Clinical trial

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

Opening soon · Phase 3 · 0 countries · Registry ID NCT07399743

Opening soonPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 45 Years

SexFemale

Healthy volunteersNot accepted

ConditionKnee Osteoarthritis

Full registry criteria

* Inclusion criteria 1. Female participants aged between 20-45 years. 2. Their BMI ranged between 20-25 kg/m². 3. All had radiographic confirmation of mild to moderate knee osteoarthritis. 4. Medical history recorded with no major prior injuries or surgeries affecting outcomes. 5. Participants reported knee pain, functional limitation, and activity-related symptoms. 6. Radiographic grading confirmed as Kellgren-Lawrence grade II or III. Exclusion criteria: 1. No recent traumatic hip, knee, or ankle surgery within the past 6 months. 2. No severe knee OA (Kellgren-Lawrence grade 0 or 4). 3. No history of rheumatoid arthritis, chronic reactive arthritis, or psoriatic arthritis. 4. Free from conditions that limit safe study participation or adherence to protocol. 5. No neurological impairments affecting lower limb function. 6. No contraindications to exercise or physiotherapy (e.g., severe cardiovascular, respiratory, or metabolic conditions). 7. Not pregnant or planning pregnancy during the study. 8. Not involved in other clinical trials or conflicting interventions (e.g., intra-articular injections, surgery, or rehab programs).

Treatments and study arms

Alpha-Lipoic Acid (ALA)+PT

Drug

Thioctacid 600+PT

Omega-3 cap+ PT

Drug

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

Lower body positive pressure therapy (LBPP)+PT

Device

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

Standard physical therapy (PT)

Device

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

Primary outcomes

Change in VAS pain score (0-10 cm)from baseline to 12 weeks

Change in WOMAC total score (0-96)from baseline to 12 weeks

Study locations

0 locations were listed when this page was built. The first 40 are shown.

No public site location was included in this record. Check the original registry for updates.