Sanomechanics® Rehabilitative Technology
Development of Sanomechanics® Rehabilitative Technology for Normalizing Contact Pressure in Painful Joints by Activating the Newly Discovered Floating Skeleton System.
1 other identifier
observational
15
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2022
CompletedFirst Posted
Study publicly available on registry
August 23, 2022
CompletedStudy Start
First participant enrolled
January 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedSeptember 9, 2022
August 1, 2022
1.9 years
August 21, 2022
September 8, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Interventions
Physical Therapy Program
Eligibility Criteria
Study intends to enroll diversified patient population diagnosed with unilateral osteoarthritis of the knee
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2022
First Posted
August 23, 2022
Study Start
January 30, 2023
Primary Completion
December 30, 2024
Study Completion
December 30, 2024
Last Updated
September 9, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share