A Protocol for a Single-Centered, Pragmatic, Randomized, Controlled, Parallel Trial Comparing Comprehensive Nonsurgical Therapy Options for Individuals with Lumbar Spinal Stenosis

References

• Jensen RK, Lauridsen HH, Andresen A, Mieritz RM, Schiottz-Christensen B, Vach W. Diagnostic screening for lumbar spinal stenosis. Clin Epidemiol. 2020;12:891–905. doi:10.2147/CLEP.S263646
   PubMed Web of Science ®Google Scholar
• Katz JN, Zimmerman ZE, Mass H, Makhni MC. Diagnosis and management of lumbar spinal stenosis: a review. JAMA. 2022;327:1688–1699. doi:10.1001/jama.2022.5921
   PubMed Web of Science ®Google Scholar
• Lurie J, Tomkins-Lane C. Management of lumbar spinal stenosis. BMJ. 2016;352:h6234.
   PubMed Web of Science ®Google Scholar
• 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. Physiother Theory Pract. 2022;20:1–46.
   Google Scholar
• Ammendolia C, Stuber KJ, Rok E, et al. Nonoperative treatment for lumbar spinal stenosis with neurogenic claudication. Cochrane Database Syst Rev. 2013;2013:D10712.
   Google Scholar
• Ammendolia C, Hofkirchner C, Plener J, et al. Non-operative treatment for lumbar spinal stenosis with neurogenic claudication: an updated systematic review. BMJ Open. 2022;12:e57724.
   Google Scholar
• Kwon CY, Yoon SH, Lee B, Leem J. Acupotomy for the treatment of lumbar spinal stenosis: a systematic review and meta-analysis. Medicine. 2019;98:e16662. doi:10.1097/MD.0000000000016662
   PubMedGoogle Scholar
• Kim KH, Kim TH, Lee BR, et al. Acupuncture for lumbar spinal stenosis: a systematic review and meta-analysis. Complement Ther Med. 2013;21:535–556.
   PubMedGoogle Scholar
• Chen X, Zheng Z, Lin J. Clinical effectiveness of conservative treatments on lumbar spinal stenosis: a network meta-analysis. Front Pharmacol. 2022;13:859296. doi:10.3389/fphar.2022.859296
   PubMedGoogle Scholar
• Jacobi S, Beynon A, Dombrowski SU, Wedderkopp 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;102:2247–2260. doi:10.1016/j.apmr.2021.03.033
   PubMedGoogle Scholar
• Bussieres A, Cancelliere C, Ammendolia C, et al. Non-surgical interventions for lumbar spinal stenosis leading to neurogenic claudication: a clinical practice guideline. J Pain. 2021;22:1015–1039. doi:10.1016/j.jpain.2021.03.147
   PubMed Web of Science ®Google Scholar
• Kim K, Shin KM, Hunt CL, et al. Nonsurgical integrative inpatient treatments for symptomatic lumbar spinal stenosis: a multi-arm randomized controlled pilot trial. J Pain Res. 2019;12:1103–1113. doi:10.2147/JPR.S173178
   PubMed Web of Science ®Google Scholar
• World Federation of Chinese Medicine Associations, Chinese Society of Traditional Chinese Medicine. International clinical practice guidelines for traditional Chinese medicine for degenerative lumbar spinal stenosis. PLoS One. 2021;16:2371–2374.
   Google Scholar
• Manchikanti L, Knezevic NN, Navani A, et al. Epidural interventions in the management of chronic spinal pain: American Society of Interventional Pain Physicians (ASIPP) comprehensive evidence-based guidelines. Pain Physician. 2021;24:S27–208.
   PubMedGoogle Scholar
• Friedly JL, Comstock BA, Turner JA, et al. A randomized trial of epidural glucocorticoid injections for spinal stenosis. N Engl J Med. 2014;371:11–21.
   PubMed Web of Science ®Google Scholar
• Ammendolia C, Cote P, Rampersaud YR, et al. Effect of active TENS versus de-tuned TENS on walking capacity in patients with lumbar spinal stenosis: a randomized controlled trial. Chiropr Man Therap. 2019;27:24. doi:10.1186/s12998-019-0245-z
   PubMedGoogle Scholar
• Linton SJ, Andersson T. Can chronic disability be prevented? A randomized trial of a cognitive-behavior intervention and two forms of information for patients with spinal pain. Spine. 2000;2825:2824.
   Google Scholar
• Chung SS, Lee CS, Kim SH, Chung MW, Ahn JM. Effect of low back posture on the morphology of the spinal canal. Skeletal Radiol. 2000;29:217–223. doi:10.1007/s002560050596
   PubMed Web of Science ®Google Scholar
• Ammendolia C, Cote P, Southerst D, et al. Comprehensive nonsurgical treatment versus self-directed care to improve walking ability in lumbar spinal stenosis: a randomized trial. Arch Phys Med Rehabil. 2018;99:2408–2419. doi:10.1016/j.apmr.2018.05.014
   PubMed Web of Science ®Google Scholar
• Yi H, Wei X, Zhang W, et al. Reliability and validity of simplified Chinese version of Swiss Spinal Stenosis Questionnaire for patients with degenerative lumbar spinal stenosis. Spine. 2014;39:820–825. doi:10.1097/BRS.0000000000000273
   PubMedGoogle Scholar
• Stucki G, Liang MH, Fossel AH, Katz JN. Relative responsiveness of condition-specific and generic health status measures in degenerative lumbar spinal stenosis. J Clin Epidemiol. 1995;48:1369–1378. doi:10.1016/0895-4356(95)00054-2
   PubMed Web of Science ®Google Scholar
• Zucherman JF, Hsu KY, Hartjen CA, et al. A prospective randomized multi-center study for the treatment of lumbar spinal stenosis with the X STOP interspinous implant: 1-year results. Eur Spine J. 2004;13:22–31. doi:10.1007/s00586-003-0581-4
   PubMed Web of Science ®Google Scholar
• Liu HTao H, Luo Z. Validation of the simplified Chinese version of the Oswestry Disability Index. Spine. 2009;1211:1217.
   Google Scholar
• Lue YJ, Hsieh CL, Huang MH, Lin GT, Lu YM. Development of a Chinese version of the Oswestry Disability Index version 2.1. Spine. 2008;33:2354–2360. doi:10.1097/BRS.0b013e31818018d8
   PubMed Web of Science ®Google Scholar
• Su SW, Wang D. The reliability and validity of short form-12 health survey version 2 for Chinese older adults. Iran J Public Health. 2019;48:1014–1024.
   PubMedGoogle Scholar
• Liu C, Wang X, Wang X, et al. Blood-letting and herbal-cupping therapy for lumbar spinal stenosis: prospective case series study. Int J Trad Chin Med. 2018;40:799–804.
   Google Scholar
• Kreiner DS, Shaffer WO, Baisden JL, et al. An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spinal stenosis (update). Spine J. 2013;13:734–743.
   PubMedGoogle Scholar
• Deyo RA. Treatment of lumbar spinal stenosis: a balancing act. Spine J. 2010;10:625–627. doi:10.1016/j.spinee.2010.05.006
   PubMed Web of Science ®Google Scholar
• Lurie JD, Tosteson TD, Tosteson A, et al. Long-term outcomes of lumbar spinal stenosis: eight-year results of the Spine Patient Outcomes Research Trial (SPORT). Spine. 2015;40:63–76. doi:10.1097/BRS.0000000000000731
   PubMed Web of Science ®Google Scholar
• Weinstein JN, Lurie JD, Tosteson TD, et al. Surgical versus nonoperative treatment for lumbar disc herniation: four-year results for the Spine Patient Outcomes Research Trial (SPORT). Spine. 2008;33:2789–2800. doi:10.1097/BRS.0b013e31818ed8f4
   PubMed Web of Science ®Google Scholar
• Zaina F, Tomkins-Lane C, Carragee E, Negrini S. Surgical versus nonsurgical treatment for lumbar spinal stenosis. Spine. 2016;41:E857–68. doi:10.1097/BRS.0000000000001635
   PubMedGoogle Scholar
• Comer CM, Redmond AC, Bird HA, Conaghan PG. Assessment and management of neurogenic claudication associated with lumbar spinal stenosis in a UK primary care musculoskeletal service: a survey of current practice among physiotherapists. BMC Musculoskelet Disord. 2009;10:121.
   PubMed Web of Science ®Google Scholar
• Rousing R, Jensen RK, Fruensgaard S, et al. Danish national clinical guidelines for surgical and nonsurgical treatment of patients with lumbar spinal stenosis. Eur Spine J. 2019;28:1386–1396. doi:10.1007/s00586-019-05987-2
   PubMed Web of Science ®Google Scholar
• Haig AJ, Tong HC, Yamakawa KS, et al. Predictors of pain and function in persons with spinal stenosis, low back pain, and no back pain. Spine. 2006;31:2950–2957.
   PubMedGoogle Scholar
• 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;319:872–882. doi:10.1001/jama.2018.0899
   PubMed Web of Science ®Google Scholar
• Budgell BS, Sovak G, Soave D. TENS augments blood flow in somatotopically linked spinal cord segments and mitigates compressive ischemia. Spinal Cord. 2014;52:744–748. doi:10.1038/sc.2014.120
   PubMedGoogle Scholar
• Clijsen R, Brunner A, Barbero M, Clarys P, Taeymans J. Effects of low-level laser therapy on pain in patients with musculoskeletal disorders: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2017;53:603–610. doi:10.23736/S1973-9087.17.04432-X
   PubMedGoogle Scholar
• Qaseem A, Wilt TJ, McLean RM, et al. Noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2017;166:514–530. doi:10.7326/M16-2367
   PubMed Web of Science ®Google Scholar
• Furlan AD, Giraldo M, Baskwill A, Irvin E, Imamura M. Massage for low-back pain. Cochrane Database Syst Rev. 2015;2015:D1929.
   Google Scholar
• Kong LJ, Fang M, Zhan HS, et al. Tuina-focused integrative Chinese medical therapies for inpatients with low back pain: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2012;2012:578305. doi:10.1155/2012/578305
   PubMedGoogle Scholar
• Kim K, Youn Y, Lee SH, et al. The effectiveness and safety of nonsurgical integrative interventions for symptomatic lumbar spinal spondylolisthesis: a randomized controlled multinational, multicenter trial protocol. Medicine. 2018;97:e667.
   Google Scholar
• Zhao H, Liu B, Liu Z, et al. Clinical practice guidelines of using acupuncture for low back pain. World J Acupunct Moxibust. 2016;26:1–13. doi:10.1016/S1003-5257(17)30016-8
   Google Scholar
• Pei XZhan H, Li Y. Classification of Chinese spinal Tuina. In: Li Y, Ye G, editors. Chinese Spinal Tuina Encyclopedia. Beijing, China: Military Medical Science Press; 2005:12–16.
   Google Scholar
• Chou R, Qaseem A, Snow V, et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007;147:478–491. doi:10.7326/0003-4819-147-7-200710020-00006
   PubMed Web of Science ®Google Scholar
• Moura CC, Chaves E, Cardoso A, Nogueira DA, Correa HP, Chianca T. Cupping therapy and chronic back pain: systematic review and meta-analysis. Rev Lat Am Enfermagem. 2018;26:e3094.
   PubMedGoogle Scholar
• Furhad S, Bokhari AA. Cupping Therapy. StatPearls Publishing; 2022.
   Google Scholar
• Cao H, Hu H, Colagiuri B, Liu J. Medicinal cupping therapy in 30 patients with fibromyalgia: a case series observation. Forsch Komplementmed. 2011;18:122–126. doi:10.1159/000329329
   PubMedGoogle Scholar
• Wu X, Hu H, Guo L, Wang H. 药罐治疗带状疱疹后遗神经痛临床观察 [Clinical observation of post-herpetic neuralgia treated with TCM herbal cupping therapy]. Zhongguo Zhen Jiu. 2013;33:141–144. Chinese.
   PubMedGoogle Scholar
• Luo Y, Wang CZ, Sawadogo R, Tan T, Yuan CS. Effects of herbal medicines on pain management. Am J Chin Med. 2020;48:1–16. doi:10.1142/S0192415X20500019
   PubMedGoogle Scholar
• Wu J, Su S. Analysis of medication rule in treating lumbar spinal stenosis with traditional Chinese medicine based on data mining. Asia Pacific Trad Med. 2021;17:161–165.
   Google Scholar
• Jahromi B, Pirvulescu I, Candido KD, Knezevic NN. Herbal medicine for pain management: efficacy and drug interactions. Pharmaceutics. 2021;13:251. doi:10.3390/pharmaceutics13020251
   PubMedGoogle Scholar
• Ding X, Wu J, Shen Q, Xu J, Mo W. Clinical control study of traditional Chinese medicine hot compress combined with traction in the treatment of cervical spondylotic radiculopathy: study protocol. Medicine. 2021;100:e23880. doi:10.1097/MD.0000000000023880
   PubMedGoogle Scholar