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The Effect of Different Intra-articular Injections Primary Gonarthrosis

Primary Purpose

Gonarthrosis; Primary

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tenoxicam 20 Mg Powder for Solution for Injection Vial
Methylprednisolone
Saline
Sponsored by
Nevsehir Haci Bektas Veli University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gonarthrosis; Primary focused on measuring Gonarthrosis, Saline injection, intra-articular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Acıbadem Kozyatağı Hospital
  • Kartal Lutfi Kırdar State Hospital
  • Nevşehir State Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Sham Comparator

Arm Label

NSAID group

Tenoxicam

Methylprednisolone

Saline

Arm Description

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))

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 25, 2022
Last Updated
March 22, 2022
Sponsor
Nevsehir Haci Bektas Veli University
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1. Study Identification

Unique Protocol Identification Number
NCT05291793
Brief Title
The Effect of Different Intra-articular Injections Primary Gonarthrosis
Official Title
The Effect of Different Intra-articular Injections on Pain and Function in Primary Gonarthrosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nevsehir Haci Bektas Veli University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gonarthrosis; Primary
Keywords
Gonarthrosis, Saline injection, intra-articular

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare Provider
Masking Description
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
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NSAID group
Arm Type
No Intervention
Arm Description
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))
Arm Title
Tenoxicam
Arm Type
Active Comparator
Arm Description
Group 2, patients received intraarticular tenoxicam ( 20 mg) once.
Arm Title
Methylprednisolone
Arm Type
Active Comparator
Arm Description
Group 3, patients received intraarticular methylprednisolone once(40mg).
Arm Title
Saline
Arm Type
Sham Comparator
Arm Description
Group 4, patients received an intraarticular sterile saline injection(4ml).
Intervention Type
Drug
Intervention Name(s)
Tenoxicam 20 Mg Powder for Solution for Injection Vial
Intervention Description
Tenoxicam 20 Mg Powder is mixed with dissolving solvent then administered intraarticularly
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
Methylprednisolone 40 Mg (suspension) administered intraarticularly
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
2ml sterile saline administered intraarticularly
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)
Time Frame
2 weeks prior to intra-articular injection
Title
Visual Analogue Scale (VAS)
Description
Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)
Time Frame
at 2nd week following intra-articular injection
Title
Visual Analogue Scale (VAS)
Description
Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)
Time Frame
at 4th week following intra-articular injection
Title
Visual Analogue Scale (VAS)
Description
Visual Analogue Scale ( Score:0 corresponds to 'no pain', score:10 corresponds to excessive pain)
Time Frame
at 6th week following intra-articular injection
Title
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
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.
Time Frame
2 weeks prior to intra-articular injection
Title
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
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.
Time Frame
at 2nd week following intra-articular injection
Title
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
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.
Time Frame
at 4th week following intra-articular injection
Title
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
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.
Time Frame
at 6th week following intra-articular injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Acıbadem Kozyatağı Hospital
City
Istanbul
State/Province
Kozyatağı
Country
Turkey
Facility Name
Kartal Lutfi Kırdar State Hospital
City
İstanbul
Country
Turkey
Facility Name
Nevşehir State Hospital
City
Nevşehir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
29688920
Citation
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.
Results Reference
background
PubMed Identifier
30676699
Citation
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.
Results Reference
background
PubMed Identifier
30915209
Citation
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.
Results Reference
background
PubMed Identifier
27402605
Citation
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.
Results Reference
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The Effect of Different Intra-articular Injections Primary Gonarthrosis

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