- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06015412
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
Conditions
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
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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