Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.

Chronic Knee Pain Clinical Trial

— CSAPG-37  

Official title:

Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain. A Randomized Double-blind Study. A Novel Approach.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05920382
• Other study ID #: CSAPG-37
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2023
• Est. completion date: December 1, 2027

Study information

• Verified date: March 2024
• Source: Consorci Sanitari de l'Alt Penedès i Garraf
• Contact: ITALO G PISANI, MD
• Phone: +34649034623
• Email: italopisani1976[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 1, 2027
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals who have undergone knee arthroplasty.
• Chronic knee pain post-knee arthroplasty for at least 6 months after the procedure and less than 5 years.
• Pain intensity on the numerical visual scale = 5 out of 10 points.
• Stable pain for the last 30 days.
• The knee is the location with the highest intensity of pain, in the case of patients with multiple joint pains.

Exclusion Criteria:

• Acute knee pain.
• Psychiatric illness or dementia that may interfere with or hinder study assessments.
• Diagnosis of fibromyalgia, chronic fatigue syndrome, or central sensitization syndrome.
• Knee infiltration with corticosteroids in the past 30 days.
• Changes in oral analgesic medication in the past 30 days.

Related Conditions & MeSH terms

• Chronic Knee Pain
• Chronic Pain
• Chronic Post-surgical Pain
• Pain, Postoperative

Intervention

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.

Locations

Country	Name	City	State
Spain	Consorci Sanitari Alt'Pènedes i Garraf	Barcelona	Cataluña

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari de l'Alt Penedès i Garraf

Country where clinical trial is conducted

Spain, 

References & Publications (14)

Breivik EK, Bjornsson GA, Skovlund E. A comparison of pain rating scales by sampling from clinical trial data. Clin J Pain. 2000 Mar;16(1):22-8. doi: 10.1097/00002508-200003000-00005. — View Citation

Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6. — View Citation

Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4 — View Citation

Franco CD, Buvanendran A, Petersohn JD, Menzies RD, Menzies LP. Innervation of the Anterior Capsule of the Human Knee: Implications for Radiofrequency Ablation. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):363-8. doi: 10.1097/AAP.0000000000000269. — View Citation

Fuzier R, Rousset J, Bataille B, Salces-y-Nedeo A, Magues JP. One half of patients reports persistent pain three months after orthopaedic surgery. Anaesth Crit Care Pain Med. 2015 Jun;34(3):159-64. doi: 10.1016/j.accpm.2014.09.006. Epub 2015 May 23. — View Citation

Garcia Campayo J, Rodero B, Alda M, Sobradiel N, Montero J, Moreno S. [Validation of the Spanish version of the Pain Catastrophizing Scale in fibromyalgia]. Med Clin (Barc). 2008 Oct 18;131(13):487-92. doi: 10.1157/13127277. Spanish. — View Citation

Herrero MJ, Blanch J, Peri JM, De Pablo J, Pintor L, Bulbena A. A validation study of the hospital anxiety and depression scale (HADS) in a Spanish population. Gen Hosp Psychiatry. 2003 Jul-Aug;25(4):277-83. doi: 10.1016/s0163-8343(03)00043-4. — View Citation

Leggett LE, Soril LJ, Lorenzetti DL, Noseworthy T, Steadman R, Tiwana S, Clement F. Radiofrequency ablation for chronic low back pain: a systematic review of randomized controlled trials. Pain Res Manag. 2014 Sep-Oct;19(5):e146-53. doi: 10.1155/2014/83436 — View Citation

Lopez Alonso SR, Martinez Sanchez CM, Romero Canadillas AB, Navarro Casado F, Gonzalez Rojo J. [Metric properties of WOMAC questionnaires-original and reduced versions-to measure symptoms and Physical Functional Disability]. Aten Primaria. 2009 Nov;41(11) — View Citation

Loza E, Lopez-Gomez JM, Abasolo L, Maese J, Carmona L, Batlle-Gualda E; Artrocad Study Group. Economic burden of knee and hip osteoarthritis in Spain. Arthritis Rheum. 2009 Feb 15;61(2):158-65. doi: 10.1002/art.24214. — View Citation

Orduna Valls JM, Vallejo R, Lopez Pais P, Soto E, Torres Rodriguez D, Cedeno DL, Tornero Tornero C, Quintans Rodriguez M, Baluja Gonzalez A, Alvarez Escudero J. Anatomic and Ultrasonographic Evaluation of the Knee Sensory Innervation: A Cadaveric Study to — View Citation

Perez C, Galvez R, Huelbes S, Insausti J, Bouhassira D, Diaz S, Rejas J. Validity and reliability of the Spanish version of the DN4 (Douleur Neuropathique 4 questions) questionnaire for differential diagnosis of pain syndromes associated to a neuropathic — View Citation

Phillips JR, Hopwood B, Arthur C, Stroud R, Toms AD. The natural history of pain and neuropathic pain after knee replacement: a prospective cohort study of the point prevalence of pain and neuropathic pain to a minimum three-year follow-up. Bone Joint J. — View Citation

Richards MM, Maxwell JS, Weng L, Angelos MG, Golzarian J. Intra-articular treatment of knee osteoarthritis: from anti-inflammatories to products of regenerative medicine. Phys Sportsmed. 2016;44(2):101-8. doi: 10.1080/00913847.2016.1168272. Epub 2016 Apr — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 month
Secondary	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.	3 month
Secondary	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.	3 month
Secondary	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	3 month
Secondary	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.	3 month
Secondary	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.	3 month
Secondary	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.	3 month
Secondary	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	3 month