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

NCT04736069 | Completed Results

• 1 other identifier: UfukUniv
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis, Knee

Keywords

cost-effectiveness; knee; osteoarthritis; physical therapy

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Inpatient physical therapy program

ACTIVE COMPARATOR

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

Outpatient physical therapy program

ACTIVE COMPARATOR

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

Interventions

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.

Inpatient physical therapy program; Outpatient physical therapy program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Knee OA diagnosed patients based on American College of Rheumatology Criteria

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ufuk University: lead

Related Publications (3)

• 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.

  PMID: 15766999 BACKGROUND

• 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.

  PMID: 3068365 BACKGROUND

• 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.

  PMID: 12624858 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Nihan Cüzdan
• Organization: Ufuk University

nihancuzdan@hotmail.com

5052706846

Study Officials

• Nihan CUZDAN, MD

  Ufuk University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 3, 2021
• Study Start: March 1, 2011
• Primary Completion: January 30, 2013
• Study Completion: January 30, 2013
• Last Updated: May 18, 2021
• Results First Posted: May 18, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Starting 6 months after publication
• Access Criteria: The authors will consider providing data for all individual requests after the publication.