Control of Edema in the Knee in Patients With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06010394
• Other study ID #: Uskudar50
• Status: Completed
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 6, 2023

Study information

• Verified date: December 2023
• Source: Uskudar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 6, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Edema
• Edema Leg
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• conventional physiotherapy
ultrasound electrotherapy cold applications
• exercises for the knee area
range of motion exercises strengthening exercises exercises to reduce edema
• payment oriented massage
10 / 15-minute massage treatments to reduce payment

Locations

Country	Name	City	State
Turkey	Uskudar university	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Uskudar University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Hofmann S, Kramer J, Vakil-Adli A, Aigner N, Breitenseher M. Painful bone marrow edema of the knee: differential diagnosis and therapeutic concepts. Orthop Clin North Am. 2004 Jul;35(3):321-33, ix. doi: 10.1016/j.ocl.2004.04.005. — View Citation

Kan HS, Chan PK, Chiu KY, Yan CH, Yeung SS, Ng YL, Shiu KW, Ho T. Non-surgical treatment of knee osteoarthritis. Hong Kong Med J. 2019 Apr;25(2):127-133. doi: 10.12809/hkmj187600. Epub 2019 Mar 28. — View Citation

Maricar N, Callaghan MJ, Parkes MJ, Felson DT, O'Neill TW. Clinical assessment of effusion in knee osteoarthritis-A systematic review. Semin Arthritis Rheum. 2016 Apr;45(5):556-63. doi: 10.1016/j.semarthrit.2015.10.004. Epub 2015 Oct 22. — View Citation

Molfetta L, Florian A, Saviola G, Frediani B. Bone Marrow Edema: pathogenetic features. Clin Ter. 2022 Sep-Oct;173(5):434-439. doi: 10.7417/CT.2022.2459. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Injury and Osteoarthritis Outcome Score	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
Primary	Western Ontario and McMaster Universities Osteoarthritis Index	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