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Набор скоро начнётся NCT07504094

Active Coping: Interdisciplinary Program for Chronic Pain, Physiotherapy Unit (Spain)

Без фазы С лечением Chronic Back Pain Chronic Pain Back Pain Low Back Pain, Chronic

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: Pain Neuroscience Education (PNE), Healthy Habits and Psychological Intervention, Therapeutic Exercise.
Кому может быть актуально
Состояния в реестре: Chronic Back Pain, Chronic Pain, Back Pain, Low Back Pain, Chronic. Базовые параметры: от 18 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
Испания
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

Interdisciplinary Active Coping Program for Chronic Pain in the Physiotherapy Unit in Primary Care - Teruel Health Sector (Aragón, Spain)

Обзор

The goal of this observational intervention study is to evaluate the impact of a multidisciplinary active coping program for chronic back pain in adults referred from Primary Care to the Physiotherapy Unit of Teruel Ensanche. The main questions it aims to answer are: * Does the program improve physical function, measured through gait speed, balance, and chair stand tests? * Does it reduce pain-related psychological factors such as kinesiophobia, catastrophizing, anxiety, and depression? * Does it improve quality of life and sleep quality, and reduce analgesic medication use? Participants will attend group sessions on pain neuroscience education, followed by sessions on healthy habits, nutrition and sleep hygiene and group psychological intervention focused on emotional wellbeing tools, and will complete therapeutic exercise sessions over the course of the program. They will also complete validated questionnaires and physical assessments at three timepoints: at baseline, at the end of the program, and at a 6-month follow-up.

Вмешательства

  • Поведенческое Pain Neuroscience Education (PNE)
    Group sessions led by primary care physicians aimed at shifting participants' understanding of chronic pain mechanisms, reducing unhelpful beliefs about pain and movement, and promoting active coping strategies. Knowledge is assessed before and after sessions using a validated survey. Timing: March 2026
  • Поведенческое Healthy Habits and Psychological Intervention
    Group sessions addressing nutrition and sleep hygiene, combined with group and individual psychological sessions focused on emotional wellbeing and coping tools for chronic pain management. Timing: April 2026
  • Поведенческое Therapeutic Exercise
    Timing: May-June 2026 Description: Progressive group therapeutic exercise sessions led by physiotherapists, targeting physical function, balance, gait speed, and strength in participants with chronic back pain.

Первичные конечные точки

  • Change from Baseline in Health-Related Quality of Life as Measured by the SF-36 v2 at End of Program and 6-Month Follow-Up [Срок оценки: Baseline, end of program, 6-month follow-up]
Вторичные конечные точки (12)
  • Change from Baseline in Functional Disability as Measured by the Roland-Morris Disability Questionnaire at End of Program and 6-Month Follow-Up [Срок оценки: Baseline, end of program, 6-month follow-up]
  • Change from Baseline in Physical Performance as Measured by the Short Physical Performance Battery (SPPB) at End of Program and 6-Month Follow-Up [Срок оценки: Baseline, end of program, 6-month follow-up]
  • Change from Baseline in Dynamic Balance as Measured by the Timed Up and Go Test (TUG) at End of Program and 6-Month Follow-Up [Срок оценки: Baseline, end of program, 6-month follow-up]
  • Change from Baseline in Lower Limb Strength and Balance as Measured by the 30-Second Sit-to-Stand Test at End of Program and 6-Month Follow-Up [Срок оценки: Baseline, end of program, 6-month follow-up]
  • Change from Baseline in Gait Speed and Exercise Tolerance as Measured by the 6-Minute Walk Test at End of Program and 6-Month Follow-Up [Срок оценки: Baseline, end of program, 6-month follow-up]
  • Change from Baseline in Kinesiophobia as Measured by the Tampa Scale for Kinesiophobia (TSK-11SV) at End of Program and 6-Month Follow-Up [Срок оценки: Baseline, end of program, 6-month follow-up]
  • Change from Baseline in Pain Catastrophizing as Measured by the Pain Catastrophizing Scale (ECD) at End of Program and 6-Month Follow-Up [Срок оценки: Baseline, end of program, 6-month follow-up]
  • Change from Baseline in Central Sensitization Symptoms as Measured by the Central Sensitization Inventory (CSI) at End of Program and 6-Month Follow-Up [Срок оценки: Baseline, end of program, 6-month follow-up]
  • Change from Baseline in Analgesic and Co-adjuvant Medication Use as Recorded by Medication Registry at End of Program and 6-Month Follow-Up [Срок оценки: Baseline, end of program, 6-month follow-up]
  • Change from Baseline in Frequency of Primary Care Consultations (Medical and Physiotherapy) at End of Program and 6-Month Follow-Up [Срок оценки: Baseline, end of program, 6-month follow-up]
  • Change from Baseline in Anxiety as Measured by the State-Trait Anxiety Inventory (STAI) at End of Program and 6-Month Follow-Up [Срок оценки: Baseline, end of program, 6-month follow-up]
  • Change from Baseline in Depressive Symptoms as Measured by the Beck Depression Inventory II (BDI-II) at End of Program and 6-Month Follow-Up [Срок оценки: Baseline, end of program, 6-month follow-up]

Критерии участия

Критерии включения

  • Adult (18 years or older)
  • Diagnosis of non-oncological chronic back pain
  • Referred from Primary Care to the Physiotherapy Unit of Teruel Ensanche . (UFAP) from one of the following basic health zones: Teruel Centro, Teruel Ensanche, Albarracín, Alfambra, Cella, or Villel
  • Able to provide voluntary written informed consent

Критерии исключения

  • Oncological pain
  • Cognitive impairment that prevents following the program
  • Spinal surgery in the last year
  • Internal electrostimulator device (e.g. pacemaker, spinal cord stimulator)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Испания · 2 центра
  • CS Teruel Centro — Teruel
  • Centro de Salud Teruel Ensanche — Teruel

Публикации

  • Louw A, Riera-Gilley V. Pain Neuroscience Education: Teaching People About Pain. J Pain Palliat Care Pharmacother. 2024 Sep;38(3):292-301. doi: 10.1080/15360288.2024.2424853. Epub 2024 Nov 11. PMID 39526886
  • Geneen LJ, Moore RA, Clarke C, Martin D, Colvin LA, Smith BH. Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2017 Apr 24;4(4):CD011279. doi: 10.1002/14651858.CD011279.pub3. PMID 28436583
  • Galan-Martin MA, Montero-Cuadrado F, Lluch-Girbes E, Coca-Lopez MC, Mayo-Iscar A, Cuesta-Vargas A. Pain Neuroscience Education and Physical Therapeutic Exercise for Patients with Chronic Spinal Pain in Spanish Physiotherapy Primary Care: A Pragmatic Randomized Controlled Trial. J Clin Med. 2020 Apr 22;9(4):1201. doi: 10.3390/jcm9041201. PMID 32331323

Идентификаторы

NCT: NCT07504094 · C.I.PI26/047

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗