Body Awareness Therapy and Biomarkers in Fibromyalgia

Официальное название

Effectiveness of a Rehabilitation Programme Based on Lifestyle Changes and Self-care in Patients Diagnosed With Fibromyalgia: Neuroinflammatory and Neuropsychological Biomarkers.

Обзор

A randomized trial of Basic Body Awareness Therapy (BBAT) is applied in fibromyalgia patients as compared with a control intervention consisting of stretching. Sessions of BBAT lasted 90 min each and took place twice a week form 12 weeks. The primary end point is a change in the biomarkers and neurotransmitters and the Fibromyalgia Impact Questionnaire and the secondary end points include Visual Analog Scale, State Trait Anxiety inventory, Beck Depression Inventory. All assessments will be repeated at post treatment, 12 and 24 weeks and 1 year follow-up.

Подробное описание

This work is a clinical trial of randomized and controlled groups. The hypothesis of study is that BBAT applied in patients with fibromyalgia improves, more than stretching exercises, the pain, normalization biomarkers, improve in psychological state and quality life.

The study population will be selected followed the inclusion criteria of fibromyalgia, and will be selected in Consorci Sociosanitari of Anoia, the patients will be divided in 2 groups, control and treatment group. The groups will be examined at the begin, at 2 weeks, at the end of treatment and 3, 6 and 12 months follow-up.

The dependence measurements will be biomarkers serotonin, dopamine and cortisol, also Visual Analog Scale, State Trait Anxiety Inventory (STAI A/R), Beck Depression Inventory (BDI-II) and Fibromyalgia Impact Questionnaire (FIQ). The independence measurements will be demographic items: sex, age, country, level of studies, social status...

Вмешательства

• Другое Basic Body Awareness Therapy
  The intervention will be twice a week during 12 weeks. It lasts 90 min of movements of daily life, massage and self-reflections.
• Другое Stretching Exercise
  It consists in stretching movements of whole body

Первичные конечные точки

• Serotonin [Срок оценки: through study completion, an average of 1 year]
• cortisol [Срок оценки: during the procedure]

Вторичные конечные точки (4)

• Visual Analog Scale (VAS) [Срок оценки: through study completion, an average of 1 year]
• Fibromyalgia Impact Questionnaire (FIQ) [Срок оценки: through study completion, an average of 1 year]
• Beck Depression Inventory- II (BDI-II) [Срок оценки: through study completion, an average of 1 year]
• State Trait Anxiety Inventory (STAI) [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• whose diagnosed of fibromyalgia almost 6 months before
• whose could be in different position such as lying, sitting, and stand-up

Критерии исключения

• whose are diagnosed of disease that it worse the pain
• pregnancy
• whose are diagnosed of other disease such as rheumatology, neurology, cardiac problems o another internal medical condition,malignant disease or acute infections

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

• Consorci Sanitari de l'Anoia — Igualada
• Cristina Bravo Navarro — Igualada

Публикации

• Busch AJ, Webber SC, Brachaniec M, Bidonde J, Bello-Haas VD, Danyliw AD, Overend TJ, Richards RS, Sawant A, Schachter CL. Exercise therapy for fibromyalgia. Curr Pain Headache Rep. 2011 Oct;15(5):358-67. doi: 10.1007/s11916-011-0214-2. PMID 21725900
• Atasever M, Namli Kalem M, Sonmez C, Seval MM, Yuce T, Sahin Aker S, Koc A, Genc H. Lower serotonin level and higher rate of fibromyalgia syndrome with advancing pregnancy. J Matern Fetal Neonatal Med. 2017 Sep;30(18):2204-2211. doi: 10.1080/14767058.2016.1243096. Epub 2016 Nov 29. PMID 27696917
• Bravo C, Skjaerven LH, Espart A, Guitard Sein-Echaluce L, Catalan-Matamoros D. Basic Body Awareness Therapy in patients suffering from fibromyalgia: A randomized clinical trial. Physiother Theory Pract. 2019 Oct;35(10):919-929. doi: 10.1080/09593985.2018.1467520. Epub 2018 May 3. PMID 29723080
• Bravo C, Skjaerven LH, Guitard Sein-Echaluce L, Catalan-Matamoros D. Effectiveness of movement and body awareness therapies in patients with fibromyalgia: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2019 Oct;55(5):646-657. doi: 10.23736/S1973-9087.19.05291-2. Epub 2019 May 15. PMID 31106558
• Coppieters I, Cagnie B, Nijs J, van Oosterwijck J, Danneels L, De Pauw R, Meeus M. Effects of Stress and Relaxation on Central Pain Modulation in Chronic Whiplash and Fibromyalgia Patients Compared to Healthy Controls. Pain Physician. 2016 Mar;19(3):119-30. PMID 27008285

Идентификаторы

NCT: NCT05555394 · 04 University of Lleida

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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