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Completed

NCT Number: NCT04697667

Exercise and PRP vs Exercise Alone in Patients With Knee Osteoarthritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Exercise

Other

Supervised exercise program

PRP

Biological

Intra-articular PRP injections to knee joint

Primary outcomes

  1. Pain intensity

    Time frame: 6th week

    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'.

  2. Pain intensity

    Time frame: 3rd month

    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'.

  3. Function

    Time frame: 6th week

    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.

  4. Functional performance - 40m fast-paced walk test

    Time frame: 6th week

    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).

  5. Functional performance - 10-step stair-climb test

    Time frame: 6th week

    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.

  6. Function

    Time frame: 3rd month

    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.

  7. Functional performance - 40m fast-paced walk test

    Time frame: 3rd month

    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).

  8. Functional performance - 10-step stair-climb test

    Time frame: 3rd month

    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 outcomes

  1. Range of motion

    Time frame: 6th week

    Knee joint ROMs will be measured using a universal goniometer. The process will be repeated three times and the average value will be recorded.

  2. Range of motion

    Time frame: 3rd month

    Knee joint ROMs will be measured using a universal goniometer. The process will be repeated three times and the average value will be recorded.

  3. Health related quality of life

    Time frame: 6th week

    Health related quality of life will be measured using SF 12 score that measures eight health domains to assess physical and mental health.

  4. Health related quality of life

    Time frame: 3rd month

    Health related quality of life will be measured using SF 12 score that measures eight health domains to assess physical and mental health.

  5. Patient Satisfaction

    Time frame: 6th week

    Patient satisfaction will be assessed by the Global Rating of Change scale.

  6. Patient Satisfaction

    Time frame: 3rd month

    Patient satisfaction will be assessed by the Global Rating of Change scale.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2021
Registry last updated
Mar 2, 2026

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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