Serum Nesfatin-1 and Human Cartilage Glycoprotein-39 Levels in Knee Osteoarthritis

NCT06254976 | Completed

• 1 other identifier: health sciences university
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, our objective was to assess the correlation between serum human cartilage glycoprotein-39 (YKL-40) and nesfatin-1 values, the patient's clinical condition, ultrasonographic cartilage thickness measurements, and the response to PRP treatment in knee osteoarthritis (OA)

Conditions

Osteoarthritis of Knee; Degenerative Osteoarthritis

Outcome Measures

Primary Outcomes (6)

• Change in Serum YKL-40 levels

  It will be evaluated before and after exercise and before and after PRP. 0-14-28. day

  before treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28).

• Change in Serum nesfatin-1 levels

  It will be evaluated before and after exercise and before and after PRP. 0-14-28. day

  before treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28).

• NRS pain score

  Numerical Rating Scale (NRS), is basically any scale that renders a quantitative symbolization of an attribute. This type of scale is used by presenting the respondent with an ordered set from which to choose, for example, 1 to 10, coupled with anchors.The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable.

  before treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28).

• WOMAC score

  It is a disease-specific measurement for knee and hip osteoarthritis. WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a personalized index with 5 questions for pain, 2 for stiffness, and 17 questions for questioning daily activities. It has different scores from 0 to 4 (0: none, 1: mild, 2: moderate, 3: severe, 4: very severe). Scale lengths of subheadings; pain=20, stiffness=8, physical function=68. Turkish validation is available . A high score indicates poor health.

  before treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28).

• 6 minutes walking test

  It is a test used to reveal submaximal functional performance. The test should be performed in a closed, quiet environment of at least 30 meters, marked every 3 meters, and in a straight corridor. The patient should be warned to wear comfortable clothes and suitable shoes. The turning points during walking should be marked with the help of a cone and the patient should be asked to go around this cone. The test is terminated by calculating the total distance walked in six minutes.A low score indicates poor health.

  before treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28).

• Cartilage thickness measurement with USG

  Cartilage thickness measurements (millimeter) were measured in the medial and lateral facets where the cartilage was thickest and averaged with ultrasonography.

  before treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28).

Study Arms (2)

2 week home exercise program

ACTIVE COMPARATOR

Joint range of motion exercises, four-way straight leg raises, isotonic quadriceps strengthening, hamstring and quadriceps stretching exercises were given. The exercise program was demonstrated by the same physiotherapist. The patients' exercise compliance was questioned and noted.

Behavioral: exercise

2 doses of intraarticular PRP application, 1 week apart

ACTIVE COMPARATOR

2 doses of intra-articular 3 cc LP-PRP were applied to the patients, 1 week apart, from the inferolateral aspect of the patella, in accordance with antisepsis conditions, by a physical medicine and rehabilitation specialist.

Biological: intraarticular knee PRP injections

Interventions

exercise BEHAVIORAL

2 weeks of home exercise

2 week home exercise program

intraarticular knee PRP injections BIOLOGICAL

2 doses of intra-articular platelet rich plasma (PRP) injection, 1 week apart

Also known as: PRP

2 doses of intraarticular PRP application, 1 week apart

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having patient consent,
• Having stage 2-3 knee osteoarthritis according to the Kellgren-Lawrence scale,
• Being diagnosed with knee osteoarthritis according to ACR (American college of Rheumatology),
• Being over the age of 18 - under the age of 75,
• Having NRS 4 and above

You may not qualify if:

• Those who have had knee surgery before,
• Those who have had any local injections such as physical therapy, intra-articular steroid or hyaluronic acid injection in the knee area in the last 3 months,
• Malignancies,
• Those with local infection, wound, scar in the relevant area,
• Infections, Hepatitis, Immunosuppression,
• Inflammatory arthropathies,
• Uncontrolled Hypertension, uncontrolled Diabetes Mellitus, decompensated heart failure, coronary artery disease, asthma
• Recent trauma,
• Epileptic patients,
• Pregnant women,
• Corticosteroid use,
• Avascular necrosis
• Anemia, bleeding coagulation disorder

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital

Kayseri, 38080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Joint Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Havva Talay Çalış, Prof

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

• Duygu Gökbelen Bilen

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluations were conducted by a physical therapy and rehabilitation specialist who was blinded to the patient's treatment protocol, ensuring unbiased assessments.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor doctor

Model Details: Thirty patients were evaluated at three different time points: before treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28). The assessment included the Numeric Rating Scale (NRS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), cartilage thickness measurement by ultrasonography (USG), 6-minute walk test (6MWT) parameters, and measurements of serum YKL-40 and nesfatin-1 levels.

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 12, 2024
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

TU (1)