Yoga versus education for Veterans with chronic low back pain: study protocol for a randomized controlled trial

Robert B Saper, Chelsey M Lemaster, A Rani Elwy, Ruth Paris, Patricia M Herman, Dorothy N Plumb, Karen J Sherman, Erik J Groessl, Susan Lynch, Shihwe Wang, Janice Weinberg, Robert B Saper, Chelsey M Lemaster, A Rani Elwy, Ruth Paris, Patricia M Herman, Dorothy N Plumb, Karen J Sherman, Erik J Groessl, Susan Lynch, Shihwe Wang, Janice Weinberg

Abstract

Background: Chronic low back pain is the most frequent pain condition in Veterans and causes substantial suffering, decreased functional capacity, and lower quality of life. Symptoms of post-traumatic stress, depression, and mild traumatic brain injury are highly prevalent in Veterans with back pain. Yoga for low back pain has been demonstrated to be effective for civilians in randomized controlled trials. However, it is unknown if results from previously published trials generalize to military populations.

Methods/design: This study is a parallel randomized controlled trial comparing yoga to education for 120 Veterans with chronic low back pain. Participants are Veterans ≥18 years old with low back pain present on at least half the days in the past six months and a self-reported average pain intensity in the previous week of ≥4 on a 0-10 scale. The 24-week study has an initial 12-week intervention period, where participants are randomized equally into (1) a standardized weekly group yoga class with home practice or (2) education delivered with a self-care book. Primary outcome measures are change at 12 weeks in low back pain intensity measured by the Defense and Veterans Pain Rating Scale (0-10) and back-related function using the 23-point Roland Morris Disability Questionnaire. In the subsequent 12-week follow-up period, yoga participants are encouraged to continue home yoga practice and education participants continue following recommendations from the book. Qualitative interviews with Veterans in the yoga group and their partners explore the impact of chronic low back pain and yoga on family relationships. We also assess cost-effectiveness from three perspectives: the Veteran, the Veterans Health Administration, and society using electronic medical records, self-reported cost data, and study records.

Discussion: This study will help determine if yoga can become an effective treatment for Veterans with chronic low back pain and psychological comorbidities.

Trial registration: ClinicalTrials.gov: NCT02224183.

Keywords: Cost-effectiveness; Low back pain; Military families; Randomized controlled trial; Veterans; Yoga.

Figures

Fig. 1
Fig. 1
Study flow diagram. The study will enroll and randomize 120 Veterans equally into yoga and education groups. Qualitative interviews will take place with 20 Veterans in the yoga arm and their partners before and after the 12-week intervention period. Interventions are followed by a 12-week follow-up period. Data collection takes place at baseline (prior to randomization), 6 weeks, 12 weeks, and 24 weeks
Fig. 2
Fig. 2
Defense and Veterans Pain Rating Scale. The Defense and Veterans Pain Rating Scale (DVPRS), developed by the Army Surgeon General Pain Management Task Force, is a validated patient-reported pain assessment tool [69, 70]. This integrated graphic tool incorporates a numerical rating scale, descriptors for each numerical rating, “traffic light” color-coding, and a faces scale

References

    1. Lew HL, Otis JD, Tun C, Kerns RD, Clark ME, Cifu DX. Prevalence of chronic pain, posttraumatic stress disorder, and persistent postconcussive symptoms in OIF/OEF Veterans: polytrauma clinical triad. J Rehabil Res Dev. 2009;46:697–702. doi: 10.1682/JRRD.2009.01.0006.
    1. Kerns RD. Transforming pain care in the United States Department of Veterans Affairs: the role of the VA Pain Research Network. Clin J Pain. 2013;29:93–4. doi: 10.1097/AJP.0b013e31826b6ce8.
    1. Institute of Medicine . Relieving pain in America: a blueprint for transforming prevention, care, education, and research. Washington DC: National Academies Press; 2011.
    1. Haskell SG, Brandt CA, Krebs EE, Skanderson M, Kerns RD, Goulet JL. Pain among Veterans of Operations Enduring Freedom and Iraqi Freedom: do women and men differ? Pain Med. 2009;10:1167–73. doi: 10.1111/j.1526-4637.2009.00714.x.
    1. Kirsch B, Berdine H, Zablotsky D, et al. Implementation of a pain management strategy: identifying pain as the fifth vital sign. Vet Health Syst J. 2000:49-59
    1. Seal KH, Cohen G, Waldrop A, Cohen BE, Maguen S, Ren L. Substance use disorders in Iraq and Afghanistan Veterans in VA healthcare, 2001-2010: implications for screening, diagnosis and treatment. Drug Alcohol Depend. 2011;116:93–101. doi: 10.1016/j.drugalcdep.2010.11.027.
    1. Barlas FM, Higgins WB, Pflieger JC, Diecker K. 2011 Department of Defense health related behaviors survey of active duty military personnel. Fairfax: ICF International; 2013.
    1. Guo HR, Tanaka S, Halperin WE, Cameron LL. Back pain prevalence in US industry and estimates of lost workdays. Am J Public Health. 1999;89:1029–35. doi: 10.2105/AJPH.89.7.1029.
    1. Burstrom K, Johannesson M, Diderichsen F. Swedish population health-related quality of life results using the EQ-5D. Qual Life Res. 2001;10:621–35. doi: 10.1023/A:1013171831202.
    1. Kosinski MR, Schein JR, Vallow SM, Ascher S, Harte C, Shikiar R, et al. An observational study of health-related quality of life and pain outcomes in chronic low back pain patients treated with fentanyl transdermal system. Curr Med Res Opin. 2005;21:849–62. doi: 10.1185/030079905X46377.
    1. Lincoln AE, Smith GS, Amoroso PJ, Bell NS. The natural history and risk factors of musculoskeletal conditions resulting in disability among US Army personnel. Work. 2002;18:99–113.
    1. Galloway KT, Buckenmaier CC, III, Polomano RC. Special report – war on pain: understanding pain and pain mechanisms. Am Nurse Today. 2011;6(9):3–7.
    1. Otis JD, Keane TM, Kerns RD. An examination of the relationship between chronic pain and post-traumatic stress disorder. J Rehabil Res Dev. 2003;40:397–405. doi: 10.1682/JRRD.2003.09.0397.
    1. McWilliams LA, Cox BJ, Enns MW. Mood and anxiety disorders associated with chronic pain: an examination in a nationally representative sample. Pain. 2003;106:127–33. doi: 10.1016/S0304-3959(03)00301-4.
    1. Haskell SG, Ning Y, Krebs E, Goulet J, Mattocks K, Kerns R, et al. Prevalence of painful musculoskeletal conditions in female and male Veterans in 7 years after return from deployment in Operation Enduring Freedom/Operation Iraqi Freedom. Clin J Pain. 2012;28:163–7. doi: 10.1097/AJP.0b013e318223d951.
    1. Jensen MP, Romano JM, Turner JA, Good AB, Wald LH. Patient beliefs predict patient functioning: further support for a cognitive-behavioural model of chronic pain. Pain. 1999;81:95–104. doi: 10.1016/S0304-3959(99)00005-6.
    1. Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993;52:157–68. doi: 10.1016/0304-3959(93)90127-B.
    1. Morasco BJ, Corson K, Turk DC, Dobscha SK. Association between substance use disorder status and pain-related function following 12 months of treatment in primary care patients with musculoskeletal pain. J Pain. 2011;12:352–9. doi: 10.1016/j.jpain.2010.07.010.
    1. Nampiaparampil DE. Prevalence of chronic pain after traumatic brain injury: a systematic review. JAMA. 2008;300:711–9. doi: 10.1001/jama.300.6.711.
    1. Kar N. Cognitive behavioral therapy for the treatment of post-traumatic stress disorder: a review. Neuropsychiatr Dis Treat. 2011;7:167–81. doi: 10.2147/NDT.S10389.
    1. Institute of Medicine . Returning home from Iraq and Afghanistan: assessment of readjustment needs of Veterans, service members, and their families. Washington DC: National Academies Press; 2013.
    1. Campbell P, Jordan KP, Dunn KM. The role of relationship quality and perceived partner responses with pain and disability in those with back pain. Pain Med. 2012;13:204–14. doi: 10.1111/j.1526-4637.2011.01298.x.
    1. Leonard MT, Cano A, Johansen AB. Chronic pain in a couples context: a review and integration of theoretical models and empirical evidence. J Pain. 2006;7:377–90. doi: 10.1016/j.jpain.2006.01.442.
    1. MacGregor AJ, Corson KS, Larson GE, Shaffer RA, Dougherty AL, Galarneau MR, et al. Injury-specific predictors of posttraumatic stress disorder. Injury. 2009;40:1004–10. doi: 10.1016/j.injury.2009.04.006.
    1. Koren D, Norman D, Cohen A, Berman J, Klein EM. Increased PTSD risk with combat-related injury: a matched comparison study of injured and uninjured soldiers experiencing the same combat events. Am J Psychiatry. 2005;162:276–82. doi: 10.1176/appi.ajp.162.2.276.
    1. Paris R, DeVoe ER, Ross AM, Acker ML. When a parent goes to war: effects of parental deployment on very young children and implications for intervention. Am J Orthopsychiatry. 2010;80:610–8. doi: 10.1111/j.1939-0025.2010.01066.x.
    1. Cozza SJ, Guimond JM, McKibben JB, Chun RS, Arata-Maiers TL, Schneider B, et al. Combat-injured service members and their families: the relationship of child distress and spouse-perceived family distress and disruption. J Trauma Stress. 2010;23:112–5.
    1. Saper RB, Eisenberg DM, Davis RB, Culpepper L, Phillips RS. Prevalence and patterns of adult yoga use in the United States: results of a national survey. Altern Ther Health Med. 2004;10:44–9.
    1. Peregoy JA, Clarke TC, Jones LI, Stussman BJ, Nahin RL. Regional variation in use of complementary health approaches by U.S. adults. NCHS Data Brief. 2014;146:1–8.
    1. Birdee GS, Legedza AT, Saper RB, Bertisch SM, Eisenberg DM, Phillips RS. Characteristics of yoga users: results of a national survey. J Gen Intern Med. 2008;23:1653–8. doi: 10.1007/s11606-008-0735-5.
    1. Barnes PM, Bloom B, Nahin RL. Complementary and alternative medicine use among adults and children: United States, 2007. Nat Health Stat Report. 2008;12:1–23.
    1. Sherman KJ, Cherkin DC, Erro J, Miglioretti DL, Deyo RA. Comparing yoga, exercise, and a self-care book for chronic low back pain: a randomized, controlled trial. Ann Intern Med. 2005;143:849–56. doi: 10.7326/0003-4819-143-12-200512200-00003.
    1. Chou R, Huffman LH. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007;147:492–504. doi: 10.7326/0003-4819-147-7-200710020-00007.
    1. Williams K, Abildso C, Steinberg L, Doyle E, Epstein B, Smith D, et al. Evaluation of the effectiveness and efficacy of Iyengar yoga therapy on chronic low back pain. Spine. 2009;34:2066–76. doi: 10.1097/BRS.0b013e3181b315cc.
    1. Sherman KJ, Cherkin DC, Wellman RD, Cook AJ, Hawkes RJ, Delaney K, et al. A randomized trial comparing yoga, stretching, and a self-care book for chronic low back pain. Arch Intern Med. 2011;171:2019–26. doi: 10.1001/archinternmed.2011.524.
    1. Tilbrook HE, Cox H, Hewitt CE, Kang'ombe AR, Chuang LH, Jayakody S, et al. Yoga for chronic low back pain: a randomized trial. Ann Intern Med. 2011;155(9):569–78. doi: 10.7326/0003-4819-155-9-201111010-00003.
    1. Saper RB, Boah AR, Keosaian J, Cerrada C, Weinberg J, Sherman KJ. Comparing once- versus twice-weekly yoga classes for chronic low back pain in predominantly low income minorities: a randomized dosing trial. Evid Based Complement Alternat Med. 2013;2013:658030. doi: 10.1155/2013/658030.
    1. Galantino ML, Bzdewka TM, Eissler-Russo JL, Holbrook ML, Mogck EP, Geigle P, et al. The impact of modified Hatha yoga on chronic low back pain: a pilot study. Altern Ther Health Med. 2004;10:56–9.
    1. Williams KA, Petronis J, Smith D, Goodrich D, Wu J, Ravi N, et al. Effect of Iyengar yoga therapy for chronic low back pain. Pain. 2005;115:107–17. doi: 10.1016/j.pain.2005.02.016.
    1. Saper RB, Sherman KJ, Cullum-Dugan D, Davis RB, Phillips RS, Culpepper L. Yoga for chronic low back pain in a predominantly minority population: a pilot randomized controlled trial. Altern Ther Health Med. 2009;15:18–27.
    1. Cox H, Tilbrook H, Aplin J, Semlyen A, Torgerson D, Trewhela A, et al. A randomised controlled trial of yoga for the treatment of chronic low back pain: results of a pilot study. Complement Ther Clin Pract. 2010;16:187–93. doi: 10.1016/j.ctcp.2010.05.007.
    1. Tekur P, Nagarathna R, Chametcha S, Hankey A, Nagendra HR. A comprehensive yoga programs improves pain, anxiety and depression in chronic low back pain patients more than exercise: an RCT. Complement Ther Med. 2012;20:107–18. doi: 10.1016/j.ctim.2011.12.009.
    1. Nambi GS, Inbasekaran D, Khuman R, Devi S, Shanmugananth, Jagannathan K. Changes in pain intensity and health related quality of life with Iyengar yoga in nonspecific chronic low back pain: a randomized controlled study. Int J Yoga. 2014;7:48–53. doi: 10.4103/0973-6131.123481.
    1. Posadzki P, Ernst E. Yoga for low back pain: a systematic review of randomized clinical trials. Clin Rheumatol. 2011;30:1257–62. doi: 10.1007/s10067-011-1764-8.
    1. Cramer H, Lauche R, Haller H, Dobos G. A systematic review and meta-analysis of yoga for low back pain. Clin J Pain. 2013;29:450–60. doi: 10.1097/AJP.0b013e31825e1492.
    1. Coeytaux RR, McDuffie J, Goode A, Cassel S, Porter WD, Sharma P, et al. Evidence map of yoga for high-impact conditions affecting Veterans. Washington, DC: Department of Veterans Affairs; 2014.
    1. Sherman KJ, Wellman RD, Cook AJ, Cherkin DC, Ceballos RM. Mediators of yoga and stretching for chronic low back pain. Evid Based Complement Alternat Med. 2013;2013:130818. doi: 10.1155/2013/130818.
    1. Balasubramaniam M, Telles S, Doraiswamy PM. Yoga on our minds: a systematic review of yoga for neuropsychiatric disorders. Front Psychiatry. 2012;3:117.
    1. Janakiramaiah N, Gangadhar BN, Naga Venkatesha Murthy PJ, Harish MG, Subbakrishna DK, Vedamurthachar A. Antidepressant efficacy of Sudarshan Kriya Yoga (SKY) in melancholia: a randomized comparison with electroconvulsive therapy (ECT) and imipramine. J Affect Disord. 2000;57:255–9. doi: 10.1016/S0165-0327(99)00079-8.
    1. Kinser PA, Bourguignon C, Whaley D, Hauenstein E, Taylor AG. Feasibility, acceptability, and effects of gentle hatha yoga for women with major depression: findings from a randomized controlled mixed-methods study. Arch Psychiatr Nurs. 2013;27:137–47. doi: 10.1016/j.apnu.2013.01.003.
    1. Michalsen A, Jeitler M, Brunnhuber S, Ludtke R, Bussing A, Musial F, et al. Iyengar yoga for distressed women: a 3-armed randomized controlled trial. Evid Based Complement Alternat Med. 2012;2012:408727. doi: 10.1155/2012/408727.
    1. Pilkington K, Kirkwood G, Rampes H, Richardson J. Yoga for depression: the research evidence. J Affect Disord. 2005;89:13–24. doi: 10.1016/j.jad.2005.08.013.
    1. Saeed SA, Antonacci DJ, Bloch RM. Exercise, yoga, and meditation for depressive and anxiety disorders. Am Fam Physician. 2010;81:981–6.
    1. Uebelacker LA, Epstein-Lubow G, Gaudiano BA, Tremont G, Battle CL, Miller IW. Hatha yoga for depression: critical review of the evidence for efficacy, plausible mechanisms of action, and directions for future research. J Psychiatr Pract. 2010;16:22–33. doi: 10.1097/01.pra.0000367775.88388.96.
    1. Woolery A, Myers H, Sternlieb B, Zeltzer L. A yoga intervention for young adults with elevated symptoms of depression. Altern Ther Health Med. 2004;10:60–3.
    1. Streeter CC, Whitfield TH, Owen L, Rein T, Karri SK, Yakhkind A, et al. Effects of yoga versus walking on mood, anxiety, and brain GABA levels: a randomized controlled MRS study. J Altern Complement Med. 2010;16:1145–52. doi: 10.1089/acm.2010.0007.
    1. Kohn M, Persson LU, Bryngelsson IL, Anderzen-Carlsson A, Westerdahl E. Medical yoga for patients with stress-related symptoms and diagnoses in primary health care: a randomized controlled trial. Evid Based Complement Alternat Med. 2013;2013:215348. doi: 10.1155/2013/215348.
    1. Michalsen A, Grossman P, Acil A, Langhorst J, Ludtke R, Esch T, et al. Rapid stress reduction and anxiolysis among distressed women as a consequence of a three-month intensive yoga program. Med Sci Monit. 2005;11:CR555–61.
    1. Vollestad J, Nielsen MB, Nielsen GH. Mindfulness- and acceptance-based interventions for anxiety disorders: a systematic review and meta-analysis. Br J Clin Psychol. 2012;51:239–60. doi: 10.1111/j.2044-8260.2011.02024.x.
    1. Afonso RF, Hachul H, Kozasa EH, de Souza OD, Goto V, Rodrigues D, et al. Yoga decreases insomnia in postmenopausal women: a randomized clinical trial. Menopause. 2012;19(2):186–93. doi: 10.1097/gme.0b013e318228225f.
    1. Khalsa SB. Treatment of chronic insomnia with yoga: a preliminary study with sleep-wake diaries. Appl Psychophysiol Biofeedback. 2004;29:269–78. doi: 10.1007/s10484-004-0387-0.
    1. Evans S, Moieni M, Subramanian S, Tsao JC, Sternlieb B, Zeltzer LK. “Now I see a brighter day”: expectations and perceived benefits of an Iyengar yoga intervention for young patients with rheumatoid arthritis. J Yoga Phys Ther. 2011;1:101. doi: 10.4172/2157-7595.1000101.
    1. Office of The Army Surgeon General Pain Management Task Force . Providing a standardized DoD and VHA vision and approach to pain management to optimize the care for warriors and their families. Washington, DC: Office of the Army Surgeon General; 2010.
    1. Libby DJ, Reddy F, Pilver CE, Desai RA. The use of yoga in specialized VA PTSD treatment programs. Int J Yoga Therap. 2012;22:79–87.
    1. Groessl EJ, Weingart KR, Aschbacher K, Pada L, Baxi S. Yoga for Veterans with chronic low-back pain. J Altern Complement Med. 2008;14:1123–9. doi: 10.1089/acm.2008.0020.
    1. Groessl EJ, Weingart KR, Johnson N, Baxi S. The benefits of yoga for women Veterans with chronic low back pain. J Altern Complement Med. 2012;18:832–8. doi: 10.1089/acm.2010.0657.
    1. Armed Forces Health Surveillance Center (AFHSC) MSMR. 2013;20:18–23.
    1. Moore J, Lorig K, Von Korff M, Gonzalez V, Laurent DD. The back pain helpbook. Boston: Da Capo Press; 1999.
    1. Buckenmaier CC, III, Galloway KT, Polomano RC, McDuffie M, Kwon N, Gallagher RM. Preliminary validation of the Defense and Veterans Pain Rating Scale (DVPRS) in a military population. Pain Med. 2013;14:110–23. doi: 10.1111/j.1526-4637.2012.01516.x.
    1. Nassif TH, Hull A, Holliday SB, Sullivan P, Sandbrink F. Concurrent validity of the Defense and Veterans Pain Rating Scale in VA outpatients. Pain Med. 2015;16(11):2152–61. doi: 10.1111/pme.12866.
    1. Patrick DL, Deyo RA, Atlas SJ, Singer DE, Chapin A, Keller RB. Assessing health-related quality of life in patients with sciatica. Spine. 1995;20:1899–908. doi: 10.1097/00007632-199509000-00011.
    1. Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine. 2000;25:3115–24. doi: 10.1097/00007632-200012150-00006.
    1. Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, et al. Report of the NIH Task Force on Research Standards for Chronic Low Back Pain. Spine J. 2014;39:1128–43. doi: 10.1097/BRS.0000000000000434.
    1. Grotle M, Brox JI, Vollestad NK. Concurrent comparison of responsiveness in pain and functional status measurements used for patients with low back pain. Spine. 2004;29:E492–501. doi: 10.1097/01.brs.0000143664.02702.0b.
    1. Bombardier C, Hayden J, Beaton DE. Minimal clinically important difference. Low back pain: outcome measures. J Rheumatol. 2001;28:431–8.
    1. Bormann JE, Smith TL, Becker S, Gershwin M, Pada L, Grudzinski AH, et al. Efficacy of frequent mantram repetition on stress, quality of life, and spiritual well-being in Veterans: a pilot study. J Holist Nurs. 2005;23:395–414. doi: 10.1177/0898010105278929.
    1. Polusny MA, Erbes CR, Thuras P, Moran A, Lamberty GJ, Collins RC, et al. Mindfulness-based stress reduction for posttraumatic stress disorder among Veterans: a randomized clinical trial. JAMA. 2015;314:456–65. doi: 10.1001/jama.2015.8361.
    1. Berwick DM. Developing and testing changes in delivery of care. Ann Intern Med. 1998;128:651–6. doi: 10.7326/0003-4819-128-8-199804150-00009.
    1. Saper RB, Sherman KJ, Delitto A, Herman PM, Stevans J, Paris R, et al. Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial. Trials. 2014;15:67. doi: 10.1186/1745-6215-15-67.
    1. Cherkin DC, Eisenberg DM, Sherman KJ, Barlow W, Kaptchuk TJ, Street J, et al. Randomized trial comparing Traditional Chinese Medical acupuncture, therapeutic massage, and self-care education for chronic low back pain. Arch Intern Med. 2001;161:1081–8. doi: 10.1001/archinte.161.8.1081.
    1. Costa LO, Maher CG, Latimer J, Ferreira PH, Ferreira ML, Pozzi GC, et al. Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best? Spine. 2008;33:2459–63. doi: 10.1097/BRS.0b013e3181849dbe.
    1. Ware J, Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220–33. doi: 10.1097/00005650-199603000-00003.
    1. Bombardier C. Outcome assessments in the evaluation of treatment of spinal disorders: introduction. Spine. 2000;25:3097–9. doi: 10.1097/00007632-200012150-00002.
    1. Hudak PL, Wright JG. The characteristics of patient satisfaction measures. Spine. 2000;25:3167–77. doi: 10.1097/00007632-200012150-00012.
    1. Weathers FW, Litz BT, Huska JA, Keane TM. PTSD Checklist—Civilian version (PCL-C) Boston: National Center for PTSD, Behavioral Science Division; 1991.
    1. Lowe B, Kroenke K, Herzog W, Grafe K. Measuring depression outcome with a brief self-report instrument: sensitivity to change of the Patient Health Questionnaire (PHQ-9) J Affect Disord. 2004;81:61–6. doi: 10.1016/S0165-0327(03)00198-8.
    1. Buysse DJ, Reynolds CF, III, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28:193–213. doi: 10.1016/0165-1781(89)90047-4.
    1. Cicerone KD, Kalmar K. Persistent postconcussion syndrome: the structure of subjective complaints after mild traumatic brain injury. J Head Trauma Rehabil. 1995;10:1–17. doi: 10.1097/00001199-199510030-00002.
    1. Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166:1092–7. doi: 10.1001/archinte.166.10.1092.
    1. Jensen MP, Keefe FJ, Lefebvre JC, Romano JM, Turner JA. One- and two-item measures of pain beliefs and coping strategies. Pain. 2003;104:453–69. doi: 10.1016/S0304-3959(03)00076-9.
    1. Anderson KO, Dowds BN, Pelletz RE, Edwards WT, Peeters-Asdourian C. Development and initial validation of a scale to measure self-efficacy beliefs in patients with chronic pain. Pain. 1995;63:77–84. doi: 10.1016/0304-3959(95)00021-J.
    1. Spanier GB. Measuring dyadic adjustment: new scales for assessing the quality of marriage and similar dyads. J Marriage Fam. 1976;38:15–28. doi: 10.2307/350547.
    1. Amick BC, III, Lerner D, Rogers WH, Rooney T, Katz JN. A review of health-related work outcome measures and their uses, and recommended measures. Spine. 2000;25:3152–60. doi: 10.1097/00007632-200012150-00010.
    1. Reeve BB, Hays RD, Bjorner JB, Cook KF, Crane PK, Teresi JA, et al. Psychometric evaluation and calibration of health-related quality of life item banks: plans for the Patient-Reported Outcomes Measurement Information System (PROMIS) Med Care. 2007;45:S22–31. doi: 10.1097/01.mlr.0000250483.85507.04.
    1. 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. 2001;26:1418–24. doi: 10.1097/00007632-200107010-00005.
    1. Weinstein MC, Siegel JE, Gold MR, Kamlet MS, Russell LB. Recommendations of the Panel on Cost-Effectiveness in Health and Medicine. JAMA. 1996;276:1253–8. doi: 10.1001/jama.1996.03540150055031.
    1. Kroenke K, Spitzer RL, Williams JB, Lowe B. The Patient Health Questionnaire Somatic, Anxiety, and Depressive Symptom Scales: a systematic review. Gen Hosp Psychiatry. 2010;32:345–59. doi: 10.1016/j.genhosppsych.2010.03.006.
    1. King PR, Donnelly KT, Donnelly JP, Dunnam M, Warner G, Kittleson CJ, et al. Psychometric study of the Neurobehavioral Symptom Inventory. J Rehabil Res Dev. 2012;49:879–88. doi: 10.1682/JRRD.2011.03.0051.
    1. Brazier JE, Roberts J. The estimation of a preference-based measure of health from the SF-12. Med Care. 2004;42:851–9. doi: 10.1097/01.mlr.0000135827.18610.0d.
    1. Drummond MF, O'Brien B, Stoddart GL, Torrance GW. Methods for the economic evaluation of healthcare programmes. 3. Oxford: Oxford University Press; 2005.
    1. Thompson SG, Barber JA. How should cost data in pragmatic randomised trials be analysed? BMJ. 2000;320:1197–200. doi: 10.1136/bmj.320.7243.1197.
    1. Briggs A. Economics notes: handling uncertainty in economic evaluation. BMJ. 1999;319:120. doi: 10.1136/bmj.319.7202.120.
    1. Charmaz K. Constructing grounded theory. London: SAGE Publishing; 2006.
    1. Herman PM, D'Huyvetter K, Mohler MJ. Are health services research methods a match for CAM? Altern Ther Health Med. 2006;12(3):78–83.
    1. Herman PM, Poindexter BL, Witt CM, Eisenberg DM. Are complementary therapies and integrative care cost-effective? A systematic review of economic evaluations. BMJ Open. 2012;2(5) doi: 10.1136/bmjopen-2012-001046.
    1. Sherman KJ. Guidelines for developing yoga interventions for randomized trials. Evid Based Complement Alternat Med. 2012;2012:143271. doi: 10.1155/2012/143271.

Source: PubMed

Подписаться