Cognitive Functional Therapy Compared With Sham-treatment for Low Back Pain
Efficacy of the Cognitive Functional Therapy (CFT) in Patients With Chronic Nonspecific Low Back Pain: a Study Protocol for a Randomized Sham-controlled Trial
1 other identifier
interventional
152
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2020
CompletedFirst Posted
Study publicly available on registry
August 19, 2020
CompletedStudy Start
First participant enrolled
May 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMay 10, 2022
May 1, 2022
2 years
August 15, 2020
May 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Post-intervention
Secondary Outcomes (5)
Pain intensity: Numeric pain rating scale (NPRS)
3 and 6 months after randomization
Low Back Pain Related Disability: Oswestry Disability Index (ODI)
3 and 6 months after randomization
Pain Self-Efficacy: Pain Self-Efficacy Questionnaire (PSEQ)
Post-intervention, 3 and 6 months after randomization
Global perceived effect: Global Perceived Effect Scale (GPES)
Post-intervention, 3 and 6 months after randomization
Function: Patient Specific Functional Scale (PSFS)
Post-intervention, 3 and 6 months after randomization
Other Outcomes (5)
Expactation: Standford ExpectationTreatment Scale (SETS)
Baseline
Depression: Patient Health Questionnaire 9-item (PHQ-9)
Baseline
Anxiety: Generalized Anxiety Disorder 7-item scale (GAD7)
Baseline
- +2 more other outcomes
Study Arms (2)
Cognitive Functional Therapy (CFT) Group
EXPERIMENTALThere 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 COMPARATORPlacebo 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.
Interventions
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.
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)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Sao Paulo
Ribeirão Preto, São Paulo, 14049-900, Brazil
Related Publications (2)
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.
PMID: 40049758DERIVEDde 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.
PMID: 35788240DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariana R Lira, Master
- STUDY DIRECTOR
Ney A Meziat, PhD
Augusto Motta University Center (UNISUAM)
- STUDY DIRECTOR
Thais C Chaves, PhD
University of Sao Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
August 15, 2020
First Posted
August 19, 2020
Study Start
May 17, 2021
Primary Completion
June 1, 2023
Study Completion
December 1, 2023
Last Updated
May 10, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share