NCT05238857

Brief Summary

This study aims to determine the factors affecting pain in patients with knee osteoarthritis (OA). This study will be carried out following the "Helsinki Declaration", by selecting 106 volunteers who were diagnosed with knee OA, who applied to the Department of Orthopedics between February 2022 and August 2023 and met the inclusion criteria. Before the evaluation, all the volunteers participating in the study will be informed about the purpose of the study, its duration, and the evaluations to be made. Consent will be obtained from all volunteers participating in the study with an "Informed Voluntary Consent Form". Demographic and clinical characteristics of all patients who voluntarily accepted to participate in the study will be questioned with the "Knee Osteoarthritis Evaluation Form". Quality of life, pain, range of motion (ROM), muscle strength, presence of comorbidity, and functional evaluation will be recorded on the form.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

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

February 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

February 21, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2023

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

February 3, 2022

Last Update Submit

October 1, 2023

Conditions

Keywords

PainKneeOsteoarthritisFunction

Outcome Measures

Primary Outcomes (1)

  • Pain Severity

    The pain severity will be assessed with Visual Analogue Scale (VAS), which is a numerical pain rating scale with zero corresponding to no pain and 10 corresponding to terrible pain.

    Baseline

Secondary Outcomes (4)

  • Health-Related Quality of Life

    Baseline

  • The Isometric Muscle Strength of Lower Extremity

    Baseline

  • Functional Level of Lower Extremity

    Baseline

  • Active Range of Motion in Hip and Knee

    Baseline

Interventions

There will be no intervention. Only assessments will be taken from the patients and data will be analyzed.

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll Females
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women over the age of 40 years with knee osteoarthritis

You may qualify if:

  • Volunteer participants who meet the clinical criteria for diagnosis of OA of the knee according to the American College of Rheumatology criteria will be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, KneePainOsteoarthritis

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Tansu Birinci, PT, PhD

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2022

First Posted

February 14, 2022

Study Start

February 21, 2022

Primary Completion

December 21, 2022

Study Completion

August 21, 2023

Last Updated

October 4, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations