COgNitive FuncTional Therapy+ for Chronic Low Back paIn (CONFeTTI)

  • STATUS
    Recruiting
  • End date
    Dec 6, 2022
  • participants needed
    176
  • sponsor
    Odense University Hospital
Updated on 6 May 2022

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.

Description

Evidence suggests that chronic low back pain (LBP) is a multidimensional biopsychosocial problem including various contributing factors, such as negative pain cognitions, pain-related fear and emotional distress, avoidant and protective movement behaviors,and unhelpful lifestyle factors such as activity avoidance and sleep problems. Current guidelines recommend that patients with chronic LBP who do not benefit from primary care treatment should be referred to interdisciplinary pain rehabilitation in secondary care settings. However, such treatments are often expensive, not easily accessible, and have only modest effects.

Cognitive Functional Therapy (CFT) is a newer physiotherapeutic treatment approach for patients with chronic low back pain, involving all important elements for the individual patient. Physical factors are handled via change in pain-provoking movement patterns. Psychological factors are handled in relation to fear, avoidance behaviour, catastrophization, stress, anxiety, depression and negative thoughts. Lifestyle factors are addressed in relation to physical inactivity and sleep problems. The approach is individualized and provides the patient with opportunities for action in relation to his or her own situation via information, reflection, change of movement and training of functions and physical level.

CFT has been shown to reduce fear and worry in patients with chronic low back pain compared to other interventions, and the effect of CFT alone on patients with severe chronic low back pain has been recently investigated in an observational pilot study (without randomization) in our Pain Center (publication attached in link). In this study, we found a good and clinically relevant effect of CFT compared to standard treatment in a University Hospital Interdisciplinary Pain Center. In the pilot study, we noted that there were barriers to optimal treatment engagement for some patients (e.g. lack of motivation), and that several patients with high levels of psychological distress had limited benefits. Inclusion of early psychologist support to assist in promoting behavioral change and directly target deeper behavioral strategies could potentially improve patient adherence to the CFT intervention.

This fully-powered randomized controlled study compares effectiveness of this physiotherapeutic intervention including psychologist support (CFT+) pathway with effectiveness of interdisciplinary pain treatment (recommended care) pathway in patients with severe chronic low back pain.

Details
Condition Chronic Low-back Pain
Treatment Cognitive Functional Therapy+, Interdisciplinary pain management, Cognitive Functional Therapy+ pathway, Interdisciplinary pain management pathway
Clinical Study IdentifierNCT04399772
SponsorOdense University Hospital
Last Modified on6 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults aged 18-75 years referred to interdisciplinary pain management at the Pain Center
Adequate Danish language skills
• Chronic low back pain (pain in the area between the 12th rib and buttock crease lasting more than 6 months)
Low back pain self-reported as significant contributor to daily disability (Yes/No)
Low back pain intensity > 4 on 0-10 numerical rating scale
Provide consent that data collected via questionnaires and registries can be used for research purposes

Exclusion Criteria

Previously attended an interdisciplinary pain management program
Wheel chair bound
Suicidal ideation - evaluated using Patient Health Questionnaire-9 (Item 9 has to be answered "never")
Self-reported former/ present addictive drug or alcohol behavior
Self-reported current pregnancy
Clear my responses

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