Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
PRP
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Adults 40-70 years of age,
- Grade 2-3 according to Kellgren Lawrence osteoarthritis classification,
- No medication for knee osteoarthritis in the past three months,
- Subjects who understand and sign the consent form for this study.
Exclusion Criteria:
- Patients who have received an invasive procedure, intra-articular application and / or physiotherapy in the target knee within three months,
- Previous partial or total knee replacement of the target knee,
- Body mass index > 30 kg/m2,
- Having any cardiovascular diseases, neurological disorders, rheumatic diseases, malignancy or psychiatric diseases,
- Impaired cognition that impacts the ability to give informed consent,
- Participation in another clinical trial.
Sites / Locations
- Istanbul University-Cerrahpasa
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Group I
Group II
Group III
Arm Description
Each subject in this group will receive a combined treatment protocol consisting of three PRP injections to knee joint and supervised exercise program.
Each subject in this group will receive a treatment of supervised exercise program.
Each subject in this group will receive a treatment of three PRP injections to knee joint.
Outcomes
Primary Outcome Measures
Pain intensity
Pain intensity will be measured using the numerical pain rating scale. Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Pain intensity
Pain intensity will be measured using the numerical pain rating scale. Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Function
Functional status of the patients will be evaluated by The Western Ontario and McMaster Universities Arthritis (WOMAC) Index. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (Pain, Stiffness and Physical Function). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores on the WOMAC indicate worse results.
Functional performance - 40m fast-paced walk test
Functional performance of the patients will be evaluated by 40-meter fast-paced walk test. Participants are asked to walk as quickly but as safely as possible, without running, along a 10-meter walkway for a total distance of 40 meters. Walking speed will be measured in meters/second (m/s).
Functional performance - 10-step stair-climb test
Functional performance of the patients will be evaluated by 10-step stair-climb test. Patients are instructed to ascend and descend the flight of stairs as quickly as possible but in a safe manner. The time needed is recorded in seconds.
Function
Functional status of the patients will be evaluated by The Western Ontario and McMaster Universities Arthritis (WOMAC) Index. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (Pain, Stiffness and Physical Function). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores on the WOMAC indicate worse results.
Functional performance - 40m fast-paced walk test
Functional performance of the patients will be evaluated by 40-meter fast-paced walk test. Participants are asked to walk as quickly but as safely as possible, without running, along a 10-meter walkway for a total distance of 40 meters. Walking speed will be measured in meters/second (m/s).
Functional performance - 10-step stair-climb test
Functional performance of the patients will be evaluated by 10-step stair-climb test. Patients are instructed to ascend and descend the flight of stairs as quickly as possible but in a safe manner. The time needed is recorded in seconds.
Secondary Outcome Measures
Range of motion
Knee joint ROMs will be measured using a universal goniometer. The process will be repeated three times and the average value will be recorded.
Range of motion
Knee joint ROMs will be measured using a universal goniometer. The process will be repeated three times and the average value will be recorded.
Health related quality of life
Health related quality of life will be measured using SF 12 score that measures eight health domains to assess physical and mental health.
Health related quality of life
Health related quality of life will be measured using SF 12 score that measures eight health domains to assess physical and mental health.
Patient Satisfaction
Patient satisfaction will be assessed by the Global Rating of Change scale.
Patient Satisfaction
Patient satisfaction will be assessed by the Global Rating of Change scale.
Full Information
NCT ID
NCT04697667
First Posted
January 3, 2021
Last Updated
February 11, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT04697667
Brief Title
Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis
Official Title
The Combination of Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 31, 2021 (Actual)
Primary Completion Date
January 7, 2022 (Actual)
Study Completion Date
February 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This study is a prospective randomized controlled study of different treatments for knee osteoarthritis and aims to investigate the efficacy of exercise combined platelet rich plasma (PRP) injection versus only exercise or only PRP treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
Each subject in this group will receive a combined treatment protocol consisting of three PRP injections to knee joint and supervised exercise program.
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Each subject in this group will receive a treatment of supervised exercise program.
Arm Title
Group III
Arm Type
Active Comparator
Arm Description
Each subject in this group will receive a treatment of three PRP injections to knee joint.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Supervised exercise program
Intervention Type
Biological
Intervention Name(s)
PRP
Intervention Description
Intra-articular PRP injections to knee joint
Primary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity will be measured using the numerical pain rating scale. Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Time Frame
6th week
Title
Pain intensity
Description
Pain intensity will be measured using the numerical pain rating scale. Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Time Frame
3rd month
Title
Function
Description
Functional status of the patients will be evaluated by The Western Ontario and McMaster Universities Arthritis (WOMAC) Index. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (Pain, Stiffness and Physical Function). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores on the WOMAC indicate worse results.
Time Frame
6th week
Title
Functional performance - 40m fast-paced walk test
Description
Functional performance of the patients will be evaluated by 40-meter fast-paced walk test. Participants are asked to walk as quickly but as safely as possible, without running, along a 10-meter walkway for a total distance of 40 meters. Walking speed will be measured in meters/second (m/s).
Time Frame
6th week
Title
Functional performance - 10-step stair-climb test
Description
Functional performance of the patients will be evaluated by 10-step stair-climb test. Patients are instructed to ascend and descend the flight of stairs as quickly as possible but in a safe manner. The time needed is recorded in seconds.
Time Frame
6th week
Title
Function
Description
Functional status of the patients will be evaluated by The Western Ontario and McMaster Universities Arthritis (WOMAC) Index. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (Pain, Stiffness and Physical Function). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores on the WOMAC indicate worse results.
Time Frame
3rd month
Title
Functional performance - 40m fast-paced walk test
Description
Functional performance of the patients will be evaluated by 40-meter fast-paced walk test. Participants are asked to walk as quickly but as safely as possible, without running, along a 10-meter walkway for a total distance of 40 meters. Walking speed will be measured in meters/second (m/s).
Time Frame
3rd month
Title
Functional performance - 10-step stair-climb test
Description
Functional performance of the patients will be evaluated by 10-step stair-climb test. Patients are instructed to ascend and descend the flight of stairs as quickly as possible but in a safe manner. The time needed is recorded in seconds.
Time Frame
3rd month
Secondary Outcome Measure Information:
Title
Range of motion
Description
Knee joint ROMs will be measured using a universal goniometer. The process will be repeated three times and the average value will be recorded.
Time Frame
6th week
Title
Range of motion
Description
Knee joint ROMs will be measured using a universal goniometer. The process will be repeated three times and the average value will be recorded.
Time Frame
3rd month
Title
Health related quality of life
Description
Health related quality of life will be measured using SF 12 score that measures eight health domains to assess physical and mental health.
Time Frame
6th week
Title
Health related quality of life
Description
Health related quality of life will be measured using SF 12 score that measures eight health domains to assess physical and mental health.
Time Frame
3rd month
Title
Patient Satisfaction
Description
Patient satisfaction will be assessed by the Global Rating of Change scale.
Time Frame
6th week
Title
Patient Satisfaction
Description
Patient satisfaction will be assessed by the Global Rating of Change scale.
Time Frame
3rd month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults 40-70 years of age,
Grade 2-3 according to Kellgren Lawrence osteoarthritis classification,
No medication for knee osteoarthritis in the past three months,
Subjects who understand and sign the consent form for this study.
Exclusion Criteria:
Patients who have received an invasive procedure, intra-articular application and / or physiotherapy in the target knee within three months,
Previous partial or total knee replacement of the target knee,
Body mass index > 30 kg/m2,
Having any cardiovascular diseases, neurological disorders, rheumatic diseases, malignancy or psychiatric diseases,
Impaired cognition that impacts the ability to give informed consent,
Participation in another clinical trial.
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
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Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis
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