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Trial · NCT07901374

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Knee Pain During Movement (Visual Analogue Scale)Baseline, 1, 3, 6 and 12 months after the intervention
Pain during movement (walking or climbing stairs) in the index knee, measured on a 100 mm visual analogue scale and recorded in cm with one decimal (0 = no pain, 10 = worst imaginable pain). Higher scores indicate worse pain.
SecondaryChange in Knee Pain at Rest (Visual Analogue Scale)Baseline, 1, 3, 6 and 12 months after the interventionPain at rest in the index knee, measured on a 100 mm visual analogue scale and recorded in cm with one decimal (0 = no pain, 10 = worst imaginable pain). Higher scores indicate worse pain.
SecondaryChange in Knee Function (WOMAC)Baseline, 1, 3, 6 and 12 months after the intervention
Western Ontario and McMaster Universities Osteoarthritis Index (Likert 3.1). Total score 0-96 and subscales for pain (0-20), stiffness (0-8) and physical function (0-68). Higher scores indicate worse symptoms and function.
SecondaryProportion of Participants Achieving the Minimal Clinically Important Difference in Pain1, 3, 6 and 12 months after the interventionPercentage of participants with a reduction of at least 2 points from baseline in pain during movement (visual analogue scale, 0-10).
SecondaryAnalgesic ConsumptionBaseline, 1, 3, 6 and 12 months after the interventionNumber of days with analgesic use in the previous 4 weeks (0-28) and most potent analgesic used (none, paracetamol, NSAID, weak opioid, strong opioid).
SecondaryNumber of Participants With Adverse EventsUp to 12 months after the interventionAdverse events related to the diagnostic block, radiofrequency ablation or hyaluronic acid injection, systematically recorded at each visit.
SecondaryRetreatment or Rescue TreatmentUp to 12 months after the interventionProportion of participants requiring retreatment, rescue treatment (including corticosteroid injection) or indication of total knee arthroplasty, and time to first retreatment or rescue treatment.
SecondaryHealth-Related Quality of Life (EQ-5D-5L)Baseline, 6 and 12 months after the intervention
EQ-5D-5L descriptive system (5 dimensions, 5 levels; utility index calculated with the Spanish value set, where 1 = full health and higher values indicate better health) and EQ-VAS (0-100, higher scores indicate better health).
SecondaryRate of Negative Diagnostic Genicular Nerve Blocks4 hours after the diagnostic blockPercentage of participants allocated to the radiofrequency arm with less than 50% pain reduction within 4 hours after the diagnostic block, who therefore do not receive radiofrequency ablation.
SecondaryPatient Global AssessmentBaseline, 1, 3, 6 and 12 months after the interventionPatient global assessment of the impact of knee osteoarthritis, measured on a 100 mm visual analogue scale (0 = very well, 100 = very poor). Higher scores indicate worse status.
SecondaryPatient Global Impression of Change (PGIC)1, 3, 6 and 12 months after the interventionSingle 7-point item from "very much better" to "very much worse" compared with before the study treatment. Responders are participants reporting "much better" or "very much better".
SecondaryProportion of OMERACT-OARSI Responders1, 3, 6 and 12 months after the intervention
Responder according to OMERACT-OARSI criteria, based on pain during movement, WOMAC physical function and patient global assessment, each expressed on a 0-100 scale: improvement in pain or function \>=50% and \>=20 points, or improvement \>=20% and \>=10 points in at least two of the three domains.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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