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NCT Number: NCT04399772

COgNitive FuncTional Therapy+ for Chronic Low Back paIn

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.

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Key information

Conditions

Chronic Low-back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pain Center, University Hospital Odense

Odense, Funen, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Functional Therapy+ pathway

Behavioral

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.

Interdisciplinary pain management pathway

Behavioral

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.

Primary outcomes

  1. Pain-related disability during the last 7 days

    Time frame: Change from baseline to 12 months

    Proportion of patients who have an improvement of 8 points or more on the Oswestry Disability Index (ODI) at 12 months. The ODI assesses pain-related disability within the last 7 days, asking patients to reflect on their ability to manage their everyday life despite their back pain for these domains: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and travelling. Each domain is scored on a 0-5 scale. The index is calculated by dividing the summed score by the total possible score multiplied by 100 and expressed as a percentage with 100 representing the greatest disability.

Secondary outcomes

  1. Trajectory of Pain-related disability during the last 7 days

    Time frame: Assessed after 0, 3, 6, 9, and 12 months

    Assessed with the Oswestry Disability Index (ODI) that asks patients to choose statements that reflect their ability to manage their everyday life despite their back pain for these domains: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and travelling. Each domain is scored on a 0-5 scale. The index is calculated by dividing the summed score by the total possible score multiplied by 100 and expressed as a percentage with 100 representing the greatest disability.

  2. Average pain intensity during the last 24 hours

    Time frame: Assessed at 0, 3, 6, 9, and 12 months

    Assessed by asking the participants about the level of average pain during the last 24 hours on a 11 point rating scale, ranging from 0-10 (0 = "no pain" and 10 = "worst pain") using the 5th item from the Brief Pain Inventory Short Form. A lower score indicates lower pain intensity.

  3. Health-related quality of life

    Time frame: Assessed at 0, 3 and 12 months

    Measured by European Quality of Life 5 Dimensions (EQ-5D-3L) and the Visual Analogue Scale (EQ-VAS).

    For the 5 dimensions the EQ5D-3L asks the participants to rate their ability for each domain (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), respectively on a 1-3 Verbal Rating Scale, a score of 1 indicating no problems/severity, and a score of 3 indicating extreme problems/severity. The EQ-VAS asks the participant to rate their overall health 'today' on a 0-100 VAS. A higher score indicates a better quality of life.

  4. Level of pain catastrophization

    Time frame: Assessed at 0, 3 and 12 months

    Measured by the Pain Catastrophizing Scale; asking participants to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on a 5-point Likert scale with 0 = not at all and 4 = all the time. The score is 0 to 52 with a higher score indicating a high level of pain catastrophizing.

  5. Level of patient enablement

    Time frame: Assessed at 0, 3 and 12 months

    Measured by the Patient Enablement Instrument for Back Pain; asking participants to indicate on a 11 point rating scale, ranging from 0-10 (0 = "to a very low degree" and 10 = "to a very high degree") the degree to which they during the past week were able to 1) Cope with life, 2) Understand your back problem, 3) Cope with your back problem, 4) Keep your back healthy, 5) Feel confident about your health, and 6) Help yourself.

  6. Economical evaluation

    Time frame: Assessed at 12 months

    The economic evaluation of the RCT will estimate the cost per quality adjusted life year (QALY) gained from the CFT+ intervention, compared to interdisciplinary pain program treatment. The economic analyses will utilize the EQ5D data collected during the trial for the utility weights, and total healthcare costs will be obtained from linking the trial data to Danish registries.

  7. Analgesics

    Time frame: Assessed at 0, 3 and 12 months

    Use of analgesics (opioids, NSAIDs, Paracetamol, TCA) within the last week reported by the patient by a Yes or No answer.

  8. Adverse reactions

    Time frame: Assessed at 3, 6, 9 and 12 months

    Assessed by asking the patient to report the occurence of any serious adverse reactions or adverse reactions during the last 3 months.

  9. The Patient Global Impression of Change

    Time frame: Assessed at 3, 6, 9 and 12 months

    The Patient Global Impression of Change (PGIC) scale using Likert scale responses (1=much worse, 2=worse, 3=a little worse, 4=neither worse nor better, 5=a little better, 6=better, 7=much better).

Other outcomes

  1. Depression (for patient description)

    Time frame: Baseline

    Depressive symptoms are assessed using the Patient Health Questionnaire-9 (PHQ-9). Nine items related to the core symptoms of depression are assessed on a 4-point Likert scale, ranging from 0 = 'not at all' to 3 = 'nearly every day', getting a score between 0 and 27 with a higher score indicating higher depression severity.

  2. Anxiety (for patient description)

    Time frame: Baseline

    Anxiety symptoms are assessed with the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Seven items are assessed on a 4-point Likert scale, ranging from 0 = 'not at all' to 3 = 'nearly every day', getting a score between 0 and 21 with a higher score indicating higher anxiety severity.

  3. Kinesiophobia (for patient description)

    Time frame: Baseline

    Kinesiophobia is assessed using the 17-item Tampa Scale of Kinesiophobia (TSK) questionnaire. Each of the 17 items is rated on a 4-point Likert scale with 1 = 'strongly disagree' and 4 = 'strongly agree', getting a score between 17 and 68 with a higher score indicating higher levels of fear of movement/kinesiophobia

  4. Pain distribution (for patient description)

    Time frame: Baseline

    Self-reported drawing on body chart

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Curtin University
  • Manchester Metropolitan University
  • University of Southern Denmark

Registry information

Official study 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

Acronym: CONFeTTI

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
May 22, 2020
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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