Clinical trial NCT04399772: COgNitive FuncTional Therapy+ for Chronic Low Back paIn
Official title: A COgNitive FuncTional Therapy+ Pathway Versus an Interdisciplinary Pain Management Pathway for Patients With Severe Chronic Low Back Pain (CONFeTTI Trial): a Randomized Controlled Trial of a Combined Physical/Psychological Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Low back pain
Cognitive Functional Therapy
Interdisciplinary pain management
RCT
Disability
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Curtin University
name: Manchester Metropolitan University
First posted: 2020-05-22
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a patient-blinded 2-arm randomized controlled trial with a parallel group design and 1:1 group allocation.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain-related disability during the last 7 days
timeFrame: Change from baseline to 12 months
Secondary outcomes:
measure: Trajectory of Pain-related disability during the last 7 days
timeFrame: Assessed after 0, 3, 6, 9, and 12 months
measure: Average pain intensity during the last 24 hours
timeFrame: Assessed at 0, 3, 6, 9, and 12 months
measure: Health-related quality of life
timeFrame: Assessed at 0, 3 and 12 months
measure: Level of pain catastrophization
timeFrame: Assessed at 0, 3 and 12 months
measure: Level of patient enablement
timeFrame: Assessed at 0, 3 and 12 months
measure: Economical evaluation
timeFrame: Assessed at 12 months
measure: Analgesics
timeFrame: Assessed at 0, 3 and 12 months
measure: Adverse reactions
timeFrame: Assessed at 3, 6, 9 and 12 months
measure: The Patient Global Impression of Change
timeFrame: Assessed at 3, 6, 9 and 12 months
Other outcomes:
measure: Depression (for patient description)
timeFrame: Baseline
measure: Anxiety (for patient description)
timeFrame: Baseline
measure: Kinesiophobia (for patient description)
timeFrame: Baseline
measure: Pain distribution (for patient description)
timeFrame: Baseline
Locations:
city: Odense
country: Denmark
facility: Pain Center, University Hospital Odense
state: Funen
Study officials:
affiliation: Odense University Hospital
name: Henrik B Vægter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaegter HB, Johansen JV, Sopina L, Smith A, Kent P, Fuglsang KS, Pedersen JF, Schutze R, O'Sullivan P, Handberg G, Fatoye F, Ussing K, Stegemejer I, Thorlund JB. 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. Phys Ther. 2021 Sep 1;101(9):pzab132. doi: 10.1093/ptj/pzab132.