Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorConsorci Sanitari de l'Alt Penedès i Garraf
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Radiofrequency ablation of peripheral nerves.
Procedure/SurgeryRandomized 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.
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: Radiofrequency armExperimental treatment 1 intervention
Group B: Control armSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 monthSecondary outcomes
1
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 month2
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 month3
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 month4
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 monthSponsors and contacts
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Source ClinicalTrials.gov