Prolotherapy Intervention in Patient With Frozen Shoulder
Condition: Frozen Shoulder
MeSH terms: Bursitis
Study type: Interventional
Phase: Phase 4

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
    

Intervention name(s): Dextrose 15 % in Water; Normal Saline 20 mL Injection
Intervention type(s): Drug; Drug
Intervention description(s): A 15% dextrose solution is given to shoulder segments four times with 2 weeks interval (week 0,2,4, and 6); A Normal Saline 0.9% is given to shoulder segments four times with 2 weeks interval (week 0,2,4, and 6)
Other intervention name(s): Prolotherapy; Comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study involves two arms assigned randomly for receiving different treatments. One arm for Prolotherapy and Normal Saline in the comparison group.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MMP-1; TIMP-1; Prolotherapy; Functional Outcome; Frozen Shoulder