The Level of Cartilage Oligomeric Matrix Protein (COMP) and Urinary C-Terminal Telopeptides of Type II Collagen (uCTX-II) After Prolotherapy Intervention and The Functional Outcome in Patient With Knee Osteoarthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Cartilage Oligomeric Matrix Protein (COMP)
研究概览
简要总结
Introduction :
Prolotherapy is regenerative tissue therapy which is considered to be efficacious in reducing symptoms and morbidity of Knee Osteoarthritis (KOA), but only a few studies demonstrate the effect of prolotherapy at the biomolecular level, particularly the level of Cartilage Oligomeric Matrix Protein (COMP), and Urinary C-Terminal Telopeptides of Type II Collagen (uCTX-II) as the biomarkers of cartilage repair.
Objective:
To determine the effect of prolotherapy on COMP and uCTX-II levels, and functional outcomes in KOA patients.
Method:
a double-blind randomized controlled trial study involving 36 participants who had been diagnosed with KOA. History taking, functional outcome assessment, COMP, and uCTX-II were measured. The prolotherapy via intraarticular and extraarticular was performed at Day-1, Day-29, and Day-57 followed by the evaluation of functional outcome, COMP, and uCTX-II at day 78
Alternative Hypothesis :
Prolotherapy provides improvement of cartilage based on COMP and UCTX-II levels and functional outcome among KOA patients
详细描述
Design :
Double-blind randomized trial
Randomization :
Simple Randomization generated by an online randomizer
Sample Size :
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
- Double (Participant, Outcomes Assessor)
盲法说明
A sealed envelope of the randomized sequence was given to the investigator and care provider, and participants were recruited consecutively according to the sequence. Participants were masked from the therapy by receiving treatment individually in different rooms and occasions. On the day of the assessment, the physician and laboratory technicians were blinded from group allocation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient provides consent to be part of the research.
- •The diagnosis of Knee Osteoarthritis was made based on clinical criteria/radiology American College of Rheumatology (ACR) 2012 with radiology grading according to Kellgren-Lawrence 2-3
排除标准
- •The Patient has received other forms of intraarticular injection therapy.
- •The patient has received Non Steroid Anti inflammation drug (NSAID) therapy for one week before the start of the intervention.
- •The patient has one or more contraindications for prolotherapy (e.g., Abscess, cellulitis, or septic arthritis).
- •Drop Out Criteria :
- •The patient has undergone a strenuous physical activity that precipitates a degree of complication (i.e., joint effusion).
- •The use of NSAID within one week after the intervention.
- •The patient does not adhere to the intervention.
- •The patient developed or being diagnosed with osteoarthritis or other forms of inflammatory disease in other joints.
研究组 & 干预措施
Sodium Hyaluronate
Hyaluronate sodium injection is performed intra-articularly using 2 mL of Adant® Disposable. The treatment will be given five times, on day 1st, 8th, 15th, 22nd, and 29th
干预措施: Sodium Hyaluronate (Drug)
Prolotherapy
Prolotherapy injection is performed intra-articularly and extra-articularly by a physician. Intra-articular injection with 25% dextrose will be carried out with the following details: 5 mL of 40% dextrose, 2 mL of lidocaine, and 1 mL of aqua dest are inserted into the 10-mL syringe, then 5 mL are injected with the superolateral approach. An extra-articular injection with 15% dextrose will be carried out with the following details:
in the 10-mL syringe 4 mL of 40% dextrose, 2 mL lidocaine, and 4 mL of distilled water are injected, to make a total of 30-40 mL injections. Treatment will be carried out on day 1st, 29th, and 57th.
干预措施: Prolotherapy (Drug)
结局指标
主要结局
Cartilage Oligomeric Matrix Protein (COMP)
时间窗: Measured on the first day before intervention and day 78 after the first dose of treatment in all groups
cartilage oligomeric matrix protein from whole blood measured using Enzyme-linked Immunoassay (ELISA). Mean difference between group will be assessed
次要结局
- Functional Outcome(Measured on the first day before intervention and day 78 after the first injection on the prolotherapy group and Day 50 after the first injection for the hyaluronate group)
- Urinary C-Terminal Telopeptides of Type II Collagen (uCTX-II)(Measured on the first day before intervention and day 78 after the first injection on the prolotherapy group and Day 50 after the first injection for the hyaluronate group)
研究者
Bumi Herman
Researcher
Hasanuddin University