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Knee OsteoarthritisRF-PROSPECTIUNCT07901374

Genicular Nerve Radiofrequency Ablation Versus Hyaluronic Acid Injection for Knee Osteoarthritis Pain

A study testing Thermal Radiofrequency Ablation of the Genicular Nerves and Intra-articular Hyaluronic Acid in people with Knee Osteoarthritis and Chronic Knee Pain, run by Hospital Universitari Joan XXIII de Tarragona. at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if thermal radiofrequency ablation of the genicular nerves (the nerves that carry pain signals from the knee) works better than a single injection of hyaluronic acid into the knee to relieve pain in adults with knee osteoarthritis who have not improved with conservative… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Knee Osteoarthritis, Chronic Knee Pain
What is being tested?
Thermal Radiofrequency Ablation of the Genicular Nerves and Intra-articular Hyaluronic Acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSpain
Study dates
Oct 2026to May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults (18 years or older) with symptomatic knee osteoarthritis of more than 6 months' duration.
  • Pain during movement >4 on a 0-10 visual analogue scale.
  • Failure of conservative treatment: pain during movement >4 despite at least 3 months of NSAIDs and/or rehabilitation (physical therapy), documented in the medical record. Patients with a documented contraindication to NSAIDs may be included if they have undergone rehabilitation.
  • Radiographic Kellgren-Lawrence grade II or III, or
  • Kellgren-Lawrence grade IV in patients who are not candidates for total knee arthroplasty because of at least one of the following: body mass index >39.9 kg/m2; Charlson Comorbidity Index >=5 (original, not age-adjusted); or a documented multidisciplinary decision of the Orthopaedic Surgery Department.
  • Signed informed consent.

Who cannot join

  • Acute or chronic knee joint infection.
  • Intra-articular hyaluronic acid or corticosteroid injection in the previous 6 months.
  • Coagulopathy or anticoagulant treatment that does not allow a safe therapeutic window for the procedure.
  • Major lower limb surgery in the previous 6 months that may affect function or pain of the index knee (including contralateral total or partial knee arthroplasty, hip arthroplasty, or tibial or femoral osteotomy).
  • Cardiac pacemaker or metallic implant (contraindication for radiofrequency).
  • Known allergy to hyaluronic acid.
Show all 13Show fewer
  • Severe dementia.
  • Institutionalized patients.
  • Decompensated systemic disease.
  • Active neurological or inflammatory rheumatological disease.
  • Terminal oncological disease.
  • Inability to understand the study questionnaires.
  • Radiofrequency arm only: negative diagnostic genicular nerve block (<50% pain reduction within 4 hours).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Laura Pallares Valls, MD contact

+34 646973140

laura-pallares@hotmail.com

Marta Sabater Martos, PhD contact

676625869

Sabaterms@gmail.com

Spain1 site
  • Hospital Universitari Joan XXIII de Tarragona

    Tarragona, Tarragona, 43005

    Laura Pallarès Valls, MD, +34 646973140, lpallares.hj23.ics@gencat.cat

Other trials in Spain

About this study

Official title: A Prospective Comparative Study of Conventional Conservative Treatment Versus Genicular Radiofrequency Ablation in Non-Surgical Knee Osteoarthritis: A Randomized Controlled Trial of Thermal Radiofrequency of the Genicular Nerves Versus Intra-Articular Hyaluronic Acid

The goal of this clinical trial is to learn if thermal radiofrequency ablation of the genicular nerves (the nerves that carry pain signals from the knee) works better than a single injection of hyaluronic acid into the knee to relieve pain in adults with knee osteoarthritis who have not improved with conservative treatment. The study also includes patients with severe knee osteoarthritis who are not candidates for knee replacement surgery.

The main questions it aims to answer are:

Read more
  • Does genicular nerve radiofrequency reduce knee pain during movement more than hyaluronic acid over 12 months?
  • Does it improve knee function and quality of life, and does its effect last longer?

Researchers will compare radiofrequency ablation with hyaluronic acid injection to see which treatment gives greater and longer-lasting pain relief.

Participants will:

  • Be randomly assigned to one of the two treatments.
  • If assigned to radiofrequency, first receive a diagnostic nerve block with local anesthetic. Only those whose pain decreases by at least 50% will then receive radiofrequency ablation, in a single ultrasound-guided session.
  • If assigned to hyaluronic acid, receive a single injection of hyaluronic acid into the knee.
  • Attend follow-up visits at 1, 3, 6 and 12 months, where they will rate their pain and answer questionnaires about knee function, overall status and quality of life.
Read the detailed description

Knee osteoarthritis is a leading cause of chronic pain and disability. Conventional conservative treatments, such as non-steroidal anti-inflammatory drugs and intra-articular hyaluronic acid, provide partial and time-limited relief. Thermal radiofrequency ablation of the genicular nerves is a minimally invasive technique that interrupts pain transmission from the knee joint. Most published studies have short follow-up (3-6 months), and evidence is scarce in patients with advanced osteoarthritis (Kellgren-Lawrence grade IV) who are not candidates for total knee arthroplasty because of severe comorbidity, morbid obesity or a documented multidisciplinary decision.

Design: single-center, randomized, parallel-group (1:1) controlled trial conducted at Hospital Universitari Joan XXIII de Tarragona (Spain). Patients and clinicians are not blinded; the outcome assessor and the statistician are blinded to treatment allocation.

Randomization: computer-generated sequence (sealedenvelope.com) with variable block sizes, stratified by Kellgren-Lawrence grade (II-III vs IV) and body mass index (<40 vs >=40 kg/m2).

Interventions: in the radiofrequency group, an ultrasound-guided diagnostic block of the superomedial, superolateral and inferomedial genicular nerves (1 ml of 1% lidocaine per nerve) is performed first. Patients with at least 50% pain reduction within 4 hours undergo ultrasound-guided thermal radiofrequency ablation of the same nerves (80 C for 90 seconds per nerve). Patients with a negative block do not receive radiofrequency, are withdrawn from the study and are reported in the CONSORT flow diagram. In the hyaluronic acid group, patients receive a single 6 ml intra-articular injection of high molecular weight hyaluronic acid (hylan G-F 20 or similar).

Sample size: 25 patients per group are required to detect a minimal clinically important difference of 2 points in the visual analogue scale (standard deviation 2.5, power 80%, two-sided alpha 0.05). Allowing for 20% losses over 12 months, 35 patients per group (70 in total) will be included.

A pre-specified subgroup analysis will compare treatment response in Kellgren-Lawrence grade II-III versus grade IV patients, and according to comorbidity (Charlson Comorbidity Index) and body mass index. Health-related quality of life data will be collected for a potential cost-effectiveness analysis.

Being tested
Thermal Radiofrequency Ablation of the Genicular Nerves, Intra-articular Hyaluronic Acid
Keywords
Genicular Nerve, Radiofrequency Ablation, Hyaluronic Acid, Viscosupplementation, Gonarthrosis, Kellgren-Lawrence Grade IV, Non-Surgical Candidates, Ultrasound-Guided
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thermal Radiofrequency Ablation of the Genicular NervesProcedure or surgery

    Ultrasound-guided thermal radiofrequency ablation (80 C, 90 seconds per nerve) of the superomedial, superolateral and inferomedial genicular nerves, performed only after a positive diagnostic block (>=50% pain reduction within 4 hours after 1 ml of 1% lidocaine per nerve).

  • Intra-articular Hyaluronic AcidDevice

    Single 6 ml intra-articular injection of high molecular weight hyaluronic acid into the index knee.

Study groups in NCT07901374
Study groupRoleWhat they receive
Genicular Nerve Radiofrequency AblationExperimentalUltrasound-guided diagnostic block of the superomedial, superolateral and inferomedial genicular nerves with 1 ml of 1% lidocaine per nerve. Participants with at least 50% pain reduction within 4 hours undergo ultrasound-guided thermal radiofrequency ablation of the same three nerves (80 C for 90 seconds per nerve) in a single session. Participants with a negative block do not receive radiofrequency and are withdrawn from the study.
Receives: Procedure: Thermal Radiofrequency Ablation of the Genicular Nerves
Intra-articular Hyaluronic AcidActive comparatorSingle intra-articular injection of 6 ml of high molecular weight hyaluronic acid (hylan G-F 20, Synvisc-One, or similar) into the index knee.
Receives: Device: Intra-articular Hyaluronic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Knee Pain During Movement (Visual Analogue Scale)

    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.

    Measured: Baseline, 1, 3, 6 and 12 months after the intervention

Secondary outcomes (11)
  1. Change in Knee Pain at Rest (Visual Analogue Scale)

    Pain 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.

    Measured: Baseline, 1, 3, 6 and 12 months after the intervention

  2. Change in Knee Function (WOMAC)

    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.

    Measured: Baseline, 1, 3, 6 and 12 months after the intervention

  3. Proportion of Participants Achieving the Minimal Clinically Important Difference in Pain

    Percentage of participants with a reduction of at least 2 points from baseline in pain during movement (visual analogue scale, 0-10).

    Measured: 1, 3, 6 and 12 months after the intervention

  4. Analgesic Consumption

    Number of days with analgesic use in the previous 4 weeks (0-28) and most potent analgesic used (none, paracetamol, NSAID, weak opioid, strong opioid).

    Measured: Baseline, 1, 3, 6 and 12 months after the intervention

  5. Number of Participants With Adverse Events

    Adverse events related to the diagnostic block, radiofrequency ablation or hyaluronic acid injection, systematically recorded at each visit.

    Measured: Up to 12 months after the intervention

  6. Retreatment or Rescue Treatment

    Proportion of participants requiring retreatment, rescue treatment (including corticosteroid injection) or indication of total knee arthroplasty, and time to first retreatment or rescue treatment.

    Measured: Up to 12 months after the intervention

  7. Health-Related Quality of Life (EQ-5D-5L)

    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).

    Measured: Baseline, 6 and 12 months after the intervention

  8. Rate of Negative Diagnostic Genicular Nerve Blocks

    Percentage 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.

    Measured: 4 hours after the diagnostic block

  9. Patient Global Assessment

    Patient 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.

    Measured: Baseline, 1, 3, 6 and 12 months after the intervention

  10. Patient Global Impression of Change (PGIC)

    Single 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".

    Measured: 1, 3, 6 and 12 months after the intervention

  11. Proportion of OMERACT-OARSI Responders

    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.

    Measured: 1, 3, 6 and 12 months after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized (1:1), parallel-group trial comparing ultrasound-guided thermal radiofrequency ablation of the genicular nerves (preceded by a diagnostic block) versus a single intra-articular injection of hyaluronic acid. Randomization is stratified by Kellgren-Lawrence grade (II-III vs IV) and body mass index (\<40 vs \>=40 kg/m2), using variable block sizes.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07901374
Sponsor's protocol ID
Ceim-116/2026
Other IDs
116/2026
Acronym
RF-PROSPECTIU
Status last verified
Oct 2026
First submitted
21 Oct 2026
Last updated
28 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared publicly, as participant consent for data sharing was not obtained and data are protected under the EU General Data Protection Regulation (GDPR). Data will be pseudonymized using participant codes and entered into REDCap, where the statistical analysis will be performed. Aggregated results will be published in peer-reviewed journals.

Questions about this trial

What is this clinical trial studying?

A study testing Thermal Radiofrequency Ablation of the Genicular Nerves and Intra-articular Hyaluronic Acid in people with Knee Osteoarthritis and Chronic Knee Pain, run by Hospital Universitari Joan XXIII de Tarragona. at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laura Pallares Valls, MD (+34 646973140, laura-pallares@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Knee Pain During Movement (Visual Analogue Scale) (time frame: Baseline, 1, 3, 6 and 12 months after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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