A Phase 4 interventional study of Dextrose 15 % in Water and Normal Saline 20 mL Injection in Frozen Shoulder, sponsored by Bumi Herman. Completed at 1 site in Indonesia. Open to participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-12-22.
Sponsored by Bumi Herman · Phase 4, Interventional, and Treatment
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
Design :
Double-blind randomized trial
Randomization :
Simple Randomization generated by an online randomizer
Sample Size :
Difference between two means of primary outcome where
Detailed Intervention
Injection location
Statistical analysis :
411 studies on the registry are indexed under Bursitis; 112 are open to participants now.
This study's enrollment of 32 is below the median of 45 across 371 interventional studies indexed under Bursitis.
Browse Bursitis studies →Bumi Herman is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Age 35-70
Receiving other intraarticular injection
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. 1. Supraspinatus muscle 2-4 ml 2. Infraspinatus muscle 2-4 ml 3. Teres minor muscle 2-3 ml, 4. Subscapularis muscle 2-3 ml. 5. Intraarticular glenohumeral joint 5 ml 6. Bursa sub acromial 1-2 ml, 7. Long head tendon biceps 1-2 ml 8. Acromioclavicular joint 1 ml
Drug: Dextrose 15 % in Water
A solution of 20 ml normal saline 0.9% is given to these shoulder segments as follows. 1. Supraspinatus muscle 2-4 ml 2. Infraspinatus muscle 2-4 ml 3. Teres minor muscle 2-3 ml, 4. Subscapularis muscle 2-3 ml. 5. Intraarticular glenohumeral joint 5 ml 6. Bursa sub acromial 1-2 ml, 7. Long head tendon biceps 1-2 ml 8. Acromioclavicular joint 1 ml
Drug: Normal Saline 20 mL Injection
A 15% dextrose solution is given to shoulder segments four times with 2 weeks interval (week 0,2,4, and 6)
Also known as: Prolotherapy
A Normal Saline 0.9% is given to shoulder segments four times with 2 weeks interval (week 0,2,4, and 6)
Also known as: Comparator
Matrix Metalloproteinase 1 in Blood
Matrix Metalloproteinase 1 from whole blood measured using Enzyme-linked Immunoassay (ELISA). Mean difference between group will be assessed
Time frame: changes of Matrix Metalloproteinase 1 value from baseline to week 6
Tissue Inhibitor Metalloproteinase 1 in Blood
Tissue Inhibitor Metalloproteinase 1 from whole blood measured using Enzyme-linked Immunoassay (ELISA). Mean difference between group will be assessed
Time frame: changes of Tissue Inhibitor Metalloproteinase 1 value from baseline to week 6
The Functional Outcome of the Shoulder
The functional outcome is measured using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire where the patient were asked to do simple task involving the arm, shoulder and hand and also the assessment of additional symptoms and impact to daily life. Higher score indicates disabilities
Time frame: changes of Functional Outcome value from baseline to week 6
Plan to share: No — De-identified data will be shared accordingly
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Bumi Herman