Sanomechanics® Rehabilitative Technology

September 8, 2022 updated by: PolyOrth International

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Knee Osteoarthritis

Intervention / Treatment

Behavioral: Physical Therapy Program

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study intends to enroll diversified patient population diagnosed with unilateral osteoarthritis of the knee

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PolyOrth International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 30, 2023

Primary Completion (Anticipated)

December 30, 2024

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

August 21, 2022

First Submitted That Met QC Criteria

August 21, 2022

First Posted (Actual)

August 23, 2022

Study Record Updates

Last Update Posted (Actual)

September 9, 2022

Last Update Submitted That Met QC Criteria

September 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

POI 052022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.