Fibromyalgia
Conditions
Keywords
Body awareness therapy, physical therapy, serotonin, cortisol
Brief 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. 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...
Interventions
The intervention will be twice a week during 12 weeks. It lasts 90 min of movements of daily life, massage and self-reflections.
OTHERStretching Exercise
It consists in stretching movements of whole body
Sponsors
Consorci Sanitari de l'Anoia
Universitat de Lleida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
the patients don't know what intervention of study. Investigator don't know the allocation of patients outcomes assessor don't know the allocation of patients.
Intervention model description
clinical trial randomized allocated controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serotonin | through study completion, an average of 1 year | Neurotransmitter neurologic |
| cortisol | during the procedure | acute hormone relating stress |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | through study completion, an average of 1 year | Assess of subjective pain of patient. It consists in a number between 0 to 10 |
| Fibromyalgia Impact Questionnaire (FIQ) | 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. |
| Beck Depression Inventory- II (BDI-II) | 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 |
| State Trait Anxiety Inventory (STAI) | 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) |
Countries
Spain
Contacts
Primary ContactCristina Bravo, PhD
Outcome results
None listed