Physical Parameters in Osteoarthritis Stages

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06015412
• Other study ID #: 2023/11-21
• Status: Completed
• Start date: November 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2023
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: July 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Pain
• Quality of Life

Intervention

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

Locations

Country	Name	City	State
Turkey	Selcuk University	Konya	Selçuklu

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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