A Comparative Study of Betamethasone (Diprospan) and Triamcinolone Acetonide as Single Intra-Articular Injection in Knee Osteoarthritis, A Double-Blinded, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Difference of 100-mm Visual analog scale (VAS) Pain Score between Betamethasone (Diprospan) and Triamcinolone group
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
- Participant and Care Provider will not know which drug is injected to the investigated knee because the opaque syringe is used to inject.
- Investigator and outcomes assessor will not known the group of participants because randomization, they only know the number of the participants.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic Primary knee osteoarthritis (Kellgren-Lawrence stage 2 or 3)
- •Failed other conservative treatment
- •Comply with protocol
排除标准
- •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
研究组 & 干预措施
Betamethasone (Diprospan)
Participant received single intra-articular Betamethasone Dipropionate / Betamethasone Sodium Phosphate 1 ml
干预措施: Betamethasone Dipropionate / Betamethasone Sodium Phosphate (Drug)
Triamcinolone acetonide
Participant received single intra-articular Triamcinolone acetonide 40 mg
干预措施: Triamcinolone Acetonide 40mg/mL (Drug)
结局指标
主要结局
Difference of 100-mm Visual analog scale (VAS) Pain Score between Betamethasone (Diprospan) and Triamcinolone group
时间窗: 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
次要结局
- 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)
- Difference of Total Paracetamol and Tramadol used between Betamethasone (Diprospan) and Triamcinolone group(6 months after intra-articular injection)
- 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)
- 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)
- 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)
- 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)
- Incidence of side effects of intra-articular steroid injection(1 month, 3 months, 6 months after intra-articular injection)
研究者
Kittipong Wattanasirisombat
Principal investigator
Thammasat University