Clinical trial NCT06010394: Control of Edema in the Knee in Patients With Knee Osteoarthritis
Official title: Comparison of the Effectiveness of Exercise and Classical Massage in the Control of Edema in the Knee in Patients With Knee Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Edema
Edema Leg
Keywords: massage
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 75
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: classical physical therapy, exercise therapy, classical massage
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 4 weeks
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Uskudar university
Study officials:
affiliation: Uskudar University
name: Enver Deniz YILDIRIM
role: STUDY_CHAIR
References:
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.
citation: 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.
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.
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.