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

3 maja 2026 zaktualizowane przez: Centro Universitário Augusto Motta

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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).

Typ studiów

Interwencyjne

Zapisy (Szacowany)

90

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.
Pozorny komparator: 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.
Urządzenie: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Disability on ODI
Ramy czasowe: 12 weeks

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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Pain Intensity (NPRS)
Ramy czasowe: 12 weeks, 24 weeks

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
Ramy czasowe: 12 weeks, 24 weeks
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
Ramy czasowe: 24 weeks
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
Ramy czasowe: 12 weeks, 24 weeks
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
12 weeks, 24 weeks
Depression
Ramy czasowe: 12 weeks, 24 weeks
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
12 weeks, 24 weeks
Catastrophization
Ramy czasowe: 12 weeks, 24 weeks
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
12 weeks, 24 weeks
Fear of movement
Ramy czasowe: 12 weeks, 24 weeks
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
12 weeks, 24 weeks
Social isolation
Ramy czasowe: 12 weeks, 24 weeks
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
12 weeks, 24 weeks
Stress
Ramy czasowe: 12 weeks, 24 weeks
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
12 weeks, 24 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Centro Universitário Augusto Motta

Współpracownicy

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

  • 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.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 maja 2026

Zakończenie podstawowe (Szacowany)

1 maja 2027

Ukończenie studiów (Szacowany)

1 listopada 2027

Daty rejestracji na studia

Pierwszy przesłany

3 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 maja 2026

Pierwszy wysłany (Rzeczywisty)

8 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

8 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 maja 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CFT_SHAM_SURG

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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