Which Physical Therapy Program is Cost-effective in Knee Osteoarthritis?

The Cost-effectiveness of Inpatient and Outpatient Physical Therapy Programs in Knee Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: Physical therapy program

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Inpatient physical therapy program; The group received 21 sessions of physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program at inpatient clinic.	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.
ACTIVE_COMPARATOR: Outpatient physical therapy program; The group received the same physical therapy program including electrotherapy, superficial-deep heat applications and basic knee exercise program at outpatient clinic.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Median Total Cost Per Participant for Health Care	median total expenses for health care at the end of the study	baseline-six months

Collaborators and Investigators

• Sponsor: Ufuk University
• Investigators: Principal Investigator: Nihan CUZDAN, MD, Ufuk University School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: Appl Nurs Res. 2003 Aug;16(3):208.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2011
• Primary Completion (ACTUAL): January 30, 2013
• Study Completion (ACTUAL): January 30, 2013

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (ACTUAL): February 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: osteoarthritis; knee; physical therapy; cost-effectiveness
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: UfukUniv

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The authors will consider providing data for all individual requests after the publication. Requests can be done through e-mail. All individual requests will be evaluated and the data will be shared by the principal investigator.
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Access Criteria: The authors will consider providing data for all individual requests after the publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No