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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2021
Source Ufuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ufuk University

References & Publications (3)

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

Outcome

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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