Chronic Low-back PainCONFeTTINCT04399772
COgNitive FuncTional Therapy+ for Chronic Low Back paIn
A study testing Cognitive Functional Therapy+ pathway and Interdisciplinary pain management pathway in people with Chronic Low-back Pain, run by Odense University Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Cognitive Functional Therapy+ pathway and Interdisciplinary pain management pathway
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Sep 2020to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chronic Low-back Pain
- Being tested
- Cognitive Functional Therapy+ pathway, Interdisciplinary pain management pathway
- Keywords
- Low back pain, Cognitive Functional Therapy, Interdisciplinary pain management, RCT, Disability
- 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+ pathwayBehavioural
The CFT+ intervention comprises 4 main components: (1) making sense of pain: context-based patient education focusing on the multidimensional nature of pain and disability, while reducing the threat of structural damage and correcting unhelpful beliefs; (2) exposure with control: graded exposure to painful, feared, or avoided activities with body relaxation; (3) lifestyle changes: encouraged to perform physical activity based on preference and taught strategies to manage stress and poor sleep, (4) focus on coping strategies in life and how these strategies influence the current situation.
After CFT+, patients can be offered the comparator pathway should that be clinically indicated from these criteria: the patient does not feel ready to stop treatment AND Analgesic treatment is inappropriate OR Social situation is problematic OR Significantly psychological distress that requires further treatment by psychologist. This decision is based on a multidisciplinary team conference.
Interdisciplinary pain management pathwayBehavioural
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.
Individualized 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), (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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Functional Therapy+ pathway | Experimental | 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. Receives: Behavioral: Cognitive Functional Therapy+ pathway |
| Interdisciplinary pain management pathway | Active comparator | 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. Receives: Behavioral: Interdisciplinary pain management pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-related disability during the last 7 days
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.
Measured: Change from baseline to 12 months
Secondary outcomes (9)
Trajectory of Pain-related disability during the last 7 days
Assessed with the Oswestry Disability Index (ODI) that asks patients to choose statements that reflect 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.
Measured: Assessed after 0, 3, 6, 9, and 12 months
Average pain intensity during the last 24 hours
Assessed by asking the participants about the level of average pain during the last 24 hours on a 11 point rating scale, ranging from 0-10 (0 = "no pain" and 10 = "worst pain") using the 5th item from the Brief Pain Inventory Short Form. A lower score indicates lower pain intensity.
Measured: Assessed at 0, 3, 6, 9, and 12 months
Health-related quality of life
Measured by European Quality of Life 5 Dimensions (EQ-5D-3L) and the Visual Analogue Scale (EQ-VAS).
For the 5 dimensions the EQ5D-3L asks the participants to rate their ability for each domain (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), respectively on a 1-3 Verbal Rating Scale, a score of 1 indicating no problems/severity, and a score of 3 indicating extreme problems/severity. The EQ-VAS asks the participant to rate their overall health 'today' on a 0-100 VAS. A higher score indicates a better quality of life.
Measured: Assessed at 0, 3 and 12 months
Level of pain catastrophization
Measured by the Pain Catastrophizing Scale; asking participants to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on a 5-point Likert scale with 0 = not at all and 4 = all the time. The score is 0 to 52 with a higher score indicating a high level of pain catastrophizing.
Measured: Assessed at 0, 3 and 12 months
Level of patient enablement
Measured by the Patient Enablement Instrument for Back Pain; asking participants to indicate on a 11 point rating scale, ranging from 0-10 (0 = "to a very low degree" and 10 = "to a very high degree") the degree to which they during the past week were able to 1) Cope with life, 2) Understand your back problem, 3) Cope with your back problem, 4) Keep your back healthy, 5) Feel confident about your health, and 6) Help yourself.
Measured: Assessed at 0, 3 and 12 months
Economical evaluation
The economic evaluation of the RCT will estimate the cost per quality adjusted life year (QALY) gained from the CFT+ intervention, compared to interdisciplinary pain program treatment. The economic analyses will utilize the EQ5D data collected during the trial for the utility weights, and total healthcare costs will be obtained from linking the trial data to Danish registries.
Measured: Assessed at 12 months
Analgesics
Use of analgesics (opioids, NSAIDs, Paracetamol, TCA) within the last week reported by the patient by a Yes or No answer.
Measured: Assessed at 0, 3 and 12 months
Adverse reactions
Assessed by asking the patient to report the occurence of any serious adverse reactions or adverse reactions during the last 3 months.
Measured: Assessed at 3, 6, 9 and 12 months
The Patient Global Impression of Change
The Patient Global Impression of Change (PGIC) scale using Likert scale responses (1=much worse, 2=worse, 3=a little worse, 4=neither worse nor better, 5=a little better, 6=better, 7=much better).
Measured: Assessed at 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start27 Sep 2020
- Primary completion1 Mar 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a patient-blinded 2-arm randomized controlled trial with a parallel group design and 1:1 group allocation.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Curtin University, Manchester Metropolitan University
- Responsible party
- Principal investigator, Henrik Bjarke Vægter, Odense University Hospital
- Investigators
- Henrik B Vægter, PhD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399772
- Sponsor's protocol ID
- 69712
- Acronym
- CONFeTTI
- Status last verified
- Mar 2024
- First submitted
- 19 May 2020
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vaegter HB, Johansen JV, Sopina L, Smith A, Kent P, Fuglsang KS, Pedersen JF, Schutze R, O'Sullivan P, Handberg G, Fatoye F, Ussing K, Stegemejer I, Thorlund JB. A Cognitive Functional Therapy+ Pathway Versus an Interdisciplinary Pain Management Pathway for Patients With Severe Chronic Low Back Pain (CONFeTTI Trial): Protocol for a Pragmatic Randomized Controlled Trial. Phys Ther. 2021 Sep 1;101(9):pzab132. doi: 10.1093/ptj/pzab132.
PubMed 34003285
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04399772
- Acronym / sponsor ID
- CONFeTTI / 69712
- Conditions
- Chronic Low-back Pain
- Keywords
- Low back pain, Cognitive Functional Therapy, Interdisciplinary pain management, RCT, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Curtin University, Manchester Metropolitan University
- Study start
- 27 Sep 2020 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 22 May 2020 (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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a patient-blinded 2-arm randomized controlled trial with a parallel group design and 1:1 group allocation.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Functional Therapy+ pathway | Experimental | Behavioral: Cognitive Functional Therapy+ pathwayTreatment 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. |
| Interdisciplinary pain management pathway | Active comparator | Behavioral: Interdisciplinary pain management pathwayTreatment 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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+ pathwayThe CFT+ intervention comprises 4 main components: (1) making sense of pain: context-based patient education focusing on the multidimensional nature of pain and disability, while reducing the threat of structural damage and correcting unhelpful beliefs; (2) exposure with control: graded exposure to painful, feared, or avoided activities with body relaxation; (3) lifestyle changes: encouraged to perform physical activity based on preference and taught strategies to manage stress and poor sleep, (4) focus on coping strategies in life and how these strategies influence the current situation. After CFT+, patients can be offered the comparator pathway should that be clinically indicated from these criteria: the patient does not feel ready to stop treatment AND Analgesic treatment is inappropriate OR Social situation is problematic OR Significantly psychological distress that requires further treatment by psychologist. This decision is based on a multidisciplinary team conference. | Behavioural | Cognitive Functional Therapy+ pathway |
| Interdisciplinary pain management pathwayTreatment at the Interdisciplinary University Pain Center are based on elements from cognitive-behavioral therapy, Acceptance and Commitment Therapy, and Mindfulness-Based Stress Reduction programs. Individualized 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), (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. | Behavioural | Interdisciplinary pain management pathway |
Primary outcome
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.
9 secondary outcomes
Trajectory of Pain-related disability during the last 7 days
Time frame: Assessed after 0, 3, 6, 9, and 12 months
Average pain intensity during the last 24 hours
Time frame: Assessed at 0, 3, 6, 9, and 12 months
Health-related quality of life
Time frame: Assessed at 0, 3 and 12 months
Level of pain catastrophization
Time frame: Assessed at 0, 3 and 12 months
Level of patient enablement
Time frame: Assessed at 0, 3 and 12 months
Economical evaluation
Time frame: Assessed at 12 months
Analgesics
Time frame: Assessed at 0, 3 and 12 months
Adverse reactions
Time frame: Assessed at 3, 6, 9 and 12 months
The Patient Global Impression of Change
Time frame: Assessed at 3, 6, 9 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Derived from this study: PubMed 34003285Vaegter HB, Johansen JV, Sopina L, Smith A, Kent P, Fuglsang KS, Pedersen JF, Schutze R, O'Sullivan P, Handberg G, Fatoye F, Ussing K, Stegemejer I, Thorlund JB. A Cognitive Functional Therapy+ Pathway Versus an Interdisciplinary Pain Management Pathway for Patients With Severe Chronic Low Back Pain (CONFeTTI Trial): Protocol for a Pragmatic Randomized Controlled Trial. Phys Ther. 2021 Sep 1;101(9):pzab132. doi: 10.1093/ptj/pzab132.
- CFT pilot study in the Pain CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Henrik B Vægter, PhD principal investigator
Odense University Hospital
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+ pathway and Interdisciplinary pain management pathway in people with Chronic Low-back Pain, run by Odense University Hospital at 1 site in Denmark.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 25 Mar 2024. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain-related disability during the last 7 days (time frame: Change from baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04399772, which also lists 1 linked publication.
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 25 Mar 2024; AzTrials last refreshed its copy on 29 Oct 2026.