FibromyalgiaBATBFNCT05555394
Body Awareness Therapy and Biomarkers in Fibromyalgia
A study testing Basic Body Awareness Therapy and Stretching Exercise in people with Fibromyalgia, run by Universitat de Lleida at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Basic Body Awareness Therapy and Stretching Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesSpain
- Study dates
- 8 May 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- whose diagnosed of fibromyalgia almost 6 months before
- whose could be in different position such as lying, sitting, and stand-up
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Consorci Sanitari de l'Anoia
Igualada, Barcelona, 08700
Aurora Garriga, Dr, +34 8075800, agarriga@csa.cat
Cristina Bravo, Pt
- Recruiting
Cristina Bravo Navarro
Igualada, Barcelona, 08700
Cristina Bravo Navarro, 656312125, cristinabn@gmail.com
About this study
Official title: 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.
Read the 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...
- Conditions
- Fibromyalgia
- Being tested
- Basic Body Awareness Therapy, Stretching Exercise
- Keywords
- Body awareness therapy, physical therapy, serotonin, cortisol
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Body Awareness TherapyOther
Also called BBAT
The intervention will be twice a week during 12 weeks. It lasts 90 min of movements of daily life, massage and self-reflections.
Stretching ExerciseOther
It consists in stretching movements of whole body
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Stretching Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serotonin
Neurotransmitter neurologic
Measured: through study completion, an average of 1 year
cortisol
acute hormone relating stress
Measured: during the procedure
Secondary outcomes (4)
Visual Analog Scale (VAS)
Assess of subjective pain of patient. It consists in a number between 0 to 10
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
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
Measured: through study completion, an average of 1 year
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)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start8 May 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- clinical trial randomized allocated controlled
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat de Lleida
- Sponsor type
- University, hospital or other
- Collaborators
- Consorci Sanitari de l'Anoia
- Responsible party
- Principal investigator, Cristina Bravo, Universitat de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555394
- Sponsor's protocol ID
- 04 University of Lleida
- Acronym
- BATBF
- Status last verified
- May 2025
- First submitted
- 14 Sep 2022
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21725900Atasever 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.
PubMed 27696917Bravo 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.
PubMed 29723080Bravo 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.
PubMed 31106558Coppieters 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.
PubMed 27008285
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Rehabilitation Programme Based on Lifestyle Changes and Self-care in Patients Diagnosed With Fibromyalgia: Neuroinflammatory and Neuropsychological Biomarkers.
- ClinicalTrials.gov ID
- NCT05555394
- Acronym / sponsor ID
- BATBF / 04 University of Lleida
- Conditions
- Fibromyalgia
- Keywords
- Body awareness therapy, physical therapy, serotonin, cortisol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Universitat de LleidaUniversity, hospital or other
- Collaborators
- Consorci Sanitari de l'Anoia
- Study start
- 8 May 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- clinical trial randomized allocated controlled
| Arm | Type | Receives |
|---|---|---|
| Basic Body Awareness Therapy | Experimental | Other: Basic Body Awareness Therapythe 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 |
| Stretching group | Active comparator | Other: Stretching ExerciseStretching 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- whose diagnosed of fibromyalgia almost 6 months before
- whose could be in different position such as lying, sitting, and stand-up
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basic Body Awareness TherapyAlso: BBATThe intervention will be twice a week during 12 weeks. It lasts 90 min of movements of daily life, massage and self-reflections. | Other | Basic Body Awareness Therapy |
| Stretching ExerciseIt consists in stretching movements of whole body | Other | Stretching group |
Primary outcome
Serotonin
Time frame: through study completion, an average of 1 year
Neurotransmitter neurologic
cortisol
Time frame: during the procedure
acute hormone relating stress
4 secondary outcomes
Visual Analog Scale (VAS)
Time frame: through study completion, an average of 1 year
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: through study completion, an average of 1 year
Beck Depression Inventory- II (BDI-II)
Time frame: through study completion, an average of 1 year
State Trait Anxiety Inventory (STAI)
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Background: PubMed 21725900Busch 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.
- Results publication: PubMed 27696917Atasever 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.
- Results publication: PubMed 29723080Bravo 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.
- Results publication: PubMed 31106558Bravo 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.
- Results publication: PubMed 27008285Coppieters 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.
- Individual participant dataSharing planned: No
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basic Body Awareness Therapy and Stretching Exercise in people with Fibromyalgia, run by Universitat de Lleida at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Bravo, PhD (+34 656312125, cristina.bravo@udl.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serotonin (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05555394, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.