Body Awareness Therapy and Biomarkers in Fibromyalgia
ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversitat de Lleida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
whose diagnosed of fibromyalgia almost 6 months before
whose could be in different position such as lying, sitting, and stand-up
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Basic Body Awareness Therapy
Other interventionThe intervention will be twice a week during 12 weeks. It lasts 90 min of movements of daily life, massage and self-reflections.
Stretching Exercise
Other interventionIt consists in stretching movements of whole body
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Basic Body Awareness TherapyExperimental treatment 1 intervention
Group B: Stretching groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Serotonin
Neurotransmitter neurologic
Time frame
through study completion, an average of 1 year2
cortisol
acute hormone relating stress
Time frame
during the procedureSecondary outcomes
1
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 year2
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 year3
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 year4
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitat de Lleida
Lead sponsor
Consorci Sanitari de l'Anoia
Collaborator
Source ClinicalTrials.gov