NCT07576062|Not Yet Recruiting
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Sponsor study identifier
interventional
90
0 countries
N/A
Study Start
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 3, 2026
Actual (reported)May 8, 2026
Actual (reported)May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Disability on ODI
Disability due to low back pain (LBP), assessed using the Oswestry Disability Index (ODI; 0-100) at post-treatment (12 weeks), will be the primary outcome measure. The ODI was originally developed by Fairbank et al. (1980) and consists of 10 items, each with six response options. The version adapted and validated for Brazilian Portuguese was proposed by Vigatto et al. (2007). The total score will be calculated by summing the items, with a maximum score of 50 points, which is subsequently converted into a percentage (0 to 100), with higher scores indicating greater functional disability.
12 weeks
Pain Intensity (NPRS)
12 weeks, 24 weeks
Sleep Disturbance
Participants allocated to this group will receive Cognitive Functional Therapy (CFT), a physiotherapy-led intervention targeting pain-related behaviors, beliefs, and functional limitations. The program includes individualized sessions focusing on making sense of pain, exposure with control, and lifestyle changes. Sessions will be delivered weekly over a period of up to 12 weeks. The physiotherapist--researcher has completed more than 80 hours of training, including in--person and online courses, supervisions and interactive case discussions with feedback by physical therapists with more than 10 years of clinical experience using CFT in Brazil.
Participants allocated to this group will receive sham photobiomodulation combined with neutral talking. The intervention is designed to control for non-specific effects such as therapist attention and interaction, without delivering an active intervention. Sessions will be conducted weekly over the study period.
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 protective behaviors, promoting functional movement, and supporting lifestyle changes. The program also incorporates strategies for autonomous management of symptom exacerbations. The fidelity of the CFT intervention will be monitored through recorded sessions throughout the clinical trial. Recordings will be made for every seven participants allocated to the CFT group. Three researchers with expertise in the CFT will watch the recorded videos and provide feedback to the treating physiotherapist.
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.
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.
First Submitted
May 3, 2026
First Posted
May 8, 2026
Study Start
12 weeks, 24 weeks
Disability on ODI
24 weeks
Anxiety
12 weeks, 24 weeks
Depression
12 weeks, 24 weeks
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 maladaptive beliefs will not be challenged. The therapist will maintain an empathetic and engaging posture while encouraging discussion of neutral topics (e.g., hobbies, sports, current events), without providing advice or problem-solving. Pain-related or emotional discussions will be gently redirected. 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.
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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.
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-2016-097327. Epub 2017 Jul 12.
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)00135-3. Epub 2025 Aug 6.
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.
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.
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.
Tomazoni SS, Costa LDCM, Guimaraes LS, Araujo AC, Nascimento DP, Medeiros FC, Avanzi MA, Costa LOP. Effects of photobiomodulation therapy in patients with chronic non-specific low back pain: protocol for a randomised placebo-controlled trial. BMJ Open. 2017 Oct 24;7(10):e017202. doi: 10.1136/bmjopen-2017-017202.
Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Korwisi B, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. Chronic pain as a symptom or a disease: the IASP Classification of Chronic Pain for the International Classification of Diseases (ICD-11). Pain. 2019 Jan;160(1):19-27. doi: 10.1097/j.pain.0000000000001384.
Zhang J, Jiang N, Xu H, Wu Y, Cheng S, Liang B. Efficacy of cognitive functional therapy in patients with low back pain: A systematic review and meta-analysis. Int J Nurs Stud. 2024 Mar;151:104679. doi: 10.1016/j.ijnurstu.2023.104679. Epub 2023 Dec 28.
Devonshire JJ, Wewege MA, Hansford HJ, Odemis HA, Wand BM, Jones MD, McAuley JH. Effectiveness of Cognitive Functional Therapy for Reducing Pain and Disability in Chronic Low Back Pain: A Systematic Review and Meta-analysis. J Orthop Sports Phys Ther. 2023 May;53(5):244-285. doi: 10.2519/jospt.2023.11447.
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 8, 2026
Record last verified: 2026-04
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