Osteoarthritis, Knee Clinical Trial
Official title:
The Cost-effectiveness of Inpatient and Outpatient Physical Therapy Programs in Knee Osteoarthritis
NCT number | NCT04736069 |
Other study ID # | UfukUniv |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2011 |
Est. completion date | January 30, 2013 |
Verified date | April 2021 |
Source | Ufuk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 30, 2013 |
Est. primary completion date | January 30, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ufuk University |
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. — View Citation
Dieppe PA, Lohmander LS. Pathogenesis and management of pain in osteoarthritis. Lancet. 2005 Mar 12-18;365(9463):965-73. Review. — View 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. Erratum in: Appl Nurs Res. 2003 Aug;16(3):208. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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' | Change from Baseline VAS scores at 6 months | |
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. | 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. | 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. | 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 | baseline-six months |
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