- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07700784
Radiofrequency in Knee Osteoarthritis
Efficacy of Ultrasound Guided Laser Genicular Nerves Ablation Versus Conventional Radiofrequancy For Chronic Knee Osteoarthritis Pain
Knee osteoarthritis is one of the most common causes of chronic pain and disability worldwide, particularly in middle-aged and elderly populations. It is characterised by progressive cartilage degeneration, subchondral bone remodelling, and synovial inflammation.
There were many trails to provide pain relief by using systemic opioids or Non steroidal anti inflammatory drugs (with side effects such as peptic ulcer and hepatic, renal impairment)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Knee osteoarthritis is one of the most common causes of chronic pain and disability worldwide, particularly in middle-aged and elderly populations. It is characterized by progressive cartilage degeneration, subchondral bone remodeling, and synovial inflammation.
There were many trails to provide pain relief by using systemic opioids or non steroidal anti inflammatory drugs (with side effects such as peptic ulcer and hepatic, renal impairment) In knee osteoarthritis .these nerves are believed to be sensitised, leading to increased pain signalling . This can result in chronic pain and discomfort in patients with knee osteoarthritis.
Radiofrequency targeting these nerves aims to provide pain relief by disrupting the pain signals transmitted through these nerves .
By selectively targeting the articular branches, these interventions can alleviate pain and improve the physical function and quality of life of patients with knee osteoarthritis. The positive therapeutic effect of radiofrequency on genicular nerves has been reported in many previous studies . However, little is known about its effects on patients with intractable knee pain.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- American society of anesthesiologist's physical status class I, II- Body mass index (BMI): 18.5 - 29.9 kg/m2- Confirmation of knee OA on radiograph- Chronic knee pain ≥ 3 months.
Exclusion Criteria:
- History of clinically significant cardiac, hepatic, renal or neurological disease- Allergy to study medication- Coagulopathy- Infection at injection site
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Laser genicular nerve ablation
Laser genicular nerve ablation Using ultrasound
|
Ultrasoud guided Laser genicular nerve ablation for pain relief in knee osteoarthritis
|
|
Aktiv komparator: Conventional Radiofrequency genicular nerve ablation
Conventional Radiofrequency genicular nerve ablation using ultrasound
|
Conventional radiofrequency genicular nerve ablation for pain relief in knee osteoarthritis
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual Analogue scale pain score
Tidsramme: 24 hour
|
To assess pain intensity using Visual Analogue Scale score between laser and radiofrequency group with score 10 indicates worst pain and score 0 indicates no pain.
|
24 hour
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
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
- Analgesia
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Analgesi
-
Cukurova UniversityScientific Research Projects Coordination UnitAktiv, ikke rekrutterendeSygepleje | Intensiv pleje | Neurokirurgisk kirurgi | Sedo-AnalgesiaTyrkiet (Türkiye)
Kliniske forsøg med Laser genicular nerve ablation
-
Yale UniversityRekrutteringLændesmerter | Vertebrogent smertesyndrom | Basivertebralnerven AblationForenede Stater
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Ain Shams UniversityAfsluttetPostoperative smerter | Funktionelt resultatEgypten