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HDP vs NS Intra-articular Injection Among KOA With Obese Patient

NCT05966948 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-10-18

No results posted yet for this study

Summary

The aim of this randomized controlled trial study was to compare the effect of intra-articular injection of Hypertonic Dextrose Prolotherapy (HDP) with Normal Saline (NS) in the clinical improvement of knee osteoarthritis (KOA) patients with comorbid obesity. The main questions to be answered are:

* How does the effect of HDP versus NS intra-articular injection compare to the numerical rating score (NRS) in obese KOA patients?
* How does the effect of HDP versus NS intra-articular injection compare to scores of The Western Ontario and McMaster Universities Arthritis Index (WOMAC) in obese KOA patients?
* How does the effect of HDP versus NS intra-articular injection compare to the thickness of the femoral cartilage in obese KOA patients?

Participants who meet the inclusion and exclusion criteria will be randomized based on the order of the outpatient department each day, with odd numbers as the HDP intervention group and even numbers as NS. They received ultrasound-guided intra-articular injections on day 1 and day 30.

Researchers will compare HDP versus NS groups to see which group improves NRS, WOMAC, and femoral cartilage thickness.

Conditions

Interventions

DRUG

Dextrose Solution

Prolotherapy is a regenerative tissue therapy that is considered efficacious for reducing the symptoms and morbidity of Knee Osteoarthritis (KOA) using hypertonic dextrose as an injectable substance. Treatment will be given two times, on day 1st and 30th day.

DRUG

Normal Saline

Normal Saline will be intra-articular injected and given two times, on day 1st and 30th day.

Sponsors & Collaborators

  • Rumah Sakit Umum Daerah Haji Provinsi Jawa Timur, Indonesia

    lead OTHER

Principal Investigators

  • Rita Vivera Pane, MD, PhD · Universitas Nahdlatul Ulama Surabaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2023-09-30
Completion
2023-10-01

Countries

  • Indonesia

Study Locations

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Entities

Diseases

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 NCT05966948 on ClinicalTrials.gov