FibromyalgiaBBATNCT02830295
Effectiveness of Basic Body Awareness Therapy (BBAT) in Patients Suffering From Fibromyalgia
A study testing Basic Body Awareness Therapy in people with Fibromyalgia, run by Cristina Bravo at 1 site 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 treatment as an usual. Sessions of BBAT lasted 90 minutes each and took place twice a week for 5 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- patients diagnosed of fibromyalgia according the American college of Rheumatology with 6 months at least
- the patients have to stay in different position as lying, sitting and standing
Who cannot join
- pregnancy
- suffering from another diseases that increase the pain or another specific diagnosis as rheumatic, heart disease and infectious disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiotherapy in Mental Health: A Clinical Trial of Basic Body Awareness Therapy in Patients Suffering From Fibromyalgia
A randomized trial of Basic Body Awareness Therapy (BBAT) is applied in fibromyalgia patients as compared with a control intervention consisting of treatment as an usual. Sessions of BBAT lasted 90 minutes each and took place twice a week for 5 weeks. The primary end point is a change in the Visual Analog Scale score and Body Awareness Rating Scale and the secondary end points include Hospital Anxiety Depression, State Trait Anxiety Inventory, Beck Depression Inventory and Short Form 36. All assessments will be repeated at post treatment, 12 weeks and 24 weeks
Read the detailed description
This work is a clinical trial of randomised and controlled groups. The hypothesis of study is that Basic Body Awareness Therapy applied in patients with fibromyalgia improves, more than usual treatment, the pain, normalization of postural pattern and movement, improve in psychologic state and improve of quality life.
The study population will be selected followed the inclusion criteria of fibromyalgia, and will be selected in area of primary health center, the patients will be divided in 2 groups, control group and treatment group. The groups will be examined at the begin, at 1 month of the begin of treatment, in 3 months, 6 months and one year to evaluated the outcomes in long time.
The dependence measurements will be Visual Analog Scale, Basic Body Awareness Rating Scale (BARS), SF-36, STAI A/R, BDI-II. The independence measurements will be demographic items: sex, age, country, level of studies, social status,..
- Conditions
- Fibromyalgia
- Being tested
- Basic Body Awareness Therapy
- Keywords
- body awareness therapy, physical therapy, movement therapy
- 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 (acronym)
Basic body awareness therapy is a health oriented and person-centred approach with focus on the patient's resources. This is a method in physiotherapy, where we search to promote movement quality in daily life through self-exploration and self-experience.BBAT conceives the person from the biomechanical, physiological, bio-psycho-social and existential aspects, using the movement quality as a witness of the link in between all these perspectives.It can be done individually or in groups, through different daily life movements: lying, sitting, standing, walking, pair movements, use of voice and massages. BBAT has validated and reliable assesment tools, as BARS and BAS-I
| Study group | Role | What they receive |
|---|---|---|
| Basic Body Awareness Therapy | Experimental | The Basic Body Awareness Therapy is usual therapy of physiotherapy in health mental in nord of europe. BBAT is based in twelve movements and massage that improve the movement quality of patient, also BBAT improves others movement qualities like biomechanical, physiologic, socio-cultural and existential. Receives: Other: Basic Body Awareness Therapy |
| control | No intervention | the patients which below receive the treatment as usual, according the clinic guidelines of Health government |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
This scale evaluates the pain refered by patient with a scale from 0 to 10 being 10 the maximum pain
Measured: up to 24 weeks
Secondary outcomes (4)
Hospital Anxiety Depression
this scale evaluates the level of depression and anxiety with a questionary that score goes from 0 to 21, being 21 the maximum level of disease
Measured: up to 24 weeks
Beck Depression Inventory
this scale evaluates the level of depression with a questionary that scores from 0 to 63, being 63 the maximum level of depression
Measured: up to 24 weeks
State Trait Anxiety Inventory
this questionary evaluates the level of anxiety that scores from 0 to 60, being 60 the maximum level of anxiety
Measured: up to 24 weeks
Short Form 36
this questionary evaluates the quality of life in different components. The score goes from 0 to 100 being 100 the best score for quality of life
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cristina Bravo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cristina Bravo, Universitat de Lleida
- Investigators
- Bravo Cristina, PT, Principal investigator, Universitat de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830295
- Sponsor's protocol ID
- University of Lleida
- Acronym
- BBAT
- Status last verified
- May 2017
- First submitted
- 11 Jun 2016
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Gard G. Body awareness therapy for patients with fibromyalgia and chronic pain. Disabil Rehabil. 2005 Jun 17;27(12):725-8. doi: 10.1080/09638280400009071.
PubMed 16012065Courtois I, Cools F, Calsius J. Effectiveness of body awareness interventions in fibromyalgia and chronic fatigue syndrome: a systematic review and meta-analysis. J Bodyw Mov Ther. 2015 Jan;19(1):35-56. doi: 10.1016/j.jbmt.2014.04.003. Epub 2014 Apr 18.
PubMed 25603742Jones KD, King LA, Mist SD, Bennett RM, Horak FB. Postural control deficits in people with fibromyalgia: a pilot study. Arthritis Res Ther. 2011 Aug 2;13(4):R127. doi: 10.1186/ar3432.
PubMed 21810264
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy in Mental Health: A Clinical Trial of Basic Body Awareness Therapy in Patients Suffering From Fibromyalgia
- ClinicalTrials.gov ID
- NCT02830295
- Acronym / sponsor ID
- BBAT / University of Lleida
- Conditions
- Fibromyalgia
- Keywords
- body awareness therapy, physical therapy, movement therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cristina BravoUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Jul 2016 (estimated)
- 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 treatment as an usual. Sessions of BBAT lasted 90 minutes each and took place twice a week for 5 weeks. The primary end point is a change in the Visual Analog Scale score and Body Awareness Rating Scale and the secondary end points include Hospital Anxiety Depression, State Trait Anxiety Inventory, Beck Depression Inventory and Short Form 36. All assessments will be repeated at post treatment, 12 weeks and 24 weeks
Detailed description
This work is a clinical trial of randomised and controlled groups. The hypothesis of study is that Basic Body Awareness Therapy applied in patients with fibromyalgia improves, more than usual treatment, the pain, normalization of postural pattern and movement, improve in psychologic state and improve of quality life.
The study population will be selected followed the inclusion criteria of fibromyalgia, and will be selected in area of primary health center, the patients will be divided in 2 groups, control group and treatment group. The groups will be examined at the begin, at 1 month of the begin of treatment, in 3 months, 6 months and one year to evaluated the outcomes in long time.
The dependence measurements will be Visual Analog Scale, Basic Body Awareness Rating Scale (BARS), SF-36, STAI A/R, BDI-II. 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
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basic Body Awareness Therapy | Experimental | Other: Basic Body Awareness TherapyThe Basic Body Awareness Therapy is usual therapy of physiotherapy in health mental in nord of europe. BBAT is based in twelve movements and massage that improve the movement quality of patient, also BBAT improves others movement qualities like biomechanical, physiologic, socio-cultural and existential. |
| control | No intervention | –the patients which below receive the treatment as usual, according the clinic guidelines of Health government |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients diagnosed of fibromyalgia according the American college of Rheumatology with 6 months at least
- the patients have to stay in different position as lying, sitting and standing
Key exclusion criteria (2 listed)
- pregnancy
- suffering from another diseases that increase the pain or another specific diagnosis as rheumatic, heart disease and infectious disease
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: BBAT (acronym)Basic body awareness therapy is a health oriented and person-centred approach with focus on the patient's resources. This is a method in physiotherapy, where we search to promote movement quality in daily life through self-exploration and self-experience.BBAT conceives the person from the biomechanical, physiological, bio-psycho-social and existential aspects, using the movement quality as a witness of the link in between all these perspectives.It can be done individually or in groups, through different daily life movements: lying, sitting, standing, walking, pair movements, use of voice and massages. BBAT has validated and reliable assesment tools, as BARS and BAS-I | Other | Basic Body Awareness Therapy |
Primary outcome
Visual Analog Scale
Time frame: up to 24 weeks
This scale evaluates the pain refered by patient with a scale from 0 to 10 being 10 the maximum pain
4 secondary outcomes
Hospital Anxiety Depression
Time frame: up to 24 weeks
Beck Depression Inventory
Time frame: up to 24 weeks
State Trait Anxiety Inventory
Time frame: up to 24 weeks
Short Form 36
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Results publication: PubMed 16012065Gard G. Body awareness therapy for patients with fibromyalgia and chronic pain. Disabil Rehabil. 2005 Jun 17;27(12):725-8. doi: 10.1080/09638280400009071.
- Results publication: PubMed 25603742Courtois I, Cools F, Calsius J. Effectiveness of body awareness interventions in fibromyalgia and chronic fatigue syndrome: a systematic review and meta-analysis. J Bodyw Mov Ther. 2015 Jan;19(1):35-56. doi: 10.1016/j.jbmt.2014.04.003. Epub 2014 Apr 18.
- Results publication: PubMed 21810264Jones KD, King LA, Mist SD, Bennett RM, Horak FB. Postural control deficits in people with fibromyalgia: a pilot study. Arthritis Res Ther. 2011 Aug 2;13(4):R127. doi: 10.1186/ar3432.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Bravo Cristina, PT principal investigator
Universitat de Lleida
1 site 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 in people with Fibromyalgia, run by Cristina Bravo at 1 site 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 2 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: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: up to 24 weeks). 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 NCT02830295, which also lists 3 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 9 May 2017.