Sanomechanics® Rehabilitative Technology

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Behavioral: Physical Therapy Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral knee pain with WOMAC score 6-9. Knee pain, aching or stiffness on most days in the past month and definite radiographic osteoarthritis in the index knee. Morning stiffness >30 min. Age: 40-75 years of age. More pain in the morning compared to evening. English speakers. Have daily access to an email address and a computer with Internet Allowed to be on prescription or non-prescription medicine for pain during the course of the study. Exclusion Criteria: Inability to communicate in English Lower limb injury, surgery, or intra-articular injection in the past 6-months Current pregnancy Have a pacemaker or other internal medical device Cancer not in remission Gout History of stroke affecting lower limb Major trauma Gross knee instability on exam Lumbar radiculopathy affecting symptomatic limb KL radiographic score 4 Morphological indications (bone-on-bone contact) for joint replacement

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Physical Therapy Program|Physical Therapy Program|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The WOMAC self-reported pain score . | 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. | 90 days | 
| The WOMAC self-reported function score | 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. | 90 days |