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.
Highlights
The stratified model of care has been an effective approach for the treatment of low back pain
Fagundes et al Trials (2017) 18:49 (Continued from previous page). This will be the first study to understand the effect of combining enhanced therapeutic alliance to a treatment based on counseling, information and advice
The addition of the therapeutic alliance to minimal intervention may improve the treatment of chronic, nonspecific low back pain
Summary
The stratified model of care has been an effective approach for the treatment of low back pain. 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. Despite the increase in quantity and quality of research in recent decades, the available treatments for low back pain tend to produce minor or moderate effects. These effects are positive in the short term and only some of them maintain long-term improvements [3]. It is important to identify patients who would benefit from a specific treatment from those who would show little benefit or even worsening of symptoms [4]
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