COgNitive FuncTional Therapy+ for Chronic Low Back paIn
CompletedNot applicableNCT04399772
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Interventions
- Behavioral: Cognitive Functional Therapy+ pathway
- Behavioral: Interdisciplinary pain management pathway
- Sponsor
- Odense University Hospital
- Collaborators
- University of Southern Denmark; Curtin University; Manchester Metropolitan University
- Start date
- 2020-09-27
- Primary completion
- 2023-03-01
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- Denmark
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04399772