Body Awareness Therapy and Biomarkers in Fibromyalgia

NCT05555394 | Recruiting DMC

• 1 other identifier: 04 University of Lleida
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Fibromyalgia

Keywords

Body awareness therapy; physical therapy; serotonin; cortisol

Outcome Measures

Primary Outcomes (2)

• Serotonin

  Neurotransmitter neurologic

  through study completion, an average of 1 year

• cortisol

  acute hormone relating stress

  during the procedure

Secondary Outcomes (4)

• Visual Analog Scale (VAS)

  through study completion, an average of 1 year

• Fibromyalgia Impact Questionnaire (FIQ)

  through study completion, an average of 1 year

• Beck Depression Inventory- II (BDI-II)

  through study completion, an average of 1 year

• State Trait Anxiety Inventory (STAI)

  through study completion, an average of 1 year

Study Arms (2)

Basic Body Awareness Therapy

EXPERIMENTAL

the Basic Body Awareness Therapy is usual therapy of physiotherapy in mental health in nord europe. BBAT is based in twelve movements and massage that improve the movements quality of patient, also improves other movement qualities like biomechanical, physiologic, socio-cultural and existential

Other: Basic Body Awareness Therapy

Stretching group

ACTIVE COMPARATOR

Stretching exercise will be developed in control group in order to blind the intervention of interest. It will consist in analytic stretching of trunk, upper and lower limb. It will last around 45 min twice a week during 12 weeks.

Other: Stretching Exercise

Interventions

Basic Body Awareness Therapy OTHER

The intervention will be twice a week during 12 weeks. It lasts 90 min of movements of daily life, massage and self-reflections.

Also known as: BBAT

Basic Body Awareness Therapy

Stretching Exercise OTHER

It consists in stretching movements of whole body

Stretching group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat de Lleida: lead
• Consorci Sanitari de l'Anoia: collaborator

Study Sites (2)

Consorci Sanitari de l'Anoia

Igualada, Barcelona, 08700, Spain

RECRUITING

Cristina Bravo Navarro

Igualada, Barcelona, 08700, Spain

RECRUITING

Related 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: 10.1080/14767058.2016.1243096. Epub 2016 Nov 29.

  PMID: 27696917 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Cristina Bravo, PhD

CONTACT

+34 656312125; cristina.bravo@udl.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the patients don't know what intervention of study. Investigator don't know the allocation of patients outcomes assessor don't know the allocation of patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Researcher

Model Details: clinical trial randomized allocated controlled

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 26, 2022
• Study Start: May 8, 2024
• Primary Completion: May 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)