Comparison The Added Effect of External Knee Supports with Home-based Exercise on Pain, Physical Function and Muscular Performance in Patients with Mild to Moderate Degrees of Knee Osteoarthritis

Comparison The Added Effect of External Knee Supports with Home-based Exercise on Pain, Physical Function and Muscular Performance in Patients with Mild to Moderate Degrees of Knee Osteoarthritis

Parallel group, Randomized controlled trial with outcome assessor blinded

All the assessments, interventions, and data collection steps will be carried out at the School of sport sciences and health, Shahid Beheshti University. The outcome assessor and statistician will be blinded.

aged: 50-65 years old, Kellgren and Lawrence grade 2 or 3 according to AP knee radiographs, the American College of Rheumatology classification criteria pain intensity of at least 4, standing and walking without assistance

Three groups: home-based exercise, home-based exercise plus Kinesiotape, home-based exercise plus flexible knee orthosis

Primary outcome measures: Pain via VAS, physical disability via WOMAC. Secondary outcome measures: maximal isometric contracrtion. force sense, force steadiness, kinesiophobia, 30-seconds sit-to-stand test

The group allocation will be performed through permuted block randomization at an assignment ratio of 1:1:1. For allocation concealment, the randomization codes will be kept in opaque, sealed, sequentially numbered envelopes. Sample size is estimated at 54, however, to take account of potential withdrawals, 60 patients (n=20 per group) will be recruited for the study. First, create and seal 20 treatment A envelopes, 20 treatment B envelopes, and 20 treatment C envelopes. To create a block of 6, we will select 2 treatment A envelopes, 2 treatment B envelopes, and 2 treatment C envelopes. We will shuffle these 6 envelopes thoroughly, and place this block of 6 in a separate pile. Then, we will prepare additional blocks of 6 until all 20 treatment A, B, and C envelopes have been used. All additional blocks will be placed in their own individual piles. We will have 10 individuals piles of shuffled blocks of 6.

The outcome assessor will be blinded to group allocation, because all dependent variables will be measured without the orthosis and or kinesiotape, and the patients will remove their orthosis / kinesiotape before referring for post-intervention assessment. Furthermore, all data will be encoded to prevent bias and to blind the statistician.

Our research findings will be shared with all researchers, and practitioners. We will publish our research findings in scientific journals

All documents can be shared 1 year after article publication

Researchers and health practitioners

Use of data is only possible by mentioning the name and organizational affiliation of the correspond and co-author of the project and the published article.

Fatemeh Azadinia

Send email to corresponding author.