About this trial
The current study is a single-blinded, parallel-group pilot randomized controlled trial involving 20 participants diagnosed with knee osteoarthritis (KOA). The trial will compare the effects of a knee and heel off-loader brace combined with non-weight bearing (NWB) strength training versus a conventional knee off-loader brace combined with NWB strength training. Interventions will be delivered three times per week for four weeks.
The primary outcome of the study is pain intensity, while secondary outcomes include gait variability and functional outcome. Assessments will be conducted at baseline and after completion of the intervention period. The study will be carried out at the outpatient physiotherapy departments of Kaazi Hospital and Ghurki Trust Hospital, Lahore.
The hypothesis is that the combination of knee and heel off-loader brace with NWB strength training will result in greater reductions in pain, improved gait variability, and enhanced functional outcomes compared to the conventional knee off-loader brace with NWB strength training.
Eligibility criteria
Qualifiers
Clinically diagnosed KOA with radiographic Kellgren and Lawrence grade II-III, confirmed within the previous six months
History of knee pain for at least three months, consistent with chronic KOA
Ability to ambulate independently, with or without assistive devices
No change in pharmacological management for KOA during the previous three months
Disqualifiers
Severe venous insufficiency or history of deep vein thrombosis
Acute inflammatory knee conditions (e.g., septic arthritis, acute synovitis)
Rheumatic or systemic inflammatory joint diseases (e.g., rheumatoid arthritis)
Traumatic onset of knee pain within the previous six months
Trial design
Treatments tested in this trial
- Knee and Heel Off-Loader Brace with NWB Strength Training
- Conventional Knee Off-Loader Brace with NWB Strength Training