Education With Therapeutic Alliance Did Not Improve Symptoms in Patients With Chronic Low Back Pain and Low Risk of Poor Prognosis Compared to Education Without Therapeutic Alliance: A Randomized Controlled Trial.

OBJECTIVES: To compare the effectiveness of an education intervention with or without the addition of the therapeutic alliance to no education intervention in patients with nonspecific chronic low back pain (LBP) and low risk of poor prognosis. DESIGN: Randomized controlled trial. Randomization was performed using randomly generated numbers. METHODS: Two hundred twenty-two patients with nonspecific chronic LBP and low risk of poor prognosis from 2 university physical therapy services in Taubaté, Brazil were randomized into 3 groups: education plus therapeutic alliance, education only, and no education. Primary outcomes were pain (measured with the numeric pain-rating scale) and patient-specific disability (measured with the Patient-Specific Functional Scale), assessed 1 month after randomization. The patients, therapists, and assessors were not blinded due to the nature of the intervention and self-reported outcomes. RESULTS: Patients were recruited between November 2015 and February 2017. There was a loss of 17 (7.6%) follow-up assessments at 1 month, 28 (12.6%) at 6 months, and 31 (13.9%) at 12 months after randomization, and intention-to-treat analyses were conducted. There were no significant differences in pain between groups. However, there was a significant improvement in patient-specific disability for the education-plus-therapeutic alliance and education-only groups compared to no education after 1 month (mean difference, -1.41; 95% confidence interval: -2.31, -0.51 and -0.95; 95% confidence interval: -1.85, -0.04, respectively). CONCLUSION: An education intervention did not provide clinically relevant improvements in patient-specific disability and did not influence pain in patients with nonspecific chronic LBP and low risk of poor prognosis. Additionally, there was no difference between interventions with or without emphasis on the therapeutic alliance. J Orthop Sports Phys Ther 2021;51(8):392-400. Epub 7 May 2021. doi:10.2519/jospt.2021.9636.

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).

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.