Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial

Trials

Robert B Wallace¹  Fredric D Wolinsky¹  Lisa Z Killinger³  Maria A Hondras²  Kevin J Lyons⁵  Mark E Jones⁴  Andrew A Andresen⁴  Cynthia R Long²  Robert D Vining²  Stacie A Salsbury²  Christine M Goertz² 

[1] The University of Iowa College of Public Health, S161 CPHB, 101 River St, Iowa City, IA, 52242, USA;Palmer College of Chiropractic, Palmer Center for Chiropractic Research, 741 Brady St, Davenport, IA, 52803, USA;Department of Diagnosis and Radiology, Palmer College of Chiropractic, 1000 Brady St, Davenport, IA, 52803, USA;Genesis Quad Cities Family Medicine Residency Program, 1345 W. Central Park Ave, Davenport, IA, 52804, USA;Thomas Jefferson University Center for Collaborative Research, 720 Edison, 130 S. 9th St, Philadelphia, PA, 19107, USA

关键词: Therapy;    Low back pain;    Interprofessional relations;    Integrative medicine;    Family practice;    Electronic health records;    Professional;    Education;    Chiropractic;    Aged;   

Others  :  1094933
DOI  :  10.1186/1745-6215-14-18

 received in 2012-07-18, accepted in 2013-01-03,  发布年份 2013

【 摘 要 】

Background

Low back pain is a prevalent and debilitating condition that affects the health and quality of life of older adults. Older people often consult primary care physicians about back pain, with many also receiving concurrent care from complementary and alternative medicine providers, most commonly doctors of chiropractic. However, a collaborative model of treatment coordination between these two provider groups has yet to be tested. The primary aim of the Collaborative Care for Older Adults Clinical Trial is to develop and evaluate the clinical effectiveness and feasibility of a patient-centered, collaborative care model with family medicine physicians and doctors of chiropractic for the treatment of low back pain in older adults.

Methods/design

This pragmatic, pilot randomized controlled trial will enroll 120 participants, age 65 years or older with subacute or chronic low back pain lasting at least one month, from a community-based sample in the Quad-Cities, Iowa/Illinois, USA. Eligible participants are allocated in a 1:1:1 ratio to receive 12 weeks of medical care, concurrent medical and chiropractic care, or collaborative medical and chiropractic care. Primary outcomes are self-rated back pain and disability. Secondary outcomes include general and functional health status, symptom bothersomeness, expectations for treatment effectiveness and improvement, fear avoidance behaviors, depression, anxiety, satisfaction, medication use and health care utilization. Treatment safety and adverse events also are monitored. Participant-rated outcome measures are collected via self-reported questionnaires and computer-assisted telephone interviews at baseline, and at 4, 8, 12, 24, 36 and 52 weeks post-randomization. Provider-rated expectations for treatment effectiveness and participant improvement also are evaluated. Process outcomes are assessed through qualitative interviews with study participants and research clinicians, chart audits of progress notes and content analysis of clinical trial notes.

Discussion

This pragmatic, pilot randomized controlled trial uses a mixed method approach to evaluate the clinical effectiveness, feasibility, and participant and provider perceptions of collaborative care between medical doctors and doctors of chiropractic in the treatment of older adults with low back pain.

Trial registration

This trial registered in ClinicalTrials.gov on 04 March 2011 with the ID number of NCT01312233.

【 授权许可】

   
2013 Goertz et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Strine TW, Hootman JM: US national prevalence and correlates of low back and neck pain among adults. Arthritis Rheum 2007, 57:656-665.
• [2]Deyo RA, Mirza SK, Martin BI: Back pain prevalence and visit rates: estimates from U.S. national surveys, 2002. Spine (Phila Pa 1976) 2006, 31:2724-2727.
• [3]Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F, National Arthritis Data Workgroup: Estimates of the prevalence of arthritis and other rheumatic conditions in the United States: Part II. Arthritis Rheum 2008, 58:26-35.
• [4]Hestbaek L, Leboeuf-Yde C, Manniche C: Low back pain: what is the long-term course? A review of studies of general patient populations. Eur Spine J 2003, 12:149-165.
• [5]Dunn KM, Croft PR: Epidemiology and natural history of low back pain. Eura Medicophys 2001, 40:9-13.
• [6]Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS: The rising prevalence of chronic low back pain. Arch Intern Med 2009, 169:251-258.
• [7]Martin BI, Deyo RA, Mirza SK, Turner JA, Comstock BA, Hollingworth W, Sullivan SD: Expenditures and health status among adults with back and neck problems. JAMA 2008, 299:656-664.
• [8]Fejer R, Leboeuf-Yde C: Does back and neck pain become more common as you get older? A systematic literature review. Chiropr Man Therap 2012, 20:24. BioMed Central Full Text
• [9]Hicks GE, Gaines JM, Shardell M, Simonsick EM: Associations of back and leg pain with health status and functional capacity of older adults: findings from the retirement community back pain study. Arthritis Rheum 2008, 59:1306-1313.
• [10]Rudy TE, Weiner DK, Lieber SJ, Slaboda J, Boston JR: The impact of chronic low back pain on older adults: a comparative study of patients and controls. Pain 2007, 131:293-301.
• [11]Deyo RA, Weinstein JN: Low back pain. N Engl J Med 2001, 344:363-370.
• [12]Luo X, Pietrobon R, Sun SX, Liu GG, Hey L: Estimates and patterns of direct health care expenditures among individuals with back pain in the United States. Spine (Phila Pa 1976) 2004, 29:79-86.
• [13]Lind BK, Lafferty WE, Tyree PT, Sherman KJ, Deyo RA, Cherkin DC: The role of alternative medical providers for the outpatient treatment of insured patients with back pain. Spine (Phila Pa 1976) 2005, 30:1454-1459.
• [14]Barnes PM, Bloom B, Nahin RL: Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Report 2008, 1-23. http://www.ncbi.nlm.nih.gov/pubmed/19361005 webcite
• [15]Wolinsky FD, Liu L, Miller TR, Geweke JF, Cook EA, Greene BR, Wright KB, Chrischilles EA, Pavlik CE, An H, Ohsfeldt RL, Richardson KK, Rosenthal GE, Wallace RB: The use of chiropractors by older adults in the United States. Chiropr Osteopat 2007, 15:12. BioMed Central Full Text
• [16]Dougherty P, Hawk C, Weiner D, Gleberzon B, Andrew K, Killinger L: The role of chiropractic care in older adults. Chiropr Man Therap 2012, 20:3. BioMed Central Full Text
• [17]Carey TS, Freburger JK, Holmes GM, Castel L, Darter J, Agans R, Kalsbeek W, Jackman A: A long way to go: practice patterns and evidence in chronic low back pain care. Spine (Phila Pa 1976) 2009, 34:718-724.
• [18]Stevens L, Duarte H, Park J: Promising implications for integrative medicine for back pain: a profile of a Korean hospital. J Altern Complement Med 2007, 13:481-484.
• [19]Eisenberg DM, Post DE, Davis RB, Connelly MT, Legedza AT, Hrbek AL, Prosser LA, Buring JE, Inui TS, Cherkin DC: Addition of choice of complementary therapies to usual care for acute low back pain: a randomized controlled trial. Spine (Phila Pa 1976) 2007, 32:151-158.
• [20]Wolsko PM, Eisenberg DM, Davis RB, Kessler R, Phillips RS: Patterns and perceptions of care for treatment of back and neck pain: results of a national survey. Spine (Phila Pa 1976) 2003, 28:292-297.
• [21]Cherkin DC, MacCornack FA: Patient evaluations of low back pain care from family physicians and chiropractors. West J Med 1989, 150:351-355.
• [22]Haas M, Groupp E, Muench J, Kraemer D, Brummel-Smith K, Sharma R, Ganger B, Attwood M, Fairweather A: Chronic disease self-management program for low back pain in the elderly. J Manipulative Physiol Ther 2005, 28:228-237.
• [23]Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, Sowden G, Vohora K, Hay EM: Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet 2011, 378:1560-1571.
• [24]Hawk C, Long CR, Boulanger KT, Morschhauser E, Fuhr AW: Chiropractic care for patients aged 55 years and older: report from a practice-based research program. J Am Geriatr Soc 2000, 48:534-545.
• [25]Hawk C, Cambron J: Chiropractic care for older adults: effects on balance, dizziness, and chronic pain. J Manipulative Physiol Ther 2009, 32:431-437.
• [26]Hawk C, Cambron JA, Pfefer MT: Pilot study of the effect of a limited and extended course of chiropractic care on balance, chronic pain, and dizziness in older adults. J Manipulative Physiol Ther 2009, 32:438-447.
• [27]Hondras MA, Long CR, Cao Y, Rowell RM, Meeker WC: A randomized controlled trial comparing 2 types of spinal manipulation and minimal conservative medical care for adults 55 years and older with subacute or chronic low back pain. J Manipulative Physiol Ther 2009, 32:330-343.
• [28]Maiers MJ, Hartvigsen J, Schulz C, Schulz K, Evans RL, Bronfort G: Chiropractic and exercise for seniors with low back pain or neck pain: the design of two randomized clinical trials. BMC Musculoskelet Disord 2007, 8:94. BioMed Central Full Text
• [29]Coulter ID, Singh BB, Riley D, Der-Martirosian C: Interprofessional referral patterns in an integrated medical system. J Manipulative Physiol Ther 2005, 28:170-174.
• [30]Greene BR, Smith M, Allareddy V, Haas M: Referral patterns and attitudes of primary care physicians towards chiropractors. BMC Complement Altern Med 2006, 6:5. BioMed Central Full Text
• [31]Smith M, Greene BR, Haas M, Allareddy V: Intra-professional and inter-professional referral patterns of chiropractors. Chiropr Osteopat 2006, 14:12. BioMed Central Full Text
• [32]Weigel PA, Hockenberry JM, Bentler SE, Kaskie B, Wolinsky FD: Chiropractic episodes and the co-occurrence of chiropractic and health services use among older Medicare beneficiaries. J Manipulative Physiol Ther 2012, 35:168-175.
• [33]Knauer SR, Freburger JK, Carey TS: Chronic low back pain among older adults: a population-based perspective. J Aging Health 2010, 22:1213-1234.
• [34]Arcury TA, Grzywacz JG, Neiberg RH, Lang W, Nguyen H, Altizer K, Stoller EP, Bell RA, Quandt SA: Older adults’ self-management of daily symptoms: complementary therapies, self-care, and medical care. J Aging Health 2012, 24:569-597.
• [35]Hsiao AF, Ryan GW, Hays RD, Coulter ID, Andersen RM, Wenger NS: Variations in provider conceptions of integrative medicine. Soc Sci Med 2006, 62:2973-2987.
• [36]Arcury TA, Bell RA, Altizer KP, Grzywacz JG, Sandberg JC, Quandt SA: Attitudes of older adults regarding disclosure of complementary therapy use to physicians. J Appl Gerontol 2012. Epub before print
• [37]Kaboli PJ, Doebbeling BN, Saag KG, Rosenthal GE: Use of complementary and alternative medicine by older patients with arthritis: a population-based study. Arthritis Rheum 2001, 45:398-403.
• [38]Sleath B, Rubin RH, Campbell W, Gwyther L, Clark T: Ethnicity and physician-older patient communication about alternative therapies. J Altern Complement Med 2001, 7:329-335.
• [39]Greene BR, Smith M, Haas M, Allareddy V: How often are physicians and chiropractors provided with patient information when accepting referrals? J Ambul Care Manage 2007, 30:344-346.
• [40]Hsiao AF, Hays RD, Ryan GW, Coulter ID, Andersen RM, Hardy ML, Diehl DL, Hui KK, Wenger NS: A self-report measure of clinicians’ orientation toward integrative medicine. Health Serv Res 2005, 40:1553-1569.
• [41]Boon HS, Mior SA, Barnsley J, Ashbury FD, Haig R: The difference between integration and collaboration in patient care: results from key informant interviews working in multiprofessional health care teams. J Manipulative Physiol Ther 2009, 32:715-722.
• [42]Boon H, Verhoef M, O’Hara D, Findlay B: From parallel practice to integrative health care: a conceptual framework. BMC Health Serv Res 2004, 4:15. BioMed Central Full Text
• [43]Hurwitz EL, Morgenstern H, Harber P, Kominski GF, Belin TR, Yu F, Adams AH, University of California-Los Angeles: A randomized trial of medical care with and without physical therapy and chiropractic care with and without physical modalities for patients with low-back pain: 6-month follow-up outcomes from the UCLA Low-Back Pain Study. Spine (Phila Pa 1976) 2002, 27:2193-2204.
• [44]Hurwitz EL, Morgenstern H, Kominski GF, Yu F, Chiang LM: A randomized trial of chiropractic and medical care for patients with low back pain: eighteen-month follow-up outcomes from the UCLA low back pain study. Spine (Phila Pa 1976) 2006, 31:611-621.
• [45]Kopansky-Giles D, Vernon H, Steiman I, Tibbles A, Decina P, Goldin J, Kelly M: Collaborative community-based teaching clinics at the Canadian Memorial Chiropractic College: addressing the needs of local poor communities. J Manipulative Physiol Ther 2007, 30:558-565.
• [46]Garner MJ, Birmingham M, Aker P, Moher D, Balon J, Keenan D, Manga P: Developing integrative primary healthcare delivery: adding a chiropractor to the team. Explore (NY) 2008, 4:18-24.
• [47]Branson RA: Hospital-based chiropractic integration within a large private hospital system in Minnesota: a 10-year example. J Manipulative Physiol Ther 2009, 32:740-748.
• [48]Westrom KK, Maiers MJ, Evans RL, Bronfort G: Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach. Trials 2010, 11:24. BioMed Central Full Text
• [49]American Geriatrics Society: The management of chronic pain in older persons: AGS Panel on Chronic Pain in Older Persons. J Am Geriatr Soc 1998, 46:635-651.
• [50]Hawk C, Schneider M, Dougherty P, Gleberzon BJ, Killinger LZ: Best practices recommendations for chiropractic care for older adults: results of a consensus process. J Manipulative Physiol Ther 2010, 33:464-473.
• [51]Chou R, Qaseem A, Snow V, Casey D, Cross JT Jr, Shekelle P, Owens DK: 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.
• [52]Khorsan R, Coulter ID, Hawk C, Choate CG: Measures in chiropractic research: choosing patient-based outcome assessments. J Manipulative Physiol Ther 2008, 31:355-375.
• [53]NIH Office of Extramural Research: Protecting Human Research Participants. Bethesda, MD: NIH Office of Extramural Research; 2012. www.soc.iastate.edu/sapp/IRBCourse.pdf
• [54]MacPherson H: Pragmatic clinical trials. Complement Ther Med 2004, 12:136-140.
• [55]Godwin M, Ruhland L, Casson I, MacDonald S, Delva D, Birtwhistle R, Lam M, Seguin R: Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity. BMC Med Res Methodol 2003, 3:28. BioMed Central Full Text
• [56]Luce BR, Kramer JM, Goodman SN, Connor JT, Tunis S, Whicher D, Schwartz JS: Rethinking randomized clinical trials for comparative effectiveness research: the need for transformational change. Ann Intern Med 2009, 151:206-209.
• [57]Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W: Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain 2004, 8:283-291.
• [58]Roland M, Fairbank J: The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine (Phila Pa 1976) 2000, 25:3115-3124.
• [59]US Census Bureau: State and County Quick Facts. Washington, DC, USA: Census Bureau; 2012.
• [60]Podsiadlo D, Richardson S: The timed “Up & Go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc 1991, 39:142-148.
• [61]Spitzer WO, LeBlanc FE, Dupuis M, et al.: Scientific approach to the assessment and management of activity-related spinal disorders. A monograph for clinicians. Report of the Quebec Task Force on Spinal Disorders. Spine (Phila Pa 1976) 1987, 12(Suppl 17):S1-S59.
• [62]Wilder DG, Vining RD, Pohlman KA, Meeker WC, Xia T, Devocht JW, Gudavalli RM, Long CR, Owens EF, Goertz CM: Effect of spinal manipulation on sensorimotor functions in back pain patients: study protocol for a randomised controlled trial. Trials 2011, 12:161. BioMed Central Full Text
• [63]Schulz C, Hondras M, Evans R, Gudavalli M, Long C, Owens E, Wilder D, Bronfort G: Chiropractic and self-care for back-related leg pain: design of a randomized clinical trial. Chiropractic Manual Ther 2011, 19:1-14. BioMed Central Full Text
• [64]Globe GA, Morris CE, Whalen WM, Farabaugh RJ, Hawk C: Chiropractic management of low back disorders: report from a consensus process. J Manipulative Physiol Ther 2008, 31:651-658.
• [65]Practice Management Information Corporation (PMIC): International Classification of Diseases, Ninth revision (ICD-9). Los Angeles, CA: PMIC; 2010.
• [66]Hondras MA, Long CR, Haan AG, Spencer LB, Meeker WC: Recruitment and enrollment for the simultaneous conduct of 2 randomized controlled trials for patients with subacute and chronic low back pain at a CAM research center. J Altern Complement Med 2008, 14:983-992.
• [67]Kroenke K, Spitzer R, Williams J: The PHQ-9: validation of a brief depression severity measure. J Gen Intern Med 2001, 16:606-613.
• [68]Spitzer RL, Kroenke K, Williams JB, Lowe B: A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med 2006, 166:1092-1097.
• [69]National Institute on Alcohol Abuse and Alcoholism: A Pocket Guide for Alcohol Screening and Brief Intervention. Rockville, MD: NIAAA; 2005.
• [70]Yudko E, Lozhkina O, Fouts A: A comprehensive review of the psychometric properties of the Drug Abuse Screening Test. J Subst Abuse Treat 2007, 32:189-198.
• [71]Kanis J, McCloskey E, Johansson H, Oden A, Strom O, Borgstrom F: Development and use of FRAX in osteoporosis. Osteoporosis Int 2010, 21:S407-S413.
• [72]Bussieres A, Taylor J, Peterson C: Diagnostic imaging practice guidelines for musculoskeletal complaints in adults: an evidence-based approach, part 3: spinal disorders. J Manipulative Physiol Ther 2008, 31:33-88.
• [73]Gudavalli M, Cambron J, McGregor M, Jedlicka J, Keenum M, Ghanayem A, Patwardhan A: A randomized clinical trial and subgroup analysis to compare flexion-distraction with active exercise for chronic low back pain. Eur Spine J 2006, 15:1070-1082.
• [74]Cambron JA, Gudavalli MR, Hedeker D, McGregor M, Jedlicka J, Keenum M, Ghanayem AJ, Patwardhan AG, Furner SE: One-year follow-up of a randomized clinical trial comparing flexion distraction with an exercise program for chronic low-back pain. J Altern Complemen Med 2006, 12:659-668.
• [75]Murphy D, Hurwitz E, Gregory A, Clary R: A non-surgical approach to the management of lumbar spinal stenosis: A prospective observational cohort study. BMC Musculoskelet Disord 2006, 7:16. BioMed Central Full Text
• [76]Evans DW, Lucas N: What is manipulation? A reappraisal. Man Ther 2010, 15:286-291.
• [77]Evans DW: Mechanisms and effects of spinal high-velocity, low-amplitude thrust manipulation: previous theories. J Manipulative Physiol Ther 2002, 25:251-262.
• [78]Keller TS, Colloca CJ, Fuhr AW: Validation of the force and frequency characteristics of the activator adjusting instrument: effectiveness a mechanical impedence measurement tool. J Manipulative Physiol Ther 1999, 22:75-86.
• [79]Bronfort G, Haas M, Evans R, Kawchuk G, Dagenais S: Evidence-informed management of chronic low back pain with spinal manipulation and mobilization. Spine J 2008, 8:213-225.
• [80]Cooperstein R, Perle SM, Gatterman MI, Lantz C, Schneider MJ: Chiropractic technique procedures for specific low back conditions: characterizing the literature. J Manipulative Physiol Ther 2001, 24:407-424.
• [81]Gleberzon BJ: Chiropractic care of the older person: developing an evidence-based approach. J Can Chiropr Assoc 2001, 45:156-171.
• [82]Liebenson C: Rehabilitation of the Spine: a Practitioner’s Manual. Philadelphia, PA: Lippincott Williams & Wilkins; 2007.
• [83]Leininger B, Bronfort G, Evans R, Reiter T: Spinal manipulation or mobilization for radiculopathy: a systematic review. Phys Med Rehabil Clin N Am 2011, 22:105.
• [84]Bronfort G, Haas M, Evans R, Leininger B, Triano J: Effectiveness of manual therapies: the UK evidence report. Chiropr Osteopat 2010, 18:3. BioMed Central Full Text
• [85]Murphy DR, Hurwitz EL, McGovern EE: A nonsurgical approach to the management of patients with lumbar radiculopathy secondary to herniated disk: a prospective observational cohort study with follow-up. J Manipulative Physiol Ther 2009, 32:723-733.
• [86]Interprofessional Education Collaboration Expert Panel: Core Competencies for Interprofessional Collaborative Practice: Report of an Expert Panel. Washington, DC: Interprofessional Education Collaborative; 2011.
• [87]Goertz C, Lyons SS, Andresen A, Hondras M, Jones M, Killinger LZ, Long C, Lyons K, Mulhausen P, Vining R: Collaborative Care for Older Adults (COCOA), Palmer College of Chiropractic. J Allied Health 2010, 39:e135-e136.
• [88]Coulter I, Adams A, Coggan P, Wilkes M, Gonyea M: A comparative study of chiropractic and medical education. Altern Ther Health Med 1998, 4:64-75.
• [89]Killinger LZ: Chiropractic and geriatrics: a review of the training, role, and scope of chiropractic in caring for aging patients. Clin Geriatr Med 2004, 20:223-235.
• [90]Riva J, Lam J, Stanford E, Moore A, Endicott A, Krawchenko I: Interprofessional education through shadowing experiences in multi-disciplinary clinical settings. Chiropr Osteopat 2010, 18:31. BioMed Central Full Text
• [91]Institute of Medicine, Committee on Improving the Patient Record: The Computer-Based Patient Record: An Essential Technology for Health Care, Revised. 2nd edition. Edited by Dick RS, Steen EB, Detmer DE. Washington, DC: National Academies Press; 1997.
• [92]Vohra S, Feldman K, Johnston B, Waters K, Boon H: Integrating complementary and alternative medicine into academic medical centers: experience and perceptions of nine leading centers in North America. BMC Health Serv Res 2005, 5:78. BioMed Central Full Text
• [93]Shaw WS, Pransky G, Roter DL, Winters T, Tveito TH, Larson SM: The effects of patient-provider communication on 3-month recovery from acute low back pain. J Am Board Fam Med 2011, 24:16-25.
• [94]Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole RM: Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001, 94:149-158.
• [95]Childs JD, Piva SR, Fritz JM: Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976) 2005, 30:1331-1334.
• [96]van der Roer N, Ostelo RW, Bekkering GE, van Tulder MW, de Vet HC: Minimal clinically important change for pain intensity, functional status, and general health status in patients with nonspecific low back pain. Spine (Phila Pa 1976) 2006, 31:578-582.
• [97]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 (Phila Pa 1976) 1983, 8:141-144.
• [98]Roland M, Morris R: A study of the natural history of low-back pain. Part II: development of guidelines for trials of treatment in primary care. Spine (Phila Pa 1976) 1983, 8:145-150.
• [99]Stratford PW, Binkley JM, Riddle DL: Development and initial validation of the back pain functional scale. Spine (Phila Pa 1976) 2000, 25:2095-2102.
• [100]Deyo RA, Cherkin D, Conrad D: The back pain outcome assessment team. Health Serv Res 1990, 25:733-737.
• [101]Bombardier C, Hayden J, Beaton DE: Minimal clinically important difference. Low back pain: outcome measures. J Rheumatol 2001, 28:431-438.
• [102]Plouvier S, Renahy E, Chastang JF, Bonenfant S, Leclerc A: Biomechanical strains and low back disorders: quantifying the effects of the number of years of exposure on various types of pain. Occup Environ Med 2008, 65:268-274.
• [103]Kazis LE, Miller DR, Clark J, Skinner K, Lee A, Rogers W, Spiro A III, Payne S, Fincke G, Selim A, Linzer M: Health-related quality of life in patients served by the Department of Veterans Affairs: results from the Veterans Health Study. Arch Intern Med 1998, 158:626-632.
• [104]Kazis LE, Selim A, Rogers W, Ren XS, Lee A, Miller DR: Dissemination of methods and results from the veterans health study: final comments and implications for future monitoring strategies within and outside the veterans healthcare system. J Ambul Care Manage 2006, 29:310-319.
• [105]Jacob T, Baras M, Zeev A, Epstein L: Low back pain: reliability of a set of pain measurement tools. Arch Phys Med Rehabil 2001, 82:735-742.
• [106]George SZ, Fritz JM, McNeil DW: Fear-avoidance beliefs as measured by the fear-avoidance beliefs questionnaire: change in fear-avoidance beliefs questionnaire is predictive of change in self-report of disability and pain intensity for patients with acute low back pain. Clin J Pain 2006, 22:197-203.
• [107]George SZ, Fritz JM, Childs JD: Investigation of elevated fear-avoidance beliefs for patients with low back pain: a secondary analysis involving patients enrolled in physical therapy clinical trials. J Orthop Sports Phys Ther 2008, 38:50-58.
• [108]Patrick DL, Deyo RA, Atlas SJ, Singer DE, Chapin A, Keller RB: Assessing health-related quality of life in patients with sciatica. Spine (Phila Pa 1976) 1995, 20:1899-1908.
• [109]Lowe B, Ututzer J, Callahan CM, Perkins AJ, Kroenke K: Monitoring depression treatment outcomes with the Patient Health Questionnaire-9. Med Care 2004, 42:1194-1201.
• [110]Shumway-Cook A, Brauer S, Woollacott M: Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther 2000, 80:896-903.
• [111]Cherkin DC, Deyo RA, Street JH, Barlow W: Predicting poor outcomes for back pain seen in primary care using patients’ own criteria. Spine (Phila Pa 1976) 1996, 21:2900-2907.
• [112]Kalauokalani D, Cherkin DC, Sherman KJ, Koepsell TD, Deyo RA: Lessons from a trial of acupuncture and massage for low back pain: patient expectations and treatment effects. Spine (Phila Pa 1976) 2001, 26:1418-1424.
• [113]Allegretti A, Borkan J, Reis S, Griffiths F: Paired interviews of shared experiences around chronic low back pain: classic mismatch between patients and their doctors. Fam Pract 2010, 27:676-683.
• [114]Crabtree BF, Miller WL: Doing Qualitative Research. 2nd edition. Thousand Oaks, CA: Sage Publications, Inc.; 1999.
• [115]National Institutes of Health: Guidance on Reporting Adverse Events to Institutional Review Boards for NIH-supported Multicenter Clinical Trials. Bethesda, MD: National Institutes of Health; 1999.
• [116]Thomas EJ, Petersen LA: Measuring errors and adverse events in health care. J Gen Intern Med 2003, 18:61-67.
• [117]Denzin NK, Lincoln YS: Handbook of Qualitative Research. 2nd edition. Thousand Oaks, CA: Sage Publications, Inc.; 2000.