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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Effectiveness of the addition of therapeutic alliance with minimal intervention in the treatment of patients with chronic, nonspecific low back pain and low risk of involvement of psychosocial factors: a study protocol for a randomized controlled trial (TalkBack trial)

Authors: Felipe Ribeiro Cabral Fagundes, Caique de Melo do Espírito Santo, Francine Mendonça de Luna Teixeira, Thaís Vanelli Tonini, Cristina Maria Nunes Cabral

Published in: Trials | Issue 1/2017

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Abstract

Background

The stratified model of care has been an effective approach for the treatment of low back pain. However, the treatment of patients with low risk of psychosocial-factor involvement is unclear. The addition of the therapeutic alliance to a minimal intervention may be an option for the treatment of low back pain. This paper reports on the rationale, design and protocol for a randomized controlled trial with blind assessor to assess the effectiveness of the addition of therapeutic alliance with minimal intervention on pain and disability in patients with chronic, nonspecific low back pain.

Methods

Two hundred and twenty-two patients with chronic, nonspecific low back pain and low risk of involvement of psychosocial factors will be assessed and randomly allocated into three groups (n = 74 patients per group). The Positive Therapeutic Alliance group will receive counseling and guidance with an emphasis on therapeutic alliance and empathy. The Usual Treatment group will receive the same information and counseling with limited interaction with the therapist. The Control group will not receive any intervention. The treatment will be composed by two intervention sessions with a 1-week interval. A blinded assessor will collect the following outcomes at baseline, 1 month, 6 months and 12 months after randomization: pain intensity (Pain Numerical Rating Scale), specific disability (Patient-specific Functional Scale), general disability (Oswestry Disability Index), global perceived effect (Global Perceived Effect Scale), empathy (Consultation and Relational Empathy Measure), credibility and expectations related to treatment. The analysis will be performed using linear mixed models.

Discussion

This will be the first study to understand the effect of combining enhanced therapeutic alliance to a treatment based on counseling, information and advice (minimal intervention). The addition of the therapeutic alliance to minimal intervention may improve the treatment of chronic, nonspecific low back pain.

Trial registration

ClinicalTrials.gov, NCT 02497625. Registered on 10 July 2015.
Appendix
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Literature
1.
Murray CJ, Vos T, Lozano R, Naghavi M, Flaxman AD, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, et al. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380:2197–223.CrossRefPubMed
2.
Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380:2163–96.CrossRefPubMed
3.
4.
Foster NE, Hill JC, O’Sullivan P, Hancock M. Stratified models of care. Best Pract Res Clin Rheumatol. 2013;27:649–61.CrossRefPubMed
5.
6.
7.
Foster NE, Mullis R, Hill JC, Lewis M, Whitehurst DG, Doyle C, Konstantinou K, Main C, Somerville S, Sowden G, et al. Effect of stratified care for low back pain in family practice (IMPaCT Back): a prospective population-based sequential comparison. Ann Fam Med. 2014;12:102–11.CrossRefPubMedPubMedCentral
8.
Hill JC, Fritz JM. Psychosocial influences on low back pain, disability, and response to treatment. Phys Ther. 2011;91:712–21.CrossRefPubMed
9.
Wadell G. The back pain revolution. 2nd ed. London: Churchill Livingstone; 2004.
10.
Pinheiro MB, Ferreira ML, Refshauge K, Ordonana JR, Machado GC, Prado LR, Maher CG, Ferreira PH. Symptoms of depression and risk of new episodes of low back pain: a systematic review and meta-analysis. Arthritis Care Res (Hoboken). 2015;67:1591–603.CrossRef
11.
Ramond A, Bouton C, Richard I, Roquelaure Y, Baufreton C, Legrand E, Huez JF. Psychosocial risk factors for chronic low back pain in primary care—a systematic review. Fam Pract. 2011;28:12–21.CrossRefPubMed
12.
Harms MC, Peers CE, Chase D. Low back pain: what determines functional outcome at six months? An observational study. BMC Musculoskelet Disord. 2010;11:236.CrossRefPubMedPubMedCentral
13.
Hingorani AD, Windt DA, Riley RD, Abrams K, Moons KG, Steyerberg EW, Schroter S, Sauerbrei W, Altman DG, Hemingway H. Prognosis research strategy (PROGRESS) 4: stratified medicine research. BMJ. 2013;346:e5793.CrossRefPubMedPubMedCentral
14.
Whitehurst DG, Bryan S, Lewis M, Hill J, Hay EM. Exploring the cost-utility of stratified primary care management for low back pain compared with current best practice within risk-defined subgroups. Ann Rheum Dis. 2012;71:1796–802.CrossRefPubMedPubMedCentral
15.
Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, et al. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2011;378:1560–71.CrossRefPubMedPubMedCentral
16.
Hall AM, Maher CG, Latimer J, Ferreira ML, Costa LO. The Patient-specific Functional Scale is more responsive than the Roland Morris disability questionnaire when activity limitation is low. Eur Spine J. 2011;20:79–86.CrossRefPubMed
17.
Sowden G, Hill JC, Konstantinou K, Khanna M, Main CJ, Salmon P, Somerville S, Wathall S, Foster NE. Targeted treatment in primary care for low back pain: the treatment system and clinical training programmes used in the IMPaCT Back study (ISRCTN 55174281). Fam Pract. 2012;29:50–62.CrossRefPubMed
18.
van Tulder M, Becker A, Bekkering T, Breen A, del Real MT, Hutchinson A, Koes B, Laerum E, Malmivaara A, Care CBWGoGftMoALBPiP. Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care. Eur Spine J. 2006;15 Suppl 2:S169–91.CrossRefPubMedPubMedCentral
19.
Crepeau EB, Garren KR. I looked to her as a guide: the therapeutic relationship in hand therapy. Disabil Rehabil. 2011;33:872–81.CrossRefPubMed
20.
Hall AM, Ferreira ML, Clemson L, Ferreira P, Latimer J, Maher CG. Assessment of the therapeutic alliance in physical rehabilitation: a RASCH analysis. Disabil Rehabil. 2012;34:257–66.CrossRefPubMed
21.
Hall AM, Ferreira PH, Maher CG, Latimer J, Ferreira ML. The influence of the therapist-patient relationship on treatment outcome in physical rehabilitation: a systematic review. Phys Ther. 2010;90:1099–110.CrossRefPubMed
22.
Joyce AS, Ogrodniczuk JS, Piper WE, McCallum M. The alliance as mediator of expectancy effects in short-term individual therapy. J Consult Clin Psychol. 2003;71:672–9.CrossRefPubMed
23.
Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, Kirsch I, Schyner RN, Nam BH, Nguyen LT, et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ. 2008;336:999–1003.CrossRefPubMedPubMedCentral
24.
Pollo A, Benedetti F. The placebo response: neurobiological and clinical issues of neurological relevance. Prog Brain Res. 2009;175:283–94.CrossRefPubMed
25.
Fuentes JP. Therapeutic contextual factors in physiotherapy: magnitude, mechanisms and contributors of placebo mediated analgesia in chronic low back pain. Edmonton: University of Alberta, Faculty of Rehabilitation Science; 2012.
26.
Riess H, Kraft-Todd G. E.M.P.A.T.H.Y: a tool to enhance nonverbal communication between clinicians and their patients. Acad Med. 2014;89:5.CrossRef
27.
Benz LN, Flynn TW. Placebo, nocebo, and expectations: leveraging positive outcomes. J Orthop Sports Phys Ther. 2013;43:439–41.CrossRefPubMed
28.
Riess H, Kelley JM, Bailey RW, Dunn EJ, Phillips M. Empathy training for resident physicians: a randomized controlled trial of a neuroscience-informed curriculum. J Gen Intern Med. 2012;27:1280–6.CrossRefPubMedPubMedCentral
29.
Kaplan SH, Greenfield S, Ware Jr JE. Assessing the effects of physician-patient interactions on the outcomes of chronic disease. Med Care. 1989;27:S110–27.CrossRefPubMed
30.
Hill JC, Dunn KM, Lewis M, Mullis R, Main CJ, Foster NE, Hay EM. A primary care back pain screening tool: identifying patient subgroups for initial treatment. Arthritis Rheum. 2008;59:632–41.CrossRefPubMed
31.
Pilz B, Vasconcelos RA, Marcondes FB, Lodovichi SS, Mello W, Grossi DB. The Brazilian version of STarT Back Screening Tool—translation, cross-cultural adaptation and reliability. Braz J Phys Ther. 2014;18:453–61.CrossRefPubMedPubMedCentral
32.
Costa LO, Maher CG, Latimer J, Ferreira PH, Ferreira ML, Pozzi GC, Freitas LM. Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best? Spine (Phila Pa 1976). 2008;33:2459–63.CrossRef
33.
Stratford P, Gill C, Westaway M, Binkley J. Assessing disability and change on individual patients: a report of a patient specific measure. Physioter Can. 1995;47:258–63.CrossRef
34.
Stratford PW, Binkley JM, Riddle DL. Development and initial validation of the Back Pain Functional Scale. Spine (Phila Pa 1976). 2000;25:2095–102.CrossRef
35.
Fairbank JC, Pynsent PB. The oswestry disability index. Spine (Phila Pa 1976). 2000;25:2940–52. discussion 2952.CrossRef
36.
Vigatto R, Alexandre NM, Correa Filho HR. Development of a Brazilian Portuguese version of the Oswestry Disability Index: cross-cultural adaptation, reliability, and validity. Spine (Phila Pa 1976). 2007;32:481–6.CrossRef
37.
Mercer SW, Maxwell M, Heaney D, Watt GC. The consultation and relational empathy (CARE) measure: development and preliminary validation and reliability of an empathy-based consultation process measure. Fam Pract. 2004;21:699–705.CrossRefPubMed
38.
Mercer SW, McConnachie A, Maxwell M, Heaney D, Watt GC. Relevance and practical use of the Consultation and Relational Empathy (CARE) measure in general practice. Fam Pract. 2005;22:328–34.CrossRefPubMed
39.
Wirtz M, Boecker M, Forkmann T, Neumann M. Evaluation of the “Consultation and Relational Empathy” (CARE) measure by means of Rasch-analysis at the example of cancer patients. Patient Educ Couns. 2011;82:298–306.CrossRefPubMed
40.
Devilly GJ, Borkovec TD. Psychometric properties of the Credibility/expectancy Questionnaire. J Behav Ther Exp Psychiatry. 2000;31:73–86.CrossRefPubMed
41.
Overmeer T, Boersma K, Denison E, Linton SJ. Does teaching physical therapists to deliver a biopsychosocial treatment program result in better patient outcomes? A randomized controlled trial. Phys Ther. 2011;91:804–19.CrossRefPubMed
42.
Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006;15 Suppl 2:S192–300.CrossRefPubMedPubMedCentral
43.
Roland M, Waddell G, Klaber-Moffett J, Burton AK, Main C, Cantrell T. The Back Book. London: The Stationery Office; 1996.
44.
Altman DG. Practical statistics for medical research. London: Chapman & Hall; 1991.
45.
Costa LO, Lin CW, Grossi DB, Mancini MC, Swisher AK, Cook C, Vaughn D, Elkins MR, Sheikh U, Moore A, et al. Clinical trial registration in physical therapy journals: recommendations from the International Society of Physiotherapy Journal Editors. Phys Ther. 2013;93:6–10.CrossRefPubMed
46.
De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Lancet. 2004;364:911–2.CrossRefPubMed
47.
Chou R, Qaseem A, Snow V, Casey D, Cross Jr JT, 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;147:478–91.CrossRefPubMed
48.
Delitto A, George SZ, Van Dillen LR, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ. Low back pain. J Orthop Sports Phys Ther. 2012;42:A1–57.CrossRefPubMedPubMedCentral
49.
Hasenbring MI, Pincus T: Effective Reassurance in Primary Care of Low Back Pain: What Messages From Clinicians are Most Beneficial at Early Stages of LBP? Clin J Pain 2014.
50.
Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011;92:2041–56.CrossRefPubMed
51.
Louw A, Puentedura EL, Mintken P. Use of an abbreviated neuroscience education approach in the treatment of chronic low back pain: a case report. Physiother Theory Pract. 2012;28:50–62.CrossRefPubMed
52.
Moseley GL, Nicholas MK, Hodges PW. A randomized controlled trial of intensive neurophysiology education in chronic low back pain. Clin J Pain. 2004;20:324–30.CrossRefPubMed
53.
Traeger AC, Hubscher M, Henschke N, Moseley GL, Lee H, McAuley JH. Effect of primary care-based education on reassurance in patients with acute Low back pain: systematic review and meta-analysis. JAMA Intern Med. 2015;175:10.CrossRef
54.
Zimney K, Louw A, Puentedura EJ. Use of Therapeutic Neuroscience Education to address psychosocial factors associated with acute low back pain: a case report. Physiother Theory Pract. 2014;30:202–9.CrossRefPubMed
55.
Blanch-Hartigan D. An effective training to increase accurate recognition of patient emotion cues. Patient Educ Couns. 2012;89:274–80.CrossRefPubMed
56.
Butow P, Sharpe L. The impact of communication on adherence in pain management. Pain. 2013;154 Suppl 1:S101–7.CrossRefPubMed
57.
Derksen F, Bensing J, Lagro-Janssen A. Effectiveness of empathy in general practice: a systematic review. Br J Gen Pract. 2013;63:e76–84.CrossRefPubMed
58.
Murray A, Hall AM, Williams GC, McDonough SM, Ntoumanis N, Taylor IM, Jackson B, Matthews J, Hurley DA, Lonsdale C. Effect of a self-determination theory-based communication skills training program on Physiotherapists’ psychological support for their patients with chronic low back pain: a randomized controlled trial. Arch Phys Med Rehabil. 2014;95:8.
59.
Neumann M, Bensing J, Mercer S, Ernstmann N, Ommen O, Pfaff H. Analyzing the “nature” and “specific effectiveness” of clinical empathy: a theoretical overview and contribution towards a theory-based research agenda. Patient Educ Couns. 2009;74:339–46.CrossRefPubMed
Metadata
Title
Effectiveness of the addition of therapeutic alliance with minimal intervention in the treatment of patients with chronic, nonspecific low back pain and low risk of involvement of psychosocial factors: a study protocol for a randomized controlled trial (TalkBack trial)
Authors
Felipe Ribeiro Cabral Fagundes
Caique de Melo do Espírito Santo
Francine Mendonça de Luna Teixeira
Thaís Vanelli Tonini
Cristina Maria Nunes Cabral
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1784-z

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