Osteoarthritis, Knee/Rehabilitation
Conditions
Keywords
Nerve Block[MeSH Terms], Exercise[MeSH Terms], Ultrasound-guided infiltration, Genicular nerves
Brief summary
Osteoarthritis is a pathology with high prevalence in the world and is increasing due to sedentary lifestyles. Recent researches that claim for conservative treatment have shown the utility of genicular nerve blocks for relief of chronic knee pain. Likewise, the ultrasound-guided technique has been more popular among professionals in recent years due to its low cost and safety. This pilot study tries to evaluate if the infiltration of local anesthetic could avoid the use of corticosteroids with the secondary effects that they entail, therefore, it is carried out with the intention of estimating the size of the effect and the use of the variable response for later carrying out a clinical trial. For this, we propose the comparative analysis of three randomized groups of patients (n=90), where all of them will perform a quadriceps strengthening exercise at home. Moreover, we will assess the reduction of pain through the visual analog scale (VAS) after the genicular nerve block with ultrasound-guided infiltration. Group 1 (n=30) will be infiltrated with local anesthetic and steroid, group 2 (n=30) with local anesthetic and group 3 (n=30), as a control group, will receive physiological saline. We will also record demographic data, functionality and mood using validated scales.
Detailed description
Osteoarthritis affects approximately 302 million people worldwide, with the knee, hip, and hands being the most commonly affected areas. Knee osteoarthritis is highly prevalent and increasing in the region due to aging, obesity, and the progressive sedentary lifestyle of the population. According to recent epidemiological studies, it has a prevalence of 29.3% in the Spanish population. Currently, multiple treatment options are available, ranging from conservative measures to surgical procedures. Within conservative treatment, various tools benefit patients and may even avoid the need for surgery. These non-surgical options include patient education, weight control, physical exercise, orthotics, oral analgesics, topical anti-inflammatories, and interventional procedures. However, there are no prior studies demonstrating the advantages of one over another, and many do not follow up beyond three months. When conservative treatment is ineffective, surgical intervention is usually considered. Therapeutic options include knee arthroscopy, high tibial osteotomy, total knee replacement, and unicompartmental knee replacement in patients without lateral compartment disease. Traditionally, rest and caution in exercise were recommended for knee osteoarthritis pain. However, this paradigm has been strongly rejected. One of the current first-line treatments for knee osteoarthritis is physical exercise, with quadriceps strengthening being the most indicated. Most patients seek recommendations on what type of exercise to perform, including the duration, intensity, and frequency for better adherence. No exercise has been shown to be superior to another, with the most studied being yoga and tai chi exercises. Despite the well-documented benefits of exercise for this condition, one emerging procedure for pain management is the genicular nerve block. This treatment option can facilitate progress in the exercise program. It is also indicated for patients who have previously had successful genicular block, those who do not wish to undergo surgery, those not eligible for surgery, or even post-surgical patients for better pain control. The term "genicular nerves" refers to a group of nerves responsible for the sensory innervation of the knee joint capsule and the internal and external ligaments. The superior and inferior medial genicular nerves are sensory branches of the tibial nerve, whereas the superior and inferior lateral genicular nerves are branches of the common peroneal nerve. These nerves are named after the arteries they accompany, which are located using ultrasound during the procedure. Genicular nerve block is a simple technique that significantly reduces opioid consumption in patients undergoing total knee arthroplasty within the first 24 hours. It also provides temporary relief that allows progression in the rehabilitation program through a structured exercise regimen. This technique involves injecting medication into the genicular nerves, locating the genicular artery using Doppler ultrasound. Various cadaveric studies have investigated the anatomical distribution of the descending genicular artery and the nerves accompanying its branches. Some authors suggest that up to 10 points may need to be blocked for complete coverage. However, this is not feasible in routine clinical practice. Most studies target three sensory nerves of the knee: the superior lateral genicular nerve, the superior medial genicular nerve, and the inferior medial genicular nerve. In most studies, 2 to 3 ml of local anesthetic is administered per point. It has been shown that 0.5 ml of injected fluid spreads within the tissue over an area of 6 cm², likely covering more nerve targets with 2 ml. Typically, the procedure involves infiltrating local anesthetic (lidocaine, bupivacaine, ropivacaine, levobupivacaine) and 20 mg of corticosteroid (triamcinolone). In this study, bupivacaine is chosen as the local anesthetic, as it inhibits prostaglandin production by binding to the E2 receptor, providing an anti-inflammatory effect. It is a lipophilic amide-type anesthetic with 100% bioavailability and a longer duration than other local anesthetics. Additionally, it produces a more significant blockade of sensory and sympathetic nerve fibers than motor fibers, differentiating it from other local anesthetics. Recent guidelines for the treatment of knee osteoarthritis highlight the recommendation of intra-articular corticosteroid injections. However, several studies mention that systemic and local corticosteroid effects can cause adverse effects such as skin atrophy, hypertension, insulin resistance, decreased bone mineralization, and septic arthritis, among others. Nonetheless, these effects have not demonstrated a direct relationship with pain, functionality, or radiological changes. The clinical benefit of corticosteroid administration compared to local anesthesia alone remains unclear. Given the potential adverse effects, corticosteroids may not be suitable as adjuvants. Therefore, genicular nerve block using local anesthetic alone proves to be a promising technique, avoiding the use of corticosteroids and not being an intra-articular procedure. A study is proposed at a tertiary hospital in the Community of Madrid (Hospital Universitario Fundación Alcorcón). Considering the absence of previous studies that evaluate and quantify the three described treatment options, this study aims to address this objective through a pilot experimental randomized controlled trial. All patients will receive guidelines for an exercise program, and the outcomes of adding genicular nerve block with and without corticosteroid will be assessed. This unprecedented study could identify the optimal treatment for this prevalent and debilitating condition in a significant portion of the population. Additionally, it will help optimize resource allocation for these patients by identifying the best therapeutic target, thus avoiding unnecessary resource consumption
Interventions
\- GROUP 1:Genicular Nerve Block with Bupivacaine and Corticosteroids: 2.5 mL at three genicular nerve points. All injections are ultrasound-guided and administered once. The primary outcome is pain reduction, measured using NRS, KOOS, WOMAC, and KUJALA scales at 4, 12, and 24 weeks post-injection. Follow-up includes phone and in-person consultations to monitor pain, functionality, and adverse effects.
\- GROUP 2: Genicular Nerve Block with Bupivacaine: 2.5 mL at three genicular nerve points. All injections are ultrasound-guided and administered once. The primary outcome is pain reduction, measured using NRS, KOOS, WOMAC, and KUJALA scales at 4, 12, and 24 weeks post-injection. Follow-up includes phone and in-person consultations to monitor pain, functionality, and adverse effects.
\- GROUP 3: Genicular Nerve Block with Saline: 2.5 mL at three genicular nerve points. All injections are ultrasound-guided and administered once. The primary outcome is pain reduction, measured using NRS, KOOS, WOMAC, and KUJALA scales at 4, 12, and 24 weeks post-injection. Follow-up includes phone and in-person consultations to monitor pain, functionality, and adverse effects.
Sponsors
Hospital Universitario Fundación Alcorcón
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Concealed Random Assignment: Participants will be assigned to one of three treatment groups using a computer-generated sequence. Opaque, sequentially numbered envelopes with treatment assignments will be opened after patient inclusion. Blinding of Participants: Participants will not know the specific injection content (bupivacaine with or without corticosteroids, or saline). They will only know they are receiving one of the study interventions. Blinding of Investigators: Investigators for initial evaluation and follow-up will not administer treatments. Independent personnel will prepare and administer treatments without evaluating outcomes. Blind Evaluations: Pain and functionality (VAS, KOOS, WOMAC, KUJALA) will be assessed by blinded investigators. Follow-up consultations will be handled by personnel unaware of treatment details. Documentation and Verification: Secure treatment assignment records will be accessible only to the data and safety monitoring committee.
Intervention model description
Study Design Type of Study: Pilot randomized controlled experimental clinical trial. Number of Groups: Three parallel treatment arms. Intervention Groups: Group 1: Block with 0.5% bupivacaine and corticosteroid (triamcinolone). Group 2: Block with 0.5% bupivacaine. Group 3 (Control): Block with saline solution. Randomization Technique Description: Patient Position: Supine with knee extended. Ultrasound-Guided Localization: Use of ultrasound with Doppler to locate genicular nerves and associated arteries. Injection Points: Superior medial and lateral genicular nerves: Femoral condyle and junction with the femoral shaft. Inferior medial genicular nerve: Medial tibial-femoral joint line. Injection Doses: Group 1: 2.5 mL of 0.5% bupivacaine + 20 mg of triamcinolone. Group 2: 2.5 mL of 0.5% bupivacaine. Group 3: 2.5 mL of saline solution.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over 18 years * Anterior knee pain of patellofemoral origin and/or femorotibial compartment osteoarthritis with no previous response to pharmacological treatment (oral and/or topical) * Pain duration of 3 months * Pain assessment scale (Numerical Rating Scale) ≥ 5 * Radiological study with Kellgren-Lawrence classification \> 2
Exclusion criteria
* Allergy to the active ingredients and excipients of: bupivacaine, triamcinolone, or saline solution * Patients who have undergone total or unicompartmental knee replacement surgery * Viscosupplementation or intra-articular corticosteroid injection within the last 3 months * Pregnant women or those suspected of being pregnant * Cognitive impairment or additional neuropsychiatric symptoms * Failure to sign informed consent or revocation of it * Patients with heart disease requiring blockade with levobupivacaine * Inability to write, speak, or read in Spanish * Active tumoral or infectious pathology * Osteoarthritis secondary to inflammatory pathology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Pain | Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure | * Measurement Tool: Numeric Rating Scale (NRS) * Minimum Value: 0 * Maximum Value: 10 * Interpretation: Higher scores indicate worse pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Examination | Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure | Degrees of Knee Flexion and Extension \[Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure\] * Measurement Tool: Goniometer * Minimum Value: 0 degrees (full extension) * Maximum Value: 140 degrees (full flexion) * Interpretation: Higher values indicate greater knee flexion. Description: Physical examination to assess changes in the range of motion of the knee |
| Functionality Improvement | Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure | \- KOOS (Knee Injury and Osteoarthritis Outcome Score) \[Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure\] * Minimum Value: 0 * Maximum Value: 100 * Interpretation: Higher scores indicate better knee function. |
| Functionality improvement | Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure | \- WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index Score) * Minimum Value: 0 * Maximum Value: 96 * Interpretation: Lower scores indicate better knee function. |
| Mood Evaluation | Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure | EVEA (Emotional State Evaluation Scale) \[Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure\] * Minimum Value: 0 * Maximum Value: 100 * Interpretation: Higher scores indicate a worse emotional state |
| Demographic and clinical variables | Baseline | 2\. Sex \[Time Frame: Baseline\] o Measurement: Gender (Male/Female) |
| Demographic and Clinical Variables | Baseline | 1\. Age \[Time Frame: Baseline\] o Measurement: Age in years |
| Analgesic Medication Use | Through study completion, an average of 1 year | Description: Analysis of the reduction in the use of analgesic medications post-procedure |
| Incidence of Adverse Events | Through study completion, an average of 1 year | Monitoring and documentation of any adverse events to evaluate the safety of the interventions. |
Countries
Spain
Outcome results
None listed