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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inpatient physical therapy program | Active Comparator | The group received 21 sessions of physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program at inpatient clinic. |
|
| Outpatient physical therapy program | Active Comparator | The group received the same physical therapy program including electrotherapy, superficial-deep heat applications and basic knee exercise program at outpatient clinic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical therapy program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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' | Change from Baseline VAS scores at 6 months |
| 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. | Change from Baseline WOMAC scores at 6 months |
| 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. | Change from Baseline Hendrich II Fall Risk Scale at 6 months |
| 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. | Change from Baseline Short-Form 36 scores at 6 months |
| Median Total Cost Per Participant for Health Care | median total expenses for health care at the end of the study | baseline-six months |
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Inclusion Criteria:
-Knee OA diagnosed patients based on American College of Rheumatology Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nihan CUZDAN, MD | Ufuk University School of Medicine | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15766999 | Background | 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. | |
| 3068365 | Background | 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. |
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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.
Starting 6 months after publication
The authors will consider providing data for all individual requests after the publication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inpatient Physical Therapy | Patients who received physical therapy and rehabilitation program at inpatient clinic |
| FG001 | Outpatient Physical Therapy | Patients who received physical therapy and rehabilitation program at outpatient clinic |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inpatient Physical Therapy | Group 1 received 21 physical therapy sessions, including electrotherapy, superficial-deep heat applications, and a basic knee exercise program at inpatient clinic. |
| BG001 | Outpatient Physical Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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' | Posted | Median | Inter-Quartile Range | cm | Change from Baseline VAS scores at 6 months |
|
6 months
Skin and Subcutaneous Tissue Disorders
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inpatient Physical Therapy | Patients who received physical therapy and rehabilitation program at inpatient clinic |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nihan Cüzdan | Ufuk University | 5052706846 | nihancuzdan@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 3, 2010 | Feb 19, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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.
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|
| 12624858 | Background | 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. |
Group 2 received 21 physical therapy sessions, including electrotherapy, superficial-deep heat applications, and a basic knee exercise program at outpatient clinic.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Occupation | Count of Participants | Participants |
|
| Occupational intensity | Count of Participants | Participants |
|
| Trauma history presence | Count of Participants | Participants |
|
| Kellgren Lawrence Grading | Kellgren-Lawrence classification system is used for osteoarthritis grading; grade: 0: none; grade:1 doubtful, grade 2: minimal, grade 3: moderate, grade 4:severe | Count of Participants | Participants |
|
| OG001 | Outpatient Physical Therapy | The group received the same physical therapy program including electrotherapy, superficial-deep heat applications and basic knee exercise program at outpatient clinic. Physical therapy program: 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 | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Change from Baseline WOMAC scores at 6 months |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Change from Baseline Hendrich II Fall Risk Scale at 6 months |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Change from Baseline Short-Form 36 scores at 6 months |
|
|
|
| Primary | Median Total Cost Per Participant for Health Care | median total expenses for health care at the end of the study | Posted | Median | Full Range | euros | baseline-six months |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Outpatient Physical Therapy | Patients who received physical therapy and rehabilitation program at outpatient clinic | 0 | 30 | 0 | 30 | 0 | 30 |
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| heavy |
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| grade 4 |
|