Sanomechanics® Rehabilitative Technology

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05512507
• Other study ID #: POI 052022
• Status: Not yet recruiting
• Start date: January 30, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: August 2022
• Source: PolyOrth International
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Physical Therapy Program
Physical Therapy Program

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
PolyOrth International

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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