Sanomechanics® Rehabilitative Technology

PolyOrth International15 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Knee Osteoarthritis

Interventions

Physical Therapy ProgramBEHAVIORAL

Physical Therapy Program

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 90 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.