Sanomechanics® Rehabilitative Technology

Not yet recruiting

• Conditions: Knee Osteoarthritis

• Registration Number: NCT05512507
• Lead Sponsor: PolyOrth International

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.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-21
• Study First Submitted QC: 2022-08-21
• Study First Posted: 2022-08-23
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-09
• Study Start: 2023-01-30
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.