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Prolotherapy Intervention in Patient With Frozen Shoulder

NCT05131269 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-12-22

No results posted yet for this study

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

Conditions

  • Frozen Shoulder

Interventions

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)

Sponsors & Collaborators

  • Bumi Herman

    lead OTHER

Principal Investigators

  • Nuralam Sarif, MD · Hasanuddin University

  • Irawan Yusuf, PhD · Hasanuddin University

  • Endy Adnan, PhD · Hasanuddin University

  • Irfan Idris, PhD · Hasanuddin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-05-31
Completion
2022-11-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05131269 on ClinicalTrials.gov