Acute Low Back Pain (Low Back Pain for Less Than 3 Months)FIN-BACKNCT07877454
Preventing the Transition From Acute to Persistent Disabling Low Back Pain Through Cognitive Functional Therapy
A study testing Cognitive Functional Therapy (CFT) in people with Acute Low Back Pain (Low Back Pain for Less Than 3 Months), run by University of Oulu at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Low Back Pain (Low Back Pain for Less Than 3 Months)
- What is being tested?
- Cognitive Functional Therapy (CFT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 461 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2027to Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years
- first physiotherapy visit for the current low back pain episode of <3 months' duration (pain located between the 12th rib and the gluteal fold, preceded by at least one month with-out low back pain), with or without leg symptoms.
Who cannot join
- acute urinary retention
- fecal incontinence
- saddle anesthesia
- motor deficit or marked limb numbness
- fever or unexplained weight loss related to pain
- cancer
Show all 21Show fewer
- dementia
- severe mental disorder (e.g., schizophrenia or psychotic depression)
- pregnancy or childbirth within previous 3 months
- a planned major surgical procedure within the next three months
- For Physiotherapists
- To be included, the physiotherapists need to meet all the following criteria:
- working in primary care as a direct access physiotherapist and treating low back pain weekly
- intention to remain in the same clinic for the next two years
- ≥1 year of clinical experience
- sufficient English proficiency for the CFT training
- willingness to complete a 6 month CFT training program (~90 hours)
- willingness to provide CFT based care during the study after reaching a pre specified competency level
- willingness to provide video-recorded consultations before and during the study period for competency assessment, treatment fidelity monitoring, and characterization of usual care.
- commitment not to undertake CFT training during the study if randomized to control
- ability to continue patient care at their clinic with the jointly agreed number of visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site
University of Oulu
Oulu, North Ostrobothnia, 90014
Sami Pahkala, MHSci, +358504331641, sami.pahkala@oulu.fi
About this study
Official title: FIN-BACK: Preventing the Transition From Acute to Persistent Disabling Low Back Pain Through Cognitive Functional Therapy
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:
Read more
- 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.
Read the detailed description
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.
- Being tested
- Cognitive Functional Therapy (CFT), Usual Care
- Keywords
- Cognitive Functional Therapy, Low Back Pain, Acute Low Back Pain, Prevention, Disability, Physiotherapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Functional Therapy (CFT)Other
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.
Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Not described Receives: Other: Usual Care |
| Cognitive Functional Therapy (CFT) | Experimental | Not described Receives: Other: Cognitive Functional Therapy (CFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 52 weeks
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline and at weeks 2, 6, 12, 24, 52 and 156.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study startSep 2027 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Low Back Pain (Low Back Pain for Less Than 3 Months)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, parallel-group, cluster-randomized controlled trial. Physiotherapy units will be randomized to the intervention or control group, and participants within each cluster will receive the intervention assigned to that cluster. Approximately 461 participants will be enrolled from approximately 24 clusters.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 461 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Wellbeing Services County of Lapland, Wellbeing Services County of Central Ostrobothnia, Wellbeing Services County of Kainuu, Wellbeing Services County of North Karelia, Wellbeing Services County of Satakunta, Wellbeing Services County of Southwest Finland, Wellbeing Services County of South Ostrobothnia, Wellbeing Services County of North Ostrobothnia, LUT University, Macquarie University, Australia, Curtin University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877454
- Sponsor's protocol ID
- FIN-BACK
- Acronym
- FIN-BACK
- Status last verified
- Jun 2026
- First submitted
- 5 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIN-BACK: Preventing the Transition From Acute to Persistent Disabling Low Back Pain Through Cognitive Functional Therapy
- ClinicalTrials.gov ID
- NCT07877454
- Acronym / sponsor ID
- FIN-BACK / FIN-BACK
- Keywords
- Cognitive Functional Therapy, Low Back Pain, Acute Low Back Pain, Prevention, Disability, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 461 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Wellbeing Services County of Lapland, Wellbeing Services County of Central Ostrobothnia, Wellbeing Services County of Kainuu, Wellbeing Services County of North Karelia, Wellbeing Services County of Satakunta, Wellbeing Services County of Southwest Finland, Wellbeing Services County of South Ostrobothnia, Wellbeing Services County of North Ostrobothnia, LUT University, Macquarie University, Australia, Curtin University
- Study start
- Sep 2027 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group, cluster-randomized controlled trial. Physiotherapy units will be randomized to the intervention or control group, and participants within each cluster will receive the intervention assigned to that cluster. Approximately 461 participants will be enrolled from approximately 24 clusters.
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual Care |
| Cognitive Functional Therapy (CFT) | Experimental | Other: Cognitive Functional Therapy (CFT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥18 years
- first physiotherapy visit for the current low back pain episode of <3 months' duration (pain located between the 12th rib and the gluteal fold, preceded by at least one month with-out low back pain), with or without leg symptoms.
Key exclusion criteria (21 listed)
- acute urinary retention
- fecal incontinence
- saddle anesthesia
- motor deficit or marked limb numbness
- fever or unexplained weight loss related to pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Cognitive Functional Therapy (CFT) |
| Usual CarePatients 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. | Other | Usual care |
Primary outcome
Average low back pain-related disability over 12-month follow-up
Time frame: Baseline to 52 weeks
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.
19 secondary outcomes
Low back pain-related disability
Time frame: Baseline and at weeks 2, 4, 12, 24, 52, and 156.
Pain intensity
Time frame: Baseline and at weeks 2, 4, 12, 24, 52, and 156.
Average pain intensity over 12-month follow-up
Time frame: Baseline to 52 weeks
Recovery (pain-free and minimal disability)
Time frame: At 12, 24, 52, and 156 weeks after baseline
Pain catastrophizing
Time frame: At baseline and 2, 6, 12, 24, 52, and 156 weeks after baseline
Pain self-efficacy
Time frame: At baseline and 2, 6, 12, 24, 52, and 156 weeks after baseline.
Fear-avoidance beliefs
Time frame: At baseline and 2, 6, 12, 24, 52, and 156 weeks after baseline
Patient-specific functional limitation
Time frame: At baseline and 6, 12, 24, 52, and 156 weeks after baseline.
Patient satisfaction with care
Time frame: 12 weeks after baseline.
Treatment adherence
Time frame: At 2, 6, and 12 weeks after baseline.
Therapeutic relationship
Time frame: At 2 weeks after baseline.
Health-related quality of life
Time frame: Baseline, weeks 12, 24, 52, and 156
Sick leave due to low back pain
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)
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)
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
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
Time frame: Weeks 2, 6, 12, 24, 52, and 156
Adverse events
Time frame: At 2, 6, 12, 24, 40, 52, and 156 weeks after baseline.
Back pain knowledge and beliefs
Time frame: Baseline and at weeks 2, 6, 12, 24, 52 and 156.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Functional Therapy (CFT) in people with Acute Low Back Pain (Low Back Pain for Less Than 3 Months), run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sami Pahkala, MHSci (+358504331641, sami.pahkala@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average low back pain-related disability over 12-month follow-up (time frame: Baseline to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.