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Which Physical Therapy Program is Cost-effective in Knee Osteoarthritis?

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical therapy program
Sponsored by
Ufuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring cost-effectiveness, knee, osteoarthritis, physical therapy

Eligibility Criteria

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

Inclusion Criteria:

-Knee OA diagnosed patients based on American College of Rheumatology Criteria

Exclusion Criteria:

  • visual disturbances
  • malignancy
  • inflammatory rheumatic diseases
  • pregnancy
  • advanced cardiovascular, kidney or liver pathologies
  • uncontrolled hypertension
  • patients who had injuries in their lower extremities
  • patients who underwent under total hip or knee prosthetic surgeries.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Inpatient physical therapy program

    Outpatient physical therapy program

    Arm Description

    The group received 21 sessions of physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program at inpatient clinic.

    The group received the same physical therapy program including electrotherapy, superficial-deep heat applications and basic knee exercise program at outpatient clinic.

    Outcomes

    Primary Outcome Measures

    Pain; Visual Analog Scale (VAS)
    Patients were requested to sign their pain level on a 10 cm horizontal line with terminal ends of 'no pain' and 'the worst pain'
    Physical Function; Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
    WOMAC questionnaire includes five items for pain, two for stiffness, and 17 for functional limitation (score range 0-68). All the items are scored on a scale of 0-4, with higher scores indicating a higher level of symptoms or physical disability.
    Fall Risk Assessment; Hendrich II Fall Risk Scale
    The scale includes seven items. These items are confusion & disorientation, depression, change in excretion, dizziness, gender, antiepileptic & benzodiazepine use, and get up and walk test. The final score is the sum of these scores; (the score range is between 0-16; 16 is the highest possible score) Patients five or more scores on the scale are considered to be at high risk.
    Quality of Life; Short-Form 36-General Health
    Short-Form 36 (SF-36) which is composed of eight multi-item scales as bodily pain, physical functioning, social functioning, role-physical, role-emotional, vitality, general health, mental health. Each score of these scales ranging from 0 to 100; higher scores indicating higher QoL.
    Median Total Cost Per Participant for Health Care
    median total expenses for health care at the end of the study

    Secondary Outcome Measures

    Full Information

    First Posted
    January 27, 2021
    Last Updated
    April 26, 2021
    Sponsor
    Ufuk University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04736069
    Brief Title
    Which Physical Therapy Program is Cost-effective in Knee Osteoarthritis?
    Official Title
    The Cost-effectiveness of Inpatient and Outpatient Physical Therapy Programs in Knee Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2011 (Actual)
    Primary Completion Date
    January 30, 2013 (Actual)
    Study Completion Date
    January 30, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ufuk 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
    Knee osteoarthritis (OA) is a disease with significant levels of socioeconomic burden to the society. P The non-pharmacologic interventions in knee OA include weight loss, exercise, and physical therapy. In this study, we aimed to to compare the cost-effectiveness of inpatient and outpatient physical therapy programs in patients with knee osteoarthritis.
    Detailed Description
    Knee osteoarthritis (OA) is a major problem for society with a heavy economic burden. Especially in the elderly population, integrated rehabilitation programs are frequently used to improve patients' symptoms and quality of life. To estimate the costs and utility of the rehabilitation programs may help clinicians decide optimal treatment strategy with proper usage of resources. Therefore, we aimed to to compare the cost-effectiveness of inpatient and outpatient physical therapy programs in patients with knee osteoarthritis.The study included 52 patients with the diagnose of knee osteoarthritis. Patients were divided into two groups. Group 1 (n=30) received 21 sessions of inpatient physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program. Group 2 (n=22) received the same physical therapy program at outpatient clinic.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee
    Keywords
    cost-effectiveness, knee, osteoarthritis, physical therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group 1 received 21 sessions of inpatient physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program. Group 2 received the same physical therapy program at outpatient clinic.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Inpatient physical therapy program
    Arm Type
    Active Comparator
    Arm Description
    The group received 21 sessions of physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program at inpatient clinic.
    Arm Title
    Outpatient physical therapy program
    Arm Type
    Active Comparator
    Arm Description
    The group received the same physical therapy program including electrotherapy, superficial-deep heat applications and basic knee exercise program at outpatient clinic.
    Intervention Type
    Other
    Intervention Name(s)
    Physical therapy program
    Intervention Description
    In the physical therapy program, 20 minutes of hot pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS; 30 to 40 Hz), 6 minutes of ultrasound (US; 1 MHz, 1 to 1.5 Watt/cm2) therapy were applied to both groups. Both of the programs were supervised by physical therapists. A combined range of motion and strengthening exercises were given to both groups to be performed two times a day.
    Primary Outcome Measure Information:
    Title
    Pain; Visual Analog Scale (VAS)
    Description
    Patients were requested to sign their pain level on a 10 cm horizontal line with terminal ends of 'no pain' and 'the worst pain'
    Time Frame
    Change from Baseline VAS scores at 6 months
    Title
    Physical Function; Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
    Description
    WOMAC questionnaire includes five items for pain, two for stiffness, and 17 for functional limitation (score range 0-68). All the items are scored on a scale of 0-4, with higher scores indicating a higher level of symptoms or physical disability.
    Time Frame
    Change from Baseline WOMAC scores at 6 months
    Title
    Fall Risk Assessment; Hendrich II Fall Risk Scale
    Description
    The scale includes seven items. These items are confusion & disorientation, depression, change in excretion, dizziness, gender, antiepileptic & benzodiazepine use, and get up and walk test. The final score is the sum of these scores; (the score range is between 0-16; 16 is the highest possible score) Patients five or more scores on the scale are considered to be at high risk.
    Time Frame
    Change from Baseline Hendrich II Fall Risk Scale at 6 months
    Title
    Quality of Life; Short-Form 36-General Health
    Description
    Short-Form 36 (SF-36) which is composed of eight multi-item scales as bodily pain, physical functioning, social functioning, role-physical, role-emotional, vitality, general health, mental health. Each score of these scales ranging from 0 to 100; higher scores indicating higher QoL.
    Time Frame
    Change from Baseline Short-Form 36 scores at 6 months
    Title
    Median Total Cost Per Participant for Health Care
    Description
    median total expenses for health care at the end of the study
    Time Frame
    baseline-six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: -Knee OA diagnosed patients based on American College of Rheumatology Criteria Exclusion Criteria: visual disturbances malignancy inflammatory rheumatic diseases pregnancy advanced cardiovascular, kidney or liver pathologies uncontrolled hypertension patients who had injuries in their lower extremities patients who underwent under total hip or knee prosthetic surgeries.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nihan CUZDAN, MD
    Organizational Affiliation
    Ufuk University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The authors will consider providing data for all individual requests after the publication. Requests can be done through e-mail. All individual requests will be evaluated and the data will be shared by the principal investigator.
    IPD Sharing Time Frame
    Starting 6 months after publication
    IPD Sharing Access Criteria
    The authors will consider providing data for all individual requests after the publication.
    IPD Sharing URL
    http://'nihancuzdan@hotmail.com
    Citations:
    PubMed Identifier
    15766999
    Citation
    Dieppe PA, Lohmander LS. Pathogenesis and management of pain in osteoarthritis. Lancet. 2005 Mar 12-18;365(9463):965-73. doi: 10.1016/S0140-6736(05)71086-2.
    Results Reference
    background
    PubMed Identifier
    3068365
    Citation
    Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.
    Results Reference
    background
    PubMed Identifier
    12624858
    Citation
    Hendrich AL, Bender PS, Nyhuis A. Validation of the Hendrich II Fall Risk Model: a large concurrent case/control study of hospitalized patients. Appl Nurs Res. 2003 Feb;16(1):9-21. doi: 10.1053/apnr.2003.YAPNR2. Erratum In: Appl Nurs Res. 2003 Aug;16(3):208.
    Results Reference
    background

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