Trial reportTrials2017
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).
Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02497625 (Effectiveness of the Addition of Therapeutic Alliance to Minimal Intervention Treatment for Chronic Low Back Pain With Low Risk of Psychosocial Factors), which is not on this map. Cited by 5 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effectiveness of the Addition of Therapeutic Alliance to Minimal Intervention Treatment for Chronic Low Back Pain With Low Risk of Psychosocial Factors: a Randomized Controlled Trial
Who cites it
5 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Models of care for managing non-specific low back pain.The Cochrane database of systematic reviews · 2025Pooled it
- Shared decision making in musculoskeletal pain consultations in low- and middle-income countries: a systematic review.International health · 2020Pooled it
- Different ways to reach the same goal: Are the analgesic effects of different types of tactile stimuli similar?European journal of pain (London, England) · 2025Article
- Development of a standard set of outcome measures for non-specific low back pain in Dutch primary care physiotherapy practices: a Delphi study.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2019Review
- Emotional Effects on Factors Associated with Chronic Low Back Pain.Journal of pain research · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
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. 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 registrationClinicalTrials.gov, NCT 02497625. Registered on 10 July 2015.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.