Prolotherapy Intervention in Patient With Frozen Shoulder

Frozen Shoulder Clinical Trial

Official title: 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

Clinical Trial 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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Bursitis
• Frozen Shoulder

• NCT number: NCT05131269
• Study type: Interventional
• Source: Hasanuddin University
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2021
• Completion date: November 30, 2022