Effects of Various Types of Ultrasound Therapy in Knee Osteoarthritis

Horus University80 enrolled

Overview

Knee osteoarthritis (KOA) is a degenerative joint condition characterized by degeneration, which is commonly attributed to the cumulative effects of mechanical stress and the slow deterioration of articular cartilage. KOA is a highly prevalent musculoskeletal disorder that affected 300 million people globally in 2017. It can affect any joint, although the most commonly affected are the knees, hands, hips, and spine

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Knee Arthritis Osteoarthritis

Interventions

MetfominDRUG

The metformin gel (medicinal coupling medium) was prepared with the assistance of Professor Abdel-Hamid M Nabil at the Faculty of Pharmacy, Kafr El-Sheikh Uni¬versity. Metformin gel 1% was prepared as described by Baldassari et al. \[27\]. \[27\]. All the required formulation ingredients were weighed accurately. Metformin HCl powder 34.5 g was dissolved in 20 ml glycerin. Then, the prepared solution was added gradually to 2850 g of the ultrasound gel with constant mixing to ensure homo¬geneity. Finally, 2.85 g of sodium citrate was added as a preservative, and the mixing continued until clear gel was obtained (10-15 min). Its color, appearance, and odor were quite like the coupling agent routinely used in the US. Lastly, the prepared gel was sealed in 30 g tubes and subsequently utilized to evaluate the clinical impacts.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 45 to 65 years. * Body mass index (BMI) 18.5-29.9 kg/m². * Diagnosis of knee osteoarthritis according to the American College of Rheumatology criteria. * Kellgren-Lawrence grade I-III. Exclusion Criteria: * Rheumatologic conditions such as rheumatoid arthritis. * Prior knee surgery. * Previous lower-extremity fracture involving the knee joint. * Diabetes mellitus. * Neuropathy or sensory disorders. * Intra-articular corticosteroid injection or platelet-rich plasma treatment within the previous 6 months. * Thrombosis of the lower limbs. * Contraindications to therapeutic ultrasound, including open epiphysis, infection, cardiac disease, metal implants, pacemaker, pregnancy, or thrombophlebitis. * Wound or laceration in the soft tissues surrounding the knee. * Skin disease around the treatment area. * Use of pain medications during the study that could influence outcomes. * Knee physiotherapy within the previous 3 months. * Other knee procedures, including aspiration or knee arthroplasty.

Locations (1)

Horus University

Quweisna, Monufia Governorate, Egypt

Outcomes

Primary Outcomes

Change in Knee Pain Intensity (VAS Score) Description: Pain intensity will be assessed using the 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain. The

Pain intensity will be assessed using the 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain. The primary outcome is the change in VAS score from baseline to

Time frame: Baseline and after 12 weeks of intervention

The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used to evaluate pain, stiffness, and physical function. The total score ranges from 0 to 96, with higher scores indicating worse symptoms. The outcome is the change in total score from baseline to post-treatment.

Time frame: Baseline and after 12 weeks of intervention

Change in Knee Joint Range of Motion (ROM)

Knee flexion and extension range of motion will be measured using a standard universal goniometer. The outcome is the change in degrees of motion from baseline to post-treatment.

Time frame: Baseline and after 12 weeks of intervention

Data from ClinicalTrials.gov

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