COgNitive FuncTional Therapy+ for Chronic Low Back paIn

Summary

This study is a patient-blinded 2-arm randomized controlled trial (RCT) assessing the effectiveness (in the short and long term) as well as total healthcare costs of a CFT+ (a combined physiotherapist/psychologist intervention) pathway compared with interdisciplinary pain management pathway (usual care) for patients with chronic low back pain referred to interdisciplinary pain treatment.

The primary aim of this pragmatic randomized controlled trial (RCT) is to investigate if a physiotherapy-led CFT pathway that includes psychologist support (CFT+) with the option of additional usual care (if needed) is superior to the currently recommended interdisciplinary pain management pathway (usual care) in reducing disability at 12 months in patients with severe cLBP. In addition, an economic evaluation will investigate total health care costs of the two pathways at 12 months.

In addition the study will explore changes in pain intensity, quality of life, thoughts and beliefs about back pain, and analgesic consumption in patients randomized to the CFT+ pathway compared with patients randomized to the interdisciplinary pain management pathway.

Conditions

• Chronic Low-back Pain

Interventions

BEHAVIORAL

Cognitive Functional Therapy+ pathway

The CFT+ intervention comprises 4 main components: (1) making sense of pain: context-based patient education focusing on the multidimensional nature of pain and disability, while reducing the threat of structural damage and correcting unhelpful beliefs; (2) exposure with control: graded exposure to painful, feared, or avoided activities with body relaxation; (3) lifestyle changes: encouraged to perform physical activity based on preference and taught strategies to manage stress and poor sleep, (4) focus on coping strategies in life and how these strategies influence the current situation. After CFT+, patients can be offered the comparator pathway should that be clinically indicated from these criteria: the patient does not feel ready to stop treatment AND Analgesic treatment is inappropriate OR Social situation is problematic OR Significantly psychological distress that requires further treatment by psychologist. This decision is based on a multidisciplinary team conference.

BEHAVIORAL

Interdisciplinary pain management pathway

Treatment at the Interdisciplinary University Pain Center are based on elements from cognitive-behavioral therapy, Acceptance and Commitment Therapy, and Mindfulness-Based Stress Reduction programs. Individualized combination of (1) medical treatment with a specialist pain consultant+specialist pain nurse (ie, individual adjustment of analgesics to improve effect and reduce side effects), (2) one or more of the following: individual consultations with a specialist pain psychologist, physiotherapist or social worker with cognitive-behavioral therapy training as well as participation in a group program with relaxation therapy, acceptance and commitment therapy or standardized mindfulness-based stress reduction programs.

Sponsors & Collaborators

• University of Southern Denmark

  collaborator OTHER

• Curtin University

  collaborator OTHER

• Manchester Metropolitan University

  collaborator OTHER

• Odense University Hospital

  lead OTHER

Principal Investigators

• Henrik B Vægter, PhD · Odense University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-27

Primary Completion

2023-03-01

Completion

2024-02-29

Countries

• Denmark

Study Locations