Control of Edema in the Knee in Patients With Knee Osteoarthritis

Sponsor
Uskudar University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06010394
Collaborator
(none)
75
3
1.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: conventional physiotherapy
  • Other: exercises for the knee area
  • Other: payment oriented massage
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
classical physical therapy, exercise therapy, classical massageclassical physical therapy, exercise therapy, classical massage
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of the Effectiveness of Exercise and Classical Massage in the Control of Edema in the Knee in Patients With Knee Osteoarthritis.
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Oct 15, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Knee Injury and Osteoarthritis Outcome Score [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Uskudar University

Investigators

  • Study Chair: Enver Deniz YILDIRIM, Uskudar University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. Öğr. Üyesi Ömer Şevgin, Asst. Prof. Dr., Uskudar University
ClinicalTrials.gov Identifier:
NCT06010394
Other Study ID Numbers:
  • Uskudar50
First Posted:
Aug 24, 2023
Last Update Posted:
Aug 25, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Öğr. Üyesi Ömer Şevgin, Asst. Prof. Dr., Uskudar University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2023