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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05512507
Other study ID # POI 052022
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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