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Control of Edema in the Knee in Patients With Knee Osteoarthritis

NCT ID: NCT06010394

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2023-12-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Knee Osteoarthritis Edema Edema Leg

Keywords

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massage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

classical physical therapy, exercise therapy, classical massage
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control group

commensal physiotherapy will be applied

Group Type ACTIVE_COMPARATOR

conventional physiotherapy

Intervention Type OTHER

ultrasound electrotherapy cold applications

exercise group

exercises will be given

Group Type EXPERIMENTAL

conventional physiotherapy

Intervention Type OTHER

ultrasound electrotherapy cold applications

exercises for the knee area

Intervention Type OTHER

range of motion exercises strengthening exercises exercises to reduce edema

massage group

massage will be done

Group Type EXPERIMENTAL

conventional physiotherapy

Intervention Type OTHER

ultrasound electrotherapy cold applications

payment oriented massage

Intervention Type OTHER

10 / 15-minute massage treatments to reduce payment

Interventions

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conventional physiotherapy

ultrasound electrotherapy cold applications

Intervention Type OTHER

exercises for the knee area

range of motion exercises strengthening exercises exercises to reduce edema

Intervention Type OTHER

payment oriented massage

10 / 15-minute massage treatments to reduce payment

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uskudar University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Öğr. Üyesi Ömer Şevgin

Asst. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Enver Deniz YILDIRIM

Role: STUDY_CHAIR

Uskudar University

Locations

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Uskudar university

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 26581486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15271540 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36155729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30919810 (View on PubMed)

Other Identifiers

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Uskudar50

Identifier Type: -

Identifier Source: org_study_id