analysis for the Global Burden of Disease Study 2010","volume":"380","author":"Vos","year":"2012","journal-title":"Lancet"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"1204","DOI":"10.1016\/S0140-6736(20)30925-9","article-title":"Global burden of 369 diseases and injuries in 204 countries and territories, 1990\u20132019: A systematic analysis for the Global Burden of Disease Study 2019","volume":"396","author":"Vos","year":"2020","journal-title":"Lancet"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"e433","DOI":"10.5435\/JAAOS-D-19-00174","article-title":"Burden of sciatica on us Medicare recipients","volume":"28","author":"Maslak","year":"2020","journal-title":"JAAOS-J. Am. Acad. Orthop. Surg."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"2464","DOI":"10.1097\/BRS.0b013e318183a4a2","article-title":"Sciatica: Review of epidemiological studies and prevalence estimates","volume":"33","author":"Konstantinou","year":"2008","journal-title":"Spine"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"1240","DOI":"10.1056\/NEJMra1410151","article-title":"Sciatica","volume":"372","author":"Ropper","year":"2015","journal-title":"N. Engl. J. Med."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"e401","DOI":"10.1016\/S2665-9913(20)30099-0","article-title":"Stratified care versus usual care for management of patients presenting with sciatica in primary care (SCOPiC): A randomised controlled trial","volume":"2","author":"Konstantinou","year":"2020","journal-title":"Lancet Rheumatol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"644","DOI":"10.1097\/AJP.0b013e31826f9a52","article-title":"The impact of low back-related leg pain on outcomes as compared with low back pain alone: A systematic review of the literature","volume":"29","author":"Konstantinou","year":"2013","journal-title":"Clin. J. Pain"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"444","DOI":"10.1007\/s00586-014-3355-2","article-title":"Pain location matters: The impact of leg pain on health care use, work disability and quality of life in patients with low back pain","volume":"24","author":"Hider","year":"2015","journal-title":"Eur. Spine J."},{"key":"ref_11","doi-asserted-by":"crossref","unstructured":"Goupille, P., Jayson, M.I., Valat, J.-P., and Freemont, A.J. (1998). The role of inflammation in disk herniation-associated radiculopathy. Seminars in Arthritis and Rheumatism, WB Saunders.","DOI":"10.1016\/S0049-0172(98)80029-2"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"530","DOI":"10.1016\/j.jbspin.2007.07.004","article-title":"Sciatica from disk herniation: Medical treatment or surgery?","volume":"74","author":"Legrand","year":"2007","journal-title":"Jt. Bone Spine"},{"key":"ref_13","first-page":"463","article-title":"Conservative treatment of sciatica: A systematic review","volume":"13","author":"Vroomen","year":"2000","journal-title":"Clin. Spine Surg."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"601","DOI":"10.1016\/j.berh.2013.10.004","article-title":"Trajectories of low back pain","volume":"27","year":"2013","journal-title":"Best Pract. Res. Clin. Rheumatol."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"514","DOI":"10.7326\/M16-2367","article-title":"Noninvasive treatments for acute, subacute, and chronic low back pain: A clinical practice guideline from the American College of Physicians","volume":"166","author":"Qaseem","year":"2017","journal-title":"Ann. Intern. Med."},{"key":"ref_16","doi-asserted-by":"crossref","unstructured":"Goo, B., Jo, M.-g., Kim, E.-J., Lee, H.-J., Kim, J.-S., Nam, D., Kang, J.W., Kim, T.-H., Park, Y.-C., and Baek, Y.-H. (2022). Korean Medicine Clinical Practice Guidelines for Lumbar Herniated Intervertebral Disc in Adults: Based on Grading of Recommendations Assessment, Development and Evaluation (GRADE). Healthcare, 10.","DOI":"10.3390\/healthcare10020246"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"i6748","DOI":"10.1136\/bmj.i6748","article-title":"Low back pain and sciatica: Summary of NICE guidance","volume":"356","author":"Bernstein","year":"2017","journal-title":"BMJ"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"60","DOI":"10.1007\/s00586-017-5099-2","article-title":"National Clinical Guidelines for non-surgical treatment of patients with recent onset low back pain or lumbar radiculopathy","volume":"27","author":"Stochkendahl","year":"2018","journal-title":"Eur. Spine J."},{"key":"ref_19","first-page":"27","article-title":"Epidural interventions in the management of chronic spinal pain: American Society of Interventional Pain Physicians (ASIPP) comprehensive evidence-based guidelines","volume":"24","author":"Manchikanti","year":"2021","journal-title":"Pain Physician"},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"2368","DOI":"10.1016\/S0140-6736(18)30489-6","article-title":"Prevention and treatment of low back pain: Evidence, challenges, and promising directions","volume":"391","author":"Foster","year":"2018","journal-title":"Lancet"},{"key":"ref_21","unstructured":"Chou, R., Deyo, R., and Friedly, J. (2016). Noninvasive Treatments for Low Back Pain."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"1624","DOI":"10.1001\/jama.2016.1464","article-title":"CDC guideline for prescribing opioids for chronic pain\u2014United States, 2016","volume":"315","author":"Dowell","year":"2016","journal-title":"JAMA"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"g6380","DOI":"10.1136\/bmj.g6380","article-title":"Opioids for low back pain","volume":"350","author":"Deyo","year":"2015","journal-title":"BMJ"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"116","DOI":"10.7326\/0003-4819-146-2-200701160-00006","article-title":"Systematic review: Opioid treatment for chronic back pain: Prevalence, efficacy, and association with addiction","volume":"146","author":"Martell","year":"2007","journal-title":"Ann. Intern. Med."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"e012432","DOI":"10.1136\/bmjopen-2016-012432","article-title":"Evaluation of use and cost of medical care of common lumbar disorders in Korea: Cross-sectional study of Korean Health Insurance Review and Assessment Service National Patient Sample data","volume":"6","author":"Ahn","year":"2016","journal-title":"BMJ Open"},{"key":"ref_26","unstructured":"Hoe, D.S. (2010). Clinical Effectiveness of Injection Therapy for Low Back Pain, National Evidence-based Healthcare Collaborating Agency."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"3197","DOI":"10.2147\/JPR.S421148","article-title":"A Pilot Study for Effectiveness of Non-Pharmacological versus Pharmacological Treatment Strategies for Lumbar Disc Herniation: A Pragmatic Randomized Controlled Trial","volume":"16","author":"Kim","year":"2023","journal-title":"J. Pain Res."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"59","DOI":"10.56986\/pim.2023.02.009","article-title":"A Study Protocol for a Multicenter, Pragmatic, Randomized Controlled, Parallel-Grouped Pilot Clinical Trial: Effectiveness of Non-Pharmacological Versus Pharmacological Treatments for Non-Acute Lumbar Disc Herniation","volume":"2","author":"Zhao","year":"2023","journal-title":"Perspect. Integr. Med."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"142","DOI":"10.56986\/pim.2023.10.002","article-title":"An Umbrella Review of Systematic Reviews for Chuna (or Tuina) Manual Therapy on Musculoskeletal Disorders","volume":"2","author":"Kim","year":"2023","journal-title":"Perspect. Integr. Med."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"146","DOI":"10.4184\/jkss.2005.12.2.146","article-title":"Cross-cultural adaptation of the Korean version of the Oswestry Disability Index (ODI)","volume":"12","author":"Jeon","year":"2005","journal-title":"J. Korean Soc. Spine Surg."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"R177","DOI":"10.1186\/ar3141","article-title":"Validity of the work productivity and activity impairment questionnaire-general health version in patients with rheumatoid arthritis","volume":"12","author":"Zhang","year":"2010","journal-title":"Arthritis Res. Ther."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"40","DOI":"10.1186\/s40814-021-00770-x","article-title":"Determining sample size for progression criteria for pragmatic pilot RCTs: The hypothesis test strikes back!","volume":"7","author":"Lewis","year":"2021","journal-title":"Pilot Feasibility Stud."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"457","DOI":"10.1016\/j.pmr.2014.01.007","article-title":"Side effects of commonly prescribed analgesic medications","volume":"25","author":"Carter","year":"2014","journal-title":"Phys. Med. Rehabil. Clin. N. Am."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"2105","DOI":"10.1056\/NEJMp0908913","article-title":"A difficult balance--pain management, drug safety, and the FDA","volume":"361","author":"Woodcock","year":"2009","journal-title":"N. Engl. J. Med."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"192","DOI":"10.1016\/j.jmpt.2016.02.013","article-title":"Symptomatic, MRI confirmed, lumbar disc herniations: A comparison of outcomes depending on the type and anatomical axial location of the hernia in patients treated with high-velocity, low-amplitude spinal manipulation","volume":"39","author":"Ehrler","year":"2016","journal-title":"J. Manip. Physiol. Ther."},{"key":"ref_36","doi-asserted-by":"crossref","unstructured":"Trager, R.J., Baumann, A.N., Perez, J.A., Dusek, J.A., Perfecto, R.-P.T., and Goertz, C.M. (2024). Association between chiropractic spinal manipulation and cauda equina syndrome in adults with low back pain: Retrospective cohort study of US academic health centers. PLoS ONE, 19.","DOI":"10.1371\/journal.pone.0299159"},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"707","DOI":"10.1016\/j.ajem.2018.01.008","article-title":"A systematic review of the pain scales in adults: Which to use?","volume":"36","author":"Karcioglu","year":"2018","journal-title":"Am. J. Emerg. Med."},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"S240","DOI":"10.1002\/acr.20543","article-title":"Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) (sf-36 bps)","volume":"63","author":"Hawker","year":"2011","journal-title":"Arthritis Care Res."},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"231","DOI":"10.1016\/j.pain.2010.03.016","article-title":"Validation of the Individualized Numeric Rating Scale (INRS): A pain assessment tool for nonverbal children with intellectual disability","volume":"150","author":"Solodiuk","year":"2010","journal-title":"Pain"},{"key":"ref_40","doi-asserted-by":"crossref","first-page":"565","DOI":"10.1016\/j.pain.2008.02.007","article-title":"Estimation of pain intensity in emergency medicine: A validation study","volume":"138","author":"Daoust","year":"2008","journal-title":"Pain"},{"key":"ref_41","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1016\/j.pain.2004.09.012","article-title":"Core outcome measures for chronic pain clinical trials: IMMPACT recommendations","volume":"113","author":"Dworkin","year":"2005","journal-title":"Pain"},{"key":"ref_42","doi-asserted-by":"crossref","first-page":"1845","DOI":"10.1007\/s11136-015-1205-2","article-title":"The EQ-5D-5L valuation study in Korea","volume":"25","author":"Kim","year":"2016","journal-title":"Qual. Life Res."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/4\/1204\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T16:32:04Z","timestamp":1760027524000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/4\/1204"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2,12]]},"references-count":42,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2025,2]]}},"alternative-id":["jcm14041204"],"URL":"https:\/\/doi.org\/10.3390\/jcm14041204","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,2,12]]}}}