Knee Osteoarthritis, Obesity
Conditions
Keywords
knee osteoarthritis, obesity
Brief 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.
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.
Interventions
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.
DRUGNormal Saline
Normal Saline will be intra-articular injected and given two times, on day 1st and 30th day.
Sponsors
Rumah Sakit Umum Daerah Haji Provinsi Jawa Timur, Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants who met the eligibility of the study who were on outpatient treatment on that day were randomized in order of queue, odd numbers as the intervention group and even numbers as the control group.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC Score | 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. |
| Femoral Cartilage Thickness | 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. |
Countries
Indonesia
Outcome results
None listed