NCT06010394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2023

Completed
Last Updated

December 7, 2023

Status Verified

December 1, 2023

Enrollment Period

1 month

First QC Date

August 18, 2023

Last Update Submit

December 6, 2023

Conditions

Keywords

massage

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (3)

control group

ACTIVE COMPARATOR

commensal physiotherapy will be applied

Other: conventional physiotherapy

exercise group

EXPERIMENTAL

exercises will be given

Other: conventional physiotherapyOther: exercises for the knee area

massage group

EXPERIMENTAL

massage will be done

Other: conventional physiotherapyOther: payment oriented massage

Interventions

ultrasound electrotherapy cold applications

control groupexercise groupmassage group

range of motion exercises strengthening exercises exercises to reduce edema

exercise group

10 / 15-minute massage treatments to reduce payment

massage group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to continue treatment regularly
  • situations that prevent you from doing the exercise
  • inflammation that interferes with massage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar university

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 26581486BACKGROUND
  • 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.

    PMID: 15271540BACKGROUND
  • 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.

    PMID: 36155729BACKGROUND
  • 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.

    PMID: 30919810BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeEdema

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Enver Deniz YILDIRIM

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: classical physical therapy, exercise therapy, classical massage
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

August 18, 2023

First Posted

August 24, 2023

Study Start

September 1, 2023

Primary Completion

October 15, 2023

Study Completion

December 6, 2023

Last Updated

December 7, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations