Efficacy of Cognitive Functional Therapy in Individuals With Chronic Low Back Pain After Spinal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CFT, Sham Detuned Photobiomodulation.
- Who it may be relevant to
- Registry conditions: Chronic Low Back Pain, After Lumbar Spine Surgery, Failed Back Surgery Syndrome (FBSS). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of Cognitive Functional Therapy in Individuals With Chronic Low Back Pain After Spinal Surgery: A Randomized, Sham-Controlled Trial
Overview
Chronic low back pain after spinal surgery is a complex and disabling condition influenced by biopsychosocial factors. Cognitive Functional Therapy (CFT) is a promising intervention targeting these multidimensional aspects. This randomized, sham-controlled trial aims to compare the efficacy of CFT versus a sham intervention (detuned photobiomodulation) in participants with chronic low back pain after spinal surgery.
Detailed description
Cognitive Functional Therapy (CFT) is a multidimensional intervention based on the biopsychosocial nature of chronic pain. The intervention comprises three main components: (1) making sense of pain, (2) exposure with control, and (3) lifestyle changes. The trial will be conducted at a private outpatient clinic located in Cachoeiro de Itapemirim, Espírito Santo, Brazil. A total of 90 participants of both sexes with chronic low back pain after spinal surgery will be randomly allocated to one of two intervention groups: (I) the CFT group (n = 45) and (II) the sham group (n = 45). Participants will attend one session per week for a period of 12 weeks. The primary outcome will be disability, measured using the Oswestry Disability Index (ODI; 0-100).
Interventions
- Behavioral CFT
Participants will receive up to eight sessions of Cognitive Functional Therapy (CFT), each lasting 50 minutes, delivered once per week over a maximum of 12 weeks; the first session will last 60 minutes. Weekly reminders will be provided to enhance adherence. All participants will receive an educational booklet addressing chronic pain, maladaptive beliefs, and unhelpful pain-related behaviors. The intervention includes individualized strategies aimed at improving pain understanding, reducing pro - Device Sham Detuned Photobiomodulation
A detuned photobiomodulation device (infrared DMC 904 nm, non-visible beam) will be used, delivering no therapeutic dose (0 J). Applications will be performed at standardized points in the lumbar region, including central points over the spinous processes and bilateral paravertebral regions, without active energy delivery. Each session will last 27 minutes, totaling eight sessions per participant. Additionally, participants will receive at least 15 minutes of neutral talking, in which maladapti
Primary outcome measures
- Disability on ODI [Time frame: 12 weeks]
Secondary outcome measures (9)
- Pain Intensity (NPRS) [Time frame: 12 weeks, 24 weeks]
- Sleep Disturbance [Time frame: 12 weeks, 24 weeks]
- Disability on ODI [Time frame: 24 weeks]
- Anxiety [Time frame: 12 weeks, 24 weeks]
- Depression [Time frame: 12 weeks, 24 weeks]
- Catastrophization [Time frame: 12 weeks, 24 weeks]
- Fear of movement [Time frame: 12 weeks, 24 weeks]
- Social isolation [Time frame: 12 weeks, 24 weeks]
- Stress [Time frame: 12 weeks, 24 weeks]
Eligibility criteria
Inclusion criteria
- Age 18-75 years
- Chronic low back pain ≥12 weeks
- History of lumbar surgery ≥3 months
- Pain intensity ≥3 (NPRS)
- ODI ≥14%
Exclusion criteria
- Serious spinal pathology
- Neurological disorders
- Radiculopathy
- Pregnancy
- Unstable cardiac conditions
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Avila L, da Silva MD, Neves ML, Abreu AR, Fiuza CR, Fukusawa L, de Sa Ferreira A, Meziat-Filho N. Effectiveness of Cognitive Functional Therapy Versus Core Exercises and Manual Therapy in Patients With Chronic Low Back Pain After Spinal Surgery: Randomized Controlled Trial. Phys Ther. 2024 Jan 1;104(1):pzad105. doi: 10.1093/ptj/pzad105. PMID 37548608
- de 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 35788240
- 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 40049758
- Garcia AN, Costa LDCM, Hancock MJ, Souza FS, Gomes GVFO, Almeida MO, Costa LOP. McKenzie Method of Mechanical Diagnosis and Therapy was slightly more effective than placebo for pain, but not for disability, in patients with chronic non-specific low back pain: a randomised placebo controlled trial with short and longer term follow-up. Br J Sports Med. 2018 May;52(9):594-600. doi: 10.1136/bjsports-2 PMID 28701365
- Hancock M, Smith A, O'Sullivan P, Schutze R, Caneiro JP, Laird R, O'Sullivan K, Hartvigsen J, Campbell A, Wareham D, Chang R, Kent P. Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain (RESTORE): 3-year follow-up of a randomised, controlled trial. Lancet Rheumatol. 2025 Nov;7(11):e789-e798. doi: 10.1016/S2665-9913(25)0013 PMID 40780241
- O'Keeffe M, O'Sullivan P, Purtill H, Bargary N, O'Sullivan K. Cognitive functional therapy compared with a group-based exercise and education intervention for chronic low back pain: a multicentre randomised controlled trial (RCT). Br J Sports Med. 2020 Jul;54(13):782-789. doi: 10.1136/bjsports-2019-100780. Epub 2019 Oct 19. PMID 31630089
- O'Sullivan P, Caneiro JP, O'Keeffe M, O'Sullivan K. Unraveling the Complexity of Low Back Pain. J Orthop Sports Phys Ther. 2016 Nov;46(11):932-937. doi: 10.2519/jospt.2016.0609. PMID 27802794
- Thiveos L, Kent P, Pocovi NC, O'Sullivan P, Hancock MJ. Cognitive Functional Therapy for Chronic Low Back Pain: A Systematic Review and Meta-Analysis. Phys Ther. 2024 Dec 6;104(12):pzae128. doi: 10.1093/ptj/pzae128. PMID 39236249
Identifiers
NCT: NCT07576062 · CFT_SHAM_SURG