Comparative Efficacy of Dextrose Prolotherapy and Intra Articular Corticosteroids in Grade II Knee Osteoarthritis:A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
研究概览
简要总结
This randomized single blind two arm clinical trial aims to compare the effectiveness of dextrose prolotherapy and intra articular corticosteroid injection in patients with grade II knee osteoarthritis. A total of 126 adults aged 40 to 80 years with at least 6 months of knee pain not responding to conservative treatment will be enrolled and randomized equally into two groups. All procedures will be performed under ultrasound guidance using standard drug protocols. The primary objective is to assess pain reduction using Visual Analogue Scale, secondary objectives include assessment of functional improvement using the Knee Injury and Osteoarthritis Outcome Score, duration of relief and adverse effects. Follow up assessment will be conducted at 4 and 12 weeks. Patients with recent trauma or surgery, Intra-articular injection in the past 6 months, secondary OA or inflammatory arthritis, bleeding disorders or anticoagulant therapy, active infection or systemic illness will be excluded. Data will be analyzed using appropriate parametric and non parametric tests. The study is expected to identify whether dextrose prolotherapy provides superior clinical improvement compared to corticosteroid injection in early knee osteoarthritis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients diagnosed with primary knee osteoarthritis fulfulling ACR criteria.
- •2.Radiologically confirmed Kellgren Lawrence Grade II knee Osteoarthritis.
- •3.VAS pain score more than or equal to 6 in past 2 weeks.
- •4.Willing and able to provide informed consent and comply with study follow up.
排除标准
- •1.Intra-articular injection in any joint within the past 6 months.
- •2.Use of NSAIDs, analgesics, or slow-acting OA drugs within the restricted time frame.
- •3.History of knee surgery or arthroscopic procedure in the last 1 year.
- •4.Secondary or inflammatory arthritis, generalized OA, or coexisting hip/foot OA or back pain.
- •5.Ligament or meniscal injury, tense effusion, or cutaneous lesions over the knee.
- •6.BMI more than 35 7.Haemoglobin less than 10 g/dL.
- •8.Bleeding disorders, or anticoagulant therapy.
- •9.Presence of active infection, immunosuppression, neoplasm, or systemic illness (e.g., uncontrolled diabetes, thyroid disease).
- •10.Presence of nociplastic pain.
研究者
Premi Sapam
NRS Medical College
