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NOT YET RECRUITING
NCT07877454
NA

Preventing the Transition From Acute to Persistent Disabling Low Back Pain Through Cognitive Functional Therapy

Sponsor: University of Oulu

View on ClinicalTrials.gov

Summary

Acute low back pain often resolves spontaneously, but some patients develop persistent pain and disability. The goal of this clinical trial is to determine whether Cognitive Functional Therapy (CFT), compared with usual care, can help prevent recent low back pain from becoming persistent in adults receiving direct-access physiotherapy in primary care. The main questions it aims to answer are: * Does CFT reduce low back pain-related disability over 12 months compared with usual care? * Is CFT cost-effective compared with usual care? * What are the long-term effects of CFT compared with usual care over a 3-year follow-up period? Researchers will compare CFT to usual care to see if CFT prevents the transition from acute to persistent low back pain. Participants will: * Receive either Cognitive Functional Therapy or usual care. * Complete questionnaires at baseline and follow-up assessments throughout the study.

Official title: FIN-BACK: Preventing the Transition From Acute to Persistent Disabling Low Back Pain Through Cognitive Functional Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

461

Start Date

2027-09

Completion Date

2031-09

Last Updated

2026-10-16

Healthy Volunteers

No

Interventions

OTHER

Cognitive Functional Therapy (CFT)

Participants receive Cognitive Functional Therapy delivered by CFT-trained physiotherapists. CFT is a patient-centred, behaviourally oriented physiotherapy approach targeting individual physical, lifestyle related and psychosocial barriers to recovery. Through structured interviewing and functional movement assessment, individualized biopsychosocial factors contributing to the condition are identified. A personalized management plan is then developed collaboratively with the patient. The intervention includes three components: (1) Making sense of pain; (2) Exposure with control; and (3) Lifestyle change. Treatment is delivered over 3 months in primary care physiotherapy settings, in person or via telehealth. Sessions last \~60 minutes initially and 30-45 minutes thereafter, with \~2-5 sessions based on clinical judgement. Where clinically appropriate, the treating physiotherapist may arrange a 6-month follow-up call, with a follow-up visit if needed.

OTHER

Usual Care

Patients receive care according to the physiotherapist's usual practice. The number and content of visits are not restricted or pre-specified, and sessions may be delivered in person or remotely and typically last 30-60 minutes. As this is a pragmatic trial conducted in direct-access physiotherapy settings, the care pathway may vary according to clinical presentation and local practice. Additional treatments are not restricted. Care received during follow-up will be characterized using patient-reported questionnaires, electronic medical records, national healthcare registry data, and video recordings of a sample of consultations.

Locations (1)

University of Oulu

Oulu, North Ostrobothnia, Finland