Body Awareness Therapy and Biomarkers in Fibromyalgia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-08

Study Completion Date

2025-09-01

Brief Summary

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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.

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Detailed Description

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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

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

clinical trial randomized allocated controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Basic Body Awareness Therapy

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

Group Type EXPERIMENTAL

Basic Body Awareness Therapy

Intervention Type OTHER

The intervention will be twice a week during 12 weeks. It lasts 90 min of movements of daily life, massage and self-reflections.

Stretching group

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.

Group Type ACTIVE_COMPARATOR

Stretching Exercise

Intervention Type OTHER

It consists in stretching movements of whole body

Interventions

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Basic Body Awareness Therapy

The intervention will be twice a week during 12 weeks. It lasts 90 min of movements of daily life, massage and self-reflections.

Intervention Type OTHER

Stretching Exercise

It consists in stretching movements of whole body

Intervention Type OTHER

Other Intervention Names

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BBAT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No