NCT05131269

Prolotherapy Intervention in Patient With Frozen Shoulder

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Bumi Herman · Academic / Other
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Frozen Shoulder

Interventions

Type	Name	Description
DRUG	Dextrose 15 % in Water	A 15% dextrose solution is given to shoulder segments four times with 2 weeks interval (week 0,2,4, and 6)
DRUG	Normal Saline 20 mL Injection	A Normal Saline 0.9% is given to shoulder segments four times with 2 weeks interval (week 0,2,4, and 6)

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-05-31
• Completion: 2022-11-30
• First posted: 2021-11-23
• Last updated: 2022-12-22

Locations

1 site across 1 country: Indonesia