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

NCT ID: NCT04736069

Last Updated: 2021-05-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-01

Study Completion Date

2013-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Physical therapy program

Intervention Type OTHER

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 program

The group received the same physical therapy program including electrotherapy, superficial-deep heat applications and basic knee exercise program at outpatient clinic.

Group Type ACTIVE_COMPARATOR

Physical therapy program

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ufuk University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nihan Cuzdan

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nihan CUZDAN, MD

Role: PRINCIPAL_INVESTIGATOR

Ufuk University School of Medicine

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15766999 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3068365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12624858 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UfukUniv

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.