Sanomechanics® Rehabilitative Technology

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05512507

Enrollment

Registered

2022-08-23

Start date

2023-01-30

Completion date

2024-12-30

Last updated

2022-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Brief 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.

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.

Interventions

BEHAVIORALPhysical Therapy Program

Physical Therapy Program

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The WOMAC self-reported pain score .	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.
The WOMAC self-reported function score	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026