Sanomechanics® Rehabilitative Technology

Knee Osteoarthritis Clinical Trial

Official title: Development of Sanomechanics® Rehabilitative Technology for Normalizing Contact Pressure in Painful Joints by Activating the Newly Discovered Floating Skeleton System.

Status Not yet recruiting

Clinical Trial Summary

Rehabilitative Sanomechanics Method (RSM) of exercise designed to restore normal subperiosteal transmission of in-joint pressures and normalizing contact pressures on cartilages, will reduce pain in the affected joints and improve locomotor function.

Clinical Trial Description

Specific Aim 1: In a clinical trial with subjects reporting arthritic knee pain, demonstrate that the Sanomechanics method of exercise, focused on restoring normal subperiosteal transmission of in-joint pressures, will reduce pain. Using the validated WOMAC questionnaire as a Patient- Reported Outcome (PRO) tool, the associated primary endpoint is that 80% of patients will report a reduction in pain at the end of the 3-month study based on the 5-point categorical WOMAC pain scale.

Specific Aim 2: To demonstrate that Sanomechanics will improve normal synergy in gait by mitigating compensatory gait strategy, which one develops to avoid unbearable pain in the joint. The associated co-primary endpoint is that 80% of patients will experience an increase in stance knee flexion angle. The secondary endpoint is that the 80% of patients will report a lowered WOMAC function score based on 5-point categorical WOMAC scale (lower score corresponds to better self-reported function) after the three-month study. ;

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT05512507
• Study type: Observational
• Source: PolyOrth International
• Status: Not yet recruiting
• Start date: January 30, 2023
• Completion date: December 30, 2024