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

Study Overview
=================
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.

Official Title
-----------------
The Cost-effectiveness of Inpatient and Outpatient Physical Therapy Programs in Knee Osteoarthritis

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Other: Physical therapy program


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inpatient physical therapy program<br>The group received 21 sessions of physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program at inpatient clinic. | Other: Physical therapy program<br>* 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.<br>|
| Active Comparator: Outpatient physical therapy program<br>The group received the same physical therapy program including electrotherapy, superficial-deep heat applications and basic knee exercise program at outpatient clinic. | Other: Physical therapy program<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cost-effectiveness, knee, osteoarthritis, physical therapy