Physical Parameters in Osteoarthritis Stages

August 23, 2023 updated by: Emine Cihan, Selcuk University

Effects Of Osteoarthritis Grades On Pain, Function, And Quality Of Life

To investigate the extent to which pain, functionality, and quality of life change over the progression of osteoarthritis grades.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Selçuklu
      • Konya, Selçuklu, Turkey, 42130
        • Selcuk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

diagnosed with the same grade of knee OA in both knees by the responsible physician in the hospital

Description

Inclusion Criteria:

  • having the same OA grade in both knees
  • volunteering to participate in the study
  • not having undergone previous lower extremity surgery

Exclusion Criteria:

  • neurological disorders;
  • those with a history of surgery related to the lower extremities;
  • those with orthopedic problems in the lower extremities, such as tendinopathy and bursitis;
  • those who had neurological, orthopedic, or cognitive disorders that would prevent walking;
  • those with a diagnosis of diabetes, obesity, or rheumatological disorders;
  • those who had received intra-articular injection therapy within the last three months;
  • and those with malignancy or perception problems.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Grade 1 osteoarthritis
disease stages 1 according to the Kellgren-Lawrence radiographic classification system
disease stages ranged from 1 to 4 according to the Kellgren-Lawrence radiographic classification system
Grade 2 osteoarthritis
disease stages 2 according to the Kellgren-Lawrence radiographic classification system
disease stages ranged from 1 to 4 according to the Kellgren-Lawrence radiographic classification system
Grade 3 osteoarthritis
disease stages 3 according to the Kellgren-Lawrence radiographic classification system
disease stages ranged from 1 to 4 according to the Kellgren-Lawrence radiographic classification system
Grade 4 osteoarthritis
disease stages 4 according to the Kellgren-Lawrence radiographic classification system
disease stages ranged from 1 to 4 according to the Kellgren-Lawrence radiographic classification system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: 2 minutes
a 10-cm straight line with 0 on one end indicating no pain and 10 on the other end signifying unbearable pain. The participants were asked to mark the intensity of their current pain on the line
2 minutes
two-minute walk test (2MWT)
Time Frame: 2 minutes
A 45-meter corridor was used for the 2MWT. The start and end points were marked, and the participants were asked to walk at a normal pace within these boundaries. The distance covered in two minutes was recorded
2 minutes
Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame: 10 minutes
The questionnaire consists of 24 items, each scored from 0 to 4. The total score is obtained by summing the point equivalents of the responses given to all items. A higher score indicates poorer functionality
10 minutes
Nottingham Health Profile (NHP)
Time Frame: 10 minutes
This tool comprises 38 questions in six domains, namely energy, pain, social isolation, physical mobility, emotional reactions, and sleep. Each domain is scored from 0 to 100. The total score is obtained by summing the scores obtained from the six domains. High scores indicate a good quality of life.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 29, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2023/11-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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