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

October 17, 2023 updated by: Rumah Sakit Umum Daerah Haji Provinsi Jawa Timur, Indonesia

Hypertonic Dextrose Prolotherapy Versus Normal Saline Intra-articular Injection Among Knee Osteoarthritis With Obese Patient

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized controlled study, which recruited KOA patients with obese comorbidity who were treated at the Outpatient Department of Physical Medicine and Rehabilitation at Rumah Sakit Daerah Haji Provinsi Jawa Timur, Surabaya, Indonesia from May to August 2023. The participants were divided into two groups, including HDP versus NS injections.

Each study participant's identity including age, gender, weight, height, and BMI was recorded. Then an evaluation of the NRS, WOMAC score, and femoral cartilage thickness was carried out using ultrasound.

This study assessed using the NRS scale for pain reduction on a scale of 0 to 10 (0 means no pain, while 10 means very pain). The WOMAC Score consists of 24 questions with four scales, namely 0: none, 1: mild, 2: moderate, 3: severe, and 4: very severe. Femoral cartilage thickness scan using ultrasound with millimeter units.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • East Java
      • Surabaya, East Java, Indonesia
        • Rumah Sakit Umum Daerah Haji Provinsi Jawa Timur, Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient was diagnosed with knee osteoarthritis (KOA).
  • Patient was diagnosed with obesity.

Exclusion Criteria:

  • Patient with a history of knee trauma.
  • Patient with a history of knee surgery.
  • Patient with a history of intra-articular injection before.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypertonic Dextrose Prolotherapy
This group received a Hypertonic dextrose intra articular is 25%, while extra articular 20% injection on day 1 and day 30 with same dose.
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.
Other Names:
  • Dextrose Injection
Placebo Comparator: Normal Saline
This group received Normal Saline injection on day 1 and day 30.
Drug: Normal Saline
Normal Saline will be intra-articular injected and given two times, on day 1st and 30th day.
Other Names:
  • Normal Saline Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale
Time Frame: Before intervention, day 1, and day 30 after intervention
A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. We classified from 0 to 10, where 0 is no pain and 10 is the worst pain.
Before intervention, day 1, and day 30 after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC Score
Time Frame: Before intervention, day 1, and day 30 after intervention

The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 sub-scales:

(1) Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright; (2) Stiffness (2 items): after first waking and later in the day; (3) Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.
Before intervention, day 1, and day 30 after intervention
Femoral Cartilage Thickness
Time Frame: Before intervention, day 1, and day 30 after intervention
The ultrasound measurement of femoral cartilage thickness is divided into three sites: medial condyle, intercondylar, and lateral condyle on the right and left sides. This measurement is in millimeters units.
Before intervention, day 1, and day 30 after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rumah Sakit Umum Daerah Haji Provinsi Jawa Timur, Indonesia

Investigators

  • Study Chair: Rita Vivera Pane, MD, PhD, Universitas Nahdlatul Ulama Surabaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

July 11, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSUHajiJaTimProv

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Dextrose Solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe