Clinical trial NCT04736069: Which Physical Therapy Program is Cost-effective in Knee Osteoarthritis?
Official title: The Cost-effectiveness of Inpatient and Outpatient Physical Therapy Programs in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: cost-effectiveness
knee
osteoarthritis
physical therapy
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain; Visual Analog Scale (VAS)
timeFrame: Change from Baseline VAS scores at 6 months
measure: Physical Function; Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
timeFrame: Change from Baseline WOMAC scores at 6 months
measure: Fall Risk Assessment; Hendrich II Fall Risk Scale
timeFrame: Change from Baseline Hendrich II Fall Risk Scale at 6 months
measure: Quality of Life; Short-Form 36-General Health
timeFrame: Change from Baseline Short-Form 36 scores at 6 months
measure: Median Total Cost Per Participant for Health Care
timeFrame: baseline-six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ufuk University School of Medicine
name: Nihan CUZDAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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. doi: 10.1053/apnr.2003.YAPNR2.