The current study is a single-blind, parallel-group randomized controlled trial involving 18 participants with knee osteoarthritis. The trial will compare a program of two-bar knee off-load brace combined with non-weight bearing strength training with a program of standard knee off-loader brace combined with non-weight bearing strength training. Interventions will be delivered three times per week for six weeks. The primary outcomes are pain, stiffness, and patient satisfaction. Assessments will be conducted at baseline and after six weeks. The trial will be carried out at Water and Power Development Authority Hospital Complex and Fatima Memorial Hospital, Lahore. The hypothesis is that the two-bar knee off-load brace combined with non-weight bearing strength training will result in greater reductions in pain and stiffness as well as improved patient satisfaction compared with the standard knee off-loader brace with non-weight bearing strength training.
Age between 45-60 years
Have a confirmed diagnosis of KOA of grade II to III according to Kellgren and Lawrence classification
Participants must have had no changes in pharmacological treatment and not received any intra-articular knee injection (glucocorticosteroids with analgesics) during the last three months
Patient must be able to understand instructions and complete self-reported questionnaires
Participants will be excluded if they have severe venous insufficiency
Acute inflammatory knee conditions (septic arthritis, gout, pseudogout)
Systemic disease (rheumatoid arthritis, fibromyalgia)
Traumatic onset of knee pain
Parallel
Two-Bar Knee Off-Load Brace with Non-Weight Bearing Strength Training Intervention
Other interventionParticipants will be instructed to wear the two-bar knee off-loader brace during waking hours. Participants will be advised not to wear the brace during sleep, bathing, or personal hygiene activities, and to remove it during prolonged periods of sitting or lying down. Daily skin inspection will be recommended to monitor for discomfort or irritation. The Non-Weight Bearing Strength Training is a structured program of strengthening and stretching exercises for the lower extremities. The strength training will be administered three times per week throughout the six-week intervention period. Each treatment session will begin with 10 minutes warm-up, followed by resistance training, and ending with 10 minutes cool-down. The overall session duration is expected to range between 45 and 60 minutes. Rest intervals of 20-30 seconds will be provided between sets, with a 1-minute rest period before transitioning to the next exercise.
Standard Knee Off-Loader Brace with Non-Weight Bearing Strength Training Intervention
Other interventionParticipants in the control group will receive the same non-weight bearing strength training program along with the use of a standard knee off-loader brace. The strengthening program will target hip, knee, and ankle muscles and will be performed in non-weight bearing positions to minimize joint stress while improving muscular strength and joint stability.
Knee Pain
Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS). The NPRS is a widely used, validated self-reported scale that assesses the intensity of pain on an 11-point numerical scale ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Participants will be asked to rate their average knee pain based on their experience. The NPRS is simple to administer and has demonstrated excellent reliability and validity in musculoskeletal conditions. Pain levels will be categorized as mild (1-3), moderate (4-6), and severe (7-10). Changes in NPRS scores from baseline to the end of the intervention will be used to determine the effectiveness of the treatment.
Stiffness
Stiffness will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale. The WOMAC is a disease-specific questionnaire developed for individuals with osteoarthritis. The stiffness subscale consists of two items that assess the severity of knee stiffness after first waking in the morning and later in the day. Each item is scored on a Likert scale, producing a total stiffness score ranging from 0 to 8, where higher scores indicate greater stiffness severity. The WOMAC has demonstrated good reliability and validity for assessing symptoms and functional limitations in patients with knee osteoarthritis.
Patient Satisfaction
Patient satisfaction will be measured using the Satisfaction Section of the Knee Society Score (KSS). This section consists of five items evaluating the patient's satisfaction with knee function and treatment outcomes. Each item is scored from 0 to 8, giving a total score ranging from 0 to 40, where higher scores indicate greater satisfaction. The Knee Society Score is a validated tool widely used in clinical research for evaluating patient-reported outcomes related to knee conditions.
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