Comparison of non-surgical treatment methods for patients with lumbar spinal stenosis: protocol for a randomized controlled trial

Chiropractic & Manual Therapies - Tập 22 Số 1 - 2014
Michael J. Schneider1, Carlo Ammendolia2, Donald R. Murphy3, Ronald M. Glick4, Sara R. Piva1, Elizabeth Hile1, Dana Tudorascu5, Sally C. Morton6
1School of Health and Rehabilitation Sciences, Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, USA
2Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
3Clinical Director, Rhode Island Spine Center, Providence, RI, USA
4Departments of Physical Medicine, Family Medicine, and Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA
5School of Medicine, Biostatistics, Clinical and Translational Science Institute, University of Pittsburgh, Pittsburgh, PA, USA
6Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA

Tóm tắt

Abstract Background Lumbar spinal stenosis is the most common reason for spinal surgery in older adults. Previous studies have shown that surgery is effective for severe cases of stenosis, but many patients with mild to moderate symptoms are not surgical candidates. These patients and their providers are seeking effective non-surgical treatment methods to manage their symptoms; yet there is a paucity of comparative effectiveness research in this area. This knowledge gap has hindered the development of clinical practice guidelines for non-surgical treatment approaches for lumbar spinal stenosis. Methods/design This study is a prospective randomized controlled clinical trial that will be conducted from November 2013 through October 2016. The sample will consist of 180 older adults (>60 years) who have both an anatomic diagnosis of stenosis confirmed by diagnostic imaging, and signs/symptoms consistent with a clinical diagnosis of lumbar spinal stenosis confirmed by clinical examination. Eligible subjects will be randomized into one of three pragmatic treatment groups: 1) usual medical care; 2) individualized manual therapy and rehabilitative exercise; or 3) community-based group exercise. All subjects will be treated for a 6-week course of care. The primary subjective outcome is the Swiss Spinal Stenosis Questionnaire, a self-reported measure of pain/function. The primary objective outcome is the Self-Paced Walking Test, a measure of walking capacity. The secondary objective outcome will be a measurement of physical activity during activities of daily living, using the SenseWear Armband, a portable device to be worn on the upper arm for one week. The primary analysis will use linear mixed models to compare the main effects of each treatment group on the changes in each outcome measure. Secondary analyses will include a responder analysis by group and an exploratory analysis of potential baseline predictors of treatment outcome. Discussion Our study should provide evidence that helps to inform patients and providers about the clinical benefits of three non-surgical approaches to the management of lumbar spinal stenosis symptoms. Trial registration ClinicalTrials.gov identifier: NCT01943435

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Tài liệu tham khảo

Hootman JM, Helmick CG, Brady TJ: A public health approach to addressing arthritis in older adults: the most common cause of disability. Am J Public Health. 2012, 102 (3): 426-433. 10.2105/AJPH.2011.300423

Kalichman L, Cole R, Kim DH, Li L, Suri P, Guermazi A, Hunter DJ: Spinal stenosis prevalence and association with symptoms: the Framingham study. Spine J. 2009, 9: 545-550. 10.1016/j.spinee.2009.03.005

Binder DK, Schmidt MH, Weinstein PR: Lumbar spinal stenosis. Semin Neurol. 2002, 22 (2): 157-166. 10.1055/s-2002-36539

Wiesel SW, Tsourmas N, Feffer HL, Citrin C, Patronas N: A study of computer-assisted tomography: the incidence of positive CAT scans in an asymptomatic group of patients. Spine. 1984, 9 (6): 549-551. 10.1097/00007632-198409000-00003

Boden SD, Davis D, Dina T, Patronas N, Wiesel SW: Abnormal magnetic-resonance scans of the lumbar spine in asymptomatic subjects. J Bone Joint Surg. 1990, 72 (3): 403-408.

Sugioka T, Hayashino Y, Konno S, Kikuchi S, Fukuhara S: Predictive value of self-reported patient information for the identification of lumbar spinal stenosis. Fam Pract. 2008, 25 (4): 237-244. 10.1093/fampra/cmn031

Winter CC, Brandes M, Muller C, Schubert T, Ringling M, Hillmann A, Rosenbaum D, Schulte TL: Walking ability during daily life in patients with osteoarthritis of the knee or the hip and lumbar spinal stenosis: a cross sectional study. BMC Musculoskelet Disord. 2010, 11: 233- 10.1186/1471-2474-11-233

Kim HJ, Chun HJ, Han CD, Moon SH, Kang KT, Kim HS, Park JO, Moon ES, Kim BR, Sohn JS, Shin SY, Jang JW, Lee KI, Lee HM: The risk assessment of a fall in patients with lumbar spinal stenosis. Spine. 2011, 36 (9): E588-E592. 10.1097/BRS.0b013e3181f92d8e

Muraki S, Akune T, Oka H, En-Yo Y, Yoshida M, Nakamura K, Kawaguchi H, Yoshimura N: Prevalence of falls and the association with knee osteoarthritis and lumbar spondylosis as well as knee and lower back pain in Japanese men and women. Arthritis Care Res. 2011, 63 (10): 1425-1431. 10.1002/acr.20562.

Fanuele JC, Birkmeyer N, Abdu W, Tosteson T, Weinstein JN: The impact of spinal problems on the health status of patients: have we underestimated the effect?. Spine. 2000, 25 (12): 1509-1514. 10.1097/00007632-200006150-00009

Weinstein JN, Tosteson T, Lurie J, Tosteson A, Blood E, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H: Surgical versus non-operative treatment for lumbar spinal stenosis: four-year results of the spine patient outcomes research trial. Spine. 2010, 35 (14): 1329-1338.

Ammendolia C, Stuber K, de Bruin LK, Furlan AD, Kennedy CA, Rampersaud YR, Steenstra IA, Pennick V: Non-operative treatment for lumbar spinal stenosis with neurogenic claudication: a systematic review. Spine. 2012, 37 (10): E609-E616. 10.1097/BRS.0b013e318240d57d

Conn A, Buenaventura R, Datta S, Abdi S, Diwan S: Systematic review of caudal epidural injections in the management of chronic low back pain. Pain Physician. 2009, 12 (1): 109-135.

Slutsky JR, Clancy CM: AHRQ's effective health care program: why comparative effectiveness matters. Am J Med Qual. 2009, 24 (1): 67-70.

McDermott MM, Criqui MH, Liu K, Guralnik JM, Greenland P, Martin GJ, Pearce W: Lower ankle/brachial index, as calculated by averaging the dorsalis pedis and posterior tibial arterial pressures, and association with leg functioning in peripheral arterial disease. J Vasc Surg. 2000, 32 (6): 1164-1171. 10.1067/mva.2000.108640

Jeon CH, Han SH, Chung NS, Hyun HS: The validity of ankle-brachial index for the differential diagnosis of peripheral arterial disease and lumbar spinal stenosis in patients with atypical claudication. Eur Spine J. 2012, 21 (6): 1165-1170. 10.1007/s00586-011-2072-3

Kreiner DS, Shaffer W, Baisden J, Gilbert T, Summers J, Toton J, Hwang SW, Mendel RC, Reitman CA: An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spinal stenosis (update). Spine J. 2013, 13 (7): 734-743. 10.1016/j.spinee.2012.11.059

Ellis RF, Hing WA: Neural mobilization: a systematic review of randomized controlled trials with an analysis of therapeutic efficacy. J Man Manip Ther. 2008, 16 (1): 8-22. 10.1179/106698108790818594

Pratt RK, Fairbank JC, Virr A: The reliability of the shuttle walking test, the Swiss Spinal Stenosis Questionnaire, the Oxford Spinal Stenosis Score, and the Oswestry Disability Index in the assessment of patients with lumbar spinal stenosis. Spine. 2002, 27 (1): 84-91. 10.1097/00007632-200201010-00020

Tomkins CC, Battié MC, Rogers T, Jiang H, Petersen S: A criterion measure of walking capacity in lumbar spinal stenosis and its comparison with a treadmill protocol. Spine. 2009, 34 (22): 2444-2449. 10.1097/BRS.0b013e3181b03fc8

Cole PJ, LeMura LM, Klinger TA, Strohecker K, McConnell TR: Measuring energy expenditure in cardiac patients using the body media armband versus indirect calorimetry: a validation study. J Sports Med Phys Fitness. 2004, 44 (3): 262-271.

Rigler SK, Studenski S, Wallace D, Reker DM, Duncan PW: Comorbidity adjustment for functional outcomes in community-dwelling older adults. Clin Rehabil. 2002, 16: 420-428. 10.1191/0269215502cr515oa

Tinetti ME, Richman D, Powell L: Falls efficacy as a measure of fear of falling. J Gerontol. 1990, 45 (6): 239-243. 10.1093/geronj/45.6.P239.

Fairbank JC, Couper J, Davies JB, O'Brien J: The Oswestry low back pain disability questionnaire. Physiotherapy. 1980, 66 (8): 271-273.

Powell LE, Meyers AM: The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995, 50 (1): M28-M34.

Woby SR, Roach NK, Urmston M, Watson PJ: Psychometric properties of the TSK-11: a shortened version of the Tampa scale for kinesiophobia. Pain. 2005, 117 (1–2): 137-144.

Choi SW, Reise SP, Pilkonis PA, Hays RD, Cella D: Efficiency of static and computer adaptive short forms compared to full-length measures of depressive symptoms. Qual Life Res. 2010, 19 (1): 125-136. 10.1007/s11136-009-9560-5

Smeets RJ, Beelen S, Goossens M, Schouten E, Knottnerus J, Vlaeyen J: Treatment expectancy and credibility are associated with the outcome of both physical and cognitive-behavioral treatment in chronic low back pain. Clin J Pain. 2008, 24: 305-315. 10.1097/AJP.0b013e318164aa75

Vasunilashorn S, Coppin AK, Patel KV, Lauretani F, Ferrucci L, Bandinelli S, Guralnik JM: Use of the short physical performance battery score to predict loss of ability to walk 400 meters: analysis from the InCHIANTI study. J Gerontol A Biol Sci Med Sci. 2009, 64 (2): 223-229.

Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA: Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. Pain. 2008, 9 (2): 105-121. 10.1016/j.jpain.2007.09.005.

Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, Farrar JT, Hertz S, Raja SN, Rappaport BA, Rauschkolb C, Sampaio C: Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain. 2009, 146 (3): 238-244. 10.1016/j.pain.2009.08.019

Rubin DB: Inference and missing data. Biometrika. 1976, 63 (3): 581-592. 10.1093/biomet/63.3.581.

Graham JW, Olchowski AE, Gilreath TD: How many imputations are really needed? Some practical clarifications of multiple imputation theory. Prev Sci. 2007, 8: 206-213. 10.1007/s11121-007-0070-9

Hedecker D, Gibbons RD: Application of random-effects pattern mixture models for missing data in longitudinal studies. Psych Methods. 1997, 2: 64-78.

Stigsby B, Taves DR: Rank-minimization for balanced assignment of subjects in clinical trials. Contemp Clin Trials. 2010, 31 (2): 147-150. 10.1016/j.cct.2009.12.001

Deyo RA, Mirza S, Martin B, Kreuter W, Goodman D, Jarvik J: Trends, major medical complications, and charges associate with surgery for lumbar spinal stenosis in older adults. JAMA. 2010, 303 (13): 1259-1265. 10.1001/jama.2010.338

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Tập 22 Số 1

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