Clinical trial NCT05512507: Sanomechanics® Rehabilitative Technology
Official title: Development of Sanomechanics® Rehabilitative Technology for Normalizing Contact Pressure in Painful Joints by Activating the Newly Discovered Floating Skeleton System.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Lead sponsor: PolyOrth International
Sponsor class: INDUSTRY
First posted: 2022-08-23
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study intends to enroll diversified patient population diagnosed with unilateral osteoarthritis of the knee

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.

Eligibility criteria: 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

Primary outcomes:
measure: The WOMAC self-reported pain score .
timeFrame: 90 days
measure: The WOMAC self-reported function score
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: