Comparing Intra-articular Betamethasone (Diprospan) and Triamcinolone Acetonide Injection in Knee Osteoarthritis

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of Intra-articular corticosteroid injection between Betamethasone (Diprospan) and Triamcinolone acetonide for treatment of knee osteoarthritis

Detailed Description
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After being informed about the study and potential risks, all patients giving written informed consent will be chosen for eligibility for the study entry. At day 0 (before intra-articular injection), patients who meet the eligibility criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Betamethasone (Diprospan 1 ml) or Triamcinolone acetonide (40 mg) single intra-articular injection

Official Title
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A Comparative Study of Betamethasone (Diprospan) and Triamcinolone Acetonide as Single Intra-Articular Injection in Knee Osteoarthritis, A Double-Blinded, Randomized Controlled Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Drug: Betamethasone Dipropionate / Betamethasone Sodium Phosphate
* Drug: Triamcinolone Acetonide 40mg/mL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic Primary knee osteoarthritis (Kellgren-Lawrence stage 2 or 3) Failed other conservative treatment Comply with protocol Exclusion Criteria: Allergy to any of the medications in this protocol (Betamethasone, Triamcinolone, Paracetamol, Tramadol) Previous fracture or surgical procedure Previous intra-articular injection in the past 6 months Previous oral Symptomatic slow-acting drugs for osteoarthritis (SYSADOA) (Glucosamine, Diacerein) used in the past 6 months Current infection in the affected limb Uncontrolled Diabetes Mellitus Primary or secondary adrenal insufficiency Coagulopathy or current anticoagulant used Current steroid used Lower extremity weakness
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomized and assigned to betamethasone (Diprospan) group or Triamcinolone acetonide group in parallel for the duration of the study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Betamethasone (Diprospan)<br>Participant received single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate 1 ml | Drug: Betamethasone Dipropionate / Betamethasone Sodium Phosphate<br>* Single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate (Diprospan) injections to affected knee<br>* Other names: Diprospan;|
| Active Comparator: Triamcinolone acetonide<br>Participant received single intra-articular Triamcinolone acetonide 40 mg | Drug: Triamcinolone Acetonide 40mg/mL<br>* Single intra-articular Triamcinolone Acetonide injections to affected knee<br>* Other names: Kanolone-F;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of 100-mm Visual analog scale (VAS) Pain Score between Betamethasone (Diprospan) and Triamcinolone group | The 100-mm VAS pain score is a self-reported instrument assessing Pain Score at 1 day, 2 days, 3 days, 1 week, 3 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months after the day of intra-articular injection Participants will assess the VAS pain score at rest and on-movement VAS Pain at rest is evaluated when the participant's wakeup in the morning VAS Pain on-movement is evaluated when the participant's walking for 10 meters and then resting for 5 minutes Possible scores range from 0 (no pain) to 100 (worst imaginable pain) Higher scores mean a worse pain | Baseline before intra-articular injection, 1 day, 2 days, 3 days, 1 week, 3 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months after the day of intra-articular injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of Modified Western Ontario and McMaster Universities Arthritis Index (WOMAC) score between Betamethasone (Diprospan) and Triamcinolone group | The Modified WOMAC score is a validated, self-reported instrument consisting of 24 items divided into 3 subscales (Pain, Stiffness, Physical function). The test questions are scored on a scale of 0-4, which corresponds to None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Possible scores range from 0-20 for pain, 0-8 for Stiffness, 0-68 for Physical function. a sum of the scores for all three subscales gives a total WOMAC score (0-96) Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. | Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection | 
| Difference of University of California and Los Angeles (UCLA) score between Betamethasone (Diprospan) and Triamcinolone group | The UCLA is a 10-point scale measurement that evaluates patients' daily activity levels. The 10-point scale is leveled from 1 to 10 (1= worst, 10 = best). Level 1 is wholly inactive and dependent on others, while level 6 is unlimited housework and shopping and level 10 is regular participation in impact sports, such as jogging or tennis. | Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection | 
| Difference of Range of motion between Betamethasone (Diprospan) and Triamcinolone group | - Flexion and extension angle of the knee is measured by a long-arm goniometer | Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection | 
| Difference of Time up-and-go test between Betamethasone (Diprospan) and Triamcinolone group | The Time up-and-go test (TUGT) measures the time (seconds) that the patient takes to rise from a chair and walk for 3 meters. Then, he or she turns around and comes back to the seat at the initial position. They were permitted to use walking aids if they wished. TUGT was a reliable and valid test for quantifying functional mobility. | Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection | 
| Difference of 2-minutes walking test between Betamethasone (Diprospan) and Triamcinolone group | Participants were instructed to walk for 2 minutes at their normal pace up and down a designated corridor, turning around at each end of the corridor without stopping They were permitted to use walking aids if they wished. The results were recorded as the total distance walked in meters. | Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection | 
| Incidence of side effects of intra-articular steroid injection | Injection site reaction, Erythema, Swelling, Injection-site pain, Pruritus, cellulitis were observed after intra-articular injection. | 1 month, 3 months, 6 months after intra-articular injection | 
| Difference of Total Paracetamol and Tramadol used between Betamethasone (Diprospan) and Triamcinolone group | Post-injection protocol, Participants can use Paracetamol 500 mg 2 tabs every 4 hours for knee pain if it did not relieve the pain they can take Tramadol 50 mg 1 cap every 6 hours. The total use of Paracetamol and Tramadol was recorded. (tablet) | 6 months after intra-articular injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intra-articular injections, Corticosteroids, Triamcinolone acetonide, Betamethasone, Nonoperative management