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
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring cost-effectiveness, knee, osteoarthritis, physical therapy
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.
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
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
Learn more about this trial
Which Physical Therapy Program is Cost-effective in Knee Osteoarthritis?
We'll reach out to this number within 24 hrs