Prolotherapy Intervention in Patient With Frozen Shoulder

Bumi Herman

Status and phase: Completed; Phase 4

Conditions: Frozen Shoulder

Treatments: Drug: Dextrose 15 % in Water; Drug: Normal Saline 20 mL Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05131269

0411211741

Details and patient eligibility

About

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

Full 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

Enrollment: 32 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion Criteria

   1. Age 35-70
   2. Diagnosed with frozen shoulder
   3. At least showing symptoms more than 3 months

2. Exclusion Criteria

   1. Receiving other intraarticular injection
   2. Taking Nonsteroid Antiinflammation drugs 1 week prior to intervention
   3. Skin disorder around the injection site
   4. Septic arthritis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups, including a placebo group

Prolotherapy

Experimental group

Description:

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

Treatment:

Drug: Dextrose 15 % in Water

Normal Saline 0.9%

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal Saline 20 mL Injection