The Level of Matrix Metalloproteinase-1 (MMP-1), Tissue Inhibitor Matrix Metalloproteinase-1 (TIMP-1) After Prolotherapy Intervention and The Functional Outcome in Patient With Frozen Shoulder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Tissue Inhibitor Metalloproteinase 1 in Blood
研究概览
简要总结
Introduction :
Prolotherapy is regenerative tissue therapy that is considered to be efficacious in reducing symptoms and morbidity of frozen shoulder, but only a few studies demonstrate the effect of prolotherapy at the biomolecular level, particularly the level of Matrix Metalloproteinase- I (MMP-1), Tissue Inhibitor Matrix Metalloproteinase (TIMP-1), as the biomarkers of cartilage repair.
Objective:
To determine the effect of prolotherapy on MMP-1, TIMP-1, and functional outcomes in frozen shoulder patients
Method:
a double-blind randomized controlled trial study involving participants who had been diagnosed with Frozen Shoulder. History taking, functional outcome assessment, MMP-1, and TIMP-1 were measured. The prolotherapy via intraarticular and extraarticular was performed four times, followed by the evaluation of functional outcome, MMP-1, and TIMP-1 at week 12
Alternative Hypothesis :
Prolotherapy will increase the MMP-1, TIMP-1 levels, and improve functional outcome among Frozen Shoulder 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
- None
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 permutation 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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Prolotherapy
A solution of 7.5 ml of 15% dextrose with 2 ml of 40% lidocaine and 10.5 water is given to these shoulder segments as follows.
- Supraspinatus muscle 2-4 ml
- Infraspinatus muscle 2-4 ml
- Teres minor muscle 2-3 ml,
- Subscapularis muscle 2-3 ml.
- Intraarticular glenohumeral joint 5 ml
- Bursa sub acromial 1-2 ml,
- Long head tendon biceps 1-2 ml
- Acromioclavicular joint 1 ml
干预措施: Dextrose 15 % in Water (Drug)
Normal Saline 0.9%
A solution of 20 ml normal saline 0.9% is given to these shoulder segments as follows.
- Supraspinatus muscle 2-4 ml
- Infraspinatus muscle 2-4 ml
- Teres minor muscle 2-3 ml,
- Subscapularis muscle 2-3 ml.
- Intraarticular glenohumeral joint 5 ml
- Bursa sub acromial 1-2 ml,
- Long head tendon biceps 1-2 ml
- Acromioclavicular joint 1 ml
干预措施: Normal Saline 20 mL Injection (Drug)
结局指标
主要结局
Tissue Inhibitor Metalloproteinase 1 in Blood
时间窗: changes of Tissue Inhibitor Metalloproteinase 1 value from baseline to week 6
Tissue Inhibitor Metalloproteinase 1 from whole blood measured using Enzyme-linked Immunoassay (ELISA). Mean difference between group will be assessed
Matrix Metalloproteinase 1 in Blood
时间窗: changes of Matrix Metalloproteinase 1 value from baseline to week 6
Matrix Metalloproteinase 1 from whole blood measured using Enzyme-linked Immunoassay (ELISA). Mean difference between group will be assessed
次要结局
- The Functional Outcome of the Shoulder(changes of Functional Outcome value from baseline to week 6)
研究者
Bumi Herman
Assistant Lecturer
Hasanuddin University