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

NCT07399743 | Not Yet Recruiting Phase 3

• 1 other identifier: IRB00014233-49
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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 Arms (4)

ALA tab 300 mg BID (Thioctacid) + PT

ACTIVE COMPARATOR

Drug: Alpha-Lipoic Acid (ALA)+PT

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

ACTIVE COMPARATOR

Drug: Omega-3 cap+ PT

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

ACTIVE COMPARATOR

Device: Lower body positive pressure therapy (LBPP)+PT

PT

ACTIVE COMPARATOR

Device: Standard physical therapy (PT)

Interventions

Alpha-Lipoic Acid (ALA)+PT DRUG

Thioctacid 600+PT

ALA tab 300 mg BID (Thioctacid) + PT

Omega-3 cap+ PT DRUG

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

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

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

PT

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Participants reported knee pain, functional limitation, and activity-related symptoms.
• Radiographic grading confirmed as Kellgren-Lawrence grade II or III.

You may not qualify if:

• 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.
• No neurological impairments affecting lower limb function.
• No contraindications to exercise or physiotherapy (e.g., severe cardiovascular, respiratory, or metabolic conditions).
• Not pregnant or planning pregnancy during the study.
• Not involved in other clinical trials or conflicting interventions (e.g., intra-articular injections, surgery, or rehab programs).

Sponsors & Collaborators

• Badr University: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: February 15, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share