An interventional study of Dextrose Solution and Normal Saline in Knee Osteoarthritis and Obesity, sponsored by Rumah Sakit Umum Daerah Haji Provinsi Jawa Timur, Indonesia. Completed at 1 site in Indonesia. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by Rumah Sakit Umum Daerah Haji Provinsi Jawa Timur, Indonesia · Not applicable, Interventional, and Treatment
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:
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →This is the only study on the registry with Rumah Sakit Umum Daerah Haji Provinsi Jawa Timur, Indonesia as lead sponsor.
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Exclusion Criteria:
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
This group received Normal Saline injection on day 1 and day 30.
Drug: Normal Saline
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.
Also known as: Dextrose Injection
Normal Saline will be intra-articular injected and given two times, on day 1st and 30th day.
Also known as: Normal Saline Injection
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.
Time frame: Before intervention, day 1, and day 30 after intervention
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.
Time frame: 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.
Time frame: Before intervention, day 1, and day 30 after intervention
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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