Efficacy of Cognitive Functional Therapy in Individuals With Chronic Low Back Pain After Spinal Surgery

Efficacy of Cognitive Functional Therapy in Individuals With Chronic Low Back Pain After Spinal Surgery: A Randomized, Sham-Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Low Back Pain; Failed Back Surgery Syndrome (FBSS); After Lumbar Spine Surgery
• Intervention / Treatment: Behavioral: CFT; Device: Sham Detuned Photobiomodulation

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).

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thátira Camilo, PhD student; Phone Number: +5528999696872; Email: thatirabalestrero@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Functional Therapy (CFT); 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.	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 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.
Sham Comparator: Sham Detuned Photobiomodulation; 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.	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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity (NPRS)	The Numeric Pain Rating Scale (NPRS), which will be administered verbally in this study in the form of an interview at the time of assessment, is a unidimensional measure that is easy to apply across different cultures and languages, and has been validated for assessing pain intensity in adults. It consists of 11 integer points ranging from 0 to 10, where 0 represents "no pain" and 10 represents "the worst imaginable pain" (Childs, Piva, & Fritz, 2005). Lower NPRS scores indicate lower pain intensity, which can be qualitatively classified as mild (1-3 points), moderate (4-6 points), and severe (7-10 points).	12 weeks, 24 weeks
Sleep Disturbance	The outcome related to sleep disturbance will be extracted from this inventory (Eriksen, Ihlebæk, & Ursin, 1999). This variable will be assessed using the question: "Have you had problems with sleep in the past month?" Based on the Subjective Health Complaints Inventory, response options range from "none" = 0, "a little" = 1, "some" = 2, and "severe" = 3.	12 weeks, 24 weeks
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.	24 weeks
Anxiety	Brief Psychosocial Questions (0-10), higher scores mean a worse outcome	12 weeks, 24 weeks
Depression	Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.	12 weeks, 24 weeks
Catastrophization	Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.	12 weeks, 24 weeks
Fear of movement	Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.	12 weeks, 24 weeks
Social isolation	Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.	12 weeks, 24 weeks
Stress	Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.	12 weeks, 24 weeks

Collaborators and Investigators

• Sponsor: Centro Universitário Augusto Motta
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Publications and helpful links

General Publications

• AVILA, L.; SILVA, M. D.; NEVES, M. L.; ABREU, A. R.; FIUZA, C. R.; FUKUSAWA, L.; FERREIRA, A. S.; 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. Physical Therapy, [S.L.], v. 104, n. 1, p. 1-9, ago. 2023.
• DE LIRA, M. R.; DE MELLO MEZIAT-FILHO, N. A.; SILVA, G. Z. M.; CHAVES, T. C. 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, v. 23, n. 1, p.544, jul. 2022.
• 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, A. N.; COSTA, L. C. M.; HANCOCK, M. J; SOUZA, F. S.; GOMES, G. V. F. O.; ALMEIDA, M. O.; COSTA, L. O. P. 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. British Journal Of Sports Medicine, [S.L.], v. 52, n. 9, p. 594-600, jul. 2017.
• KENT, P. et al. Long-term outcomes of cognitive functional therapy with or without movement sensor biofeedback for chronic disabling low back pain (RESTORE 3-year follow-up): a randomised controlled trial. The Lancet Rheumatology, v. 7, n. 2, p. e121-e131, 2025.
• 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). British Journal Of Sports Medicine, [S.L.], v. 54, n. 13, p. 782-789, out. 2019.
• O'SULLIVAN, P.; CANEIRO, J. P.; O'KEEFFE, M.; O'SULLIVAN, K. Unraveling the Complexity of Low Back Pain. Journal Of Orthopaedic & Sports Physical Therapy, [S.L.], v. 46, n. 11, p. 932-937, nov. 2016.
• 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 .
• TOMAZONI, S. S.; COSTA, L. C. M.; GUIMARÃES, L. S.; ARAUJO, A. C.; NASCIMENTO, D. P.; MEDEIROS, F. C.; AVANZI, M. A.; COSTA, L. O. P. Effects of 48 photobiomodulation therapy in patients with chronic non-specific low back pain: protocol for a randomised placebo-controlled trial. Bmj Open, [S.L.], v. 7, n. 10, p. e017202, out. 2017.
• TREEDE, R. D., RIEF, W., BARKE, A., AZIZ, Q., BENNETT, M. I., BENOLIEL, R., COHEN, M., EVERS, S., FINNERUP, N. B., FIRST, M. B., GIAMBERARDINO, M. A., KAASA, S., KORWISI, B., KOSEK, E., LAVAND'HOMME, P., NICHOLAS, M., PERROT, S., SCHOLZ, J., SCHUG, S., ... WANG, S.-J. (2019). Chronic pain as a symptom or a disease: The IASP classification of chronic pain for the International Classification of Diseases (ICD-11). Pain, 160(1), 19-27. https://doi.org/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. International Journal Of Nursing Studies, [S.L.], v. 151, p. 104679, mar. 2024.
• DEVONSHIRE, J. J.; WEWEGE, M. A.; HANSFORD, H. J.; ODEMIS, H. A.; WAND, B. M.; JONES, M. D.; MCAULEY, J. H. Effectiveness of Cognitive Functional Therapy in reducing pain and disability in chronic low back pain: a systematic review and meta-analysis. Journal of Orthopaedic & Sports Physical Therapy, v. 53, n. 5, p. 244-285, Apr. 2023.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: May 3, 2026
• First Submitted That Met QC Criteria: May 3, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: chronic pain; low back pain; back pain; Pain management; Placebo; Sham; Cognitive Functional Therapy; Spinal Surgery; Low-intensity light therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Back Pain; Chronic Pain; Low Back Pain; Agnosia; Failed Back Surgery Syndrome
• Other Study ID Numbers: CFT_SHAM_SURG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No