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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age20-45
SponsorBadr University

About this trial

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.

Eligibility criteria

Qualifiers

1. Female participants aged between 20-45 years.

Their BMI ranged between 20-25 kg/m².

All had radiographic confirmation of mild to moderate knee osteoarthritis.

Medical history recorded with no major prior injuries or surgeries affecting outcomes.

Disqualifiers

No recent traumatic hip, knee, or ankle surgery within the past 6 months.

No severe knee OA (Kellgren-Lawrence grade 0 or 4).

No history of rheumatoid arthritis, chronic reactive arthritis, or psoriatic arthritis.

Free from conditions that limit safe study participation or adherence to protocol.

Trial design

Treatments tested in this trial

  • Alpha-Lipoic Acid (ALA)+PT
  • Omega-3 cap+ PT
  • Lower body positive pressure therapy (LBPP)+PT
  • Standard physical therapy (PT)

Treatment groups

160 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators