Osteoarthritis, KneeNCT04736069

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

A study testing Physical therapy program in people with Osteoarthritis, Knee, run by Ufuk University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: Physical therapy program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: No sites listed yet
Study dates: 1 Mar 2011to 30 Jan 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

About this study

Official title: 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.

Read the 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.

Conditions: Osteoarthritis, Knee
Being tested: Physical therapy program
Keywords: cost-effectiveness, knee, osteoarthritis, physical therapy
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Physical therapy programOther
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.

Study groups in NCT04736069
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Physical therapy program

What is being measured

The primary outcome is the main question the study is designed to answer.

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'
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: baseline-six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201130 Jan 2013

First posted3 Feb 2021
Study start1 Mar 2011
Primary completion30 Jan 2013
Study completion30 Jan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04736069
Sponsor's protocol ID: UfukUniv
Status last verified: Apr 2021
First submitted: 27 Jan 2021
Last updated: 18 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 15766999
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.
PubMed 3068365
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.
PubMed 12624858

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Cost-effectiveness of Inpatient and Outpatient Physical Therapy Programs in Knee Osteoarthritis
ClinicalTrials.gov ID: NCT04736069
Acronym / sponsor ID: UfukUniv
Conditions: Osteoarthritis, Knee
Keywords: cost-effectiveness, knee, osteoarthritis, physical therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Ufuk UniversityUniversity, hospital or other
Study start: 1 Mar 2011 (actual)
Primary completion: 30 Jan 2013 (actual)
Study completion: 30 Jan 2013 (actual)
First posted: 3 Feb 2021 (actual)
Results: Posted 18 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Inpatient physical therapy program	Active comparator	Other: Physical therapy programThe group received 21 sessions of physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program at inpatient clinic.
Outpatient physical therapy program	Active comparator	Other: Physical therapy programThe group received the same physical therapy program including electrotherapy, superficial-deep heat applications and basic knee exercise program at outpatient clinic.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (8 listed)

visual disturbances
malignancy
inflammatory rheumatic diseases
pregnancy
advanced cardiovascular, kidney or liver pathologies

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Physical therapy programIn 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.	Other	Inpatient physical therapy program, Outpatient physical therapy program

Primary outcome

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'
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.
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.
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.
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

Results and safety

Results posted to the registry on 18 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Inpatient Physical Therapy	30	30
Outpatient Physical Therapy	30	22

Primary outcome: Pain; Visual Analog Scale (VAS)

Time frame: Change from Baseline VAS scores at 6 months. Median (Inter-Quartile Range). Unit: cm

Measure	Inpatient Physical Therapy n = 30	Outpatient Physical Therapy n = 22
Value	4 (3 to 6)	4 (2 to 5)

Primary outcome: Physical Function; Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index

Time frame: Change from Baseline WOMAC scores at 6 months. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Inpatient Physical Therapy n = 30	Outpatient Physical Therapy n = 22
Value	26.5 (16 to 38)	18 (12 to 38)

Primary outcome: Fall Risk Assessment; Hendrich II Fall Risk Scale

Time frame: Change from Baseline Hendrich II Fall Risk Scale at 6 months. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Inpatient Physical Therapy n = 30	Outpatient Physical Therapy n = 22
Value	1 (0 to 2)	1 (0 to 2)

Primary outcome: Quality of Life; Short-Form 36-General Health

Time frame: Change from Baseline Short-Form 36 scores at 6 months. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Inpatient Physical Therapy n = 30	Outpatient Physical Therapy n = 22
Value	-7.5 (-20 to 0)	-7.5 (-20 to 0)

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Inpatient Physical Therapy	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Outpatient Physical Therapy	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15766999Dieppe 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.
Background: PubMed 3068365Bellamy 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.
Background: PubMed 12624858Hendrich 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.
Individual participant dataSharing planned: Yes. 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.

Related trials for Osteoarthritis, Knee

Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nihan CUZDAN, MD principal investigator

Ufuk University School of Medicine

Questions about this trial

What is this clinical trial studying?

A study testing Physical therapy program in people with Osteoarthritis, Knee, run by Ufuk University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain; Visual Analog Scale (VAS) (time frame: Change from Baseline VAS scores at 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04736069, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.