Cognitive Functional Therapy Compared With Sham-treatment for Low Back Pain
Unknown statusNot applicableNCT04518891
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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…
Study details
- 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
- Conditions
- Interventions
- Behavioral: Cognitive Functional Therapy (CFT)
- Device: Sham intervention
- Sponsor
- University of Sao Paulo
- Start date
- 2021-05-17
- Primary completion
- 2023-06
- Sex
- All
- Age range
- from 18 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- Brazil
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04518891