Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

The Combination of Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04697667
• Other study ID #: TDK-2020-35062
• Status: Completed
• Phase: N/A
• Start date: January 31, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: February 2022
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 10, 2022
• Est. primary completion date: January 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Exercise
Supervised exercise program

Biological:
• PRP
Intra-articular PRP injections to knee joint

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa	The Research Fund of Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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'.	6th week
Primary	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'.	3rd month
Primary	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.	6th week
Primary	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).	6th week
Primary	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.	6th week
Primary	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.	3rd month
Primary	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).	3rd month
Primary	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.	3rd month
Secondary	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.	6th week
Secondary	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.	3rd month
Secondary	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.	6th week
Secondary	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.	3rd month
Secondary	Patient Satisfaction	Patient satisfaction will be assessed by the Global Rating of Change scale.	6th week
Secondary	Patient Satisfaction	Patient satisfaction will be assessed by the Global Rating of Change scale.	3rd month