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Open Access 01-12-2018 | Study protocol

Comparative Efficacy and Mechanisms of a Single-Session Pain Psychology Class in Chronic Low Back Pain: Study Protocol for a Randomized Controlled Trial

Authors: Beth D. Darnall, Maisa S. Ziadni, Anuradha Roy, Ming-Chih Kao, John A. Sturgeon, Karon F. Cook, Kate Lorig, John W. Burns, Sean C. Mackey

Published in: Trials | Issue 1/2018

Abstract

Background

The Institute of Medicine (IOM) reported that chronic pain affects about 100 million U.S. adults, with chronic low back pain (CLBP) cited as the most prevalent type. Pain catastrophizing is a psychological construct shown to predict the development and trajectory of chronic pain and patient response to pain treatments. While effective treatment for pain catastrophizing typically includes eight-session groups of cognitive behavioral therapy (CBT), a single-session targeted treatment class yielded promising results which, if replicated and extended, could prove to efficiently and cost-effectively reduce pain catastrophizing. In this trial, we seek to determine the comparative efficacy of this novel single-session pain catastrophizing class to an eight-session course of pain CBT and a single-session back pain health education class. We will also explore the psychosocial mechanisms and outcomes of pain catastrophizing treatment.

Methods

In this trial we will randomize 231 individuals with CLBP to one of three treatment arms: (1) pain-CBT (eight weekly 2-h group sessions with home exercises and readings); (2) a single 2-h pain catastrophizing class; or (3) a single 2-h back pain health education class (active control). For the primary outcome of pain catastrophizing, the trial is designed as a non-inferiority test between pain-CBT and the single-session pain catastrophizing class, and as a superiority test between the single-session pain catastrophizing class and the health education class. Team researchers masked to treatment assignment will assess outcomes up to six months post treatment.

Discussion

If the single-session targeted pain catastrophizing class is found to be an effective treatment for patients with CLBP, this low cost and low burden treatment could dismantle many of the current barriers and burdens of effective pain care. Further, elucidation of the mechanisms of pain catastrophizing treatments will facilitate future research on the topic as well as further development and refinement of treatments.

Trial registration

ClinicalTrials.gov, NCT03167086. Registered on 22 May 2017.

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Simon LS. Relieving pain in America: A blueprint for transforming prevention, care, education, and research. J Pain Palliat Care Pharmacother. 2012;26:197–8.CrossRef

Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, et al. The rising prevalence of chronic low back pain. Arch Intern Med. 2009;169:251–8. https://doi.org/10.1001/archinternmed.2008.543 CrossRefPubMedPubMedCentral

Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, et al. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012;64:2028–37. https://doi.org/10.1002/art.34347 CrossRefPubMed

Wertli MM, Burgstaller JM, Weiser S, Steurer J, Kofmehl R, Held U. Influence of catastrophizing on treatment outcome in patients with nonspecific low back pain: a systematic review. Spine. 2014;39:263–73. https://doi.org/10.1097/BRS.0000000000000110 CrossRefPubMed

Sullivan MJ, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychol Assess. 1995;7:524. https://doi.org/10.1037//10403590.7.4.524 CrossRef

Burton AK, Tillotson KM, Main CJ, Hollis S. Psychosocial predictors of outcome in acute and subchronic low back trouble. Spine. 1995;20:722–8.CrossRefPubMed

Picavet HSJ, Vlaeyen JW, Schouten JS. Pain catastrophizing and kinesiophobia: predictors of chronic low back pain. Am J Epidemiol. 2002;156:1028–34. https://doi.org/10.1093/aje/kwf136 CrossRefPubMed

Darnall BD, Sturgeon JA, Kao M-C, Hah JM, Mackey SC. From catastrophizing to recovery: a pilot study of a single-session treatment for pain catastrophizing. J Pain Res. 2014;7:219. https://doi.org/10.2147/JPR.S62329 CrossRefPubMedPubMedCentral

Turk DC, Dworkin RH, Allen RR, Bellamy N, Brandenburg N, Carr DB, et al. Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain. 2003;106:337–45. https://doi.org/10.1016/j.pain.2003.08.001 CrossRefPubMed

10.

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. Pain Med. 2014;15:1249–67. https://doi.org/10.1016/j.jpain.2014.03.005 CrossRefPubMed

11.

Aggarwal VR, Lovell K, Peters S, Javidi H, Joughin A, Goldthorpe J. Psychosocial interventions for the management of chronic orofacial pain. Cochrane Database Syst Rev. 2011;11:CD008456. https://doi.org/10.1002/14651858.CD008456.pub2

12.

Glombiewski JA, Sawyer AT, Gutermann J, Koenig K, Rief W, Hofmann SG. Psychological treatments for fibromyalgia: a meta-analysis. Pain. 2010;151:280–95. https://doi.org/10.1016/j.pain.2010.06.011 CrossRefPubMed

13.

Henschke N, Ostelo RW, van Tulder MW, Vlaeyen JW, Morley S, Assendelft WJ, et al. Behavioural treatment for chronic low-back pain. Cochrane Database Syst Rev. 2010;7:CD002014. https://doi.org/10.1002/14651858.CD002014.pub3

14.

Williams ACC, Eccleston C, Morley S. Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev. 2012;11:CD007407. https://doi.org/10.1002/14651858.CD007407.pub3 PubMed

15.

Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, et al. Effect of mindfulness-based stress reduction vs cognitive behavioral therapy or usual care on back pain and functional limitations in adults with chronic low back pain: a randomized clinical trial. JAMA. 2016;315:1240–9. https://doi.org/10.1001/jama.2016.2323 CrossRefPubMedPubMedCentral

16.

Cherkin DC, Sherman KJ, Balderson BH, Turner JA, Cook AJ, Stoelb B, et al. Comparison of complementary and alternative medicine with conventional mind–body therapies for chronic back pain: protocol for the Mind–body Approaches to Pain (MAP) randomized controlled trial. Trials. 2014;15:211. https://doi.org/10.1186/1745-6215-15-211 CrossRefPubMedPubMedCentral

17.

Turk DC, Winter F. The pain survival guide: How to reclaim your life. Washington, DC: American Psychological Association; 2006.CrossRef

18.

Kinser PA, Robins JL. Control group design: enhancing rigor in research of mind-body therapies for depression. Evid Based Complement Alternat Med. 2013;2013:140467. https://doi.org/10.1155/2013/140467 CrossRefPubMedPubMedCentral

19.

Papaioannou M, Skapinakis P, Damigos D, Mavreas V, Broumas G, Palgimesi A. The role of catastrophizing in the prediction of postoperative pain. Pain Med. 2009;10:1452–9. https://doi.org/10.1111/j.1526-4637.2009.00730.x CrossRefPubMed

20.

Martel M, Wasan A, Jamison R, Edwards RR. Catastrophic thinking and increased risk for prescription opioid misuse in patients with chronic pain. Drug Alcohol Depend. 2013;132:335–41. https://doi.org/10.1016/j.drugalcdep.2013.02.034 CrossRefPubMedPubMedCentral

21.

Linton SJ. Do psychological factors increase the risk for back pain in the general population in both a cross-sectional and prospective analysis? Eur J Pain. 2005;9:355. https://doi.org/10.1016/j.ejpain.2004.08.002 CrossRefPubMed

22.

Burns J, Glenn B, Bruehl S, Harden R, Lofland K. Cognitive factors influence outcome following multidisciplinary chronic pain treatment: a replication and extension of a cross-lagged panel analysis. Behav Res Ther. 2003;41:1163–82. https://doi.org/10.1016/S0005-7967(03)00029-9 CrossRefPubMed

23.

Burns JW, Kubilus A, Bruehl S, Harden RN, Lofland K. Do changes in cognitive factors influence outcome following multidisciplinary treatment for chronic pain? A cross-lagged panel analysis. J Consult Clin Psychol. 2003;71:81. https://doi.org/10.1037/0022-006X.71.1.81 CrossRefPubMed

24.

Turner JA, Holtzman S, Mancl L. Mediators, moderators, and predictors of therapeutic change in cognitive–behavioral therapy for chronic pain. Pain. 2007;127:276–86. https://doi.org/10.1016/j.pain.2006.09.005 CrossRefPubMed

25.

Abbott AD, Tyni-Lenné R, Hedlund R. Leg pain and psychological variables predict outcome 2–3 years after lumbar fusion surgery. Eur Spine J. 2011;20:1626–34. https://doi.org/10.1007/s00586-011-1709-6 CrossRefPubMedPubMedCentral

26.

Brister H, Turner JA, Aaron LA, Mancl L. Self-efficacy is associated with pain, functioning, and coping in patients with chronic temporomandibular disorder pain. J Orofac Pain. 2006;20:115–24.PubMed

27.

Jerant A, Moore M, Lorig K, Franks P. Perceived control moderated the self-efficacy-enhancing effects of a chronic illness self-management intervention. Chronic Illn. 2008;4:173–82. https://doi.org/10.1177/1742395308089057 CrossRefPubMed

28.

Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989;32:37–44. https://doi.org/10.1002/anr.1780320107 CrossRefPubMed

29.

Marks R, Allegrante JP. A review and synthesis of research evidence for self-efficacy-enhancing interventions for reducing chronic disability: implications for health education practice (part II). Health Promot Pract. 2005;6:148–56. https://doi.org/10.1177/1524839904266792 CrossRefPubMed

30.

Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148:295–309. https://doi.org/10.7326/00034819-148-4-200802190-00008 CrossRefPubMed

31.

Thorn BE, Day MA, Burns J, Kuhajda MC, Gaskins SW, Sweeney K, et al. Randomized trial of group cognitive behavioral therapy compared with a pain education control for low-literacy rural people with chronic pain. Pain. 2011;152:2710–20. https://doi.org/10.1016/j.pain.2011.07.007 CrossRefPubMedPubMedCentral

32.

D’Agostino RB, Campbell M, Greenhouse J. Non-inferiority trials: continued advancements in concepts and methodology (special papers for the 25th anniversary of Statistics in Medicine25 (7)). Stat Med. 2006;25:1097–9. https://doi.org/10.1002/sim.2553 CrossRefPubMed

33.

D’Agostino RB, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues–the encounters of academic consultants in statistics. Stat Med. 2003;22:169–86. https://doi.org/10.1002/sim.1425 CrossRefPubMed

34.

Jones B, Jarvis P, Lewis J, Ebbutt A. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996;313:36. https://doi.org/10.1136/bmj.313.7048.36 CrossRefPubMedPubMedCentral

35.

Severeijns R, Vlaeyen JW, van den Hout MA, Weber WE. Pain catastrophizing predicts pain intensity, disability, and psychological distress independent of the level of physical impairment. Clin J Pain. 2001;17:165–72.CrossRefPubMed

36.

Lecrubier Y, Sheehan DV, Weiller E, Amorim P, Bonora I, Sheehan KH, et al. The Mini International Neuropsychiatric Interview (MINI). A short diagnostic structured interview: reliability and validity according to the CIDI. Eur Psychiatry. 1997;12:224–31. https://doi.org/10.1016/S0924-9338(97)83296-8 CrossRef

37.

Beck AT, Steer RA, Brown GK. Beck depression inventory-II. San Antonio, TX: Psychological Corporation; 1996.

38.

First M, Williams J, Karg R, Spitzer R. Structured clinical interview for DSM-5—Research version (SCID-5 for DSM-5, research version; SCID-5-RV). Arlington, VA: American Psychiatric Association; 2015.

39.

Fish RA, McGuire B, Hogan M, Morrison TG, Stewart I. Validation of the Chronic Pain Acceptance Questionnaire (CPAQ) in an Internet sample and development and preliminary validation of the CPAQ-8. Pain. 2010;149:435–43. https://doi.org/10.1016/j.pain.2009.12.016 CrossRefPubMed

40.

Martin S. West Haven-Yale Multidimensional Pain Inventory: psychometrische Eigenschaften und Anwendungsmöglichkeiten in der Praxis; Überprüfung, Beurteilung, Vorschläge. na; 1993.

41.

Diener E, Emmons R, Larsen R, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985;49:71–5.CrossRefPubMed

42.

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983:385–96. https://doi.org/10.2307/2136404

43.

Bernstein DP, Ahluvalia T, Pogge D, Handelsman L. Validity of the Childhood Trauma Questionnaire in an adolescent psychiatric population. J Am Acad Child Adolesc Psychiatry. 1997;36:340–8. https://doi.org/10.1097/00004583-199703000-00012 CrossRefPubMed

44.

Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988;54:1063. https://doi.org/10.1037/0022-3514.54.6.1063 CrossRefPubMed

45.

Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113:9–19. https://doi.org/10.1016/j.pain.2004.09.012 CrossRefPubMed

46.

Tracey TJ, Kokotovic AM. Factor structure of the working alliance inventory. Psychol Assess. 1989;1:207. https://doi.org/10.1037/1040-3590.1.3.207 CrossRef

47.

Younger J, Gandhi V, Hubbard E, Mackey S. Development of the Stanford Expectations of Treatment Scale (SETS): a tool for measuring patient outcome expectancy in clinical trials. Clin Trials. 2012;9:767–76. https://doi.org/10.1177/1740774512465064 CrossRefPubMed

48.

Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000;31:73–86. https://doi.org/10.1016/S0005-7916(00)00012-4 CrossRefPubMed

49.

Revicki DA, Chen W-H, Harnam N, Cook KF, Amtmann D, Callahan LF, et al. Development and psychometric analysis of the PROMIS pain behavior item bank. Pain. 2009;146:158–69. https://doi.org/10.1016/j.pain.2009.07.029 CrossRefPubMedPubMedCentral

50.

Hung M, Hon SD, Franklin JD, Kendall RW, Lawrence BD, Neese A, et al. Psychometric properties of the PROMIS physical function item bank in patients with spinal disorders. Spine (Phila Pa 1976). 2014;39:158–63. https://doi.org/10.1097/BRS.0000000000000097 CrossRef

51.

Lai JS, Cella D, Choi S, Junghaenel DU, Christodoulou C, Gershon R, et al. How item banks and their application can influence measurement practice in rehabilitation medicine: a PROMIS fatigue item bank example. Arch Phys Med Rehabil. 2011;92:S20–7. https://doi.org/10.1016/j.apmr.2010.08.033 CrossRefPubMedPubMedCentral

52.

Revicki DA, Cook KF, Amtmann D, Harnam N, Chen WH, Keefe FJ. Exploratory and confirmatory factor analysis of the PROMIS pain quality item bank. Qual Life Res. 2014;23:245–55. https://doi.org/10.1007/s11136-013-0467-9 CrossRefPubMed

53.

Fries JF, Bruce B, Cella D. The promise of PROMIS: using item response theory to improve assessment of patient-reported outcomes. Clin Exp Rheumatol. 2005;23:S53–7.PubMed

54.

Turner JA, Mancl L, Aaron LA. Brief cognitive-behavioral therapy for temporomandibular disorder pain: effects on daily electronic outcome and process measures. Pain. 2005;117:377–87. https://doi.org/10.1016/j.pain.2005.06.025 CrossRefPubMed

Title: Comparative Efficacy and Mechanisms of a Single-Session Pain Psychology Class in Chronic Low Back Pain: Study Protocol for a Randomized Controlled Trial
Authors: Beth D. Darnall
Maisa S. Ziadni
Anuradha Roy
Ming-Chih Kao
John A. Sturgeon
Karon F. Cook
Kate Lorig
John W. Burns
Sean C. Mackey
Publication date: 01-12-2018
Publisher: BioMed Central
Published in: Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-018-2537-3

At a glance: The STEP trials

Springer Medicine

Comparative Efficacy and Mechanisms of a Single-Session Pain Psychology Class in Chronic Low Back Pain: Study Protocol for a Randomized Controlled Trial

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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