Prolotherapy Intervention in Patient With Frozen Shoulder
- Conditions
- Frozen Shoulder
- Interventions
- Drug: Normal Saline 20 mL InjectionDrug: Dextrose 15 % in Water
- Registration Number
- NCT05131269
- Lead Sponsor
- Bumi Herman
- Brief Summary
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
- Detailed Description
Design :
Double-blind randomized trial
Randomization :
Simple Randomization generated by an online randomizer
Sample Size :
Difference between two means of primary outcome where
1. mean difference (μ 1 - μ 2 ) = 0.47
2. pool variance = 0.09
3. Z 1-α/2 = 1.95 with type 1 error 5%
4. 1-β = 1.282 with power 90%. Yielding 16 patients for each arm
Detailed Intervention
1. Intervention group: Prolotherapy is given four times (Week 0, Week 2, Week 4, and Week 6)
2. Comparison group: Normal Saline is given four times with a timeframe similar to the intervention group
Injection location
1. Rotator Cuff muscles
2. Intraarticular glenohumeral joint
3. Subacromial bursa
4. long-heap of the biceps tendon
5. Acromioclavicular joint
Statistical analysis :
1. Descriptive statistic to elaborate baseline characteristic
2. Assuming the baseline characteristic between groups are similar, the independent t-test will be conducted to see the differences between group, whereas Mann Whitney will be performed for nonparametric data
3. Difference within-group (baseline and last day) will be measured by paired-t-test or Wilcoxon for non parametric scenario
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal Saline 0.9% Normal Saline 20 mL Injection 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 Prolotherapy Dextrose 15 % in Water 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
- Primary Outcome Measures
Name Time Method Tissue Inhibitor Metalloproteinase 1 in Blood 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 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
- Secondary Outcome Measures
Name Time Method The Functional Outcome of the Shoulder changes of Functional Outcome value from baseline to week 6 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
Trial Locations
- Locations (1)
Hasanuddin University, Faculty of Medicine
🇮🇩Makassar, South Sulawesi, Indonesia