Physical Parameters in Osteoarthritis Stages

NCT06015412 | Completed

• 1 other identifier: 2023/11-21
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis; Pain; Quality of Life

Outcome Measures

Primary Outcomes (4)

• Visual Analog Scale (VAS)

  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)

  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

  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)

  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

Study Arms (4)

Grade 1 osteoarthritis

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

Diagnostic Test: Radiographic classification

Grade 2 osteoarthritis

disease stages 2 according to the Kellgren-Lawrence radiographic classification system

Diagnostic Test: Radiographic classification

Grade 3 osteoarthritis

disease stages 3 according to the Kellgren-Lawrence radiographic classification system

Diagnostic Test: Radiographic classification

Grade 4 osteoarthritis

disease stages 4 according to the Kellgren-Lawrence radiographic classification system

Diagnostic Test: Radiographic classification

Interventions

Radiographic classification DIAGNOSTIC_TEST

disease stages ranged from 1 to 4 according to the Kellgren-Lawrence radiographic classification system

Grade 1 osteoarthritis; Grade 2 osteoarthritis; Grade 3 osteoarthritis; Grade 4 osteoarthritis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, Selçuklu, 42130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 29, 2023
• Study Start: November 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)