An interventional study of Cognitive Functional Therapy (CFT) and Usual Care in Acute Low Back Pain (Low Back Pain for Less Than 3 Months), sponsored by University of Oulu. Not yet recruiting at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by University of Oulu · Not applicable, Interventional, and Prevention
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:
Researchers will compare CFT to usual care to see if CFT prevents the transition from acute to persistent low back pain.
Participants will:
Low back pain is a leading cause of disability worldwide. While many individuals recover from an episode of low back pain, some experience persistent symptoms associated with long-term disability, reduced quality of life, and increased healthcare use. Interventions that can prevent the transition from acute to persistent low back pain have the potential to improve patient outcomes and reduce the burden on healthcare systems.
The FIN-BACK trial is a pragmatic two-arm cluster-randomized controlled trial conducted in Finnish primary care, in which approximately 24 physiotherapy units will be randomized to deliver either Cognitive Functional Therapy (CFT) or usual care. Physiotherapy units will be randomized using covariate-constrained allocation to achieve balance between study arms with respect to key clinic characteristics. The study evaluates the effectiveness and cost-effectiveness of CFT compared with usual care in reducing low back pain-related disability over 12 months among patients whose current low back pain episode has lasted less than three months. The effectiveness and cost-effectiveness of CFT over a 3-year follow-up period will also be evaluated.
CFT is a person-centered physiotherapy approach that targets individualized physical, lifestyle-related, and psychosocial barriers to recovery. Through careful interviewing and guided functional movement examination, the physiotherapist identifies individualized biopsychosocial factors contributing to the presentation. Based on these, a personalized care plan is developed collaboratively with the patient, tailored to their clinical status and life context. The intervention is delivered through three integrated components: making sense of pain, which aims to develop an individualized understanding of pain and address unhelpful beliefs and behaviors; exposure with control, which uses guided movement and graded exposure to reduce fear and avoidance; and lifestyle change, which supports health behaviors that facilitate recovery and long-term self-management.
Physiotherapists participating in the trial are allocated to deliver either CFT or usual care. Participants are followed longitudinally using electronic questionnaires and registry-based data collection. Additional exploratory analyses will include responder analyses and latent class growth analyses to further examine treatment response and recovery patterns over time. The study also includes analyses of treatment mechanisms to improve understanding of how the intervention may influence recovery, and analyses of treatment effect modifiers to identify which patients benefit most from CFT compared with usual physiotherapy. The primary mediators will be pain self-efficacy, fear-avoidance beliefs, back pain knowledge and beliefs, therapeutic relationship, and pain catastrophizing. Prespecified moderators include baseline low back pain duration, disability, pain intensity, and risk profile as assessed by the STarT Back Screening Tool. Demographic and clinical characteristics collected at baseline include age, sex, educational level, employment status, symptom duration, previous low back pain episodes, low back pain risk profile, comorbidities, current medications, smoking status, anthropometric measures, treatment expectations, and work-related factors.
A cost-utility analysis will assess the relative cost-effectiveness of the intervention compared with usual care. Health-related quality of life will be assessed using the EQ-5D-5L, and quality-adjusted life years (QALYs) will be calculated. The analysis will estimate the incremental cost-effectiveness ratio (ICER) based on differences in costs and QALYs between the groups. Total healthcare and social care costs and indirect costs, including costs related to sickness absence and reduced work ability, will be considered.
Sample size calculations were based on detecting a 2-point between-group difference in Roland-Morris Disability Questionnaire (RMDQ) score (0-24 scale). Using the web-based Shiny CRT Calculator, a total of 461 participants across 24 clusters (approximately 19 participants per cluster) are required to provide 80% power at a two-sided significance level of 0.05. The calculation assumed a standard deviation (SD) of 5 points, an intracluster correlation coefficient (ICC) of 0.05, a coefficient of variation in cluster size of 50%, and attrition of up to 20%. As the primary outcome is a normalized area under the curve (AUC) representing the average disability level across repeated measurements during follow-up, the standard deviation of this outcome is expected to be smaller than that of a single RMDQ measurement. Consequently, the sample size calculation is likely to be conservative.
A detailed study protocol and prespecified statistical analysis plan will be published before completion of data collection.
2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.
This study's planned enrollment of 461 is above the median of 60 across 2,315 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →University of Oulu is the lead sponsor of 141 studies on the registry; 22 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For Patients
Inclusion Criteria:
Exclusion Criteria:
For Physiotherapists
To be included, the physiotherapists need to meet all the following criteria:
Other: Usual Care
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.
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.
Average low back pain-related disability over 12-month follow-up
Low back pain-related disability will be assessed using an area under the curve (AUC) approach based on the 24-item Roland-Morris Disability Questionnaire (RMDQ) score, measured at baseline, at 2 weeks, at 4 weeks, and subsequently every 4 weeks through 52 weeks.
Time frame: Baseline to 52 weeks
Low back pain-related disability
Low back pain-related disability will be assessed using the 24-item Roland-Morris Disability Questionnaire (RMDQ). The total score ranges from 0 to 24, with higher scores indicating greater disability (worse outcome) and lower scores indicating less disability.
Time frame: Baseline and at weeks 2, 4, 12, 24, 52, and 156.
Pain intensity
Measured using the 0-10 numerical rating scale (0=no low back pain, 10=worst possible low back pain), assessing average low back pain intensity during the preceding 7 days.
Time frame: Baseline and at weeks 2, 4, 12, 24, 52, and 156.
Average pain intensity over 12-month follow-up
Average pain intensity will be assessed using an area under the curve (AUC) approach based on the 0-10 Numerical Rating Scale (NRS) score, assessing average low back pain intensity during the preceding 7 days, measured at baseline, at 2 weeks, at 4 weeks, and subsequently every 4 weeks through 52 weeks.
Time frame: Baseline to 52 weeks
Recovery (pain-free and minimal disability)
Recovery will be assessed as a dichotomous composite outcome (recovered/not recovered). Participants will be classified as recovered if they report a pain intensity score of 0 on the 0-10 Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst possible pain, and a score of less than 2 on the 24-item Roland-Morris Disability Questionnaire (RMDQ), which ranges from 0 to 24 with higher scores indicating greater disability. The outcome will be reported as the proportion of participants classified as recovered, with higher proportions indicating better outcomes.
Time frame: At 12, 24, 52, and 156 weeks after baseline
Pain catastrophizing
Pain catastrophizing will be assessed using the 13-item Pain Catastrophizing Scale (PCS). The questionnaire consists of 13 items rated on a 5-point Likert scale, yielding a total score from 0 to 52, with higher scores indicating greater pain catastrophizing.
Time frame: At baseline and 2, 6, 12, 24, 52, and 156 weeks after baseline
Pain self-efficacy
Pain self-efficacy will be assessed using the 10-item Pain Self-Efficacy Questionnaire (PSEQ). Items are rated on a 7-point scale, yielding a total score from 0 to 60, with higher scores indicating greater pain self-efficacy.
Time frame: At baseline and 2, 6, 12, 24, 52, and 156 weeks after baseline.
Fear-avoidance beliefs
Fear-avoidance beliefs will be assessed using the Fear-Avoidance Beliefs Questionnaire (FABQ), a validated 16-item self-report questionnaire that measures beliefs about how physical activity and work may affect low back pain. Total scores range from 0 to 96, with higher scores indicating greater fear-avoidance beliefs (worse outcome).
Time frame: At baseline and 2, 6, 12, 24, 52, and 156 weeks after baseline
Patient-specific functional limitation
Patient-specific functional limitation will be assessed using the Patient-Specific Functional Scale (PSFS), a validated self-report measure in which participants identify up to three activities they have difficulty performing because of their low back pain and rate their ability to perform each activity on an 11-point numeric scale (0-10). Higher scores indicate better functional ability.
Time frame: At baseline and 6, 12, 24, 52, and 156 weeks after baseline.
Patient satisfaction with care
Patient satisfaction with care will be assessed using a single-item 7-point Likert scale. Scores range from 1 (very dissatisfied) to 7 (very satisfied), with higher scores indicating greater satisfaction with care (better outcome)
Time frame: 12 weeks after baseline.
Treatment adherence
Treatment adherence will be assessed as a patient-reported outcome using a single-item 11-point numeric rating scale ranging from 0 (not at all) to 10 (completely). Higher scores indicate greater adherence to the treatment recommended by the physiotherapist.
Time frame: At 2, 6, and 12 weeks after baseline.
Therapeutic relationship
The therapeutic relationship will be assessed using the 10-item Consultation and Relational Empathy (CARE) Measure, a validated patient-reported questionnaire assessing empathy in the context of the therapeutic relationship during the consultation between a clinician and a patient. Total scores range from 10 to 50, with higher scores indicating a more positive perception of the consultation and greater relational empathy (better outcome).
Time frame: At 2 weeks after baseline.
Health-related quality of life
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L index score ranges from values below 0 to 1.0, with higher scores indicating better health-related quality of life (better outcome).
Time frame: Baseline, weeks 12, 24, 52, and 156
Sick leave due to low back pain
Number of days of sick leave due to low back pain, assessed using patient-reported questionnaires. National registry data (Kela health insurance statistics) on sickness absence will also be collected to complement the patient-reported data and support the economic evaluation.
Time frame: Patient-reported: Baseline, weeks 12, 24, 40, 52, and 156. Registry data: 52 weeks before baseline to 156 weeks after baseline
Work disability (partial or full)
Work disability status (partial or full), assessed using national registry data from the Kela health insurance statistics and the Finnish Centre for Pensions.
Time frame: Registry data: 52 weeks before baseline to 156 weeks after baseline
Direct healthcare costs (including public healthcare and patient out-of-pocket expenses)
Direct healthcare costs, estimated from healthcare resource utilization obtained from the AvoHilmo and Hilmo registries together with patient-reported out-of-pocket healthcare expenses. These data will be used in the planned economic evaluation.
Time frame: Patient-reported: Baseline, weeks 12, 24, 40, 52, and 156. Registry data: 52 weeks before baseline to 156 weeks after baseline
Healthcare utilization related to low back pain
Healthcare utilization related to low back pain will be assessed using patient-reported questionnaires and national registry data (AvoHilmo and Hilmo). Healthcare utilization includes physiotherapy visits, physician visits, imaging, hospital services, and other healthcare services related to low back pain. The outcome will be reported as the total number of low back pain-related healthcare contacts during follow-up. Values range from 0 upward, with higher values indicating greater healthcare utilization.
Time frame: Patient-reported: Baseline, weeks 12, 24, 40, 52, and 156. Registry data: 52 weeks before baseline to 156 weeks after baseline
Global perceived recovery
Global perceived recovery will be assessed using a 7-point Likert scale ranging from 1 (much worse) to 7 (fully recovered), with higher scores indicating greater perceived recovery (better outcome).
Time frame: Weeks 2, 6, 12, 24, 52, and 156
Adverse events
Adverse events related to the study interventions will be assessed using patient-reported questionnaires throughout the study. The outcome will be reported as the number of participants experiencing one or more adverse events and the total number and type of adverse events recorded during follow-up.
Time frame: At 2, 6, 12, 24, 40, 52, and 156 weeks after baseline.
Back pain knowledge and beliefs
Back pain knowledge and beliefs will be assessed using the 20-item Back Pain Knowledge and Beliefs Survey (BacKS). Items are rated on a 5-point Likert scale, yielding a total score from 20 to 100, with higher scores indicating greater evidence-based knowledge and more positive beliefs about low back pain.
Time frame: Baseline and at weeks 2, 6, 12, 24, 52 and 156.
Plan to share: No
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Start is estimated for Sep 2027; primary completion for Sep 2029, 24 months later.
Of 1,187 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 24 months is above that.
Counting every sponsor, half of 1,246 studies reached it within 11 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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