Body Awareness Therapy and Biomarkers in Fibromyalgia

Fibromyalgia Clinical Trial

— BATBF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555394
• Other study ID #: 04 University of Lleida
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: May 2024
• Source: Universitat de Lleida
• Contact: Cristina Bravo, PhD
• Phone: +34 656312125
• Email: cristina.bravo[@]udl.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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...

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: February 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• whose diagnosed of fibromyalgia almost 6 months before

• whose could be in different position such as lying, sitting, and stand-up

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• 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.
• Stretching Exercise
It consists in stretching movements of whole body

Locations

Country	Name	City	State
Spain	Consorci Sanitari de l'Anoia	Igualada	Barcelona
Spain	Cristina Bravo Navarro	Igualada	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Universitat de Lleida	Consorci Sanitari de l'Anoia

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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):119-3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serotonin	Neurotransmitter neurologic	through study completion, an average of 1 year
Primary	cortisol	acute hormone relating stress	during the procedure
Secondary	Visual Analog Scale (VAS)	Assess of subjective pain of patient. It consists in a number between 0 to 10	through study completion, an average of 1 year
Secondary	Fibromyalgia Impact Questionnaire (FIQ)	Questionnaire about the impact of symptoms of Fibromyalgia in daily life. It measures 21 items with a total score between 0 to 100. The main average is 50.	through study completion, an average of 1 year
Secondary	Beck Depression Inventory- II (BDI-II)	Questionnaire for assess the depression of patient. It consists in 21 items with scale ranking from 0-3 with a total score from 0-63. A score between 10-18 corresponds to mild to moderate depression, further than 30 corresponds to severe depression	through study completion, an average of 1 year
Secondary	State Trait Anxiety Inventory (STAI)	Questionnaire for assess the anxiety of patient. It consists in 20 questions that score range from 20 to 80. The higher scores correlating with greater anxiety. The questionnaire provide information about state (how a person is feeling at the time) and trait (how people feel across typical situations that everyone experiences on a daily basis)	through study completion, an average of 1 year