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Completed

NCT Number: NCT06010394

Control of Edema in the Knee in Patients With Knee Osteoarthritis

The aim of this study was to compare the effectiveness of exercise and classical massage in the control of knee edema in patients with knee osteoarthritis.

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Key information

Conditions

Knee Osteoarthritis Arthritis Edema Edema Leg Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uskudar university

Istanbul, Turkey (Türkiye)

About this study

This study will be a prospective randomized controlled study. It is planned to include 75 patients with knee osteoarthritis in this study. It was categorized as osteoarthritis(OA) stages according to Kellgren-Lawrence criteria. Patients were randomly divided into three groups. the investigators first group is the control group (KG) and this group will receive classical physical therapy with ultrasound and subcutaneous electrical nerve stimulation. Exercise therapy will be applied to the second group in addition to the classical physical therapy applied to the KG. The third group will be given classical massage in addition to the classical physical therapy applied to the KG. The treatments to be applied to the patients will be 3 sessions per week and it is planned to continue for 4 weeks. Knee edema, pain severity, functional status and daily life activities will be measured at the beginning and in the 4th week of the patients. The data obtained will be analyzed statistically.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being between the ages of 30-65
  • Patients with a diagnosis of osteoarthritis in stage 2 and stage 3 according to Kellgren-Lawrence criteria(1) and also with measurable edema

Exclusion criteria

  • Inability to continue treatment regularly
  • situations that prevent you from doing the exercise
  • inflammation that interferes with massage.

Treatment and study plan

Conventional Physiotherapy

Other

ultrasound electrotherapy cold applications

exercises for the knee area

Other

range of motion exercises strengthening exercises exercises to reduce edema

payment oriented massage

Other

10 / 15-minute massage treatments to reduce payment

Primary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score

    Time frame: 4 weeks

    It is used to detect symptoms and restrictions in current work that individuals do in daily life. The test is collected under 2 main headings, consisting of 6 questions about the effect of symptoms and 8 sub-activities that question the status of the activity. The answer to each question in the test is scored between 0-5. The scores that the person gets from each question are added together and these scores are divided by 70 and multiplied by 100. High score means low quality of life.

  2. Western Ontario and McMaster Universities Osteoarthritis Index

    Time frame: 4 weeks

    Pain, joint stiffness and functional status; Evaluated with the Arthritis Index of Western Ontario and McMaster Universities. The scale is a disease-specific, multidimensional, self-administered health status tool used in hip or knee osteoarthritis27. It consists of 24 questions on pain, stiffness and physical disability and is approximately 10 min. can be completed in Western Ontario and McMaster Universities Osteoarthritis Index consists of 24 questions under three sub-headings. Pain consists of 5 questions, stiffness 2 questions and function 17 questions. Each sub-parameter is scored between 0-4 points. Accordingly, it is classified as pain (0-20), stiffness (0-8) and function (0-68). A high score indicates poor health, a low score indicates good health.

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Official study title

Comparison of the Effectiveness of Exercise and Classical Massage in the Control of Edema in the Knee in Patients With Knee Osteoarthritis.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2023
Registry last updated
Dec 7, 2023

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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