- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Thátira Camilo, PhD student
- Número de teléfono: +5528999696872
- Correo electrónico: thatirabalestrero@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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. |
|
Comparador falso: 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.
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Disability on ODI
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain Intensity (NPRS)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 12 weeks, 24 weeks
|
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome
|
12 weeks, 24 weeks
|
|
Depression
Periodo de tiempo: 12 weeks, 24 weeks
|
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
|
12 weeks, 24 weeks
|
|
Catastrophization
Periodo de tiempo: 12 weeks, 24 weeks
|
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
|
12 weeks, 24 weeks
|
|
Fear of movement
Periodo de tiempo: 12 weeks, 24 weeks
|
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
|
12 weeks, 24 weeks
|
|
Social isolation
Periodo de tiempo: 12 weeks, 24 weeks
|
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
|
12 weeks, 24 weeks
|
|
Stress
Periodo de tiempo: 12 weeks, 24 weeks
|
Brief Psychosocial Questions (0-10), higher scores mean a worse outcome.
|
12 weeks, 24 weeks
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Complicaciones Postoperatorias
- Procesos Patológicos
- Manifestaciones neuroconductuales
- Trastornos de la percepción
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dolor de espalda
- Dolor crónico
- Lumbalgia
- Agnosia
- Síndrome de cirugía de espalda fallida
Otros números de identificación del estudio
- CFT_SHAM_SURG
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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