The Effect of Different Intra-articular Injections Primary Gonarthrosis

Study Overview
=================
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.

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

Conditions
-----------------
Gonarthrosis; Primary

Intervention / Treatment
-----------------
* Drug: Tenoxicam 20 Mg Powder for Solution for Injection Vial
* Drug: Methylprednisolone
* Drug: Saline


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gonarthrosis, Saline injection, intra-articular