NCT05131269

Prolotherapy Intervention in Patient With Frozen Shoulder

Completed Phase 4 Last updated 22 December 2022

What this trial tests

Phase 4 trial testing Dextrose 15 % in Water in Frozen Shoulder in 32 participants. Completed in 30 November 2022.

Timeline

1 December 2021

Primary endpoint
31 May 2022

30 November 2022

Quick facts

Lead sponsor	Bumi Herman
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	1 December 2021
Primary completion	31 May 2022
Estimated completion	30 November 2022
Sites	1 location across Indonesia

Drugs / interventions tested

• Dextrose 15 % in Water — full drug profile →
• Normal Saline 20 mL Injection — full drug profile →

Conditions studied

• Frozen Shoulder — all drugs for Frozen Shoulder →

Sponsor

Bumi Herman — full company profile →

Who can join

Adults 35 to 70, any sex, with Frozen Shoulder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The level of ratio between matrix metalloproteinase-1 (MMP-1) and tissue inhibitor matrix metalloproteinase-1 (TIMP-1) after prolotherapy intervention and the functional outcome in patient with frozen shoulder: A randomized controlled trial.
   Sam N, Yusuf I, Idris I, Adnan E, et al · · 2023 · cited 1× · PMID 37505166 · DOI 10.1097/md.0000000000034356