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:

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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: ALA tab 300 mg BID (Thioctacid) + PTActive comparator 1 intervention
Group B: Omega-3 cap 2000 mg BID (Limitless Omega) + PTActive comparator 1 intervention
Group C: LBPP (AlterG 40-60% unload, 30 min 3×/week) + PTActive comparator 1 intervention
Group D: PTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in VAS pain score (0-10 cm)

Time frame
from baseline to 12 weeks
2

Change in WOMAC total score (0-96)

Time frame
from baseline to 12 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: