دورية أكاديمية
أعرض في EDS

Efficacy of the cognitive functional therapy (CFT) in patients with chronic nonspecific low back pain: a study protocol for a randomized sham-controlled trial.

التفاصيل البيبلوغرافية
العنوان: Efficacy of the cognitive functional therapy (CFT) in patients with chronic nonspecific low back pain: a study protocol for a randomized sham-controlled trial.
المؤلفون: de Lira MR; Postgraduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes 3900, Ribeirão Preto - SP, CEP:14049-900, Brazil., de Mello Meziat-Filho NA; Postgraduate Program in Rehabilitation Sciences, Augusto Motta University Center - UNISUAM, Rio de Janeiro, Brazil., Silva GZM; Postgraduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes 3900, Ribeirão Preto - SP, CEP:14049-900, Brazil., Chaves TC; Postgraduate Program in Rehabilitation and Functional Performance, Ribeirão Preto Medical School, University of São Paulo, Avenida Bandeirantes 3900, Ribeirão Preto - SP, CEP:14049-900, Brazil. chavestc@fmrp.usp.br.; Department of Physical Therapy, Federal University of São Carlos, São Carlos, São Paulo, Brazil. chavestc@fmrp.usp.br.; Laboratory of Research on Movement and Pain (LabMovePain), . chavestc@fmrp.usp.br.
المصدر: Trials [Trials] 2022 Jul 04; Vol. 23 (1), pp. 544. Date of Electronic Publication: 2022 Jul 04.
نوع المنشور: Clinical Trial Protocol; Journal Article
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BioMed Central, 2006-
مواضيع طبية MeSH: Cognitive Behavioral Therapy*/methods , Low Back Pain*/diagnosis , Low Back Pain*/therapy, Adolescent ; Adult ; Chronic Pain/therapy ; Cognition ; Humans ; Middle Aged ; Pain Measurement ; Randomized Controlled Trials as Topic ; Treatment Outcome ; Young Adult
مستخلص: Background: Chronic low back pain is a public health problem, and there is strong evidence that it is associated with a complex interaction of biopsychosocial factors. Cognitive functional therapy (CFT) is a promising new intervention that deals with potentially modifiable multidimensional aspects of pain (e.g., provocative cognitive, movement, and lifestyle behaviors).
Methods: To investigate the efficacy of CFT compared with a sham intervention for pain intensity and disability post-intervention (immediately after the last session) in patients with non-specific chronic low back pain (CLBP). This study is a randomized controlled trial in which 152 (18-60 years old) patients with CLBP will be enrolled. The patients will be randomly allocated to receive (1) CFT intervention or (2) sham intervention. The experimental group will receive individualized CFT in a pragmatic manner (5 to 7 sessions) based on the clinical progression of the participants. The sham group will attend six sessions: consisting of 30 min of photobiomodulation using a detuned device and more than 15 min of talking about neutral topics. Patients from both groups also will receive an educational booklet (for ethical reasons). Participants will be assessed pre and post-intervention, 3 months, and 6 months after randomization. The primary outcomes will be pain intensity and disability post-intervention. The secondary outcomes will be: pain intensity and disability at 3- and 6-month follow-up, as well as self-efficacy, global perceived effect of improvement, and functioning post-intervention, 3-, and 6-month follow-up. The patients and the assessor will be blinded to the treatment administered (active vs. sham).
Statistical Analysis: The between-group differences (effects of treatment), as well as the treatment effect for the primary and secondary outcomes, and their respective 95% confidence intervals will be calculated by constructing linear mixed models.
Discussion: To the best of our knowledge, the current study will be the first to compare CFT vs. sham intervention. Sham-controlled RCTs may help to understand the influence of non-specific factors on treatment outcomes. Considering complex interventions as CFT, it is imperative to understand the impact of contextual factors on outcomes.
Trial Registration: ClinicalTrials.gov NCT04518891 . First Posted: August 19, 2020.
(© 2022. The Author(s).)
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فهرسة مساهمة: Keywords: Cognitive functional therapy; Low back pain; Pain management; Placebo effect and protocols
سلسلة جزيئية: ClinicalTrials.gov NCT04518891
تواريخ الأحداث: Date Created: 20220705 Date Completed: 20220706 Latest Revision: 20220716
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC9252077
DOI: 10.1186/s13063-022-06466-8
PMID: 35788240
قاعدة البيانات: MEDLINE
الوصف
تدمد:1745-6215
DOI:10.1186/s13063-022-06466-8