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Completed

NCT Number: NCT04736069

Which Physical Therapy Program is Cost-effective 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

physical therapy program

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.

Primary outcomes

  1. Pain; Visual Analog Scale (VAS)

    Time frame: Change from Baseline VAS scores at 6 months

    Patients were requested to sign their pain level on a 10 cm horizontal line with terminal ends of 'no pain' and 'the worst pain'

  2. Physical Function; Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index

    Time frame: Change from Baseline WOMAC scores at 6 months

    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.

  3. Fall Risk Assessment; Hendrich II Fall Risk Scale

    Time frame: Change from Baseline Hendrich II Fall Risk Scale at 6 months

    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.

  4. Quality of Life; Short-Form 36-General Health

    Time frame: Change from Baseline Short-Form 36 scores at 6 months

    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.

  5. Median Total Cost Per Participant for Health Care

    Time frame: baseline-six months

    median total expenses for health care at the end of the study

Sponsors and collaborators

Lead sponsor

Ufuk University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 3, 2021
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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