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NCT Number: NCT05555394

Body Awareness Therapy and Biomarkers in Fibromyalgia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Consorci Sanitari de l'Anoia, Igualada, Barcelona, Spain

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About this study

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...

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: BBAT

stretching exercise

Other

It consists in stretching movements of whole body

Primary outcomes

  1. Serotonin

    Time frame: through study completion, an average of 1 year

    Neurotransmitter neurologic

  2. cortisol

    Time frame: during the procedure

    acute hormone relating stress

Secondary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: through study completion, an average of 1 year

    Assess of subjective pain of patient. It consists in a number between 0 to 10

  2. Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: 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.

  3. Beck Depression Inventory- II (BDI-II)

    Time frame: 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

  4. State Trait Anxiety Inventory (STAI)

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina Bravo, PhD

CONTACT

[email protected]

+34 656312125

Sponsors and collaborators

Lead sponsor

Universitat de Lleida

Other

Collaborators

  • Consorci Sanitari de l'Anoia

Registry information

Official study title

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

Acronym: BATBF

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2022
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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