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Investigation of the Effects of Stabilization Exercises and Pelvic Floor Muscle Training on Pain and Urinary Parameters in Individuals With Chronic Low Back Pain With Urinary Incontinence

Primary Purpose

Low Back Pain, Urinary Incontinence

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pelvic floor muscle training combined with stabilization exercises
Pelvic floor muscle training
Sponsored by
Hasan Kalyoncu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, Urinary Incontinence, pelvic floor muscle training, stabilization exercises

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Those with low back pain for at least 3 months (at least once a week with low back pain) Those with urinary incontinence 4 and above according to Numerical Pains Rating Scale At least 20% according to the Oswestry Disability Index Body Mass Index 30 and below Exclusion Criteria: Those who have undergone lumbar or pelvic surgery in the last 6 months Those who received pelvic floor muscle training in the last 3 months Systemic, inflammatory, rheumatic, malignant, osseous pathologies etc. that may cause low back pain. those with diseases Those who are pregnant Stage 3-4 of pelvic organ prolapse Those who are pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Active Comparator

    Active Comparator

    Arm Label

    Control Group

    Classic Application Group

    Study Group

    Arm Description

    No application will be made until the end of this group work. After the end of the study, the effective protocol will be applied.

    In this group, classical pelvic floor muscle training will be applied.

    The protocol determined for the study will be applied in this group. This protocol is planned as follows: It will perform stabilization exercises with the activation of the pelvic floor muscles.

    Outcomes

    Primary Outcome Measures

    Numerical Pain Rating Scale
    In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'
    Euro Quality of Life 5D-3L
    The EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version) is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease
    Incontinence Severity Index
    The incontinence severity index (ISI) consists of two questions, regarding frequency and amount of leakage. It categorizes urinary incontinence (UI) into slight, moderate, severe, and very severe.

    Secondary Outcome Measures

    Modified Oxford Scale
    The Modified Oxford Scale (MOS) was used to rate pelvic floor muscle contraction on a scale of 0-511: 0 = no contraction; 1 = minor muscle 'flicker'; 2 = weak muscle contraction; 3 = moderate muscle contraction; 4 = good muscle contraction and 5 = strong muscle contraction
    Tampa Kinesiophobia Scale
    The Tampa Scale of Kinesiophobia (TSK) that was developed in 1990 is a 17 item scale originally developed to measure the fear of movement related to chronic lower back pain.
    Oswestry Disability Index
    The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.
    Pain Catastrophizing Scale
    Pain catastrophizing is characterized by the tendency to magnify the threat value of a pain stimulus and to feel helpless in the presence of pain, as well as by a relative inability to prevent or inhibit pain-related thoughts in anticipation of, during, or following a painful event.
    State-Trait Anxiety Inventory
    The State-Trait Anxiety Inventory (STAI) is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Higher scores are positively correlated with higher levels of anxiety. Its most current revision is Form Y and it is offered in more than 40 languages
    Incontinence Quality of Life Instrument
    The I-QOL has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarrassment (5 items). It is easily self-administered and takes about 5 minutes to complete.
    Urinary Distress Inventory
    The Urogenital Distress Inventory (UDI-6) is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.

    Full Information

    First Posted
    December 17, 2022
    Last Updated
    December 29, 2022
    Sponsor
    Hasan Kalyoncu University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05666427
    Brief Title
    Investigation of the Effects of Stabilization Exercises and Pelvic Floor Muscle Training on Pain and Urinary Parameters in Individuals With Chronic Low Back Pain With Urinary Incontinence
    Official Title
    Investigation of the Effect of Pelvic Floor Muscle Training Combined With Stabilization Exercises on Pain and Urinary Parameters in Individuals With Low Back Pain With Urinary Incontinence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2023 (Anticipated)
    Study Completion Date
    April 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hasan Kalyoncu 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
    The research will be done with people with urinary incontinence and low back pain. 3 groups of volunteer participants will be formed. The groups were planned as study group, classical application group and control group. Classical pelvic floor muscle training will be applied to the classical application group. Pelvic floor muscle training combined with stabilization exercises will be applied to the study group. In this study, the effect of pelvic floor muscle training combined with stabilization exercises on pain and urinary parameters compared to classical pelvic floor muscle training will be investigated in people with urinary incontinence and low back pain at the same time.
    Detailed Description
    The rehabilitation period in the study was determined as 2 months. Participants will receive treatment with a supervisor 1 or 2 days a week. On other days, they will continue as a home program.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain, Urinary Incontinence
    Keywords
    low back pain, Urinary Incontinence, pelvic floor muscle training, stabilization exercises

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    No application will be made until the end of this group work. After the end of the study, the effective protocol will be applied.
    Arm Title
    Classic Application Group
    Arm Type
    Active Comparator
    Arm Description
    In this group, classical pelvic floor muscle training will be applied.
    Arm Title
    Study Group
    Arm Type
    Active Comparator
    Arm Description
    The protocol determined for the study will be applied in this group. This protocol is planned as follows: It will perform stabilization exercises with the activation of the pelvic floor muscles.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pelvic floor muscle training combined with stabilization exercises
    Intervention Description
    While people are doing stabilization exercises, they will also work the pelvic floor muscles. Practices will be combined with breathing.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pelvic floor muscle training
    Intervention Description
    Exercises that activate the pelvic floor muscles to strengthen and increase endurance.
    Primary Outcome Measure Information:
    Title
    Numerical Pain Rating Scale
    Description
    In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'
    Time Frame
    a day before rehabilitation
    Title
    Euro Quality of Life 5D-3L
    Description
    The EQ-5D-3L (European Quality of Life 5 Dimensions 3 Level Version) is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease
    Time Frame
    a day before rehabilitation
    Title
    Incontinence Severity Index
    Description
    The incontinence severity index (ISI) consists of two questions, regarding frequency and amount of leakage. It categorizes urinary incontinence (UI) into slight, moderate, severe, and very severe.
    Time Frame
    a day before rehabilitation
    Secondary Outcome Measure Information:
    Title
    Modified Oxford Scale
    Description
    The Modified Oxford Scale (MOS) was used to rate pelvic floor muscle contraction on a scale of 0-511: 0 = no contraction; 1 = minor muscle 'flicker'; 2 = weak muscle contraction; 3 = moderate muscle contraction; 4 = good muscle contraction and 5 = strong muscle contraction
    Time Frame
    a day before rehabilitation
    Title
    Tampa Kinesiophobia Scale
    Description
    The Tampa Scale of Kinesiophobia (TSK) that was developed in 1990 is a 17 item scale originally developed to measure the fear of movement related to chronic lower back pain.
    Time Frame
    a day before rehabilitation
    Title
    Oswestry Disability Index
    Description
    The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.
    Time Frame
    a day before rehabilitation
    Title
    Pain Catastrophizing Scale
    Description
    Pain catastrophizing is characterized by the tendency to magnify the threat value of a pain stimulus and to feel helpless in the presence of pain, as well as by a relative inability to prevent or inhibit pain-related thoughts in anticipation of, during, or following a painful event.
    Time Frame
    a day before rehabilitation
    Title
    State-Trait Anxiety Inventory
    Description
    The State-Trait Anxiety Inventory (STAI) is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Higher scores are positively correlated with higher levels of anxiety. Its most current revision is Form Y and it is offered in more than 40 languages
    Time Frame
    a day before rehabilitation
    Title
    Incontinence Quality of Life Instrument
    Description
    The I-QOL has 22 questions with the following 3 subscales: avoid and limiting behaviors (items), psychosocial impacts (9 items), and social embarrassment (5 items). It is easily self-administered and takes about 5 minutes to complete.
    Time Frame
    a day before rehabilitation
    Title
    Urinary Distress Inventory
    Description
    The Urogenital Distress Inventory (UDI-6) is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women.
    Time Frame
    a day before rehabilitation

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Those with low back pain for at least 3 months (at least once a week with low back pain) Those with urinary incontinence 4 and above according to Numerical Pains Rating Scale At least 20% according to the Oswestry Disability Index Body Mass Index 30 and below Exclusion Criteria: Those who have undergone lumbar or pelvic surgery in the last 6 months Those who received pelvic floor muscle training in the last 3 months Systemic, inflammatory, rheumatic, malignant, osseous pathologies etc. that may cause low back pain. those with diseases Those who are pregnant Stage 3-4 of pelvic organ prolapse Those who are pregnant
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ibrahim Kucukcan, PHD
    Phone
    +905300351105
    Email
    pt.kucukcan@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yavuz Yakut, Professor
    Organizational Affiliation
    Hasan Kalyoncu University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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