Osteoarthritis, Knee
Conditions
Keywords
cost-effectiveness, knee, osteoarthritis, physical therapy
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.
Interventions
OTHERPhysical 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.
Sponsors
Ufuk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain; Visual Analog Scale (VAS) | Change from Baseline VAS scores at 6 months | 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 | Change from Baseline WOMAC scores at 6 months | 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 | Change from Baseline Hendrich II Fall Risk Scale at 6 months | 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 | Change from Baseline Short-Form 36 scores at 6 months | 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 | baseline-six months | median total expenses for health care at the end of the study |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Outpatient Physical Therapy Group 2 received 21 physical therapy sessions, including electrotherapy, superficial-deep heat applications, and a basic knee exercise program at outpatient clinic. | 22 |
| Total | 52 |
Baseline characteristics
| Characteristic | Inpatient Physical Therapy | Outpatient Physical Therapy | Total |
|---|---|---|---|
| Age, Continuous | 66.8 years STANDARD_DEVIATION 12.2 | 61.0 years STANDARD_DEVIATION 14.1 | 64.4 years STANDARD_DEVIATION 13.3 |
| Body Mass Index | 30.2 kg/m^2 STANDARD_DEVIATION 4 | 26.8 kg/m^2 STANDARD_DEVIATION 4.3 | 28.8 kg/m^2 STANDARD_DEVIATION 4.5 |
| Kellgren Lawrence Grading grade 1/2 | 10 Participants | 14 Participants | 24 Participants |
| Kellgren Lawrence Grading grade 3 | 14 Participants | 5 Participants | 19 Participants |
| Kellgren Lawrence Grading grade 4 | 6 Participants | 3 Participants | 9 Participants |
| Occupation unemployed | 29 Participants | 18 Participants | 47 Participants |
| Occupation working | 1 Participants | 4 Participants | 5 Participants |
| Occupational intensity heavy | 0 Participants | 1 Participants | 1 Participants |
| Occupational intensity light | 28 Participants | 17 Participants | 45 Participants |
| Occupational intensity moderate | 2 Participants | 4 Participants | 6 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Turkey | 30 Participants | 22 Participants | 52 Participants |
| Sex: Female, Male Female | 27 Participants | 16 Participants | 43 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 9 Participants |
| Trauma history presence absent | 24 Participants | 17 Participants | 41 Participants |
| Trauma history presence present | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: Change from Baseline Hendrich II Fall Risk Scale at 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Inpatient Physical Therapy | Fall Risk Assessment; Hendrich II Fall Risk Scale | 1 score on a scale |
| Outpatient Physical Therapy | Fall Risk Assessment; Hendrich II Fall Risk Scale | 1 score on a scale |
Primary
Median Total Cost Per Participant for Health Care
median total expenses for health care at the end of the study
Time frame: baseline-six months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Inpatient Physical Therapy | Median Total Cost Per Participant for Health Care | 552.4 euros |
| Outpatient Physical Therapy | Median Total Cost Per Participant for Health Care | 276.3 euros |
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'
Time frame: Change from Baseline VAS scores at 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Inpatient Physical Therapy | Pain; Visual Analog Scale (VAS) | 4 cm |
| Outpatient Physical Therapy | Pain; Visual Analog Scale (VAS) | 4 cm |
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.
Time frame: Change from Baseline WOMAC scores at 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Inpatient Physical Therapy | Physical Function; Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index | 26.5 score on a scale |
| Outpatient Physical Therapy | Physical Function; Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index | 18 score on a scale |
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.
Time frame: Change from Baseline Short-Form 36 scores at 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Inpatient Physical Therapy | Quality of Life; Short-Form 36-General Health | -7.5 score on a scale |
| Outpatient Physical Therapy | Quality of Life; Short-Form 36-General Health | -7.5 score on a scale |