- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07576062
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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Thátira Camilo, PhD student
- Numero di telefono: +5528999696872
- Email: thatirabalestrero@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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. |
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Comparatore fittizio: 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.
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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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Disability on ODI
Lasso di tempo: 12 weeks
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pain Intensity (NPRS)
Lasso di tempo: 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
Lasso di tempo: 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
|
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Disability on ODI
Lasso di tempo: 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
|
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Anxiety
Lasso di tempo: 12 weeks, 24 weeks
|
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
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12 weeks, 24 weeks
|
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Depression
Lasso di tempo: 12 weeks, 24 weeks
|
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
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12 weeks, 24 weeks
|
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Catastrophization
Lasso di tempo: 12 weeks, 24 weeks
|
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
|
12 weeks, 24 weeks
|
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Fear of movement
Lasso di tempo: 12 weeks, 24 weeks
|
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
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12 weeks, 24 weeks
|
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Social isolation
Lasso di tempo: 12 weeks, 24 weeks
|
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
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12 weeks, 24 weeks
|
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Stress
Lasso di tempo: 12 weeks, 24 weeks
|
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
|
12 weeks, 24 weeks
|
Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Dolore
- Manifestazioni neurologiche
- Malattie del sistema nervoso
- Complicanze postoperatorie
- Processi patologici
- Manifestazioni neurocomportamentali
- Disturbi percettivi
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Mal di schiena
- Dolore cronico
- Lombalgia
- Agnosi
- Sindrome da fallimento dell'intervento chirurgico alla schiena
Altri numeri di identificazione dello studio
- CFT_SHAM_SURG
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .