Knee Osteoarthritis
Conditions
Keywords
Intra-articular injections, Corticosteroids, Triamcinolone acetonide, Betamethasone, Nonoperative management
Brief summary
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
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
Interventions
DRUGBetamethasone Dipropionate / Betamethasone Sodium Phosphate
Single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate (Diprospan) injections to affected knee
Single intra-articular Triamcinolone Acetonide injections to affected knee
Sponsors
Thammasat University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
1. Participant and Care Provider will not know which drug is injected to the investigated knee because the opaque syringe is used to inject. 2. Investigator and outcomes assessor will not known the group of participants because randomization, they only know the number of the participants.
Intervention model description
Participants are randomized and assigned to betamethasone (Diprospan) group or Triamcinolone acetonide group in parallel for the duration of the study
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Symptomatic Primary knee osteoarthritis (Kellgren-Lawrence stage 2 or 3) 2. Failed other conservative treatment 3. Comply with protocol
Exclusion criteria
1. Allergy to any of the medications in this protocol (Betamethasone, Triamcinolone, Paracetamol, Tramadol) 2. Previous fracture or surgical procedure 3. Previous intra-articular injection in the past 6 months 4. Previous oral Symptomatic slow-acting drugs for osteoarthritis (SYSADOA) (Glucosamine, Diacerein) used in the past 6 months 5. Current infection in the affected limb 6. Uncontrolled Diabetes Mellitus 7. Primary or secondary adrenal insufficiency 8. Coagulopathy or current anticoagulant used 9. Current steroid used 10. Lower extremity weakness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of 100-mm Visual analog scale (VAS) Pain Score between Betamethasone (Diprospan) and Triamcinolone group | 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 | * 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference of University of California and Los Angeles (UCLA) score between Betamethasone (Diprospan) and Triamcinolone group | Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection | * 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. |
| Difference of Range of motion between Betamethasone (Diprospan) and Triamcinolone group | Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection | \- Flexion and extension angle of the knee is measured by a long-arm goniometer |
| Difference of Time up-and-go test between Betamethasone (Diprospan) and Triamcinolone group | Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection | * 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. |
| Difference of Modified Western Ontario and McMaster Universities Arthritis Index (WOMAC) score between Betamethasone (Diprospan) and Triamcinolone group | Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection | * 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. |
| Incidence of side effects of intra-articular steroid injection | 1 month, 3 months, 6 months after intra-articular injection | Injection site reaction, Erythema, Swelling, Injection-site pain, Pruritus, cellulitis were observed after intra-articular injection. |
| Difference of Total Paracetamol and Tramadol used between Betamethasone (Diprospan) and Triamcinolone group | 6 months after intra-articular injection | * 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) |
| Difference of 2-minutes walking test between Betamethasone (Diprospan) and Triamcinolone group | Baseline before intra-articular injection,1 month, 3 months, 6 months after intra-articular injection | * 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. |
Countries
Thailand
Outcome results
None listed