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Study aim: The purpose of this study will be to investigate whether a 3-months (36-sessions) selected exercises program (strength, aerobic, mobility, neuromuscular, balance and breathing exercises) combined with 3 sessions pain neuroscience education (PNE) provides greater pain relief and improvement in physical performances and psychological factors in compared PNE and exercise alone, during at 6 months follow-up and whether “booster sessions” in follow-up periods may improve outcomes and increase adherence in a population of patients with knee osteoarthritis. Design: Clinical trial with control group, with four arm factorial groups, one-way blind, randomized, on 129 patients. Block design and with help site will be used for randomization. Settings and conduct: This study will be performed in the Tehran, Rheumatology Research Center of Shariati Hospital on people with knee osteoarthritis. Data evaluators and analyzers will be blind to the participants in each group. Participants/Inclusion and exclusion criteria: Inclusion: Men and women (age 40 years or older) with knee osteoarthritis (Kellgren and Lawrence grade 1 to 3 on the 1-4 scale) Exclusion: Severe osteoporosis and Patellofemoral osteoarthritis Intervention groups: 1. Selected exercises using booster sessions (36 sessions) 2. Pain neuroscience education (PNE) (three sessions of PNE given over 2 weeks) 3. PNE+ Selected exercises using booster sessions (exercise three times a week for 3-months combined with three sessions of PNE) 4. Control (educations program comprised of the self-management, an anatomy and physiology (except PNE), daily activities ergonomic, and encouragement to be active) Main outcome variables: Primary Outcomes: pain and WOMAC/ Secondary outcomes: psychological factors; physical function; muscles strength؛ Active range of motion؛ risk of fall؛ quality of life; and the exercise adherence.
IRCTID: IRCT20220510054814N1
  1. Effects of pain neuroscience training combined with neuromuscular exercises on pain, functional disability and psychological factors related to chronic low back pain: A study protocol for a randomized controlled trial.
  2. Effect of pain neuroscience education and physical exercise for patients with lumbar radiculopathy
  3. The Effect of Pain Neuroscience Education on the Effectiveness of Neuromuscular Exercise in Women with Both Knee Osteoarthritis and Chronic Low Back Pain
  4. Investigating the effect of mixed therapeutic exercises and self-management education with and without functional strength exercises on pain and function factors in patients with avascular necrosis of the femoral head
  5. Effectiveness of adding lifestyle change approaches to comprehensive exercises on pain, strength, quality of life and function in people with knee osteoarthritis
  6. Evaluation of adding Pain neuroscience education to Pilates exercises on reducing on pain and improving function and psychological variables in individuals with knee osteoarthritis
  7. Comparing the influence of pain education and behavioral graded activity with placebo education and behavioral graded activity on pain-related outcomes, central sensitization, function, and psychological factors in individuals with knee osteoarthritis
  8. Comparison of effectiveness of an etiologic-based exercise and conventional exercises on knee loading, pain and functional activity in individuals with Knee osteoarthritis: A randomized clinical trials.
  9. Fish Oil Supplementation vs Knee Strengthening Exercises: A Comparative Study in Knee Osteoarthritis Management
  10. Evaluation of the effect of adding duloxetine to exercise therapy on pain and function of patients with knee osteoarthritis
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