An interventional study of Radiofrequency ablation of peripheral nerves. in Chronic Post-surgical Pain, Chronic Post Operative Pain and Chronic Knee Pain, sponsored by Consorci Sanitari de l'Alt Penedès i Garraf. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Consorci Sanitari de l'Alt Penedès i Garraf · Not applicable, Interventional, and Treatment
Among 85 studies in Pain, Postoperative with a site in Spain — 17 open to participants now, 22 under way, 1 of them phase 3. Pain, Postoperative · Spain.
Among the 85 studies in Pain, Postoperative with a site in Spain, this one is the 31st largest by planned enrollment of the 59 interventional ones that give a count, is one of 10 that started in 2023, is one of 29 with no phase, reaches primary completion later than 20 of the 21 other live ones, and was the 57th registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
Browse Pain, Postoperative studies →17 of the 85 studies in Pain, Postoperative with a site in Spain are open now. Recruiting first, the newest first:
Universitat Internacional de Catalunya · Sites in Spain
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Sites in Spain
Fundacin Biomedica Galicia Sur · Sites in Spain
Hospital Central de la Defensa Gómez Ulla · Sites in Spain
Universitat Internacional de Catalunya · Sites in Spain
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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85 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 13 · Phase 4 14
First in 2001; this study’s year is marked. 10 started in 2023.
This study's planned enrollment of 86 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Median enrollment 93 across the 59 interventional studies, 106 across the 26 observational. Of the 54 that completed or were terminated, 8 (15%) have results posted.
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11 of 85 have an industry lead sponsor. The 10 most frequent:
Consorci Sanitari de l'Alt Penedès i Garraf is the lead sponsor of 41 studies on the registry; 18 are open to participants now.
Consorci Sanitari de l'Alt Penedès i Garraf has 1 study filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
4 of the studies in Pain, Postoperative with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07193472Hospital del Rio HortegaSerratus Intercostal Plane Block Versus Port Infiltration in Laparoscopic Cholecystectomy | 2026-12-31 |
| NCT06638437University Rovira i VirgiliPrevention of Postsurgical Chronic Pain in Children and Adolescents (PREVENDOL) | 2027-06-30 |
| NCT07377370Universitat Internacional de CatalunyaFactors Influencing Postoperative Pain After Gingival Graft Harvesting | 2027-07 |
| NCT05920382Consorci Sanitari de l'Alt Penedès i GarrafRadiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain. | 2027-09-01 |
Among the 85 studies in Pain, Postoperative with a site in Spain, from their registry updates:
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Knee osteoarthritis pain is one of the conditions commonly seen in general and specialized medicine. Knee arthroplasty is one of the most successful orthopedic surgeries for the treatment of this disease, significantly improving pain, disability, and the overall quality of life for patients who undergo it. However, there is a subgroup of individuals in whom the pain persists or even worsens. Radiofrequency has been introduced over 10 years ago as a neuroablative technique targeting the genicular nerves, which innervate the sensory terminals of the knee joint, for the treatment of chronic pain in that region before or after arthroplasty. However, the results have not been entirely consistent. Recent anatomical studies have demonstrated the presence of other sensory terminal branches of the femoral nerve, such as the infrapatellar branch of the saphenous nerve, medial vastus nerve, intermediate vastus nerve, and lateral vastus nerve, which could be useful targets for the treatment of post-knee arthroplasty pain. To date, no studies have been conducted to address post-knee arthroplasty pain through the application of thermal radiofrequency on the sensory branches of the knee from the femoral nerve (infrapatellar branch of the saphenous nerve, medial vastus nerve, intermediate vastus nerve, lateral vastus nerve). Therefore, The investigators aim to conduct a randomized double-blind clinical trial where The investigators will apply thermal radiofrequency on the sensory terminal branches of the femoral nerve in the knee, based on recent anatomical studies. The objective of the study is to determine if radiofrequency ablation of sensory nerves in the knee improves pain and disability in patients with post-knee arthroplasty chronic pain at the L'Alt Penedés-Garraf Health Consortium. Method: This is a randomized double-blind clinical trial with two arms. Two groups will be used, where one group will receive thermal radiofrequency of sensory nerves in the knee, and the other group will receive a placebo treatment. The hypothesis The investigators propose is that radiofrequency ablation will alleviate at least 50% of baseline pain and disability in at least 50% of the patients.
Degenerative knee osteoarthritis pain is one of the main reasons for consultation in general and specialized medicine. Its assessment and treatment impose a high cost on healthcare systems, accounting for 0.5% of Spain's gross domestic product. Given the magnitude of the disease and the disability it causes in affected individuals, multiple therapies have been proposed, ranging from pharmacological therapy with nonsteroidal anti-inflammatory drugs, opioids, antidepressants, capsaicin cream treatment, and physiotherapy, to intra-articular treatments with corticosteroids and viscosupplements like hyaluronic acid, platelet-rich plasma, etc. Knee arthroplasty is one of the most successful orthopedic surgeries in current medicine, significantly improving pain, disability, and the overall quality of life for patients who undergo it. However, postoperative pain following knee arthroplasty remains a challenging problem, with incidence rates of pain and disability after the procedure ranging from 48% to 34%, respectively, at 3 and 6 months post-surgery, with iatrogenic nerve injury being the most common cause. There are limited therapeutic alternatives available from this point onwards.
Since the first description of using radiofrequency for the treatment of intractable chronic pain, it has become not only a tool for pain management but also a cornerstone in pain units' treatment. The use of radiofrequency ablation for pain is based on the premise that the transmission of radiofrequency current near nociceptive pathways would interrupt the pain stimulus through the destruction of the nervous tissue. Thermal radiofrequency has been successfully used in the treatment of facetogenic low back pain, sacroiliac joint pain, and discogenic low back pain.
In the year 2011, the first study was conducted on radiofrequency of the sensory nerves of the knee, known as the genicular nerves, using femoral and tibial condyles as anatomical references and fluoroscopy as an imaging guide. Unfortunately, discrepancies in terminology and anatomical descriptions have led to confusion among interventional physicians. Other researchers have demonstrated discrepancies with the studies published in 2011, making it more difficult to standardize the technique of neuroablation of these nerves. More recently, other researchers demonstrated a specific anatomical-ultrasound correlation of sensory terminal branches of the femoral and sciatic nerves that innervate the knee. The involved nerves include the infrapatellar branch of the saphenous nerve, the nerve to the medial vastus muscle, the nerve to the intermediate vastus muscle, the nerve to the lateral vastus muscle, the anterior branch of the obturator nerve, the recurrent peroneal nerve, and the lateral retinacular nerve.
Study justification:
Post-knee arthroplasty pain remains an unresolved problem, with various techniques applied to different anatomical targets yielding inconsistent results. To date, no studies have addressed post-knee arthroplasty pain through the application of thermal radiofrequency on sensory branches of the femoral nerve, namely the infrapatellar branch of the saphenous nerve, nerve to the medial vastus muscle, nerve to the intermediate vastus muscle, and nerve to the lateral vastus muscle guided by ultrasound.
Therefore, The investigators propose to conduct a randomized double-blind clinical trial where The investigators will apply thermal radiofrequency on the sensory terminal branches of the knee from the femoral nerve, including the medial vastus nerve, lateral vastus nerve, intermediate vastus nerve, and infrapatellar branch of the saphenous nerve.
Hypothesis:
Patients who receive radiofrequency ablation would experience a percentage reduction of at least 50% in baseline pain and disability at 3 months, which The investigators consider a clinically significant effect.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After identifying the nerves to be treated via ultrasound and confirming with neurostimulation, 1 ml of 2% lidocaine will be administered, followed by radiofrequency ablation. The physical parameters used are as follows: 90 seconds, 80 degrees Celsius, with a 22g needle with an active tip of 10 mm.
Procedure: Radiofrequency ablation of peripheral nerves.
In the same manner as with the RF group, the nerves to be treated are identified via ultrasound and confirmed by neurostimulation. Subsequently, sham radiofrequency is performed for 90 seconds.
Procedure: Radiofrequency ablation of peripheral nerves.
Randomized double-blind clinical trial where we will apply thermal radiofrequency to the sensory terminal branches of the femoral nerve in the knee, including the vasto medial nerve, vasto lateral nerve, vasto intermedio nerves, and the infrapatellar branch of the saphenous nerve.
Also known as: Radiofrecuency arm, Sham arm
Change Pain and Disability measured by Western Ontario and McMaster Universities Arthritis Index, (WOMAC).
Determine if radiofrequency ablation of the medial vastus nerve, infrapatellar branch of the saphenous nerve, intermediate vastus nerve, and lateral vastus nerve improves pain and disability at 3 months compared to baseline, as measured by WOMAC questionnaire, in patients with post-knee arthroplasty pain, compared to patients treated with placebo. The WOMAC test consists of several questions that address different aspects related to pain and functionality of the affected joint. These questions are divided into three main domains: Pain, Stiffness, Physical function The change in test scores will be evaluated throughout the study period, comparing them to the baseline.
Time frame: 3 month
Changes in pain measured by the Numeric Rating Scale for pain. (NRS)
Determine whether radiofrequency ablation of the sensory nerves in the knee under study improves pain at 3 months compared to baseline in patients with post-knee arthroplasty pain, compared to patients treated with placebo. It consists of a straight line or a series of numbers from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain imaginable." The change in test scores will be evaluated throughout the study period, comparing them to the baseline.
Time frame: 3 month
Neuropathic pain measured by Neuropathic Pain questionnaire (DN4)
Determine if radiofrequency ablation of the studied knee sensory nerves improves pain at 3 months compared to baseline in patients with neuropathic pain following knee arthroplasty, compared to patients treated with placebo.
Time frame: 3 month
Depression and anxiety measured by Hospital Anxiety and Depression Scale (HADS)
Measure levels of depression and anxiety in patients undergoing radiofrequency ablation and study their influence on the response to radiofrequency therapy of the studied knee sensory nerves. The scores on the HADS are interpreted as follows: Anxiety: 0-7: Normal (no clinically significant anxiety) 8-10: Mild anxiety 11-14: Moderate anxiety 15-21: Severe anxiety Depression: 0-7: Normal (no clinically significant depression) 8-10: Mild depression 11-14: Moderate depression 15-21: Severe depression
Time frame: 3 month
Degree of satisfaction with the procedure performed measured by categorical satisfaction scale of our hospital's pain unit.
Compare the level of satisfaction among patients undergoing radiofrequency ablation of the knee sensory nerves for the treatment of chronic post-knee arthroplasty pain. Not satisfied: The treatment provided no relief and worsened my pain. Slightly satisfied: The treatment had minimal results and my pain barely improved. Moderately satisfied: The treatment had moderate results and my pain improved to some extent. Quite satisfied: The treatment was effective and my pain improved significantly. Very satisfied: The treatment was highly effective and my pain completely disappeared.
Time frame: 3 month
Safety from the applied treatment measured by number of adverse events associated with the technique.
Determine the safety of radiofrequency ablation of the knee sensory nerves in terms of the number of adverse events associated with the technique.
Time frame: 3 month
Duration (YEARS) of pain and treatment outcomes measured by Numeric Rating Scale for pain.
Assess if the time measured in years since the last knee arthroplasty is related to the outcomes of the applied therapy, such as the 50% reduction in pain and disability measured by the visual numeric pain scale.
Time frame: 3 month
Duration (YEARS) of pain and treatment outcomes measured by WOMAC questionnaire.
Assess if the time measured in years since the last knee arthroplasty is related to the outcomes of the applied therapy, such as the 50% reduction in pain and disability measured by WOMAC questionnaire
Time frame: 3 month
Started Sep 2023 (actual). Primary completion is estimated for Sep 2027, 47 months after the start.
Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 47 months is above that.
Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 30, 2026: primary completion Sep 2026 → Sep 2027 and completion Dec 2027 → Dec 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Consorci Sanitari de l'Alt Penedès i Garraf