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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Knee Osteoarthritis, Obesity

Intervention / Treatment
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* Drug: Dextrose Solution
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study involves two arms assigned randomly for receiving different treatment. One arm for Hypertonic Dextrose Prolotherapy as intervention group and Normal Saline as control group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypertonic Dextrose Prolotherapy<br>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<br>* 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.<br>* Other names: Dextrose Injection;|
| Placebo Comparator: Normal Saline<br>This group received Normal Saline injection on day 1 and day 30. | Drug: Normal Saline<br>* Normal Saline will be intra-articular injected and given two times, on day 1st and 30th day.<br>* Other names: Normal Saline Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee osteoarthritis, obesity