Body Awareness Therapy and Biomarkers in Fibromyalgia (BATBF)

May 5, 2025 updated by: Cristina Bravo, Universitat de Lleida

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Barcelona
      • Igualada, Barcelona, Spain, 08700
        • Recruiting
        • Consorci Sanitari de l'Anoia
        • Contact:
        • Sub-Investigator:
          • Cristina Bravo, Pt
      • Igualada, Barcelona, Spain, 08700
        • Recruiting
        • Cristina Bravo Navarro
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
Other Names:
  • BBAT
Active Comparator: Stretching group

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
It consists in stretching movements of whole body

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serotonin
Time Frame: through study completion, an average of 1 year
Neurotransmitter neurologic
through study completion, an average of 1 year
cortisol
Time Frame: during the procedure
acute hormone relating stress
during the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
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
through study completion, an average of 1 year
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)
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat de Lleida

Collaborators

Consorci Sanitari de l'Anoia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

September 14, 2022

First Submitted That Met QC Criteria

September 21, 2022

First Posted (Actual)

September 26, 2022

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04 University of Lleida

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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