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NOT YET RECRUITING
NCT07399743
PHASE3

Effects of Lower Body Positive Pressure Therapy Versus Alpha Lipoic Acid and Omega-3 Fatty Acids on Knee Osteoarthritis

Sponsor: Badr University

View on ClinicalTrials.gov

Summary

Here is a \*\*concise, clear summary (\~250 words / well under 5000 characters)\*\* while preserving the key scientific points: \--- Knee osteoarthritis (KOA) is highly prevalent among overweight women, affecting more than 30% of those with BMI ≥25 kg/m². Excess body weight increases knee joint loading by 4-6 times per additional kilogram, accelerating cartilage degeneration, subchondral bone changes, and synovial inflammation. These alterations result in chronic pain, stiffness, functional limitation, and reduced quality of life, with obesity-related metabolic inflammation further worsening disease progression. Standard physical therapy (PT) remains first-line treatment, yet provides only modest benefits, achieving approximately 15-20% WOMAC improvement at 12 weeks, while up to half of overweight patients continue to experience significant symptoms. Lower body positive pressure therapy (LBPP) via antigravity treadmill offers a biomechanical enhancement by unloading 40-80% of body weight, enabling pain-free gait training and reducing joint impact forces by up to 80%. Studies report 30-40% WOMAC improvement and better walking capacity compared with conventional PT. Nevertheless, mechanical interventions alone do not address the inflammatory and oxidative mechanisms driving KOA. Alpha-lipoic acid (600 mg/day) and omega-3 fatty acids (1.5-2 g/day) provide targeted biochemical modulation, reducing pro-inflammatory cytokines, oxidative stress, and cartilage-degrading enzymes, with reported 25-35% functional improvement in clinical trials. Despite the promise of both approaches, no randomized trial has directly compared adding LBPP versus combined ALA and omega-3 supplementation to standard PT in overweight women with KOA. This study aims to fill this gap by evaluating the relative effectiveness of biomechanical versus biochemical adjuncts to optimize management of KOA in this high-risk population.

Official title: Effects of Lower Body Positive Pressure Therapy Versus Alpha Lipoic Acid and Omega-3 Fatty Acids on Pain, Function, and Inflammation in Overweight Women With Knee Osteoarthritis: A Randomized Controlled Clinical Trial

Key Details

Gender

FEMALE

Age Range

20 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-02-15

Completion Date

2026-07-01

Last Updated

2026-02-10

Healthy Volunteers

No

Interventions

DRUG

Alpha-Lipoic Acid (ALA)+PT

Thioctacid 600+PT

DRUG

Omega-3 cap+ PT

Omega-3 cap 2000 mg BID (Limitless Omega) + PT

DEVICE

Lower body positive pressure therapy (LBPP)+PT

LBPP: AlterG 40-60% unload, 30 min (3×/week) + PT

DEVICE

Standard physical therapy (PT)

PT typically includes quadriceps strengthening, flexibility exercises, proprioceptive training, stationary cycling, and aquatic therapy