NCT07576062

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started May 2026

Status
not yet recruiting

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

Study Progress1%
May 2026Nov 2027

Study Start

First participant enrolled

May 1, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

May 8, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

May 3, 2026

Last Update Submit

May 3, 2026

Conditions

Chronic Low Back PainAfter Lumbar Spine SurgeryFailed Back Surgery Syndrome (FBSS)

Keywords

Cognitive Functional TherapySpinal SurgeryLow-intensity light therapyPlaceboPain managementback painchronic painlow back painSham

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Pain Intensity (NPRS)

    12 weeks, 24 weeks

  • Sleep Disturbance

    12 weeks, 24 weeks

  • Disability on ODI

    24 weeks

  • Anxiety

    12 weeks, 24 weeks

  • Depression

    12 weeks, 24 weeks

  • +4 more secondary outcomes

Study Arms (2)

Cognitive Functional Therapy (CFT)

EXPERIMENTAL

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

Sham Detuned Photobiomodulation

SHAM COMPARATOR

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

Interventions

CFTBEHAVIORAL

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.

Cognitive Functional Therapy (CFT)
Sham Detuned PhotobiomodulationDEVICE

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.

Sham Detuned Photobiomodulation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years
  • Chronic low back pain ≥12 weeks
  • History of lumbar surgery ≥3 months
  • Pain intensity ≥3 (NPRS)
  • ODI ≥14%

You may not qualify if:

  • Serious spinal pathology
  • Neurological disorders
  • Radiculopathy
  • Pregnancy
  • Unstable cardiac conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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: 40049758BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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 .

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Failed Back Surgery SyndromeAgnosiaBack PainChronic PainLow Back Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Central Study Contacts

Thátira Camilo, PhD student

CONTACT

+5528999696872thatirabalestrero@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study will be a randomized, sham-controlled trial with concealed allocation, participant and assessor blinding, and analysis conducted according to the intention-to-treat principle. Patients will be evaluated at baseline, 12 weeks and 24 weeks after randomization. Immediately post intervention, participants will be asked if they received the sham or active intervention, as a means to confirm the blinding. The possible answers will be: 'sham', 'active treatment' or 'I don't know'. The James Blinding Index (JBI) and Cohen's kappa (k) will be used to statistically assess the success of blinding.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2026

First Posted

May 8, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

May 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share