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

Официальное название

Effects of Lower Body Positive Pressure Therapy Versus Alpha Lipoic Acid and Omega-3 Fatty Acids on Pain, Function, and Inflammation in Overweight Women With Knee Osteoarthritis: A Randomized Controlled Clinical Trial

Обзор

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.

Вмешательства

• Препарат Alpha-Lipoic Acid (ALA)+PT
  Thioctacid 600+PT
• Препарат Omega-3 cap+ PT
  Omega-3 cap 2000 mg BID (Limitless Omega) + PT
• Устройство Lower body positive pressure therapy (LBPP)+PT
  LBPP: AlterG 40-60% unload, 30 min (3×/week) + PT
• Устройство Standard physical therapy (PT)
  PT typically includes quadriceps strengthening, flexibility exercises, proprioceptive training, stationary cycling, and aquatic therapy

Первичные конечные точки

• Change in VAS pain score (0-10 cm) [Срок оценки: from baseline to 12 weeks]
• Change in WOMAC total score (0-96) [Срок оценки: from baseline to 12 weeks]

Критерии участия

• Inclusion criteria

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07399743 · IRB00014233-49

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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