The Effect of Different Intra-articular Injections Primary Gonarthrosis

NCT05291793 | Completed

• 1 other identifier: 2100027722
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

Gonarthrosis is a frequent cause of knee pain and mostly related to altered function of the knee. Intra-articular injections are a valuable noninvasive medical treatment of choice for pain management and functional enhancement. This study aims to investigate the effects of intra-articular injections without local anesthesics which are well known to be chondrotoxic. For this purpose, functional data of the patients who received intra-articular injections have been collected and analyzed.

Conditions

Gonarthrosis; Primary

Keywords

Gonarthrosis; Saline injection; intra-articular

Outcome Measures

Primary Outcomes (8)

• Visual Analogue Scale (VAS)

  Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)

  2 weeks prior to intra-articular injection

• Visual Analogue Scale (VAS)

  Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)

  at 2nd week following intra-articular injection

• Visual Analogue Scale (VAS)

  Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)

  at 4th week following intra-articular injection

• Visual Analogue Scale (VAS)

  Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)

  at 6th week following intra-articular injection

• The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Score ranges between 0-100, Higher scores represent worse pain and poorer functioning, WOMAC score:0 corresponds to no functional impairment, WOMAC score:100 represents to complete impairment.

  2 weeks prior to intra-articular injection

• The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Score ranges between 0-100, Higher scores represent worse pain and poorer functioning, WOMAC score:0 corresponds to no functional impairment, WOMAC score:100 represents to complete impairment.

  at 2nd week following intra-articular injection

• The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Score ranges between 0-100, Higher scores represent worse pain and poorer functioning, WOMAC score:0 corresponds to no functional impairment, WOMAC score:100 represents to complete impairment.

  at 4th week following intra-articular injection

• The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  The Western Ontario and McMaster Universities Arthritis Index (WOMAC), Score ranges between 0-100, Higher scores represent worse pain and poorer functioning, WOMAC score:0 corresponds to no functional impairment, WOMAC score:100 represents to complete impairment.

  at 6th week following intra-articular injection

Study Arms (4)

NSAID group

NO INTERVENTION

Group 1, patients only received non-steroid anti-inflammatory oral and topical treatment for 3 weeks. (ibuprofen 2x800 mg (1600 mg daily), 1% nimesulide + 5%Lidocain (3 times a day))

Tenoxicam

ACTIVE COMPARATOR

Group 2, patients received intraarticular tenoxicam ( 20 mg) once.

Drug: Tenoxicam 20 Mg Powder for Solution for Injection Vial

Methylprednisolone

ACTIVE COMPARATOR

Group 3, patients received intraarticular methylprednisolone once(40mg).

Drug: Methylprednisolone

Saline

SHAM COMPARATOR

Group 4, patients received an intraarticular sterile saline injection(4ml).

Drug: Saline

Interventions

Tenoxicam 20 Mg Powder for Solution for Injection Vial DRUG

Tenoxicam 20 Mg Powder is mixed with dissolving solvent then administered intraarticularly

Tenoxicam

Methylprednisolone DRUG

Methylprednisolone 40 Mg (suspension) administered intraarticularly

Methylprednisolone

Saline DRUG

2ml sterile saline administered intraarticularly

Saline

Eligibility Criteria

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

You may qualify if:

• Patients older than 18 years old
• Diagnosed as Osteoarthritis ( in weight-bearing standing Antero-Posterior and Lateral knee plain radiographs)

You may not qualify if:

• Patients refuse to enroll in the study voluntarily
• Patients refuse to give informed consent
• Patients who have received physiotherapy and/or intraarticular injection in the last 6 months.
• Patients who have used supporting brace treatment in the last 6 months
• Patients did not attend routine follow-up visits.
• Patients experienced any allergic reaction to the administered drug

Sponsors & Collaborators

• Nevsehir Haci Bektas Veli University: lead

Study Sites (3)

Acıbadem Kozyatağı Hospital

Istanbul, Kozyatağı, Turkey (Türkiye)

Location

Kartal Lutfi Kırdar State Hospital

Istanbul, Turkey (Türkiye)

Location

Nevşehir State Hospital

Nevşehir, Turkey (Türkiye)

Location

Related Publications (4)

• Jevsevar DS, Shores PB, Mullen K, Schulte DM, Brown GA, Cummins DS. Mixed Treatment Comparisons for Nonsurgical Treatment of Knee Osteoarthritis: A Network Meta-analysis. J Am Acad Orthop Surg. 2018 May 1;26(9):325-336. doi: 10.5435/JAAOS-D-17-00318.

  PMID: 29688920 BACKGROUND

• Jayaram P, Kennedy DJ, Yeh P, Dragoo J. Chondrotoxic Effects of Local Anesthetics on Human Knee Articular Cartilage: A Systematic Review. PM R. 2019 Apr;11(4):379-400. doi: 10.1002/pmrj.12007. Epub 2019 Mar 15.

  PMID: 30676699 BACKGROUND

• Busse P, Vater C, Stiehler M, Nowotny J, Kasten P, Bretschneider H, Goodman SB, Gelinsky M, Zwingenberger S. Cytotoxicity of drugs injected into joints in orthopaedics. Bone Joint Res. 2019 Mar 2;8(2):41-48. doi: 10.1302/2046-3758.82.BJR-2018-0099.R1. eCollection 2019 Feb.

  PMID: 30915209 BACKGROUND

• Bellamy JL, Goff BJ, Sayeed SA. Economic Impact of Ketorolac vs Corticosteroid Intra-Articular Knee Injections for Osteoarthritis: A Randomized, Double-Blind, Prospective Study. J Arthroplasty. 2016 Sep;31(9 Suppl):293-7. doi: 10.1016/j.arth.2016.05.015. Epub 2016 May 18.

  PMID: 27402605 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

tenoxicam; Powders; Solutions; Methylprednisolone; Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: patients were not aware of the ingredient of the injection they had received Care providers were not aware of the ingredient of injection during application
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Orthopedics and Traumatolgy Specialist, Principal Investigator

Model Details: Identical work scheme applied in 4 different centers by 4 Physicians. Both patient selection, randomization, and blind injection applications have been implemented in same order.

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 23, 2022
• Study Start: April 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Study Protocol will be available following the paper has been published.

Locations

TU (3)