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

NCT07399743 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-02-10

No results posted yet for this study

Summary

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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.

Conditions

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

Sponsors & Collaborators

  • Badr University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-15
Primary Completion
2026-06-01
Completion
2026-07-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07399743 on ClinicalTrials.gov