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NCT Number: NCT05131269

Prolotherapy Intervention in Patient With Frozen Shoulder

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

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Key information

Conditions

Frozen Shoulder Bursitis Joint Diseases Musculoskeletal Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hasanuddin University, Faculty of Medicine

Makassar, South Sulawesi, 90245, Indonesia

About this study

Design :

Double-blind randomized trial

Randomization :

Simple Randomization generated by an online randomizer

Sample Size :

Difference between two means of primary outcome where

  • mean difference (μ 1 - μ 2 ) = 0.47
  • pool variance = 0.09
  • Z 1-α/2 = 1.95 with type 1 error 5%
  • 1-β = 1.282 with power 90%. Yielding 16 patients for each arm

Detailed Intervention

  • Intervention group: Prolotherapy is given four times (Week 0, Week 2, Week 4, and Week 6)
  • Comparison group: Normal Saline is given four times with a timeframe similar to the intervention group

Injection location

  • Rotator Cuff muscles
  • Intraarticular glenohumeral joint
  • Subacromial bursa
  • long-heap of the biceps tendon
  • Acromioclavicular joint

Statistical analysis :

  • Descriptive statistic to elaborate baseline characteristic
  • 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
  • Difference within-group (baseline and last day) will be measured by paired-t-test or Wilcoxon for non parametric scenario

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria
  • Age 35-70
  • Diagnosed with frozen shoulder
  • At least showing symptoms more than 3 months
  • Exclusion Criteria
  • Receiving other intraarticular injection
  • Taking Nonsteroid Antiinflammation drugs 1 week prior to intervention
  • Skin disorder around the injection site
  • Septic arthritis

Treatment and study plan

Dextrose 15 % in Water

Drug

A 15% dextrose solution is given to shoulder segments four times with 2 weeks interval (week 0,2,4, and 6)

Other names: Prolotherapy

Normal Saline 20 mL Injection

Drug

A Normal Saline 0.9% is given to shoulder segments four times with 2 weeks interval (week 0,2,4, and 6)

Other names: Comparator

Primary outcomes

  1. Matrix Metalloproteinase 1 in Blood

    Time frame: 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

  2. Tissue Inhibitor Metalloproteinase 1 in Blood

    Time frame: 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

Secondary outcomes

  1. The Functional Outcome of the Shoulder

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bumi Herman

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 23, 2021
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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