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

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.

Patient-Reported Outcome Measurements in Temporomandibular Disorders and Headaches: Summary of Measurement Properties and Applicability.

INTRODUCTION: Several patient-reported outcome measurements (PROMs) are available in the literature to support the evaluation and diagnosis of temporomandibular disorders and headaches. However, clinicians and researchers usually complain that they had no education on PROMs and low overall knowledge about PROMs. OBJECTIVE: This study aimed to summarize, describing the measurement properties and clinical applicability of the main condition-specific PROMs available in the literature to the assessment of patients with Temporomandibular Disorders and Headaches. METHODS: The current manuscript reviewed 10 PROMs commonly used in the field. Four instruments about functioning and disability: 1. Mandibular Function Impairment Questionnaire (MFIQ), 2. Craniofacial Pain and Disability Inventory (CF-PDI), 3. 8-item and 20-item Jaw Functional Limitation Scale (JFLS), and 4. Manchester Orofacial Pain Disability Scale (MOPDS). Two instruments about headache-related disability: 5. Headache-Related Disability Index (HDI) and 6. Headache Impact Test-6 (HIT-6). Three instruments focused on TMD and headache screening: 7. 3Q/TMD, 8. Short-Form Anamnestic Fonseca Index (SFAI), 9. Headache Screening Questionnaire. In addition, one instrument about maladaptive beliefs regarding pain and injury: 10. Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD). CONCLUSIONS: The knowledge about the limitations and applicability of the PROMs commonly used to assess TMDs and Headaches can help clinicians and researchers to obtain reliable and valid outcomes to support the decision-making process. The current review recognizes the importance of using patient-reported outcome measures in research and clinical practice. However, our findings call the attention that further studies on the measurement properties of such instruments are imperative.

The Brazilian Portuguese version of the Exercise Adherence Rating Scale (EARS-Br) showed acceptable reliability, validity and responsiveness in chronic low back pain.

BACKGROUND: This study aimed to adapt the Exercise Adherence Rating Scale (EARS) into Brazilian Portuguese and evaluate its measurement properties, given as reliability, validity, and responsiveness in patients with non-specific Chronic Low Back Pain (CLBP). METHODS: A total of 108 patients with a mean age of 46.62 years (SD = 9.98) and CLBP participated in this longitudinal study. Participants were oriented on undertaking the prescribed exercises in the first session, and adherence behavior was assessed after 1 week, and finally reassessed after 2 weeks (test-retest reliability). Three weeks after the first assessment, they were invited again to full fill the EARS (responsiveness). The intraclass correlation coefficient (ICC2,1) and Cronbach's α were used to assess test-retest reliability and internal consistency, respectively. Spearman's correlation and confirmatory factor analysis (CFA) were used to assess construct validity, and the Receiver operating characteristic curve and area under the curve (AUC) were used to analyze responsiveness. RESULTS: The one-factor EARS-Br (adherence behavior) structure with 6 items showed acceptable fit indexes (comparative fit index and goodness of fit index> 0.90 and root-mean-square error of approximation< 0.08). The EARS-Br scale showed acceptable internal consistency (α = 0.88) and excellent reliability (ICC = 0.91 [95% CI 0.86-0.94]). Mild to moderate correlations were observed between EARS-Br total score vs. disability, pain catastrophizing, depression/anxiety, fear-avoidance and pain intensity. A Minimally Important Change (MIC) of 5.5 in the EARS-Br total score was considered as a meaningful change in the adherence behavior (AUC = 0.82). Moderate accuracy (AUC = 0.89) was obtained for a 17/24 total EARS cutoff score after home exercise was prescribed. The sensitivity and specificity were also acceptable (greater than 80%). CONCLUSION: Our results demonstrated acceptable EARS-Br reliability, validity, and responsiveness for patients with CLBP. A final score of 17/24 on EARS after the prescription of home-exercise could be used as a cut-off for an acceptable adherence behavior associated with improvement in patient outcomes.