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

Henrik Bjarke Vaegter, Jannick Vaaben Johansen, Liza Sopina, Anne Smith, Peter Kent, Kira Søndberg Fuglsang, Jesper Fredslund Pedersen, Rob Schutze, Peter O'Sullivan, Gitte Handberg, Francis Fatoye, Kasper Ussing, Irene Stegemejer, Jonas Bloch Thorlund

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

OBJECTIVE: Chronic low back pain (cLBP) is the leading cause of disability. Interdisciplinary pain management is recommended for patients with severe cLBP. Such programs are expensive, not easily accessible, and have limited effect and 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 (RCT) 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, two-arm, parallel-group RCT will randomly allocate patients (n = 176) aged 18 to 75 referred to an interdisciplinary pain center due to severe cLBP to one of two groups (1:1 ratio). Patients randomized to CFT+ will participate in a 3-month functional rehabilitation pathway with the option of additional usual care (if needed) while patients randomized to the interdisciplinary pain management pathway will participate in an individualized program of longer duration designed to best suit the individual patient's situation, needs and resources. The primary outcome is the proportion of patients with an 8-point improvement in the Oswestry Disability Index (ODI) score at 12 months. Exploratory outcomes is change in ODI 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 patients with severe cLBP. Findings can potentially improve future care pathways and reduce cost for the health care system.

Original languageEnglish
JournalPhysical Therapy
ISSN0031-9023
DOIs
Publication statusE-pub ahead of print - 17. May 2021

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