A Cognitive Functional Therapy+ Pathway Versus an Interdisciplinary Pain Management Pathway for Patients With Severe Chronic Low Back Pain (CONFeTTI Trial): Protocol for a Pragmatic Randomized Controlled Trial.

OBJECTIVE: Chronic low back pain (cLBP) is the leading cause of disability. Interdisciplinary pain management is recommended for patients with severe/high-impact cLBP. Such programs are expensive, not easily accessible, and have limited effect; therefore, new cost-effective strategies are warranted. Cognitive functional therapy (CFT) has shown promising results but has not been compared with an interdisciplinary pain management approach. The primary aim of this randomized controlled trial is to investigate if a pathway starting with CFT including psychologist support (CFT+) with the option of additional usual care (if needed) is superior in improving disability and more cost-effective at 12 months compared with an interdisciplinary pain management pathway (usual care). METHODS: This pragmatic, 2-arm, parallel-group randomized controlled trial will randomly allocate patients (n = 176) aged 18 to 75 years referred to an interdisciplinary pain center due to severe cLBP to 1 of 2 groups (1:1 ratio). Participants randomized to CFT+ will participate in a 3-month functional rehabilitation pathway with the option of additional usual care (if needed), and participants randomized to the interdisciplinary pain management pathway will participate in an individualized program of longer duration designed to best suit the individual's situation, needs, and resources. The primary outcome is the proportion of participants with an 8-point improvement in the Oswestry Disability Index score at 12 months. Exploratory outcomes are change in Oswestry Disability Index scores over time and an economic analysis of quality-adjusted life years using the 3-level version of the EuroQol EQ-5D. IMPACT: The study evaluates the cost-effectiveness of CFT+ with the option of additional usual care (if needed) for individuals with severe cLBP. Findings can potentially improve future care pathways and reduce cost for the health care system.

Improvements in clinical pain and experimental pain sensitivity after cognitive functional therapy in patients with severe persistent low back pain.

INTRODUCTION: Multidisciplinary care is recommended for disabling persistent low back pain (pLBP) nonresponsive to primary care. Cognitive functional therapy (CFT) is a physiotherapy-led individualised intervention targeting psychological, physical, and lifestyle barriers to recovery, to self-manage pLBP. OBJECTIVES: This pilot study investigated clinical outcomes and pain thresholds after a 12-week CFT pathway in patients with severe pLBP referred to a University Pain Center. Exploratory analyses compared changes in clinical outcomes, opioid consumption, and costs after CFT with changes after a multidisciplinary pain management (MPM) pathway. METHODS: In total, 47 consecutively referred pLBP patients consented to the CFT pathway. At baseline, 3 and 6 months, clinical outcomes and PPTs were assessed. Control patients (n = 99) who had completed an MPM pathway in the last 3 years were matched from the clinical pain registry used in the Pain Center in a 3:1 ratio based on propensity scores derived from relevant baseline variables of the CFT cases. RESULTS: Most clinical outcomes and low back pressure pain threshold were improved at 3 and 6 months after the CFT pathway. Compared with MPM, CFT patients had significantly larger reductions in disability and improved quality of life after the interventions at a lower cost (-3688€ [confidence interval: -3063 to -4314€]). Reduction in pain intensity and proportion of patients withdrawing from opioids (18.2% vs 27.8%) were similar between CFT and MPM groups. CONCLUSION: Improvements in clinical and experimental pain were found after the CFT pathway. Fully powered randomized controlled trials comparing CFT with an MPM program in patients with disabling pLBP are warranted to control for the current limitations.

Vitamin D levels appear to be normal in Danish patients attending secondary care for low back pain and a weak positive correlation between serum level Vitamin D and Modic changes was demonstrated: a cross-sectional cohort study of consecutive patients with non-specific low back pain.

BACKGROUND: Hypovitaminosis D has previously been reported in both the general population, in people with chronic musculoskeletal pain, and in people with low back pain (LBP). Myopathy-related symptoms such as diffuse bone and muscle pain, weakness and paresthesia in the legs, have also been observed in people with non-specific LBP and associations with low levels of Vitamin D have been suggested. The objectives of this study were to investigate (1) Vitamin D levels in patients seeking care for LBP in a Danish out-patient secondary care setting, and (2) their possible relationship with myopathy-related symptoms, Body Mass Index (BMI), and Modic changes. METHODS: A total of 152 consecutive patients with non-specific LBP participated in a cross-sectional study. Participants were recruited at The Spine Centre of Southern Denmark during springtime 2011. Individual serum levels of 25-Hydroxyvitamin-D were determined using Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS). Information about symptoms, height, and weight were collected from electronic questionnaires completed by the participants. All patients had an MRI from which Modic changes were identified. Correlations between Vitamin D level and pain, paresthesia, weakness in the legs, BMI or Modic changes were described using correlation coefficients and odds ratios obtained from logistic regression. RESULTS: Two-thirds of the included patients with LBP had normal Vitamin D levels of >50 nmol/L. No correlations were seen between Vitamin D deficiency and gender, age, back pain intensity, leg pain intensity, and duration of pain. Statistically significant, but low, correlation coefficients were found between Vitamin D levels and BMI as well as Modic changes. Low Vitamin D levels and Modic changes were statistically significantly associated with an odds ratio of 0.30 (95% CI 0.12; 0.75) while weakness, paresthesia and widespread pain were not. CONCLUSIONS: In patients seeking care for low back pain in a Danish outpatient clinic, Vitamin D deficiency was not common. Whether patients who are overweight or who have Modic changes might represent subgroups of people for whom their LBP may be associated with Vitamin D levels, needs further investigation.