An interventional study of Basic Body Awareness Therapy and Stretching Exercise in Fibromyalgia, sponsored by Universitat de Lleida. Recruiting at 2 sites in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by Universitat de Lleida · Not applicable, Interventional, and Treatment
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.
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...
1,335 studies on the registry are indexed under Fibromyalgia; 265 are open to participants now.
This study's planned enrollment of 110 is above the median of 60 across 1,034 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Universitat de Lleida is the lead sponsor of 33 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
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
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
The intervention will be twice a week during 12 weeks. It lasts 90 min of movements of daily life, massage and self-reflections.
Also known as: BBAT
It consists in stretching movements of whole body
Serotonin
Neurotransmitter neurologic
Time frame: through study completion, an average of 1 year
cortisol
acute hormone relating stress
Time frame: during the procedure
Visual Analog Scale (VAS)
Assess of subjective pain of patient. It consists in a number between 0 to 10
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: through study completion, an average of 1 year
Plan to share: No
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Universitat de Lleida