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Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise.

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
aquatic exercise and peloidotherapy
Sponsored by
Istanbul Arel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, peloidotherapy, aquatic exercise, water based exercise, balneotherapy, aquatic rehabilitation

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: primary knee osteoarthritis diagnosed according to the ACR criteria gave their written informed consent 40-75 ages Kellgren Lawrence grading 2-4 having symptomatic knee pain at least 3 months. Exclusion Criteria: secondary knee OA pathology of the waist, hip, or ankle joints decompensated organ failure malignancy, active bleeding infectious disease serious knee injuries or previous surgical procedures within the past 6 months the use of intraarticular steroids and hyaluronic acid injection to the knee joint within the past 6 months physiotherapy, balneotherapy, or peloidotherapy within the past 1 year.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Treatment Group

    Control Group

    Arm Description

    Treatment group received 30 minutes of aquatic exercise by a physiotherapist in a warmed up to 33° C tap water and 30 minutes of mud pack treatment at 42°C on both knees 5 weekdays for 2 consecutive weeks (totally 10 sessions).

    Control group continued to use their usual medical treatment.

    Outcomes

    Primary Outcome Measures

    Pain (VAS)
    The VAS is a commonly used scale which determines the intensity of pain. It consists of a 10-cm long line, drawn horizontally Numeric value (in cm between 0 and 10) of patients' pain intensity was determined by measuring the distance between the lowest VAS value and patients' marks.
    WOMAC (total)
    The WOMAC Scale is a commonly used well-being scale for patients with knee or hip OA. It consists of three main sections: pain, stiffness, and physical function. It contains a total of 24 items. Scoring of these items is done according to the Likert scale. In the Likert scale, patients indicate pain and difficulty levels by giving scores between 0 and 4. Turkish validity and reliability study had been conducted for WOMAC

    Secondary Outcome Measures

    IGA (VAS)
    Investivagors' Global Assessment. The VAS is a commonly used scale which determines the intensity of pain. It consists of a 10-cm long line, drawn horizontally Numeric value (in cm between 0 and 10) of patients' pain intensity was determined by measuring the distance between the lowest VAS value and patients' marks.Also is used to assess the patients' global and physicians' global assessment.
    PGA (VAS)
    Patients' Global Assessment. The VAS is a commonly used scale which determines the intensity of pain. It consists of a 10-cm long line, drawn horizontally Numeric value (in cm between 0 and 10) of patients' pain intensity was determined by measuring the distance between the lowest VAS value and patients' marks.Also is used to assess the patients' global and physicians' global assessment.
    WOMAC (pain)
    The WOMAC Scale is a commonly used well-being scale for patients with knee or hip OA. It consists of three main sections: pain, stiffness, and physical function. It contains a total of 24 items. Scoring of these items is done according to the Likert scale. In the Likert scale, patients indicate pain and difficulty levels by giving scores between 0 and 4. Turkish validity and reliability study had been conducted for WOMAC.
    WOMAC (stiffness)
    The WOMAC Scale is a commonly used well-being scale for patients with knee or hip OA. It consists of three main sections: pain, stiffness, and physical function. It contains a total of 24 items. Scoring of these items is done according to the Likert scale. In the Likert scale, patients indicate pain and difficulty levels by giving scores between 0 and 4. Turkish validity and reliability study had been conducted for WOMAC.
    WOMAC (physical function)
    The WOMAC Scale is a commonly used well-being scale for patients with knee or hip OA. It consists of three main sections: pain, stiffness, and physical function. It contains a total of 24 items. Scoring of these items is done according to the Likert scale. In the Likert scale, patients indicate pain and difficulty levels by giving scores between 0 and 4. Turkish validity and reliability study had been conducted for WOMAC.
    LAFI
    LAFI is used to determine the pain and functional severity of knee and hip OA with three parts of pain, maximum walk distance and some activities of daily living. It has 11 questions of total score of 0 to 24 that higher scores shows more involvement
    HAQ
    HAQ is used to evaluate functional disability status of patients in eight subscales; dressing, rising, eating, walking, hygiene, reach, grip and usual activities. It includes 20 items and each item has 3 likert score which 0 to 3 where 3 is unable to do
    SF-36
    The SF-36 Health Survey is a comprehensive measurement tool used to evaluate non-disease-specific overall quality of life. It has been developed and made available by Rand Corporation in order to evaluate overall quality of life (). It contains a total of 36 items with eight subscales: physical functioning, role-physical, role-emotional, bodily pain, social functioning, mental health, vitality, and general health. It grades the patient by using scores between 0 and 100,0 indicating poor health while 100 indicating good health. Turkish validity and reliability study had been con¬ducted for SF-36
    Timed Up and Go Test
    TUG is a valid and reliable functional mobility test. It has a correlation with lower extremity strength and useful for identifying older adults risk of falling

    Full Information

    First Posted
    January 3, 2023
    Last Updated
    January 7, 2023
    Sponsor
    Istanbul Arel University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05677399
    Brief Title
    Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise.
    Official Title
    The Effectiveness of Peloidotherapy and Aquatic Exercise in Knee Osteoarthritis Treatment.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    September 9, 2015 (Actual)
    Primary Completion Date
    June 10, 2016 (Actual)
    Study Completion Date
    December 10, 2016 (Actual)

    3. Sponsor/Collaborators

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

    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
    The aim was to observe the short and medium term effects of peloidotherapy and aquatic exercise applications in patients with knee osteoarthritis.
    Detailed Description
    Osteoarthritis (OA) is one of the most common musculoskeletal diseases in the world. It is a non-inflammatory chronic disease that starts from the articular cartilage and is characterized by mechanical wear and cartilage loss in the joints, and includes findings such as joint pain, stiffness, and limitation of movement. Its incidence increases with aging. OA is more common in the spine, hip, hand and knee joints. The knee, which is a load-bearing joint, is more affected. Knee osteoarthritis is one of the most common causes of disability. It is more common in women. The prevalence of symptomatic knee osteoarthritis in adults over the age of 55 was found to be 13% In the treatment guidelines, aquatic exercise and balneotherapy are among the recommendations for knee OA. Balneotherapy is a stimulus performed at a certain time interval and in a cure style, by using thermal and/or mineral waters, peloids (medical mud) and gases, in the form of bath, package, drinking and inhalation applications, whose methods and doses have been determined. compliance therapy. There are clinical studies showing that balneotherapy and mud pack applications reduce pain and increase functional capacity in knee osteoarthritis. Odabaşı et al. showed that peloidotherapy, one of the balneological methods, has not only thermic effect but also chemical effect in the treatment of knee OA. In patients with knee OA, pain, physical disability, quadriceps femoris muscle weakness and limitations in joint range of motion are observed. it reduces the level of physical activity, exercise capacity and quality of life in these people. The fact that the body is supported due to the buoyancy of the water in the exercises performed in the water reduces the load on the joints during the movement. For this reason, many movements that cannot be done on land can be done safely in water. On the other hand, because the density of water is higher than air, the muscles have to do more work even when performing a simple movement in water compared to the movements on land. Special rehabilitation programs based on water exercise programs have started to be one of the applications that can be done to increase muscle strength for these reasons. When the literature was reviewed, we could not find any study examining the combination of aquatic exercise and peloid application in patients with knee osteoarthritis. The aim of this study was to evaluate the effects of co-administration of peloid and aquatic exercises in knee osteoarthritis patients with a single-blind randomized controlled study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    knee osteoarthritis, peloidotherapy, aquatic exercise, water based exercise, balneotherapy, aquatic rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A Randomized, single blind, prospective, parallel 1:1 group study.
    Masking
    Outcomes Assessor
    Masking Description
    Patients were assessed before treatment, after treatment, 1 month after treatment and 3 month after treatment by the investigator (İ.T.) who was blinded to the study. İ.T. is medical doctor who didn't know the patients' groups.
    Allocation
    Randomized
    Enrollment
    76 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Group
    Arm Type
    Experimental
    Arm Description
    Treatment group received 30 minutes of aquatic exercise by a physiotherapist in a warmed up to 33° C tap water and 30 minutes of mud pack treatment at 42°C on both knees 5 weekdays for 2 consecutive weeks (totally 10 sessions).
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Control group continued to use their usual medical treatment.
    Intervention Type
    Other
    Intervention Name(s)
    aquatic exercise and peloidotherapy
    Other Intervention Name(s)
    water based exercise and mud pack therapy
    Intervention Description
    Treatment group received 30 minutes of aquatic exercise by a physiotherapist in a warmed up to 33° C tap water and 30 minutes of mud pack treatment at 42°C on both knees 5 weekdays for 2 consecutive weeks (totally 10 sessions).
    Primary Outcome Measure Information:
    Title
    Pain (VAS)
    Description
    The VAS is a commonly used scale which determines the intensity of pain. It consists of a 10-cm long line, drawn horizontally Numeric value (in cm between 0 and 10) of patients' pain intensity was determined by measuring the distance between the lowest VAS value and patients' marks.
    Time Frame
    Change from baseline pain (VAS) at the end of the treatment, 1 month after treatment ,3 months after treatment.
    Title
    WOMAC (total)
    Description
    The WOMAC Scale is a commonly used well-being scale for patients with knee or hip OA. It consists of three main sections: pain, stiffness, and physical function. It contains a total of 24 items. Scoring of these items is done according to the Likert scale. In the Likert scale, patients indicate pain and difficulty levels by giving scores between 0 and 4. Turkish validity and reliability study had been conducted for WOMAC
    Time Frame
    Change from baseline WOMAC scores at the end of the treatment, 1 month after treatment ,3 months after treatment.
    Secondary Outcome Measure Information:
    Title
    IGA (VAS)
    Description
    Investivagors' Global Assessment. The VAS is a commonly used scale which determines the intensity of pain. It consists of a 10-cm long line, drawn horizontally Numeric value (in cm between 0 and 10) of patients' pain intensity was determined by measuring the distance between the lowest VAS value and patients' marks.Also is used to assess the patients' global and physicians' global assessment.
    Time Frame
    Change from baseline IGA (VAS) at the end of the treatment, 1 month after treatment ,3 months after treatment.
    Title
    PGA (VAS)
    Description
    Patients' Global Assessment. The VAS is a commonly used scale which determines the intensity of pain. It consists of a 10-cm long line, drawn horizontally Numeric value (in cm between 0 and 10) of patients' pain intensity was determined by measuring the distance between the lowest VAS value and patients' marks.Also is used to assess the patients' global and physicians' global assessment.
    Time Frame
    Change from baseline PGA (VAS) at the end of the treatment, 1 month after treatment ,3 months after treatment.
    Title
    WOMAC (pain)
    Description
    The WOMAC Scale is a commonly used well-being scale for patients with knee or hip OA. It consists of three main sections: pain, stiffness, and physical function. It contains a total of 24 items. Scoring of these items is done according to the Likert scale. In the Likert scale, patients indicate pain and difficulty levels by giving scores between 0 and 4. Turkish validity and reliability study had been conducted for WOMAC.
    Time Frame
    Change from baseline WOMAC (pain) scores at the end of the treatment, 1 month after treatment ,3 months after treatment.
    Title
    WOMAC (stiffness)
    Description
    The WOMAC Scale is a commonly used well-being scale for patients with knee or hip OA. It consists of three main sections: pain, stiffness, and physical function. It contains a total of 24 items. Scoring of these items is done according to the Likert scale. In the Likert scale, patients indicate pain and difficulty levels by giving scores between 0 and 4. Turkish validity and reliability study had been conducted for WOMAC.
    Time Frame
    Change from baseline WOMAC (stiffness) scores at the end of the treatment, 1 month after treatment ,3 months after treatment.
    Title
    WOMAC (physical function)
    Description
    The WOMAC Scale is a commonly used well-being scale for patients with knee or hip OA. It consists of three main sections: pain, stiffness, and physical function. It contains a total of 24 items. Scoring of these items is done according to the Likert scale. In the Likert scale, patients indicate pain and difficulty levels by giving scores between 0 and 4. Turkish validity and reliability study had been conducted for WOMAC.
    Time Frame
    Change from baseline WOMAC (physical function) at the end of the treatment, 1 month after treatment ,3 months after treatment.
    Title
    LAFI
    Description
    LAFI is used to determine the pain and functional severity of knee and hip OA with three parts of pain, maximum walk distance and some activities of daily living. It has 11 questions of total score of 0 to 24 that higher scores shows more involvement
    Time Frame
    Change from baseline LAFI at the end of the treatment, 1 month after treatment ,3 months after treatment.
    Title
    HAQ
    Description
    HAQ is used to evaluate functional disability status of patients in eight subscales; dressing, rising, eating, walking, hygiene, reach, grip and usual activities. It includes 20 items and each item has 3 likert score which 0 to 3 where 3 is unable to do
    Time Frame
    Change from baseline HAQ at the end of the treatment, 1 month after treatment ,3 months after treatment.
    Title
    SF-36
    Description
    The SF-36 Health Survey is a comprehensive measurement tool used to evaluate non-disease-specific overall quality of life. It has been developed and made available by Rand Corporation in order to evaluate overall quality of life (). It contains a total of 36 items with eight subscales: physical functioning, role-physical, role-emotional, bodily pain, social functioning, mental health, vitality, and general health. It grades the patient by using scores between 0 and 100,0 indicating poor health while 100 indicating good health. Turkish validity and reliability study had been con¬ducted for SF-36
    Time Frame
    Change from baseline SF-36 at the end of the treatment, 1 month after treatment ,3 months after treatment.
    Title
    Timed Up and Go Test
    Description
    TUG is a valid and reliable functional mobility test. It has a correlation with lower extremity strength and useful for identifying older adults risk of falling
    Time Frame
    Change from baseline TUG at the end of the treatment, 1 month after treatment ,3 months after treatment.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: primary knee osteoarthritis diagnosed according to the ACR criteria gave their written informed consent 40-75 ages Kellgren Lawrence grading 2-4 having symptomatic knee pain at least 3 months. Exclusion Criteria: secondary knee OA pathology of the waist, hip, or ankle joints decompensated organ failure malignancy, active bleeding infectious disease serious knee injuries or previous surgical procedures within the past 6 months the use of intraarticular steroids and hyaluronic acid injection to the knee joint within the past 6 months physiotherapy, balneotherapy, or peloidotherapy within the past 1 year.

    12. IPD Sharing Statement

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    Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise.

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