Effects of Two Bar Knee Off-Load Brace With Non Weight Bearing Strength Training Among Knee Osteoarthritis Patients

Effects of Two Bar Knee Off-Load Brace With Non Weight Bearing Strength Training on Pain, Stiffness, and Satisfaction Among Knee Osteoarthritis Patients: A Randomized Controlled Trial

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.

Knee osteoarthritis is a progressive musculoskeletal condition characterized by joint degeneration, pain, stiffness, and reduced functional mobility. Conservative management strategies such as therapeutic exercise and knee bracing are commonly recommended to reduce symptoms and improve functional outcomes. Knee off-loader braces are designed to reduce joint loading by redistributing forces across the knee joint during weight-bearing activities. Recently, interest has increased in braces that provide external axial unloading through structural support, potentially reducing compressive forces on the tibio-femoral joint more effectively than traditional braces.

Non-weight bearing strength training is frequently used in rehabilitation programs for knee osteoarthritis because it strengthens periarticular muscles while minimizing joint loading during exercise. Combining mechanical unloading through bracing with structured non-weight bearing strengthening may provide a complementary therapeutic effect by simultaneously reducing mechanical stress on the knee joint and improving muscular support and joint stability.

This study will evaluate the effectiveness of a two-bar knee off-load brace combined with non-weight bearing strength training compared with a standard knee off-loader brace combined with the same strengthening program. The trial will use a single-blind, parallel-group randomized controlled design with a total of 18 participants diagnosed with knee osteoarthritis. Participants will be randomly assigned to one of two intervention groups.

The two bar knee offload brace group will receive a two-bar knee off-loader brace designed with medial and lateral rigid support bars extending from the thigh to the ground, allowing partial axial load transfer while maintaining physiological knee motion. Participants will also perform a structured non-weight bearing strength training program targeting hip, knee, and ankle musculature.

The standard brace group will receive a standard knee off-loader brace that redistributes knee joint forces without external axial load support, along with the same non-weight bearing strength training protocol. Both interventions will be administered three times per week for six weeks, with each treatment session lasting approximately 45-60 minutes.

The study aims to determine whether the addition of enhanced axial unloading through the two-bar knee off-loader brace leads to greater improvements in pain, stiffness, and patient satisfaction compared with the standard brace. Outcome measures will include the Numeric Pain Rating Scale for pain intensity, the stiffness subscale of the Western Ontario and McMaster Universities Osteoarthritis Index, and the satisfaction section of the Knee Society Score. Assessments will be conducted at baseline and after completion of the six-week intervention period.

The current study will be conducted at the physiotherapy departments of Water and Power Development Authority Hospital Complex and Fatima Memorial Hospital, Lahore. Standardized procedures will be followed to ensure consistent delivery of interventions and accurate outcome assessment across all participants.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Individuals with a major lower-limb injury requiring surgery or physiotherapy within the past year