Control of Edema in the Knee in Patients With Knee Osteoarthritis

December 6, 2023 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University

Comparison of the Effectiveness of Exercise and Classical Massage in the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Uskudar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
commensal physiotherapy will be applied
Other: conventional physiotherapy
ultrasound electrotherapy cold applications
Experimental: exercise group
exercises will be given
Other: conventional physiotherapy
ultrasound electrotherapy cold applications
Other: exercises for the knee area
range of motion exercises strengthening exercises exercises to reduce edema
Experimental: massage group
massage will be done
Other: conventional physiotherapy
ultrasound electrotherapy cold applications
Other: payment oriented massage
10 / 15-minute massage treatments to reduce payment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uskudar University

Investigators

  • Study Chair: Enver Deniz YILDIRIM, Uskudar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

October 15, 2023

Study Completion (Actual)

December 6, 2023

Study Registration Dates

First Submitted

August 18, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uskudar50

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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