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OpenTrials
Completed

NCT Number: NCT06015412

Physical Parameters in Osteoarthritis Stages

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

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Quality of Life Rheumatic Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Selcuk University

Konya, Selçuklu, 42130, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiographic classification

Diagnostic Test

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

Primary outcomes

  1. 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. 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

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 29, 2023
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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