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Acupuncture in Patients with a Vertebral Compression Fracture: A Protocol for a Randomized, Controlled, Pilot Clinical Trial

  • Lee, Hyun-Jong (Department of Acupuncture & Moxibustion, College of Oriental Medicine, Daegu Haany University) ;
  • Seo, Jung-Chul (Comprehensive and Integrative Medicine Institute) ;
  • Park, Sung-Hoon (Comprehensive and Integrative Medicine Institute) ;
  • Kwak, Min-Ah (Department of Internal Medicine, College of Oriental Medicine, Daegu Haany University) ;
  • Shin, Im Hee (Department of Medical Statistics, School of Medicine, Catholic University) ;
  • Min, Bo-Mi (Department of Anesthesiology and Pain Medicine, School of Medicine, Catholic University) ;
  • Cho, Min-Su (Department of Anesthesiology and Pain Medicine, School of Medicine, Catholic University) ;
  • Roh, Woon-Seok (Department of Anesthesiology and Pain Medicine, School of Medicine, Catholic University) ;
  • Jung, Jin-Yong (Department of Anesthesiology and Pain Medicine, School of Medicine, Catholic University)
  • Received : 2014.10.08
  • Accepted : 2014.11.24
  • Published : 2015.03.30

Abstract

Objectives: A vertebral compression fracture (VCF) is characterized by back pain and fracture of a vertebral body on spinal radiography. VCFs of the thoraco lumbar spine are common in the elderly. In general, appropriate analgesics should be prescribed to reduce pain and, thus, promote early mobilization. The ideal treatment approach for VCFs has not been determined. In Korea, acupuncture and herbal medication have been used to treat VCFs for many years. There is empirical evidence that acupuncture might benefit patients with a VCF. However, no randomized, controlled, clinical trials evaluating the efficacy and the safety of acupuncture for treating a VCF have been published. Therefore, we designed a randomized, controlled, pilot, clinical trial to obtain information for the design of a further full scale trial. Methods: A five week protocol for a randomized, controlled, pilot, clinical trial is presented. Fourteen patients will be recruited and randomly allocated to two groups: a control group receiving interlaminar epidural steroid injections once a week for three weeks, and an experimental group receiving interlaminar epidural steroid injections plus acupuncture treatment (three acupuncture sessions per week for three weeks, nine sessions in total). The primary outcomes will be the pain intensity (visual analogue scale and PainVision$^{TM}$ system). The secondary outcome measurements will be the answers on the short form McGill pain questionnaire and the oswestry disability index. Assessments will be made at baseline and at one, three, and five weeks. The last assessment (week five) will take place two weeks after treatment cessation. This study will provide both an indication of feasibility and a clinical foundation for a future large scale trial. The outcomes will provide additional resources for incorporating acupuncture into existing treatments, such as nonsteroidal anti-inflammatory medications, narcotics and vertebral augmentation. This article describes the protocol.

Keywords

acupuncture;interlaminar epidural steroid injection;vertebral compression fracture

Acknowledgement

Supported by : Ministry of Health & Welfare

References

  1. Ensrud KE, Schousboe JT. Clinical practice. vertebral fractures. N Engl J Med. 2011;364(17):1634-42. https://doi.org/10.1056/NEJMcp1009697
  2. Cooper C, Atkinson EJ, O'Fallon WM, Melton LJ 3rd. Incidence of clinically diagnosed vertebral fractures: a population-based study in rochester, minnesota, 1985-1989. J Bone Miner Res. 1992;7(2):221-7
  3. Barr JD, Barr MS, Lemley TJ, McCann RM. Percutaneous vertebroplasty for pain relief and spinal stabilization. Spine. 2000;25(8):923-8 https://doi.org/10.1097/00007632-200004150-00005
  4. Gertzbein SD, Khoury D, Bullington A, St John TA, Larson AI. Thoracic and lumbar fractures associated with skiing and snowboarding injuries according to the AO comprehensive classification. Am J Sports Med. 2012;40(8):1750-4. https://doi.org/10.1177/0363546512449814
  5. Robinson Y, Heyde CE, Forsth P, Olerud C. Kyphoplasty in osteoporotic vertebral compression fractures-guidelines and technical considerations. J Orthop Surg Res. 2011;6(43):1-8 https://doi.org/10.1186/1749-799X-6-1
  6. Nevitt MC, Ettinger B, Black DM, Stone K, Jamal SA, Ensrud K, et al. The association of radiographically detected vertebral fractures with back pain and function: a prospective study. Ann Intern Med. 1998;128(10):793-800. https://doi.org/10.7326/0003-4819-128-10-199805150-00001
  7. Kim DH, Vaccaro AR. Osteoporotic compression fractures of the spine; current options and considerations for treatment. Spine J. 2006;6(5):479-87 https://doi.org/10.1016/j.spinee.2006.04.013
  8. Prather H, Hunt D, Watson JO, Gilula LA. Conservative care for patients with osteoporotic vertebral compression fractures. Phys Med Rehabil Clin N Am. 2007;18(3):577-91. https://doi.org/10.1016/j.pmr.2007.05.008
  9. Lad SP, Patil CG, Lad EM, Boakye M. Trends in pathological vertebral fractures in the united states: 1993 to 2004. J Neurosurg Spine. 2007;7(3):305-10. https://doi.org/10.3171/SPI-07/09/305
  10. ONeill TW, Silman AJ. Definition and diagnosis of vertebral fracture. J Rheumatol. 1997;24(6):1208-11.
  11. Eastell R, Cedel SL, Wahner HW, Riggs BL, Melton LJ. Classification of vertebral fractures. J Bone Miner Res. 1991;6(3):207-15.
  12. Longo UG, Loppini M, Denaro L, Maffulli N, Denaro V. Osteoporotic vertebral fractures: current concepts of conservative care. Br Med Bull. 2012;102:171-89 https://doi.org/10.1093/bmb/ldr048
  13. Lucas TS, Einhorn TA. Osteoporosis: The role of the orthopaedist. J Am Acad Orthop Surg. 1993;1(1):48-56. https://doi.org/10.5435/00124635-199309000-00007
  14. Prather H, Watson JO, Gilula LA. Nonoperative management of osteoporotic vertebral compression fractures. Injury. 2007;38(S3):40-8 https://doi.org/10.1016/j.injury.2007.08.010
  15. Kim DJ, Yun YH, Wang JM. Nerve-root injections for the relief of pain in patients with osteoporotic vertebral fractures. J Bone Joint Surg Br. 2003;85:250-3. https://doi.org/10.1302/0301-620X.85B2.13289
  16. Bostrom MP, Lane JM. Future directions. augmentation of osteoporotic vertebral bodies. Spine. 1997;22(S24):38-42. https://doi.org/10.1097/00007632-199701010-00007
  17. Truumees E, Hilibrand A, Vaccaro AR. Percutaneous vertebral augmentation. Spine J. 2004;4(2):218-29 https://doi.org/10.1016/j.spinee.2003.08.029
  18. Vaccaro AR, Kim DH, Brodke DS, Harris M, Chapman J, Schildhauer T, et al. Diagnosis and management of thoracolumbar spine fractures. J Bone Joint Surg Am. 2003;85(12):2456-70. https://doi.org/10.2106/00004623-200312000-00029
  19. Carlsson CP, Sjolund BH. Acupuncture for chronic low back pain: a randomized placebo-controlled study with long-term follow-up. Clin J Pain. 2001;17(4):296-305. https://doi.org/10.1097/00002508-200112000-00003
  20. Sawazaki K, Mukaino Y, Kinoshita F, Honda T, Mohara O, Sakuraba H, et al. Acupuncture can reduce perceived pain, mood disturbances and medical expenses related to low back pain among factory employees. Ind Health. 2008;46(4):336-40. https://doi.org/10.2486/indhealth.46.336
  21. Leibing E, Leonhardt U, Koster G, Goerlitz A, Rosenfeldt JA, Hilgers R, et al. Acupuncture treatment of chronic low-back pain-a randomized, blinded, placebo-controlled trial with 9-month follow-up. Pain. 2002;96(1-2):189-96. https://doi.org/10.1016/S0304-3959(01)00444-4
  22. Haake M, Muller HH, Schade-Brittinger C, Basler HD, Schafer H, Maier C, et al. German acupuncture trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med. 2007;167(17):1892-8 https://doi.org/10.1001/Archinte.167.17.1892
  23. Brinkhaus B, Witt CM, Jena S, Linde K, Streng A, Wagenpfeil S, et al. Acupuncture in patients with chronic low back pain: a randomized controlled trial. Arch Intern Med. 2006;166(4):450-7
  24. Revill SI, Robinson JO, Rosen M, Hogg MI. The reliability of a linear analogue for evaluating pain. Anaesthesia. 1976;31(9):1191-8 https://doi.org/10.1111/j.1365-2044.1976.tb11971.x
  25. Carlsson AM. Assessment of chronic pain. I. aspects of the reliability and validity of the visual analogue scale. Pain. 1983;16(1):87-101. https://doi.org/10.1016/0304-3959(83)90088-X
  26. Ikeno S, Kawamata M. Painvision. Masui. 2009;58(11):1367-72.
  27. Matsumura H, Imai R, Gondo M, Watanabe K. Evaluation of pain intensity measurement during the removal of wound dressing material using 'the painvision system' for quantitative analysis of perception and pain sensation in healthy subjects. Int Wound J. 2012;9(4):451-5. https://doi.org/10.1111/j.1742-481X.2011.00911.x
  28. Burckhardt CS. The use of the mcgill pain questionnaire in assessing arthritis pain. Pain. 1984;19(3):305-14. https://doi.org/10.1016/0304-3959(84)90007-1
  29. Melzack R. The short-form mcgill pain questionnaire. Pain. 1987;30:191-7 https://doi.org/10.1016/0304-3959(87)91074-8
  30. Melzack R. The mcgill pain questionnaire: major properties and scoring methods. Pain. 1975;1(3):277-99 https://doi.org/10.1016/0304-3959(75)90044-5
  31. Roland M, Morris R. A study of the natural history of back pain. part I: development of a reliable and sensitive measure of disability in low-back pain. Spine. 1983;8(2):141-4. https://doi.org/10.1097/00007632-198303000-00004
  32. 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(6):1092-7 https://doi.org/10.3346/jkms.2006.21.6.1092
  33. Lindsay R, Silverman SL, Cooper C, Hanley DA, Barton I, Broy SB, et al. Risk of new vertebral fracture in the year following a fracture. JAMA. 2001;285(3):320-3. https://doi.org/10.1001/jama.285.3.320
  34. Alexandru D, So W. Evaluation and management of vertebral compression fractures. Perm J. 2012;16(4):46-51.
  35. Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med. 2000;343(21):1520-8 https://doi.org/10.1056/NEJM200011233432103
  36. Cherasse A, Muller G, Ornetti P, Piroth C, Tavernier C, Maillefert JF. Tolerability of opioids in patients with acute pain due to nonmalignant musculoskeletal disease. a hospital-based observational study. Joint Bone Spine. 2004;71(6):572-6. https://doi.org/10.1016/j.jbspin.2003.10.014
  37. Laredo JD, Hamze B. Complications of percutaneous vertebroplasty and their prevention. Skeletal Radiol. 2004;33(9):493-505.
  38. Taylor RS, Fritzell P, Taylor RJ. Balloon kyphoplasty in the management of vertebral compression fractures: an updated systematic review and meta-analysis. Eur Spine J. 2007;16(8):1085-100. https://doi.org/10.1007/s00586-007-0308-z
  39. Krueger A, Bliemel C, Zettl R, Ruchholtz S. Management of pulmonary cement embolism after percutaneous vertebroplasty and kyphoplasty: a systematic review of the literature. Eur Spine J. 2009;18(9):1257-65. https://doi.org/10.1007/s00586-009-1073-y
  40. Mudano AS, Bian J, Cope JU, Curtis JR, Gross TP, Allison JJ, et al. Vertebroplasty and kyphoplasty are associated with an increased risk of secondary vertebral compression fractures: a population-based cohort study. Osteoporos Int. 2009;20(5):819-26. https://doi.org/10.1007/s00198-008-0745-5

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  1. Korean Medicine for Thoracolumbar Compression Fracture in Korean Literature: a Systematic Review vol.32, pp.4, 2015, https://doi.org/10.13045/acupunct.2015069