Chronic Low-back PainNCT04518891
Cognitive Functional Therapy Compared With Sham-treatment for Low Back Pain
A study testing Cognitive Functional Therapy (CFT) in people with Chronic Low-back Pain, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Chronic low back pain is a public health problem, and there is strong evidence that it is associated with a complex interaction of biopsychosocial factors. Cognitive functional therapy (CFT) is a promising new intervention that deals with potentially modifiable multidimensional aspects of pain (eg, provocative… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Cognitive Functional Therapy (CFT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteBrazil
- Study dates
- 17 May 2021to Dec 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 to 60 years;
- Current episode of CLBP lasting more than 3 months (including cases with pain in the lower limbs);
- Seeking primary clinical care for at least 6 weeks ago for this episode of low back pain;
- Primary pain located between T12 and the gluteal folds;
- Pain intensity equal to or greater than 4 on the 0-10 numerical pain scale;
- Pain caused by certain postures, activities and movements;
- Score greater than 14% on the Oswestry Disability Index;
- And be able to speak and understand Portuguese well to complete the questionnaires.
Who cannot join
- Classification in red flags (neoplastic diseases or tumors in the spine, inflammatory diseases, infections and fractures);
- Leg pain as a primary problem (eg nerve root compression or disc prolapse with active radiculopathy, or lumbar stenosis);
- Previous physiotherapy treatments (less than six months before the evaluation period);
- History of spine surgery;
- Pregnancy;
- Rheumatological / inflammatory disease;
- Progressive neurological disease.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo
Ribeirão Preto, São Paulo, 14049-900
Thais C Chaves, PhD, 55 016 3315 4413, chavestc@fmrp.usp.br
Mariana R Lira, Master, 55 16 992740642, mari.rlira@hotmail.com
About this study
Official title: Efficacy of the Cognitive Functional Therapy (CFT) in Patients With Chronic Nonspecific Low Back Pain: a Study Protocol for a Randomized Sham-controlled Trial
Chronic low back pain is a public health problem, and there is strong evidence that it is associated with a complex interaction of biopsychosocial factors. Cognitive functional therapy (CFT) is a promising new intervention that deals with potentially modifiable multidimensional aspects of pain (eg, provocative cognitive, movement and lifestyle behaviors). In order to better understand the contextual effects, the aim of the current study is to investigate the efficacy of CFT compared with a sham-intervention for pain intensity and disability post-intervention in patients with non-specific chronic low back pain (CLBP).
This study is a randomized clinical trial (RCT) in which 152 (18 - 60 years old) patients with CLBP will be enrolled. The patients will be randomly allocated to receive: (1) CFT intervention or (2) sham-intervention. The experimental group will receive individualized CFT in a pragmatic manner (5 to 7 sessions) based on the clinical progression of participants. The sham group will attend six sessions: consisted of 30 minutes of photobiomodulation using a detuned device and more 15 minutes of talking about neutral topics. Participants will be assessed pre and post-intervention, three months and six months after randomization. Patients from both groups also will receive an educational booklet. The primary outcomes will be pain intensity and disability post-intervention. The secondary outcomes will be: pain intensity and disability at 3- and 6-month follow-up, as well as self-efficacy, global perceived effect of improvement and functioning post-intervention, 3- and 6-month follow-up. The patients and the assessor will be blinded to treatment administered (active vs. sham).
Read more
The between-group differences (effects of treatment) and their respective 95% confidence intervals will be calculated by constructing linear mixed models. Treatment effect for the primary and secondary outcomes will be estimated using mixed linear models.
To the best of our knowledge, the current study will be the first to compare CFT vs. sham intervention. Sham-controlled RCTs may help to understand the influence of non-specific factors on treatment outcomes. Considering complex interventions as CFT, it is imperative to understand the impact of contextual factors on outcomes.
Read the detailed description
The aim of the current study is to investigate the efficacy of Cognitive Functional Therapy (CFT) compared with a sham-intervention (sham photobiomodulation + neutral talking), for pain intensity and disability post-intervention in patients with non-specific chronic low back pain (CLBP). The secondary aims will be to investigate the effect of CFT for pain intensity and disability at 3- and 6-month follow-up, as well as the effect of the active treatment on self-efficacy, global perceived effect of improvement and functioning post-intervention, 3- and 6-month follow-up.
The study was submitted to and approved by the ethics committee for research involving human subjects of the Ribeirão Preto Medical School (Ethics Committee Board from Centro Saúde Escola Cuaibá) of the University of São Paulo (HCFMRP CAE number: 26780619.0.0000.5414). Written informed consent will be obtained from all participants included in the study. No significant adverse reactions are anticipated in the study, but these will be monitored.
This study will be a sham-controlled RCT and will follow the recommendations described on Consolidated Standards of Reporting Trials (CONSORT) statement. The sample will be comprised of 152 participants (both genders) with non-specific CLBP who will be referred to the physiotherapy outpatient clinic from Ribeirão Preto Medical School - University of São Paulo (Brazil).
Patients will be informed that this study will involve a sham intervention arm (fake intervention in which an inert treatment will be provided but it still can result in positive outcomes due to its psychological effects) vs. an active treatment arm, but the nature of the sham will not be elucidated (equipment detuned).
After this initial assessment, participants will be randomly assigned using block randomization by simple computerized procedures to one of the two treatment groups through the use of cards previously placed in opaque sealed envelopes: i) CFT group or ii) Sham group.
As a strategy to control for the treatment fidelity on both arms of the study, we will adopt the framework developed by the NIH Behaviour Change Consortium (BCC). To control for the "Intervention Delivery", the time of therapist-patient interaction, number of sessions and the different components of the intervention administered (e.g.: in the sham-group, the time administering the sham photobiomodulation and the time spent with neutral talking), as well as video recordings along the trial will be registered. Also, regular meetings to discuss the clinical cases will be performed. Furthermore, the "Intervention receipt" will be assessed in two different manners: i) on the completion of the study, each participant will be submitted to a manipulation check and they will be asked about the group they think they were at and ii) patients in both groups will be invited to summarize at the beginning of each session how the treatment impact their lives.
Despite it is a sham-controlled RCT, considering the differences in the interventions administered in both study arms, it will not be possible to blind the therapists, however, patients will be blinded to randomized interventions. The assessor and the participants will not have access to what type of treatment the participant will be given.
To the best of our knowledge, the current study will be the first to compare CFT vs. sham intervention. Sham-controlled RCTs may help to understand the influence of non-specific factors on treatment outcomes. Considering complex interventions as CFT, it is imperative to understand the impact of contextual factors on outcomes.
- Conditions
- Chronic Low-back Pain
- Being tested
- Cognitive Functional Therapy (CFT), Sham intervention
- Keywords
- Cognitive Functional Therapy, Low Back Pain, Pain Management, Placebo Effect, Self-efficacy
- Medical subject headings
- Low Back Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Functional Therapy (CFT)Behavioural
Cognitive functional therapy (CFT) is an intervention that deals with potentially modifiable multidimensional aspects of pain (e.g. provocative cognitive, movement and lifestyle behaviours). Treatment with CFT will be individualised, the physiotherapist will listen to the complete patient pain history and the intervention will be focused on individual needs. A detailed examination will be crucial in identifying the modifiable multidimensional mediators of pain and disability (provocative cognitive, pain, movement and lifestyle behaviors) of each participant.
Sham interventionDevice
Also called Placebo photobiomodulation + neutral listening
Due to the impossibility of applying placebo exercise, the control intervention in this study will be based on successful reports of placebo intervention in patients with chronic low back pain in the literature (Placebo photobiomodulation + neutral talking control)
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Functional Therapy (CFT) Group | Experimental | There will be 3 main components in the intervention:
1. Making sense of pain: the cognitive component will focus on identifying the factors that contribute to pain during examination. This will include discussion on the multidimensional nature of persistent pain, individual beliefs, and how emotions and behaviours regarding movement and lifestyle can reinforce a vicious cycle of pain and disability.
2. Controlled exposure: specific functional training is designed to normalise maladaptive or provocative movement and posture. functional integration is directed at activities of daily life that are avoided by the patient. This will vary among individuals but should include basic activities such as rolling in bed, sitting, sitting to standing, walking, bending and lifting.
3. Lifestyle change: Physical activity and lifestyle. Patients will be advised to gradually increase physical activity based on their preference, while also focusing on sleep hygiene, stress and management strategies. Receives: Behavioral: Cognitive Functional Therapy (CFT) |
| Sham intervention | Sham comparator | Placebo group will be treated with detuned photobiomodulation device (904Nm Ibramed Infrared - no-visible beam), without any emission of therapeutic dose. Nine sites will be applicate on the patient's lumbar region: three central sites on top of the spinous processes (between T11 and T12, L2 and L3, L5 and S1); in the same direction, but laterally, three sites on the left and three on the right. Three minutes of fake stimulation will be administered, summing up 27 minutes. In addition, a neutral talking control therapy of at least 15 minutes will be provided to patients in each session. Maladaptive beliefs will not be challenged; however, the therapists will be trained to show interest and warmth, empathy and encouraging participants to discuss neutral topics such as hobbies, sports, and current affairs. No advice or problem solving will be given, and any attempt to talk about emotional issues will be kindly discouraged and the talking will be redirect to neutral tropics. Receives: Device: Sham intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity: Numeric pain rating scale (NPRS)
The NPRS used in this trial will consist of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable". High scores mean worse pain intensity.
Measured: Post-intervention
Low Back Pain Related Disability: Oswestry Disability Index (ODI)
The ODI consists of 10 items, each of which has six response options. The total score will be calculated by summing up all the points, ranging from 10 to 50. This sum will be transformed into a percentage (0 to 100). High scores mean worse disability.
Measured: Post-intervention
Secondary outcomes (5)
Pain intensity: Numeric pain rating scale (NPRS)
The NPRS used in this trial will consist of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable". High scores mean worse pain intensity.
Measured: 3 and 6 months after randomization
Low Back Pain Related Disability: Oswestry Disability Index (ODI)
The ODI consists of 10 items, each of which has six response options. The total score will be calculated by summing up all the points, ranging from 10 to 50. This sum will be transformed into a percentage (0 to 100). High scores mean worse disability.
Measured: 3 and 6 months after randomization
Pain Self-Efficacy: Pain Self-Efficacy Questionnaire (PSEQ)
The PSEQ has 10 items related individual's confidence to perform a certain task which are rated on a 7-point ordinal scale (ranging from 0: "not at all confident" to 6: "completely confident"). The score ranges from 0 to 60, higher score means better self-efficacy.
Measured: Post-intervention, 3 and 6 months after randomization
Global perceived effect: Global Perceived Effect Scale (GPES)
GPES is an 11-point scale ranging from -5 ("vastly worse") through 0 (no change) to +5 (completely recovered).Higher score means better perception of improvement.
Measured: Post-intervention, 3 and 6 months after randomization
Function: Patient Specific Functional Scale (PSFS)
In the PSFS patients are asked to identify up to three important activities that they are having difficulties with or are unable to perform due to their condition. In addition, the patients are asked to rate, on an 11-point scale (ranging from 0 to 10) their current level of ability associated with each activity. Score ranges from 0 (unable to perform) to 10 (able to perform at preinjury level). Higher score means better function.
Measured: Post-intervention, 3 and 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start17 May 2021
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thais Cristina Chaves, University of Sao Paulo
- Investigators
- Mariana R Lira, Master, Principal investigatorNey A Meziat, PhD, Study director, Augusto Motta University Center (UNISUAM)Thais C Chaves, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518891
- Sponsor's protocol ID
- 2604/2020
- Status last verified
- May 2022
- First submitted
- 15 Aug 2020
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Lira MR, Meziat-Filho N, Zuelli Martins Silva G, Castro J, Fernandez J, Guirro RRJ, Berg R, Chaves TC. Efficacy of cognitive functional therapy for pain intensity and disability in patients with non-specific chronic low back pain: a randomised sham-controlled trial. Br J Sports Med. 2025 Jun 18;59(13):912-920. doi: 10.1136/bjsports-2024-109012.
PubMed 40049758de Lira MR, de Mello Meziat-Filho NA, Silva GZM, Chaves TC. Efficacy of the cognitive functional therapy (CFT) in patients with chronic nonspecific low back pain: a study protocol for a randomized sham-controlled trial. Trials. 2022 Jul 4;23(1):544. doi: 10.1186/s13063-022-06466-8.
PubMed 35788240
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Cognitive Functional Therapy (CFT) in Patients With Chronic Nonspecific Low Back Pain: a Study Protocol for a Randomized Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT04518891
- Acronym / sponsor ID
- 2604/2020
- Conditions
- Chronic Low-back Pain
- Keywords
- Cognitive Functional Therapy, Low Back Pain, Pain Management, Placebo Effect, Self-efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 19 Aug 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.
Chronic low back pain is a public health problem, and there is strong evidence that it is associated with a complex interaction of biopsychosocial factors. Cognitive functional therapy (CFT) is a promising new intervention that deals with potentially modifiable multidimensional aspects of pain (eg, provocative cognitive, movement and lifestyle behaviors). In order to better understand the contextual effects, the aim of the current study is to investigate the efficacy of CFT compared with a sham-intervention for pain intensity and disability post-intervention in patients with non-specific chronic low back pain (CLBP).
This study is a randomized clinical trial (RCT) in which 152 (18 - 60 years old) patients with CLBP will be enrolled. The patients will be randomly allocated to receive: (1) CFT intervention or (2) sham-intervention. The experimental group will receive individualized CFT in a pragmatic manner (5 to 7 sessions) based on the clinical progression of participants. The sham group will attend six sessions: consisted of 30 minutes of photobiomodulation using a detuned device and more 15 minutes of talking about neutral topics. Participants will be assessed pre and post-intervention, three months and six months after randomization. Patients from both groups also will receive an educational booklet. The primary outcomes will be pain intensity and disability post-intervention. The secondary outcomes will be: pain intensity and disability at 3- and 6-month follow-up, as well as self-efficacy, global perceived effect of improvement and functioning post-intervention, 3- and 6-month follow-up. The patients and the assessor will be blinded to treatment administered (active vs. sham).
The between-group differences (effects of treatment) and their respective 95% confidence intervals will be calculated by constructing linear mixed models. Treatment effect for the primary and secondary outcomes will be estimated using mixed linear models.
To the best of our knowledge, the current study will be the first to compare CFT vs. sham intervention. Sham-controlled RCTs may help to understand the influence of non-specific factors on treatment outcomes. Considering complex interventions as CFT, it is imperative to understand the impact of contextual factors on outcomes.
Detailed description
The aim of the current study is to investigate the efficacy of Cognitive Functional Therapy (CFT) compared with a sham-intervention (sham photobiomodulation + neutral talking), for pain intensity and disability post-intervention in patients with non-specific chronic low back pain (CLBP). The secondary aims will be to investigate the effect of CFT for pain intensity and disability at 3- and 6-month follow-up, as well as the effect of the active treatment on self-efficacy, global perceived effect of improvement and functioning post-intervention, 3- and 6-month follow-up.
The study was submitted to and approved by the ethics committee for research involving human subjects of the Ribeirão Preto Medical School (Ethics Committee Board from Centro Saúde Escola Cuaibá) of the University of São Paulo (HCFMRP CAE number: 26780619.0.0000.5414). Written informed consent will be obtained from all participants included in the study. No significant adverse reactions are anticipated in the study, but these will be monitored.
This study will be a sham-controlled RCT and will follow the recommendations described on Consolidated Standards of Reporting Trials (CONSORT) statement. The sample will be comprised of 152 participants (both genders) with non-specific CLBP who will be referred to the physiotherapy outpatient clinic from Ribeirão Preto Medical School - University of São Paulo (Brazil).
Patients will be informed that this study will involve a sham intervention arm (fake intervention in which an inert treatment will be provided but it still can result in positive outcomes due to its psychological effects) vs. an active treatment arm, but the nature of the sham will not be elucidated (equipment detuned).
After this initial assessment, participants will be randomly assigned using block randomization by simple computerized procedures to one of the two treatment groups through the use of cards previously placed in opaque sealed envelopes: i) CFT group or ii) Sham group.
As a strategy to control for the treatment fidelity on both arms of the study, we will adopt the framework developed by the NIH Behaviour Change Consortium (BCC). To control for the "Intervention Delivery", the time of therapist-patient interaction, number of sessions and the different components of the intervention administered (e.g.: in the sham-group, the time administering the sham photobiomodulation and the time spent with neutral talking), as well as video recordings along the trial will be registered. Also, regular meetings to discuss the clinical cases will be performed. Furthermore, the "Intervention receipt" will be assessed in two different manners: i) on the completion of the study, each participant will be submitted to a manipulation check and they will be asked about the group they think they were at and ii) patients in both groups will be invited to summarize at the beginning of each session how the treatment impact their lives.
Despite it is a sham-controlled RCT, considering the differences in the interventions administered in both study arms, it will not be possible to blind the therapists, however, patients will be blinded to randomized interventions. The assessor and the participants will not have access to what type of treatment the participant will be given.
To the best of our knowledge, the current study will be the first to compare CFT vs. sham intervention. Sham-controlled RCTs may help to understand the influence of non-specific factors on treatment outcomes. Considering complex interventions as CFT, it is imperative to understand the impact of contextual factors on outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Functional Therapy (CFT) Group | Experimental | Behavioral: Cognitive Functional Therapy (CFT)There will be 3 main components in the intervention: 1. Making sense of pain: the cognitive component will focus on identifying the factors that contribute to pain during examination. This will include discussion on the multidimensional nature of persistent pain, individual beliefs, and how emotions and behaviours regarding movement and lifestyle can reinforce a vicious cycle of pain and disability. 2. Controlled exposure: specific functional training is designed to normalise maladaptive or provocative movement and posture. functional integration is directed at activities of daily life that are avoided by the patient. This will vary among individuals but should include basic activities such as rolling in bed, sitting, sitting to standing, walking, bending and lifting. 3. Lifestyle change: Physical activity and lifestyle. Patients will be advised to gradually increase physical activity based on their preference, while also focusing on sleep hygiene, stress and management strategies. |
| Sham intervention | Sham comparator | Device: Sham interventionPlacebo group will be treated with detuned photobiomodulation device (904Nm Ibramed Infrared - no-visible beam), without any emission of therapeutic dose. Nine sites will be applicate on the patient's lumbar region: three central sites on top of the spinous processes (between T11 and T12, L2 and L3, L5 and S1); in the same direction, but laterally, three sites on the left and three on the right. Three minutes of fake stimulation will be administered, summing up 27 minutes. In addition, a neutral talking control therapy of at least 15 minutes will be provided to patients in each session. Maladaptive beliefs will not be challenged; however, the therapists will be trained to show interest and warmth, empathy and encouraging participants to discuss neutral topics such as hobbies, sports, and current affairs. No advice or problem solving will be given, and any attempt to talk about emotional issues will be kindly discouraged and the talking will be redirect to neutral tropics. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age between 18 to 60 years;
- Current episode of CLBP lasting more than 3 months (including cases with pain in the lower limbs);
- Seeking primary clinical care for at least 6 weeks ago for this episode of low back pain;
- Primary pain located between T12 and the gluteal folds;
- Pain intensity equal to or greater than 4 on the 0-10 numerical pain scale;
Key exclusion criteria (7 listed)
- Classification in red flags (neoplastic diseases or tumors in the spine, inflammatory diseases, infections and fractures);
- Leg pain as a primary problem (eg nerve root compression or disc prolapse with active radiculopathy, or lumbar stenosis);
- Previous physiotherapy treatments (less than six months before the evaluation period);
- History of spine surgery;
- 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 (CFT)Cognitive functional therapy (CFT) is an intervention that deals with potentially modifiable multidimensional aspects of pain (e.g. provocative cognitive, movement and lifestyle behaviours). Treatment with CFT will be individualised, the physiotherapist will listen to the complete patient pain history and the intervention will be focused on individual needs. A detailed examination will be crucial in identifying the modifiable multidimensional mediators of pain and disability (provocative cognitive, pain, movement and lifestyle behaviors) of each participant. | Behavioural | Cognitive Functional Therapy (CFT) Group |
| Sham interventionAlso: Placebo photobiomodulation + neutral listeningDue to the impossibility of applying placebo exercise, the control intervention in this study will be based on successful reports of placebo intervention in patients with chronic low back pain in the literature (Placebo photobiomodulation + neutral talking control) | Device | Sham intervention |
Primary outcome
Pain intensity: Numeric pain rating scale (NPRS)
Time frame: Post-intervention
The NPRS used in this trial will consist of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable". High scores mean worse pain intensity.
Low Back Pain Related Disability: Oswestry Disability Index (ODI)
Time frame: Post-intervention
The ODI consists of 10 items, each of which has six response options. The total score will be calculated by summing up all the points, ranging from 10 to 50. This sum will be transformed into a percentage (0 to 100). High scores mean worse disability.
5 secondary outcomes
Pain intensity: Numeric pain rating scale (NPRS)
Time frame: 3 and 6 months after randomization
Low Back Pain Related Disability: Oswestry Disability Index (ODI)
Time frame: 3 and 6 months after randomization
Pain Self-Efficacy: Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: Post-intervention, 3 and 6 months after randomization
Global perceived effect: Global Perceived Effect Scale (GPES)
Time frame: Post-intervention, 3 and 6 months after randomization
Function: Patient Specific Functional Scale (PSFS)
Time frame: Post-intervention, 3 and 6 months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Derived from this study: PubMed 40049758de Lira MR, Meziat-Filho N, Zuelli Martins Silva G, Castro J, Fernandez J, Guirro RRJ, Berg R, Chaves TC. Efficacy of cognitive functional therapy for pain intensity and disability in patients with non-specific chronic low back pain: a randomised sham-controlled trial. Br J Sports Med. 2025 Jun 18;59(13):912-920. doi: 10.1136/bjsports-2024-109012.
- Derived from this study: PubMed 35788240de Lira MR, de Mello Meziat-Filho NA, Silva GZM, Chaves TC. Efficacy of the cognitive functional therapy (CFT) in patients with chronic nonspecific low back pain: a study protocol for a randomized sham-controlled trial. Trials. 2022 Jul 4;23(1):544. doi: 10.1186/s13063-022-06466-8.
- 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.
Mariana R Lira, Master principal investigator
Ney A Meziat, PhD study director
Augusto Motta University Center (UNISUAM)
Thais C Chaves, PhD study director
University of Sao Paulo
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 Chronic Low-back Pain, run by University of Sao Paulo at 1 site in Brazil.
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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 May 2022. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thais C Chaves, PhD (+55 (16) 3602-4694, chavestc@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity: Numeric pain rating scale (NPRS) (time frame: Post-intervention). The study lists 2 primary outcomes in all. 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 NCT04518891, which also lists 2 linked publications.
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 10 May 2022; AzTrials last refreshed its copy on 30 Oct 2026.