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Набор скоро начнётся NCT07576062

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

Без фазы С лечением Chronic Low Back Pain After Lumbar Spine Surgery Failed Back Surgery Syndrome (FBSS)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: CFT, Sham Detuned Photobiomodulation.
Кому может быть актуально
Состояния в реестре: Chronic Low Back Pain, After Lumbar Spine Surgery, Failed Back Surgery Syndrome (FBSS). Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

  • Поведенческое 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 pro
  • Устройство 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 maladapti

Первичные конечные точки

  • Disability on ODI [Срок оценки: 12 weeks]
Вторичные конечные точки (9)
  • Pain Intensity (NPRS) [Срок оценки: 12 weeks, 24 weeks]
  • Sleep Disturbance [Срок оценки: 12 weeks, 24 weeks]
  • Disability on ODI [Срок оценки: 24 weeks]
  • Anxiety [Срок оценки: 12 weeks, 24 weeks]
  • Depression [Срок оценки: 12 weeks, 24 weeks]
  • Catastrophization [Срок оценки: 12 weeks, 24 weeks]
  • Fear of movement [Срок оценки: 12 weeks, 24 weeks]
  • Social isolation [Срок оценки: 12 weeks, 24 weeks]
  • Stress [Срок оценки: 12 weeks, 24 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Avila L, da Silva MD, Neves ML, Abreu AR, Fiuza CR, Fukusawa L, de Sa Ferreira A, 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. Phys Ther. 2024 Jan 1;104(1):pzad105. doi: 10.1093/ptj/pzad105. PMID 37548608
  • de Lira MR, de Mello Meziat-Filho NA, Silva GZM, Chaves TC. 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. 2022 Jul 4;23(1):544. doi: 10.1186/s13063-022-06466-8. PMID 35788240
  • 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 40049758
  • Garcia AN, Costa LDCM, Hancock MJ, Souza FS, Gomes GVFO, Almeida MO, Costa LOP. 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. Br J Sports Med. 2018 May;52(9):594-600. doi: 10.1136/bjsports-2 PMID 28701365
  • Hancock M, Smith A, O'Sullivan P, Schutze R, Caneiro JP, Laird R, O'Sullivan K, Hartvigsen J, Campbell A, Wareham D, Chang R, Kent P. Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain (RESTORE): 3-year follow-up of a randomised, controlled trial. Lancet Rheumatol. 2025 Nov;7(11):e789-e798. doi: 10.1016/S2665-9913(25)0013 PMID 40780241
  • 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). Br J Sports Med. 2020 Jul;54(13):782-789. doi: 10.1136/bjsports-2019-100780. Epub 2019 Oct 19. PMID 31630089
  • O'Sullivan P, Caneiro JP, O'Keeffe M, O'Sullivan K. Unraveling the Complexity of Low Back Pain. J Orthop Sports Phys Ther. 2016 Nov;46(11):932-937. doi: 10.2519/jospt.2016.0609. PMID 27802794
  • 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 Dec 6;104(12):pzae128. doi: 10.1093/ptj/pzae128. PMID 39236249

Идентификаторы

NCT: NCT07576062 · CFT_SHAM_SURG

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗