Trial Outcomes & Findings for Which Physical Therapy Program is Cost-effective in Knee Osteoarthritis? (NCT NCT04736069)
NCT ID: NCT04736069
Last Updated: 2021-05-18
Results Overview
Patients were requested to sign their pain level on a 10 cm horizontal line with terminal ends of 'no pain' and 'the worst pain'
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Change from Baseline VAS scores at 6 months
Results posted on
2021-05-18
Participant Flow
Participant milestones
| Measure |
Inpatient Physical Therapy
Patients who received physical therapy and rehabilitation program at inpatient clinic
|
Outpatient Physical Therapy
Patients who received physical therapy and rehabilitation program at outpatient clinic
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Inpatient Physical Therapy
n=30 Participants
Group 1 received 21 physical therapy sessions, including electrotherapy, superficial-deep heat applications, and a basic knee exercise program at inpatient clinic.
|
Outpatient Physical Therapy
n=22 Participants
Group 2 received 21 physical therapy sessions, including electrotherapy, superficial-deep heat applications, and a basic knee exercise program at outpatient clinic.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.8 years
STANDARD_DEVIATION 12.2 • n=30 Participants
|
61.0 years
STANDARD_DEVIATION 14.1 • n=22 Participants
|
64.4 years
STANDARD_DEVIATION 13.3 • n=52 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=30 Participants
|
16 Participants
n=22 Participants
|
43 Participants
n=52 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=30 Participants
|
6 Participants
n=22 Participants
|
9 Participants
n=52 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
30 Participants
n=30 Participants
|
22 Participants
n=22 Participants
|
52 Participants
n=52 Participants
|
|
Body Mass Index
|
30.2 kg/m^2
STANDARD_DEVIATION 4.0 • n=30 Participants
|
26.8 kg/m^2
STANDARD_DEVIATION 4.3 • n=22 Participants
|
28.8 kg/m^2
STANDARD_DEVIATION 4.5 • n=52 Participants
|
|
Occupation
unemployed
|
29 Participants
n=30 Participants
|
18 Participants
n=22 Participants
|
47 Participants
n=52 Participants
|
|
Occupation
working
|
1 Participants
n=30 Participants
|
4 Participants
n=22 Participants
|
5 Participants
n=52 Participants
|
|
Occupational intensity
light
|
28 Participants
n=30 Participants
|
17 Participants
n=22 Participants
|
45 Participants
n=52 Participants
|
|
Occupational intensity
moderate
|
2 Participants
n=30 Participants
|
4 Participants
n=22 Participants
|
6 Participants
n=52 Participants
|
|
Occupational intensity
heavy
|
0 Participants
n=30 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=52 Participants
|
|
Trauma history presence
present
|
6 Participants
n=30 Participants
|
5 Participants
n=22 Participants
|
11 Participants
n=52 Participants
|
|
Trauma history presence
absent
|
24 Participants
n=30 Participants
|
17 Participants
n=22 Participants
|
41 Participants
n=52 Participants
|
|
Kellgren Lawrence Grading
grade 1/2
|
10 Participants
n=30 Participants
|
14 Participants
n=22 Participants
|
24 Participants
n=52 Participants
|
|
Kellgren Lawrence Grading
grade 3
|
14 Participants
n=30 Participants
|
5 Participants
n=22 Participants
|
19 Participants
n=52 Participants
|
|
Kellgren Lawrence Grading
grade 4
|
6 Participants
n=30 Participants
|
3 Participants
n=22 Participants
|
9 Participants
n=52 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline VAS scores at 6 monthsPatients were requested to sign their pain level on a 10 cm horizontal line with terminal ends of 'no pain' and 'the worst pain'
Outcome measures
| Measure |
Inpatient Physical Therapy
n=30 Participants
The group received 21 sessions of physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program at inpatient 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.
|
Outpatient Physical Therapy
n=22 Participants
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.
|
|---|---|---|
|
Pain; Visual Analog Scale (VAS)
|
4 cm
Interval 3.0 to 6.0
|
4 cm
Interval 2.0 to 5.0
|
PRIMARY outcome
Timeframe: Change from Baseline WOMAC scores at 6 monthsWOMAC 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.
Outcome measures
| Measure |
Inpatient Physical Therapy
n=30 Participants
The group received 21 sessions of physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program at inpatient 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.
|
Outpatient Physical Therapy
n=22 Participants
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.
|
|---|---|---|
|
Physical Function; Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
|
26.5 score on a scale
Interval 16.0 to 38.0
|
18 score on a scale
Interval 12.0 to 38.0
|
PRIMARY outcome
Timeframe: Change from Baseline Hendrich II Fall Risk Scale at 6 monthsThe 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.
Outcome measures
| Measure |
Inpatient Physical Therapy
n=30 Participants
The group received 21 sessions of physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program at inpatient 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.
|
Outpatient Physical Therapy
n=22 Participants
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.
|
|---|---|---|
|
Fall Risk Assessment; Hendrich II Fall Risk Scale
|
1 score on a scale
Interval 0.0 to 2.0
|
1 score on a scale
Interval 0.0 to 2.0
|
PRIMARY outcome
Timeframe: Change from Baseline Short-Form 36 scores at 6 monthsShort-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.
Outcome measures
| Measure |
Inpatient Physical Therapy
n=30 Participants
The group received 21 sessions of physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program at inpatient 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.
|
Outpatient Physical Therapy
n=22 Participants
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.
|
|---|---|---|
|
Quality of Life; Short-Form 36-General Health
|
-7.5 score on a scale
Interval -20.0 to 0.0
|
-7.5 score on a scale
Interval -20.0 to 0.0
|
PRIMARY outcome
Timeframe: baseline-six monthsmedian total expenses for health care at the end of the study
Outcome measures
| Measure |
Inpatient Physical Therapy
n=30 Participants
The group received 21 sessions of physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program at inpatient 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.
|
Outpatient Physical Therapy
n=22 Participants
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.
|
|---|---|---|
|
Median Total Cost Per Participant for Health Care
|
552.4 euros
Interval 497.2 to 1372.5
|
276.3 euros
Interval 218.0 to 1023.6
|
Adverse Events
Inpatient Physical Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Outpatient Physical Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place