Evaluation and implementation of graded in vivo exposure for chronic low back pain in a German outpatient setting: a study protocol of a randomized controlled trial

Trials

Julia Anna Glombiewski¹  Winfried Rief¹  Sebastian Holzapfel¹  Jenny Riecke¹ 

[1] Department for Clinical Psychology, Psychotherapy University of Marburg, Gutenbergstr 18, Marburg, 35032, Germany

关键词: Exposure;    CLBP;    Fear avoidance;   

Others  :  1093499
DOI  :  10.1186/1745-6215-14-203

 received in 2012-10-16, accepted in 2013-06-21,  发布年份 2013

【 摘 要 】

Background

The purpose of the present study is to introduce an adapted protocol of in vivo exposure for fear avoidant back pain patients and its implementation in the German health care system without multidisciplinary teams. Case studies demonstrated promising effects but three preceding randomized controlled trials (RCTs) could not support the former results. More empirical support is necessary to further substantiate the effectiveness of in vivo exposure.

Methods

A total of 108 chronic low back pain patients are randomly assigned to one out of three conditions (A: exposure_long (15 sessions), B: exposure_short (10 sessions) or C: control condition cognitive behavioral therapy (15 sessions)). The inclusion criteria are: back pain ≥3 months and a sufficient level of fear-avoidance. An effect evaluation, a process evaluation and an economic evaluation are conducted. Primary outcomes are pain-related disability and pain intensity. Secondary outcomes are: emotional distress, fear avoidance, catastrophizing and costs. Data are collected at baseline, upon completion of the intervention, after 10 sessions, and at six months following completion of treatment. Besides the comparison of exposure in vivo and cognitive behavioral therapy (CBT), we additionally compare a short and a long version of exposure to analyze dose response effects.

Discussion

This is, to our knowledge, the first RCT comparing in vivo exposure to psychological treatment as usual in terms of cognitive behavioral therapy. Results will help to find out whether a tailored treatment for fear avoidant back pain patients is more effective than a general pain management treatment.

Trial registration

The trial has been registered to ClinicalTrial.gov. The trial registration number is NCT01484418

【 授权许可】

   
2013 Riecke et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Breivik H, Collett B, Ventafridda V, Cohen R: Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain 2006, 10:287-333.
• [2]Koes BW, van Tulder MW, Thomas S: Diagnosis and treatment of low back pain. BMJ 2006, 332:1430-1434.
• [3]van Tulder MW, Ostelo R, Vlaeyen JW, Linton SJ, Morley SJ, Assendelft WJ: Behavioral treatment for chronic low back pain: a systematic review within the framework of the Cochrane Back Review Group. Spine 2001, 26:270-281. Phila Pa 1976
• [4]Hoffman BM, Papas RK, Chatkoff DK, Kerns RD: Meta-analysis of psychological interventions for chronic low back pain. Health Psychol 2007, 26:1-9.
• [5]Ostelo RW, van Tulder MW, Vlaeyen JW, Linton SJ, Morley SJ, Assendelft WJ: Behavioural treatment for chronic low-back pain. Cochrane Database Syst Rev 2010, CD002014. Cochrane Database Syst Rev 2005, 1. CD002014
• [6]Henschke N, Ostelo RW, van Tulder MW, Vlaeyen JW, Morley S, Assendelft WJ, Main CJ: Behavioural treatment for chronic low-back pain. Cochrane Database Syst Rev 2010, 7:CD002014.
• [7]Vlaeyen JW, de Jong J, Geilen M, Heuts PH, van Breukelen G: Graded exposure in vivo in the treatment of pain-related fear: a replicated single-case experimental design in four patients with chronic low back pain. Behav Res Ther 2001, 39:151-166.
• [8]Vlaeyen JW, Linton SJ: Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain 2000, 85:317-332.
• [9]Boersma K, Linton S, Overmeer T, Jansson M, Vlaeyen J, de Jong J: Lowering fear-avoidance and enhancing function through exposure in vivo. A multiple baseline study across six patients with back pain. Pain 2004, 108:8-16.
• [10]Vlaeyen JW, de Jong JR, Onghena P, Kerckhoffs-Hanssen M, Kole-Snijders AM: Can pain-related fear be reduced? The application of cognitive-behavioural exposure in vivo. Pain Res Manag 2002, 7:144-153.
• [11]Vlaeyen JW, de Jong J, Geilen M, Heuts PH, van Breukelen G: The treatment of fear of movement/(re)injury in chronic low back pain: further evidence on the effectiveness of exposure in vivo. Clin J Pain 2002, 18:251-261.
• [12]Leeuw M, Goossens ME, van Breukelen GJ, de Jong JR, Heuts PH, Smeets RJ, Köke AJ, Vlaeyen JW: Exposure in vivo versus operant graded activity in chronic low back pain patients: results of a randomized controlled trial. Pain 2008, 138:192-207.
• [13]Woods MP, Asmundson GJ: Evaluating the efficacy of graded in vivo exposure for the treatment of fear in patients with chronic back pain: a randomized controlled clinical trial. Pain 2008, 136:271-280.
• [14]Linton SJ, Boersma K, Jansson M, Overmeer T, Lindblom K, Vlaeyen JW: A randomized controlled trial of exposure in vivo for patients with spinal pain reporting fear of work-related activities. Eur J Pain 2008, 12:722-730.
• [15]Bailey KM, Carleton RN, Vlaeyen JW, Asmundson GJ: Treatments addressing pain-related fear and anxiety in patients with chronic musculoskeletal pain: a preliminary review. Cogn Behav Ther 2010, 39:46-63.
• [16]Macedo LG, Smeets RJ, Maher CG, Latimer J, McAuley JH: Graded activity and graded exposure for persistent nonspecific low back pain: a systematic review. Phys Ther 2010, 90:860-879.
• [17]Morley S: Getting a handle on process and change in CBT for chronic pain. Pain 2007, 197-198.
• [18]Turk DC: Cognitive-behavioral approach to the treatment of chronic pain patients. Reg Anesth Pain Med 2003, 28:573-579.
• [19]Glombiewski JA, Sawyer AT, Gutermann J, Koenig K, Rief W, Hofmann SG: Psychological treatments for fibromyalgia: a meta-analysis. Pain 2010, 151:280-295.
• [20]Thieme K, Gracely RH: Are psychological treatments effective for fibromyalgia pain? Curr Rheumatol Rep 2009, 11:443-450.
• [21]Hansen NB, Lambert MJ, Forman EM: The psychotherapy dose–response effect and its implications for treatment delivery services. Clin Psychol Sci Pract 2002, 9:329-343.
• [22]Goossens ME, Evers SM: Economic evaluation of back pain interventions. J Occup Rehabil 1997, 7:15-32.
• [23]Miller RP, Kori SH, Todd DD: The Tampa Scale: a Measure of Kinisophobia. 1991. Unpublished report
• [24]Leeuw M, Goossens M, van Breukelen G, Boersma K, Vlaeyen JW: Measuring perceived harmfulness of physical activities in patients with chronic low back pain: the photograph series of daily activities - short electronic version. J Pain 2007, 8:840-849.
• [25]Kopec JA, Esdaile JM, Abrahamowicz M, Abenhaim L, Wood-Dauphinee S, Lamping DL, Williams JI: The Quebec Back Pain Disability Scale. Spine 1995, 20:341-352.
• [26]Clinical Guidelines for the Management of Acute Low Back Pain. London: Royal College of General Practitioners; 1999.
• [27]Faul F, Erdfelder E, Lang AG, Buchner A: G * power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Meth 2007, 39:175-191.
• [28]Sullivan MJ, Bishop SR, Pivik J: The Pain Catastrophizing Scale: development and validation. Psychol Assess 1995, 7:524-532.
• [29]Pollard CA: Preliminary validity study of the Pain Disability Index. Percept Motor Skill 1984, 59:974.
• [30]Leeuw M, Goossens ME, de Vet HC, Vlaeyen JW: The fidelity of treatment delivery can be assessed in treatment outcome studies: a successful illustration from behavioral medicine. J Clin Epidemiol 2009, 62:81-90.
• [31]Kugler K, Wijn J, Geilen M, de Jong J, Vlaeyen JW: The Photograph series of Daily Activities (PHODA). CD-rom version 1.0. Institute for rehabilitation research and school for physiotherapy. The Netherlands: Heerlen; 1999.
• [32]Dworkin RH, et al.: Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain 2005, 113:9-19.
• [33]Dillmann U, Nilges P, Saile H, Gerbershagen HU: Behinderungseinschätzung bei chronischen Schmerzpatienten. Schmerz 1994, 8:100-110.
• [34]Nagel B, Gerbershagen HU, Lindena G, Pfingsten M: Entwicklung und empirische Überprüfung des Deutschen Schmerzfragebogens der DGSS. Schmerz 2002, 16:263-270.
• [35]Schaub C, Klasen B, Hallner D: German Version of the Tampa Scale of Kinesiophobia: Validity, Factor Structure and Correlations with Psychosocial Factors. 2004. unpublished
• [36]McCracken LM, Zayfert C, Gross RT: The Pain Anxiety Symptoms Scale: development and validation of a scale to measure fear of pain. J Behav Med 1992, 50:67-73.
• [37]Walter B, Hampe D, Wild J, Vaitl D: Die Erfassung der Angst vor Schmerzen: eine modifizierte deutsche Version der Pain Anxiety Symptom (PASS-D). Der Schmerz 2002, 16:83.
• [38]Meyer K, Sprott H, Frances A: Cross-cultural adaptation, reliability, and validity of the German version of the Pain Catastrophizing Scale. J Psychosom Res 2008, 64:469-478.
• [39]Zigmond AS, Snaith RP: The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand 1983, 67:361-370.
• [40]Hermann C, Buss U, Snaith RP: HADS-D: Hospital Anxiety and Depression Scale, Deutsche Version. Ein Fragebogen zur Erfassung von Angst und Depressivität in der somatischen Medizin. Bern: Huber; 1995.
• [41]Rabin R, De Charro F: EQ-SD: a measure of health status from the EuroQol Group. Ann Med 2001, 33:337-343.
• [42]von der Schulenburg JM, Claes C, Greiner W, Uber A: Die deutsche Version des EuroQol-Fragebogens. The German Version of the EuroQol Questionnaire. Zeitschrift für Gesundheitswissen 1998, 11:3-20.
• [43]McCracken LM: “Attention” to pain in persons with chronic pain: a behavioral approach. Behav Ther 1997, 28:271-284.
• [44]Lautenbacher S, Huber C, Schöfer D, Kunz M, Parthum A, Weber PG, Roman C, Griessinger N, Sittl R: Attentional and emotional mechanisms related to pain as predictors of chronic postoperative pain: a comparison with other psychological and physiological predictors. Pain 2010, 151:722-731.
• [45]Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund UL, Yngve A, Sallis JF, Oja P: International Physical Activity Questionnaire: 12-country reliability and validity. Med Sci Sports Exerc 2003, 35:1381-1395.
• [46]De Vlieger P, Bussche EV, Eccleston C, Crombez G: Finding a solution to the problem of pain: conceptual formulation and the development of the Pain Solutions Questionnaire (PaSol). Pain 2006, 123:285-293.
• [47]Wicksell RK, Lekander M, Sorjonen K, Olsson GL: The Psychological Inflexibility in Pain Scale (PIPS) – statistical properties and model fit of an instrument to assess change processes in pain related disability. Eur J Pain 2010, 14:771.e1-771.e14.
• [48]Geissner E: Verarbeitung chronischer Schmerzen - Skalen zur Erfassung der Schmerzbewältigung und der schmerzbedingten psychischen Beeinträchtigung. Z Klin Psychol Psychiatr Psychothe 1999, 28:280-290.
• [49]Mangels M, Schwarz S, Sohr G, Holme M, Rief W: Der Fragebogen zur Erfassung der schmerzspezifischen Selbstwirksamkeit (FESS). Diagnostica 2009, 55:84-93.
• [50]Devilly GJ, Borkovec TD: Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psy 2000, 31:73-86.
• [51]Hakkaart-van Roijen L, Van Straten A, Donker M, Tiemens B, Institute for Medical Technology Assessment, Erasmus University Rotterdam: Manual Trimbos/iMTA Questionnaire for Costs Associated with Psychiatric Illness (TIC-P). Rotterdam; 2002.
• [52]Cohen J: Statistical Power Analysis in the Behavioral Sciences. 2nd edition. New York, NY: Psychology Press; 2009.
• [53]Farrar JT, Young JP, 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.
• [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, 117:377-387.