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NCT Number: NCT06631456

Effects of Platelet-Rich Plasma and Ozone Therapy in Knee Osteoarthritis

Knee osteoarthritis can frequently occur with advancing age. In cases of pain that persists despite hot/cold applications, drug therapy and exercise, intra-articular injections are considered. In advanced-stage gonarthrosis, steroid injections may respond. However, in mild and moderate knee arthritis, regenerative methods come to the forefront because the joint cartilage is still partially/completely intact. PRP and ozone therapy are frequently applied intra-articular treatments. This study will compare the effects of both injection methods on clinical outcomes.

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Key information

Conditions

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

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Şişli Hamidiye Etfal Training and Research Hospital, İstanbul

Istanbul, Turkey (Türkiye)

About this study

Knee osteoarthritis is a common arthrosis that can be encountered frequently with increasing life expectancy. In mild-moderate stages, hot/cold applications, drug treatments and exercise applications are usually applied, while in those who do not respond, physical therapy or intra-articular injection treatments are applied. This retrospective study aims to examine the effects of intra-articular Platelet Rich Plasma (PRP) and ozone therapy on pain, functionality and quality of life in patients with Stage 2-3 gonarthrosis according to the Kelgren-Lawrence (KL) Classification.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 30-70 years old, Stage 2-3 gonarthrosis according to KL
  • Voluntariness to participate in the study

Exclusion criteria

  • Cognitive dysfunction
  • General medical condition is not suitable for injections and evaluations
  • History of knee injections in the last 3 months
  • History of previous knee surgery
  • Bleeding disorders or those taking medications that may cause bleeding disorders after injections

Treatment and study plan

PRP injection

Other

A total of 3 doses of intra-articular PRP were applied to the symptomatic knees of the patients under ultrasound guidance, once a week.

Ozone therapy

Other

A total of 3 doses of intra-articular ozone therapy were applied to the symptomatic knees of the patients under ultrasound guidance, once a week.

Primary outcomes

  1. Pain-Numerical Rating Scale

    Time frame: From enrollment to the end of treatment at 3rd month

    Pain level will be evaluated with the Numerical Rating Scale. (minimum: 0, maximum: 10)

Secondary outcomes

  1. Pain, stiffness and physical function-WOMAC

    Time frame: From enrollment to the end of treatment at 3rd month

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used self-administered health status measure used in assessing pain, stiffness, and function in patients with OA of the hip or knee. 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). The scores for each sub-scale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three sub-scales gives a total WOMAC score.

  2. Quality of life-SF-12

    Time frame: From enrollment to the end of treatment at 3rd month

    The 12-item short-form health survey (SF-12) quality of life scale was used to evaluate general quality of life. It was presented as a physical component score (PCS) and mental component score (MCS). Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Official study title

Effects of Platelet-Rich Plasma and Ozone Therapy on Pain and Quality of Life in Knee Osteoarthritis: A Retrospective Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

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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