- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Visual Analogue scale pain score
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Analgesia
Läkemedels- och apparatinformation, studiedokument
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Studerar en amerikansk FDA-reglerad produktprodukt
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