Correlation of the Inflammatory Parameters With Pain and Radiological Findings in Coxarthrosis

Pain Clinical Trial

Official title:

Evaluation of the Correlation of the Inflammatory Parameters With Pain and Radiological Findings in Patients With Coxarthrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04796129
• Other study ID #: 2020/329
• Status: Completed
• Start date: February 11, 2021
• Est. completion date: January 10, 2022

Study information

• Verified date: February 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Osteoarthritis (OA) is a functional disease with joint degeneration with subchondral and periosteal lesions. Coxarthrosis (or hip osteoarthritis) is an important cause of disability, especially in the advanced age group.Although hip osteoarthritis is often thought to be a non-inflammatory pathology, recent studies have shown that joint degeneration is correlated with the production of inflammatory factors and cartilage destroying enzymes.

There are very few studies evaluating the correlation of Neutrophil lymphocyte ratio, monocyte lymphocyte ratio and Platelet lymphocyte ratio with inflammatory parameters CRP and ESR levels in hip osteoarthritis and its relation with the staging of hip osteoatritis.

Description:

Osteoarthritis (OA) is a disease characterized by joint degeneration with subchondral and periosteal lesions . Coxarthrosis (hip osteoarthritis) is an important cause of disability, especially in the advanced age group. The risk of symptomatic coxarthrosis in persons up to the age of 85 is approximately 25%. There is a possibility of total hip replacement at a rate of approximately 10% due to advanced stage coxarthrosis. Kellgren-Lawrence staging system is used to show disease severity in osteoarthritis staging. According to this, Stage 0: there is no radiological change, Stage 1: there is a slight narrowing in the joint space, Stage 2: osteophytes are formed in the joint space with stenosis in the anteroposterior radiography, Stage 3: multiple osteophytes, significant narrowing of the joint space, sclerosis and Stage 4 It describes a situation accompanied by large osteophytes, severe stenosis in the joint space, prominent sclerosis, and bone deformities.

Although coxarthrosis is often thought to be a non-inflammatory pathology, recent studies have shown that joint degeneration correlates with the production of inflammatory factors and cartilage destroying enzymes. At the cellular level, it has been found that macrophage and perivascular T and B lymphocyte infiltration play a role in early and advanced stage OA.

Neutrophils and lymphocytes are the main determinants of the inflammatory process. The neutrophil to lymphocyte ratio (NLR) is obtained by dividing the absolute neutrophil count by the number of lymphocytes obtained from the peripheral blood count. They are used as an indicator of the inflammatory process in inflammatory conditions such as ankylosing spondylitis, sarcoidosis, and cancers. In addition, platelet lymphocyte ratio (PLR) has also been found to be associated with disease activity and severity in diseases such as rheumatoid arthritis and psoriatic arthritis. Its use in the diagnosis and follow-up of OA has not yet been clearly demonstrated. However, changes in mean platelet volume are also used as an indicator of disease severity in systemic inflammatory diseases.

There are very few studies evaluating the correlation of Neutrophil lymphocyte ratio, monocyte lymphocyte ratio and Platelet lymphocyte ratio with inflammatory parameters CRP and ESR levels in hip osteoarthritis and its relation with the staging of hip osteoatritis. The aim of this study to evaluate of the correlation of the inflammatory parameters with pain and radiological findings in the patients with coxarthrosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: January 10, 2022
• Est. primary completion date: November 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• Being diagnosed with hip osteoarthritis

• Being aged at 45 years or older

Exclusion Criteria:

• Not accept being participation in the study.

• Having any systemic disease like the diabetes mellitus, hypertension, coronary after disease

• Having any inflammatory rheumatologic disease

• Having any disease that prevent to participate the study like mental retardation, dementia and psychotic disorders.

Related Conditions & MeSH terms

• Inflammation
• Osteoarthritis
• Osteoarthritis, Hip
• Pain

Intervention

Other:
• the patients with hip osteoarthritis and their inflammatory status
The participants in the experimental group will be evaluated for the hip osteoarthritis. They will take and X-ray for hip joints and also hemogram for the excluding the inflammatory diseases.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Suleyman Training and Research Hospital	Istanbul

Sponsors (3)

Lead Sponsor	Collaborator
Istanbul University	Abant Izzet Baysal University, Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	pain of the hip joints of the participants. It will be evaluated by using Visual Analog Scale(VAS). The scale is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. The pain range is from 1 to 10. The minimum value is 1 and it means the pain is so mild. The maximum value is 10, it means the pain is so much, like a knife stabs.	1 day
Primary	NLR	neutrophil lymphocyte ratio	1day
Primary	PLR	platelet lymphocyte ratio	1 day
Primary	MLR	monocyte lymphocyte ratio	1 day
Primary	ESR	Erythrocyte Sedimentation Ratio	1 day
Primary	CRP	C-reactive protein	1 day
Primary	X-ray of hip joints	an AP X-ray for the painful hip joints	1 day
Primary	Lequesne Index	pain severity	1 day