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Effects of Manual Therapy on Autonomic Nervous System's Balance, Pain and Well-being in Patients With Fibromyalgia.

Primary Purpose

Fibromyalgia, Manual Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active mobilization of soft tissues
Passive mobilization
Sponsored by
Universidad Francisco de Vitoria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia, Manual Therapy focused on measuring Fibromyalgia, Manual Therapy, Autonomic Nervous System, Pain, Psychological well-being

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Rheumatologic diagnosis of fibromyalgia, chronic fatigue labels, sleep disorders, recurrent cervical pain associated with fibromyalgia

Exclusion Criteria:

  • Smokers, blood pressure superior to 160/100 mm/Hg, coronary artery disease, peripheral vascular disease, presence of Diabetes I or II, being pregnant, psychiatric disorder established, any trauma suffered in the last 6 months, diagnosis of osteoarthritis, consumption of caffeine, alcohol or other stimulating substance at least 24 hours before the experimental intervention, performing moderate-intense physical activity 2 hours before the experimental intervention.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Experimental group 1

    Experimental group 2

    Control group

    Arm Description

    Active mobilization of soft tissues

    Passive mobilization

    No intervention

    Outcomes

    Primary Outcome Measures

    Change in Heart rate variability
    Heart rate variability (HRV) will be assessed as an indicator of autonomic regulation. The HRV measurement will be made through the Elite HRV application, using the value of rMSSD.

    Secondary Outcome Measures

    Pain assessed by the numerical rating scale (NRS)
    Pain will be assessed by the numerical rating scale (NRS)
    Psychological well-being
    Psychological well-being will be assessed by the Ryff scale

    Full Information

    First Posted
    November 6, 2018
    Last Updated
    November 11, 2018
    Sponsor
    Universidad Francisco de Vitoria
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03740451
    Brief Title
    Effects of Manual Therapy on Autonomic Nervous System's Balance, Pain and Well-being in Patients With Fibromyalgia.
    Official Title
    Effects of Manual Therapy on Autonomic Nervous System's Balance, Pain and Well-being in Patients With Fibromyalgia.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 5, 2018 (Anticipated)
    Primary Completion Date
    March 31, 2019 (Anticipated)
    Study Completion Date
    May 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universidad Francisco de Vitoria

    4. Oversight

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

    5. Study Description

    Brief Summary
    Scientific literature dealing with patients with fibromyalgia conveys they suffer from an abnormal response of the autonomic nervous sýstem, where a marked sympathetic hyperactivity and a decrease in heart rate variability are emphasized. It is important to know what manual therapy techniques may manage to decrease the sympathetic activity and balance the sympathetic-vagal tone, therefore improving pain and life quality. This study will compare the effects of joint passive mobilization with the effects of soft tissue active mobilization on heart rate variability (as an indicator of autonomous regulation), psychological well-being (measured by the Ryff scale) and pain in patients with fibromyalgia.
    Detailed Description
    Scientific literature dealing with patients with fibromyalgia conveys they suffer from an abnormal response of the autonomic nervous sýstem, where a marked sympathetic hyperactivity and a decrease in heart rate variability are emphasized. It is important to know what manual therapy techniques may manage to decrease the sympathetic activity and balance the sympathetic-vagal tone, therefore improving pain and life quality. This study will compare the effects of joint passive mobilization with the effects of soft tissue active mobilization on heart rate variability (as an indicator of autonomous regulation), psychological well-being (measured by the Ryff scale) and pain in patients with fibromyalgia. The authors expect a stronger decrease in the sympathetic nervous system activation; a greater reduction in pain, and a bigger improvement in well-being and anxiety in those patients treated with active mobilization of soft tissues than passive mobilization group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibromyalgia, Manual Therapy
    Keywords
    Fibromyalgia, Manual Therapy, Autonomic Nervous System, Pain, Psychological well-being

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A randomized clinical trial will be conducted where patients will be divided randomly, through the website www.random.org, in three groups: 2 of them will be the experimental group and the other one will be the control group.
    Masking
    Outcomes Assessor
    Masking Description
    Patients will be divided randomly into 3 groups, using the website www.random.org.
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group 1
    Arm Type
    Experimental
    Arm Description
    Active mobilization of soft tissues
    Arm Title
    Experimental group 2
    Arm Type
    Experimental
    Arm Description
    Passive mobilization
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    No intervention
    Intervention Type
    Other
    Intervention Name(s)
    Active mobilization of soft tissues
    Intervention Description
    This study will compare the effects of joint passive mobilization with the effects of soft tissue active mobilization on heart rate variability (as an indicator of autonomous regulation), psychological well-being (measured by the Ryff scale) and pain in patients with fibromyalgia.
    Intervention Type
    Other
    Intervention Name(s)
    Passive mobilization
    Intervention Description
    This study will compare the effects of joint passive mobilization with the effects of soft tissue active mobilization on heart rate variability (as an indicator of autonomous regulation), psychological well-being (measured by the Ryff scale) and pain in patients with fibromyalgia.
    Primary Outcome Measure Information:
    Title
    Change in Heart rate variability
    Description
    Heart rate variability (HRV) will be assessed as an indicator of autonomic regulation. The HRV measurement will be made through the Elite HRV application, using the value of rMSSD.
    Time Frame
    10 minutes (before, during and after intervention)
    Secondary Outcome Measure Information:
    Title
    Pain assessed by the numerical rating scale (NRS)
    Description
    Pain will be assessed by the numerical rating scale (NRS)
    Time Frame
    10min (before and after intervention)
    Title
    Psychological well-being
    Description
    Psychological well-being will be assessed by the Ryff scale
    Time Frame
    1 week (just before intervention, 1 week after intervention)

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Rheumatologic diagnosis of fibromyalgia, chronic fatigue labels, sleep disorders, recurrent cervical pain associated with fibromyalgia Exclusion Criteria: Smokers, blood pressure superior to 160/100 mm/Hg, coronary artery disease, peripheral vascular disease, presence of Diabetes I or II, being pregnant, psychiatric disorder established, any trauma suffered in the last 6 months, diagnosis of osteoarthritis, consumption of caffeine, alcohol or other stimulating substance at least 24 hours before the experimental intervention, performing moderate-intense physical activity 2 hours before the experimental intervention.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gabriele Bertotti, B.Sc.
    Phone
    0034622199937
    Email
    gabriele.bertotti@ufv.es
    First Name & Middle Initial & Last Name or Official Title & Degree
    Universidad Francisco de Vitoria
    Phone
    0034913 51 03 03

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Effects of Manual Therapy on Autonomic Nervous System's Balance, Pain and Well-being in Patients With Fibromyalgia.

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