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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Odense University Hospital
- Enrollment
- 133
- Locations
- 1
- Primary Endpoint
- Pain-related disability during the last 7 days
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
This study has ethical approval that the patients involved are not aware that there is a difference between the two treatment strategies in the study. Patient masking in this study is done to ensure that included patients are as representative as possible.
The randomization sequence is distributed and stored in sealed opaque envelopes handled only by an independent study secretary who has no other involvement in the trial. All outcome measurements are completed via an electronic questionnaire system sent via personal links to the patients' official digital inbox, e-Boks (used by public hospitals, municipalities and other institutions to send official documents to citizens of Denmark). The researcher responsible for the statistical analyzes are blinded to group allocation.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cognitive Functional Therapy+ pathway
Treatment is performed by a CFT trained physiotherapists and a psychologist in the Pain Center. Patients receive max 10 consultations over 3 months. The first two sessions is combined with the physiotherapist and psychologist who investigates potential maintaining factors for pain and disability in the patient's everyday life. Remaining sessions are run by the physiotherapist, and the treatment is individually tailored to the needs of the individual patient, aiming to provide the patient with skills in dealing with his / her own situation via information, reflection, change of movement and training of functions and physical level. The psychologist provide extra support for 2-3 sessions to reinforce the physiotherapist work.The ethical committee made blinding conditional on a possibility of usual care after CFT+ if: the patient does not feel ready to stop treatment AND analgesic treatment is inappropriate OR the social situation is problematic OR significant psychological distress.
Intervention: Cognitive Functional Therapy+ pathway (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.
Treatment can be diverse, but based on an individual assessment it consists of a 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) AND (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. On average patients in the pain center receives 9-10 sessions.
Intervention: Interdisciplinary pain management pathway (Behavioral)
Outcomes
Primary Outcomes
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
- Analgesics(Assessed at 0, 3 and 12 months)
- Average pain intensity during the last 24 hours(Assessed at 0, 3, 6, 9, and 12 months)
- Health-related quality of life(Assessed at 0, 3 and 12 months)
- The Patient Global Impression of Change(Assessed at 3, 6, 9 and 12 months)
- Level of pain catastrophization(Assessed at 0, 3 and 12 months)
- Level of patient enablement(Assessed at 0, 3 and 12 months)
- Economical evaluation(Assessed at 12 months)
- Trajectory of Pain-related disability during the last 7 days(Assessed after 0, 3, 6, 9, and 12 months)
- Adverse reactions(Assessed at 3, 6, 9 and 12 months)
Investigators
Henrik Bjarke Vægter
Professor in Physiotherapy
Odense University Hospital