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Body Awareness Therapy and Biomarkers in Fibromyalgia (BATBF)

Primary Purpose

Fibromyalgia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Basic Body Awareness Therapy
Stretching Exercise
Sponsored by
Universitat de Lleida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Body awareness therapy, physical therapy, serotonin, cortisol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Basic Body Awareness Therapy

    Stretching group

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    Serotonin
    Neurotransmitter neurologic
    cortisol
    acute hormone relating stress

    Secondary Outcome Measures

    Visual Analog Scale (VAS)
    Assess of subjective pain of patient. It consists in a number between 0 to 10
    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.
    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
    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)

    Full Information

    First Posted
    September 14, 2022
    Last Updated
    November 11, 2022
    Sponsor
    Universitat de Lleida
    Collaborators
    Consorci Sanitari de l'Anoia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05555394
    Brief Title
    Body Awareness Therapy and Biomarkers in Fibromyalgia
    Acronym
    BATBF
    Official Title
    Biomarkers Changes in Patients With Fibromyalgia Using Basic Body Awareness Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    February 1, 2024 (Anticipated)
    Study Completion Date
    February 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitat de Lleida
    Collaborators
    Consorci Sanitari de l'Anoia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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...

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibromyalgia
    Keywords
    Body awareness therapy, physical therapy, serotonin, cortisol

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    clinical trial randomized allocated controlled
    Masking
    ParticipantInvestigatorOutcomes 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.
    Allocation
    Randomized
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Basic Body Awareness Therapy
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Stretching group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Basic Body Awareness Therapy
    Other Intervention Name(s)
    BBAT
    Intervention Description
    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
    Intervention Name(s)
    Stretching Exercise
    Intervention Description
    It consists in stretching movements of whole body
    Primary Outcome Measure Information:
    Title
    Serotonin
    Description
    Neurotransmitter neurologic
    Time Frame
    through study completion, an average of 1 year
    Title
    cortisol
    Description
    acute hormone relating stress
    Time Frame
    during the procedure
    Secondary Outcome Measure Information:
    Title
    Visual Analog Scale (VAS)
    Description
    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
    Title
    Fibromyalgia Impact Questionnaire (FIQ)
    Description
    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
    Title
    Beck Depression Inventory- II (BDI-II)
    Description
    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
    Title
    State Trait Anxiety Inventory (STAI)
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cristina Bravo, PhD
    Phone
    +34 656312125
    Email
    cristina.bravo@udl.cat

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21725900
    Citation
    Busch AJ, Webber SC, Brachaniec M, Bidonde J, Bello-Haas VD, Danyliw AD, Overend TJ, Richards RS, Sawant A, Schachter CL. Exercise therapy for fibromyalgia. Curr Pain Headache Rep. 2011 Oct;15(5):358-67. doi: 10.1007/s11916-011-0214-2.
    Results Reference
    background
    PubMed Identifier
    27696917
    Citation
    Atasever M, Namli Kalem M, Sonmez C, Seval MM, Yuce T, Sahin Aker S, Koc A, Genc H. Lower serotonin level and higher rate of fibromyalgia syndrome with advancing pregnancy. J Matern Fetal Neonatal Med. 2017 Sep;30(18):2204-2211. doi: 10.1080/14767058.2016.1243096. Epub 2016 Nov 29.
    Results Reference
    result
    PubMed Identifier
    29723080
    Citation
    Bravo C, Skjaerven LH, Espart A, Guitard Sein-Echaluce L, Catalan-Matamoros D. Basic Body Awareness Therapy in patients suffering from fibromyalgia: A randomized clinical trial. Physiother Theory Pract. 2019 Oct;35(10):919-929. doi: 10.1080/09593985.2018.1467520. Epub 2018 May 3.
    Results Reference
    result
    PubMed Identifier
    31106558
    Citation
    Bravo C, Skjaerven LH, Guitard Sein-Echaluce L, Catalan-Matamoros D. Effectiveness of movement and body awareness therapies in patients with fibromyalgia: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2019 Oct;55(5):646-657. doi: 10.23736/S1973-9087.19.05291-2. Epub 2019 May 15.
    Results Reference
    result
    PubMed Identifier
    27008285
    Citation
    Coppieters I, Cagnie B, Nijs J, van Oosterwijck J, Danneels L, De Pauw R, Meeus M. Effects of Stress and Relaxation on Central Pain Modulation in Chronic Whiplash and Fibromyalgia Patients Compared to Healthy Controls. Pain Physician. 2016 Mar;19(3):119-30.
    Results Reference
    result

    Learn more about this trial

    Body Awareness Therapy and Biomarkers in Fibromyalgia

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