The Effect of Different Intra-articular Injections Primary Gonarthrosis

March 22, 2022 updated by: Yiğit Umur Cırdı, Nevsehir Haci Bektas Veli University

The Effect of Different Intra-articular Injections on Pain and Function in Primary Gonarthrosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intra-articular knee injections are commonly used treatment method. It is preferred to relieve the pain and functional limitation due to knee osteoarthritis. Studies have shown the benefit of intra-articular injections, including intra-articular sterile saline injection alone. In addition, studies have shown chondrotoxic effects of local anesthetics and corticosteroids such as triamcinolone. Local anesthetics are often added to the injection in intra-knee injections. Many previous studies stated that anesthetic agents were mixed with corticosteroid and NSAID intra-articular injections but not in this study. This creates confusion on which preparation is effective on pain and function. The aim of this study is to compare pain-reducing and function-improving effects of intra-articular injection with corticosteroids or NSAIDs, while avoiding local anesthetics whose chondrotoxic effects have been confirmed. In order to reveal the unmasked effect, an intra-articular saline injection group was introduced as a sham treatment. Thus, a study with a level of evidence 1 will make a significant contribution to the literature.

Patients who applied to the outpatient clinic and who were diagnosed with primary gonarthrosis by clinical and radiographic examinations have been randomized to four different groups by closed-envelope method following taking the informed consent. Accordingly, nonsteroidal anti-inflammatory (NSAI) drugs have been prescribed to all diagnosed patients. Demographic data of the patients have been noted and randomized into four equal groups of thirty individuals each. Afterwards, the first group received NSAID treatment, the second group received intra-articular methylprednisolone, the third group received intraarticular tenoxicam, and the fourth group received intra-articular sterile saline injection. All eligible patients have been given one random envelope by the secretary, then proceeded to the injection room with envelopes closed. The orthopedic technician prepared the injection depending on the information inside the envelope then the syringe is covered with opaque plaster or foil. Then, an injection was applied by the physician blindly. The patients' visual analog score(VAS) pain form and WOMAC scores are collected in each follow-up. Following the data has been obtained by an independent data recorder, all data have been saved to the database and statistical results were analyzed. According to the posthoc power analysis, the number of patients can be revised for statistical power.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Nevşehir, Turkey
        • Nevsehir State Hospital
      • İstanbul, Turkey
        • Kartal Lutfi Kırdar State Hospital
    • Kozyatağı
      • Istanbul, Kozyatağı, Turkey
        • Acıbadem Kozyatağı Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: NSAID group
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))
Active Comparator: Tenoxicam
Group 2, patients received intraarticular tenoxicam ( 20 mg) once.
Drug: Tenoxicam 20 Mg Powder for Solution for Injection Vial
Tenoxicam 20 Mg Powder is mixed with dissolving solvent then administered intraarticularly
Active Comparator: Methylprednisolone
Group 3, patients received intraarticular methylprednisolone once(40mg).
Drug: Methylprednisolone
Methylprednisolone 40 Mg (suspension) administered intraarticularly
Sham Comparator: Saline
Group 4, patients received an intraarticular sterile saline injection(4ml).
Drug: Saline
2ml sterile saline administered intraarticularly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: 2 weeks prior to intra-articular injection
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)
Time Frame: at 2nd week following intra-articular injection
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)
Time Frame: at 4th week following intra-articular injection
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)
Time Frame: at 6th week following intra-articular injection
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)
Time Frame: 2 weeks prior to intra-articular injection
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)
Time Frame: at 2nd week following intra-articular injection
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)
Time Frame: at 4th week following intra-articular injection
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)
Time Frame: at 6th week following intra-articular injection
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nevsehir Haci Bektas Veli University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

February 25, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

March 23, 2022

Study Record Updates

Last Update Posted (Actual)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2100027722

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Even recruitment has been closed this study is still on progress. We are willing the share all our available data for future studies.

IPD Sharing Time Frame

Study Protocol will be available following the paper has been published.

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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