Physical Parameters in Osteoarthritis Stages

Sponsor
Selcuk University (Other)
Overall Status
Completed
CT.gov ID
NCT06015412
Collaborator
(none)
161
1
8
20.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Radiographic classification

Study Design

Study Type:
Observational
Actual Enrollment :
161 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Effects Of Osteoarthritis Grades On Pain, Function, And Quality Of Life
Actual Study Start Date :
Nov 1, 2022
Actual Primary Completion Date :
May 1, 2023
Actual Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Grade 1 osteoarthritis

disease stages 1 according to the Kellgren-Lawrence radiographic classification system

Diagnostic Test: Radiographic classification
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

Diagnostic Test: Radiographic classification
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

Diagnostic Test: Radiographic classification
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

Diagnostic Test: Radiographic classification
disease stages ranged from 1 to 4 according to the Kellgren-Lawrence radiographic classification system

Outcome Measures

Primary Outcome Measures

  1. Visual Analog Scale (VAS) [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. two-minute walk test (2MWT) [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

  3. Western Ontario and McMaster Universities Osteoarthritis Index [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

  4. Nottingham Health Profile (NHP) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Selcuk University Konya Selçuklu Turkey 42130

Sponsors and Collaborators

  • Selcuk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emine Cihan, Asst. Prof, Selcuk University
ClinicalTrials.gov Identifier:
NCT06015412
Other Study ID Numbers:
  • 2023/11-21
First Posted:
Aug 29, 2023
Last Update Posted:
Aug 29, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 29, 2023