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)

Abstract

BackgroundThe 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.MethodsTwo 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.DiscussionThis 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 registrationClinicalTrials.gov, NCT 02497625. Registered on 10 July 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1784-z) contains supplementary material, which is available to authorized users.

A Study of <i>Hie</i> and LBP: The First Step to Improve Subjective Well-Being

“…Chronic LBP patients might benefit from psychosocial treatment. Recent RCT studies of cognitive behavioral therapy [23] the addition of therapeutic alliance [24] and mindfulness [25] revealed the effectiveness of psychosocial treatment on LBP, for example. Thus, factors of "mind" are important to take into account when examining and treating these patients.…”

<p>Emotional Effects on Factors Associated with Chronic Low Back Pain</p>

“…CLBP patients might benefit from psychosocial treatment. Recent RCT studies of cognitive behavioral therapy,58 the addition of therapeutic alliance,59 and mindfulness60 revealed the effectiveness of psychosocial treatment on CLBP, for example. Thus, the psychological factors are important to take into account when examining and treating these patients.…”

Development of an Effective Client-Practitioner Therapeutic Alliance in the Management of Low Back Pain

“…Adapted from (13). "Pain is a response to sensory stimuli, and it is not necessarily related to any tissue damage in the spine" "Pain can just be a misunderstanding of the body" Encouragement Good prognosis: subgroup of low risk of involvement of psychosocial factors…”