Body Awareness Therapy and Biomarkers in Fibromyalgia

Not Applicable

Recruiting

• Conditions: Fibromyalgia
• Interventions: Other: Stretching Exercise; Other: Basic Body Awareness Therapy

• Registration Number: NCT05555394
• Lead Sponsor: Universitat de Lleida

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.

Detailed 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...

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-26
• Study Start: 2024-05-08
• Status Verified: 2025-05
• Primary Completion: 2025-05-01
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stretching group	Stretching Exercise	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.
Basic Body Awareness Therapy	Basic Body Awareness Therapy	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

Primary Outcome Measures

Name	Time	Method
Serotonin	through study completion, an average of 1 year	Neurotransmitter neurologic
cortisol	during the procedure	acute hormone relating stress

Secondary Outcome Measures

Name	Time	Method
State Trait Anxiety Inventory (STAI)	through study completion, an average of 1 year	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)
Visual Analog Scale (VAS)	through study completion, an average of 1 year	Assess of subjective pain of patient. It consists in a number between 0 to 10
Fibromyalgia Impact Questionnaire (FIQ)	through study completion, an average of 1 year	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.
Beck Depression Inventory- II (BDI-II)	through study completion, an average of 1 year	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

Trial Locations

Locations (2)

Consorci Sanitari de l'Anoia; 🇪🇸 Igualada, Barcelona, Spain

Cristina Bravo Navarro; 🇪🇸 Igualada, Barcelona, Spain