Sanomechanics® Rehabilitative Technology
Development of Sanomechanics® Rehabilitative Technology for Normalizing Contact Pressure in Painful Joints by Activating the Newly Discovered Floating Skeleton System.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The WOMAC self-reported pain score .
Tidsramme: 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.
|
90 days
|
|
The WOMAC self-reported function score
Tidsramme: 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.
|
90 days
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- POI 052022
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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