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Effect of Scapular Stabilization Exercise Training on Posture and Pain in Fibromyalgia Patients

Primary Purpose

Fibromyalgia, Exercise, Compulsive, Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
exercises
Sponsored by
Sanko University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: between the ages of 18-60, Have not received any physical therapy and exercise therapy in the last 6 months, No musculoskeletal problems, Having no barriers to exercise therapy individuals were included in the study. Exclusion Criteria: Individuals with psychological, cardiovascular and neurological problems, Female individuals with pregnancy status, Individuals who do not want to participate in physical therapy and exercise practices excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    scapular stabilization exercises

    classic shoulder exercises

    Arm Description

    scapular stabilization exercises applied to 1st group for 5 days/week for 6 weeks

    classic shoulder exercises applied to 1st group for 5 days/week for 6 weeks

    Outcomes

    Primary Outcome Measures

    visual analog scale ( VAS)
    pain, This scale evaluates pain verbally. It questions the level of pain to the patients. It is between 0 and 10 points. O No pain, 10 means severe pain.
    tragus-to-wall distance
    cervical posture, This scale measures the cervical posture, the distance between the wall and the tragus in cm. The results vary from person to person, and increasing distance indicates that cervical posture has a poor prognosis.
    fibromyalgia impact scale
    functional status, This scale evaluates functional status. verbally questioned. scale type is survey. The questions asked are asked to give points between 0 and 3. 0 points always means 1 point often, 2 points sometimes, and 3 points never. activity, doing business, and well-being. It is stated that a high score does not affect the functional state of the disease, while a low score indicates that the disease affects the functional state. The total score range is between 0 points and 80 points.
    Nottingham Health Profile
    life quality,This scale evaluates quality of life. questions patients' problems with pain, social isolation, emotional reaction, physical activity, energy, and sleep. scale type is survey. Patients are asked and their answers are recorded. answers are yes or no. The total score scale is in 2 parts. The 1 section score range is between 0 and 600 points, and the 2nd section is between 0 and 7 points. A high score indicates that the quality of life is badly affected, while a low score indicates that the quality of life is not affected.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 18, 2023
    Last Updated
    January 26, 2023
    Sponsor
    Sanko University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05710939
    Brief Title
    Effect of Scapular Stabilization Exercise Training on Posture and Pain in Fibromyalgia Patients
    Official Title
    Comparison of the Effect of Scapular Stabilization Exercise Training on Posture and Pain in Fibromyalgia Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2016 (Actual)
    Primary Completion Date
    February 1, 2017 (Actual)
    Study Completion Date
    June 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sanko University

    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
    Our study was conducted to investigate the effect of scapular stabilization exercise training on cervical posture and pain in fibromyalgia. 59 patients aged 18-60 years were included in the study. The patients included in the study were diagnosed with fibromyalgia from the physical therapy outpatient clinic and individuals who did not have any other disease were included. The included individuals were divided into 2 groups by randomization method. Individuals were divided into scapula exercise therapy group (n=29) and classical exercise therapy group (n=30). Hotpack, tens and ultrasound applications were applied to both groups as conventional treatment before exercise. This protocol was applied to both groups for 6 weeks, 5 days a week. Following this protocol, classical shoulder exercises were given to the classical group and stabilization exercises were given to the scapular stabilization group. While the study designer applied the treatment, another designer applied the evaluation. The patients were evaluated for pain, cervical posture, functional status, and quality of life. pain was evaluated with a visual analog scale (vas), cervical posture was evaluated by tragus-wall distance, functional status was evaluated with fibromyalgia impact questionnaire and quality of life was evaluated with nottingam quality of life questionnaire. All evaluations were performed twice before and at the end of the treatment (6 weeks).
    Detailed Description
    Pain is usually seen in the scapular region in patients with fibromyalgia. We decided to do this study because we thought that there was no exercise for this area before in our study and that if it was done, improvements in pain and posture could be observed. Our study was conducted to investigate the effect of scapular stabilization exercise training on cervical posture and pain in fibromyalgia. 59 patients aged 18-60 years were included in the study. The patients included in the study were diagnosed with fibromyalgia from the physical therapy outpatient clinic and individuals who did not have any other disease were included. The included individuals were divided into 2 groups by randomization method. Individuals were divided into scapula exercise therapy group (n=29) and classical exercise therapy group (n=30). Hotpack, tens and ultrasound applications were applied to both groups as conventional treatment before exercise. This protocol was applied to both groups for 6 weeks, 5 days a week. Following this protocol, classical shoulder exercises (wand exercises, codman exercises and stretching exercises) were given to the classical group, and stabilization exercises (push-up exercises on the wall, scapular adduction, scapular elevation, rowing exercises) were given to the scapular stabilization group. While the study designer applied the treatment, another designer applied the evaluation. The patients were evaluated for pain, cervical posture, functional status, and quality of life. pain was evaluated with a visual analog scale (vas), cervical posture was evaluated by tragus-wall distance, functional status was evaluated with fibromyalgia impact questionnaire and quality of life was evaluated with nottingam quality of life questionnaire. All evaluations were performed twice before and at the end of the treatment (6 weeks).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibromyalgia, Exercise, Compulsive, Pain, Postural; Defect

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    Participants' personal information is hidden
    Allocation
    Randomized
    Enrollment
    59 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    scapular stabilization exercises
    Arm Type
    Active Comparator
    Arm Description
    scapular stabilization exercises applied to 1st group for 5 days/week for 6 weeks
    Arm Title
    classic shoulder exercises
    Arm Type
    Active Comparator
    Arm Description
    classic shoulder exercises applied to 1st group for 5 days/week for 6 weeks
    Intervention Type
    Other
    Intervention Name(s)
    exercises
    Primary Outcome Measure Information:
    Title
    visual analog scale ( VAS)
    Description
    pain, This scale evaluates pain verbally. It questions the level of pain to the patients. It is between 0 and 10 points. O No pain, 10 means severe pain.
    Time Frame
    6 weeks
    Title
    tragus-to-wall distance
    Description
    cervical posture, This scale measures the cervical posture, the distance between the wall and the tragus in cm. The results vary from person to person, and increasing distance indicates that cervical posture has a poor prognosis.
    Time Frame
    6 weeks
    Title
    fibromyalgia impact scale
    Description
    functional status, This scale evaluates functional status. verbally questioned. scale type is survey. The questions asked are asked to give points between 0 and 3. 0 points always means 1 point often, 2 points sometimes, and 3 points never. activity, doing business, and well-being. It is stated that a high score does not affect the functional state of the disease, while a low score indicates that the disease affects the functional state. The total score range is between 0 points and 80 points.
    Time Frame
    6 weeks
    Title
    Nottingham Health Profile
    Description
    life quality,This scale evaluates quality of life. questions patients' problems with pain, social isolation, emotional reaction, physical activity, energy, and sleep. scale type is survey. Patients are asked and their answers are recorded. answers are yes or no. The total score scale is in 2 parts. The 1 section score range is between 0 and 600 points, and the 2nd section is between 0 and 7 points. A high score indicates that the quality of life is badly affected, while a low score indicates that the quality of life is not affected.
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: between the ages of 18-60, Have not received any physical therapy and exercise therapy in the last 6 months, No musculoskeletal problems, Having no barriers to exercise therapy individuals were included in the study. Exclusion Criteria: Individuals with psychological, cardiovascular and neurological problems, Female individuals with pregnancy status, Individuals who do not want to participate in physical therapy and exercise practices excluded from the study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    hakan Polat
    Organizational Affiliation
    Sanko University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effect of Scapular Stabilization Exercise Training on Posture and Pain in Fibromyalgia Patients

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