- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07637682
Percutaneous Neurostimulation in Knee Osteoarthritis
Percutaneous Peripheral Temporary Neurostimulation in Moderate to Severe Knee Osteoarthritis
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Tanta, Egypten
- Faculty of medicine, Tanta University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- adults between the ages of 30 and 70 years with a clinical diagnosis of moderate to severe knee OA who suffered knee pain.
- Patients who cannot afford intra-articular injections or radiofrequency ablation (RFA).
- patients who had failed 2 different oral pain medications and 6 weeks of physical therapy.
Exclusion Criteria:
- Patients with OA show improvement in pain after physiotherapy.
- patients evaluated by an orthopaedic surgeon and deemed to be surgical candidates due to knee pathologies other than OA.
- pregnant patients.
- patients on anticoagulation therapy, who were not permitted to stop anticoagulation.
- patients with previous trauma, neurological or endocrine diseases like diabetes mellitus, and knee tumors; and patients with inflammatory arthritis.
- people who had received an intra-articular knee injection within the last 6 months.
- Patients with tendon tears, bursitis, or calcified tendonitis as proven by imaging.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: transcutaneous nerve stimulation using a nerve stimulator to the genicular nerve block
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temporary transcutaneous nerve stimulation using a nerve stimulator to the genicular nerve, with settings 2Hz, 0.2mA, 1ms, where the nerve is stimulated for 4 to 6 minutes.
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Eksperimentel: transcutaneous nerve stimulation using a nerve stimulator to the saphenous nerve
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temporary transcutaneous nerve stimulation using a nerve stimulator to the saphenous nerve, with settings 2Hz, 0.2mA, 1ms, where the nerve is stimulated for 4 to 6 minutes.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical improvement by visual analogue scale after intervention.
Tidsramme: immediately after intervention.
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Clinical improvement by visual analogue scale immediately after intervention.
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immediately after intervention.
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
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
- 36265PR60/5/26
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Plan to Share IPD: "Yes" Plan Description: "Data obtained through this study may be provided to qualified researchers with academic interest in scapular dyskinesis. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e., a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Results will be published by the investigators in academic journal.
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Neuromodulation
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Northwell HealthUniversity of OklahomaAktiv, ikke rekrutterendeNeuromodulationForenede Stater
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Massachusetts General HospitalNational Institute on Aging (NIA)Tilmelding efter invitation
-
Kessler FoundationIkke rekrutterer endnuNeuromodulation | Kræftrelateret træthedForenede Stater
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University of Castilla-La ManchaAfsluttetElektrisk stimulering | NeuromodulationSpanien
-
Moens MaartenVrije Universiteit BrusselRekrutteringUndersøgelse | Neuromodulation | RegisterTyskland
-
University of Castilla-La ManchaAfsluttetElektrisk stimulering | NeuromodulationSpanien
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IRCCS Centro Neurolesi Bonino PulejoRekruttering
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University of MalagaIkke rekrutterer endnuMuskuloskeletale lidelser | Neuromodulation | Nedre lemmer
-
University of Castilla-La ManchaAfsluttetElektrisk stimulering | NeuromodulationSpanien
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Moens MaartenAfsluttetSmerte | Undersøgelse | NeuromodulationBelgien