Osteoarthritis, Knee/RehabilitationNCT06619080
Ecoguided Genicular Nerve Block
A study testing Genicular nerve block with bupivacaine and corticosteroids, Genicular nerve block with bupivacaine and Genicular nerve block with saline in people with Osteoarthritis, Knee/Rehabilitation, run by Hospital Universitario Fundación Alcorcón at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee/Rehabilitation
- What is being tested?
- Genicular nerve block with bupivacaine and corticosteroids, Genicular nerve block with bupivacaine and Genicular nerve block with saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteSpain
- Study dates
- 26 Apr 2023to 2 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ecoguided Genicular Nerve Block in Patients With Knee Osteoarthritis by Local Anesthetic or by Combination of Local Anesthetic and Corticoid: Placebo-Controlled Randomized Blind Clinical Trial
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.
Read more
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.
Read the 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
- Conditions
- Osteoarthritis, Knee/Rehabilitation
- Being tested
- Genicular nerve block with bupivacaine and corticosteroids, Genicular nerve block with bupivacaine, Genicular nerve block with saline
- Keywords
- "Nerve Block"[MeSH Terms], "Exercise"[MeSH Terms], Ultrasound-guided infiltration, Genicular nerves
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genicular nerve block with bupivacaine and corticosteroidsDrug
- 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.
Genicular nerve block with bupivacaineDrug
- 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.
Genicular nerve block with salineDrug
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Block with 0.5% bupivacaine and corticosteroid (triamcinolone). | Active comparator | Injection Doses: 2.5 mL of 0.5% bupivacaine + 20 mg of triamcinolone. Receives: Drug: Genicular nerve block with bupivacaine and corticosteroids |
| Group 2: Block with 0.5% bupivacaine. | Active comparator | Injection Doses: 2.5 mL of 0.5% bupivacaine. Receives: Drug: Genicular nerve block with bupivacaine |
| Group 3 (Control): Block with saline solution. | Placebo comparator | Injection Doses: 2.5 mL of saline solution. Receives: Drug: Genicular nerve block with saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Pain
- Measurement Tool: Numeric Rating Scale (NRS)
- Minimum Value: 0
- Maximum Value: 10
- Interpretation: Higher scores indicate worse pain.
Measured: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure
Secondary outcomes (18)
Mood Evaluation
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
Measured: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure
Physical Examination
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
Measured: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure
Functionality Improvement
- 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.
Measured: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure
Functionality improvement
- WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index Score)
- Minimum Value: 0
- Maximum Value: 96
- Interpretation: Lower scores indicate better knee function.
Measured: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure
Functionality Improvement
KUJALA Scale:
- Minimum Value: 0
- Maximum Value: 100
- Interpretation: Higher scores indicate better knee function
Measured: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure
Incidence of Adverse Events
Monitoring and documentation of any adverse events to evaluate the safety of the interventions.
Measured: Through study completion, an average of 1 year
Demographic and clinical variables
- Sex [Time Frame: Baseline]
- Measurement: Gender (Male/Female)
Measured: Baseline
Demographic and Clinical Variables
- Age [Time Frame: Baseline]
- Measurement: Age in years
Measured: Baseline
Demographic and clinical variables
- Hypertension [Time Frame: Baseline]
- Measurement: Presence of hypertension (Yes/No)
Measured: Baseline
Demographic and clinical variables
Diabetes Mellitus [Time Frame: Baseline]
- Measurement: Presence of diabetes mellitus (Yes/No)
Measured: Baseline
Demographic and clinical variables
Body Mass Index (BMI) [Time Frame: Baseline]
- Measurement: BMI in kg/m²
- Minimum Value: Variable
- Maximum Value: Variable
- Interpretation: Higher values indicate higher body weight relative to height.
Measured: Baseline
Demographic and clinical variables
Anticoagulation Status [Time Frame: Baseline]
- Measurement: Use of anticoagulants (Yes/No)
Measured: Baseline
Demographic and clinical variables
Laterality (Left or Right Knee) [Time Frame: Baseline]
- Measurement: Knee affected (Left/Right)
Measured: Baseline
Demographic and clinical variables
Duration of Symptoms [Time Frame: Baseline]
- Measurement: Duration of knee pain in months
Measured: Baseline
Demographic and clinical variables
Previous Intra-Articular Injections [Time Frame: Baseline]
- Measurement: History of previous injections (Yes/No)
Measured: Baseline
Analgesic Medication Use
Description: Analysis of the reduction in the use of analgesic medications post-procedure
Measured: Through study completion, an average of 1 year
Demographic and clinical variables
- Use of Assistive Walking Devices Measurement: Yes/No
Measured: Baseline
Analgesic Medication Use
- Measurement: Type of analgesic medication consumed
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start26 Apr 2023
- Primary completion2 Jan 2024
- Study completion2 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (57)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, Knee/RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Fundación Alcorcón
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia de la Fuente Escudero, Hospital Universitario Fundación Alcorcón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619080
- Sponsor's protocol ID
- 22/149
- Other IDs
- 2022-003885-19
- Status last verified
- Sep 2024
- First submitted
- 30 Aug 2024
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan Description: Individual participant data (IPD) collected in this study will not be shared. The reasons for this decision include: * Privacy Concerns: Protecting participant confidentiality is paramount. Sharing IPD could potentially compromise participant privacy * Proprietary Information: The data collected includes proprietary information that cannot be disclosed due to legal or contractual reasons * Data Quality and Integrity: To maintain the accuracy and integrity of the data, sharing IPD might lead to misuse or misinterpretation * Institutional Policies: Institutional policies restrict the sharing of data to comply with ethical and regulatory standards * Resource Limitations: The study team lacks the resources to manage and facilitate IPD sharing effectively Access Criteria: As IPD will not be shared, there are no access criteria.
Publications
Luan L, El-Ansary D, Adams R, Wu S, Han J. Knee osteoarthritis pain and stretching exercises: a systematic review and meta-analysis. Physiotherapy. 2022 Mar;114:16-29. doi: 10.1016/j.physio.2021.10.001. Epub 2021 Oct 11.
PubMed 35091326Marriott KA, Hall M, Maciukiewicz JM, Almaw RD, Wiebenga EG, Ivanochko NK, Rinaldi D, Tung EV, Bennell KL, Maly MR. Are the Effects of Resistance Exercise on Pain and Function in Knee and Hip Osteoarthritis Dependent on Exercise Volume, Duration, and Adherence? A Systematic Review and Meta-Analysis. Arthritis Care Res (Hoboken). 2024 Jun;76(6):821-830. doi: 10.1002/acr.25313. Epub 2024 Apr 15.
PubMed 38317328Messier SP, Mihalko SL, Beavers DP, Nicklas BJ, DeVita P, Carr JJ, Hunter DJ, Lyles M, Guermazi A, Bennell KL, Loeser RF. Effect of High-Intensity Strength Training on Knee Pain and Knee Joint Compressive Forces Among Adults With Knee Osteoarthritis: The START Randomized Clinical Trial. JAMA. 2021 Feb 16;325(7):646-657. doi: 10.1001/jama.2021.0411.
PubMed 33591346Mo L, Jiang B, Mei T, Zhou D. Exercise Therapy for Knee Osteoarthritis: A Systematic Review and Network Meta-analysis. Orthop J Sports Med. 2023 Jun 5;11(5):23259671231172773. doi: 10.1177/23259671231172773. eCollection 2023 May.
PubMed 37346776Patterson BE, Girdwood MA, West TJ, Bruder AM, Oiestad BE, Juhl C, Culvenor AG. Muscle strength and osteoarthritis of the knee: a systematic review and meta-analysis of longitudinal studies. Skeletal Radiol. 2023 Nov;52(11):2085-2097. doi: 10.1007/s00256-022-04266-4. Epub 2022 Dec 23.
PubMed 36562820Puts S, Liberman K, Leysen L, Forti L, Muyldermans E, Vaes P, Nijs J, Beckwee D, Bautmans I. Exercise-induced effects on inflammatory markers and brain-derived neurotrophic factor in patients with knee osteoarthritis. A systematic review with meta-analysis. Exerc Immunol Rev. 2023;29:22-53.
PubMed 37358362Raposo F, Ramos M, Lucia Cruz A. Effects of exercise on knee osteoarthritis: A systematic review. Musculoskeletal Care. 2021 Dec;19(4):399-435. doi: 10.1002/msc.1538. Epub 2021 Mar 5.
PubMed 33666347Reichenbach S, Juni P, Hincapie CA, Schneider C, Meli DN, Schurch R, Streit S, Lucas C, Mebes C, Rutjes AWS, da Costa BR. Effect of transcutaneous electrical nerve stimulation (TENS) on knee pain and physical function in patients with symptomatic knee osteoarthritis: the ETRELKA randomized clinical trial. Osteoarthritis Cartilage. 2022 Mar;30(3):426-435. doi: 10.1016/j.joca.2021.10.015. Epub 2021 Nov 23.
PubMed 34826572Rezasoltani Z, Azizi S, Najafi S, Sanati E, Dadarkhah A, Abdorrazaghi F. Physical therapy, intra-articular dextrose prolotherapy, botulinum neurotoxin, and hyaluronic acid for knee osteoarthritis: randomized clinical trial. Int J Rehabil Res. 2020 Sep;43(3):219-227. doi: 10.1097/MRR.0000000000000411.
PubMed 32776763Rocha TC, Ramos PDS, Dias AG, Martins EA. The Effects of Physical Exercise on Pain Management in Patients with Knee Osteoarthritis: A Systematic Review with Metanalysis. Rev Bras Ortop (Sao Paulo). 2020 Oct;55(5):509-517. doi: 10.1055/s-0039-1696681. Epub 2019 Sep 23.
PubMed 33093712Santos ACG, Caiado VDS, Moreira-Marconi E, Teixeira-Silva Y, De Meirelles AG, Seixas A, Lacerda ACR, Sonza A, Mendonca VA, Bernardo-Filho M, De Sa-Caputo DDC. The Influence of Physical Exercises on the Flexibility of Older Individuals with Knee Osteoarthritis: A Systematic Review. Iran J Public Health. 2024 Feb;53(2):255-267. doi: 10.18502/ijph.v53i2.14911.
PubMed 38894836Si J, Sun L, Li Z, Zhu W, Yin W, Peng L. Effectiveness of home-based exercise interventions on pain, physical function and quality of life in individuals with knee osteoarthritis: a systematic review and meta-analysis. J Orthop Surg Res. 2023 Jul 17;18(1):503. doi: 10.1186/s13018-023-04004-z.
PubMed 37461112Sinatti P, Sanchez Romero EA, Martinez-Pozas O, Villafane JH. Effects of Patient Education on Pain and Function and Its Impact on Conservative Treatment in Elderly Patients with Pain Related to Hip and Knee Osteoarthritis: A Systematic Review. Int J Environ Res Public Health. 2022 May 19;19(10):6194. doi: 10.3390/ijerph19106194.
PubMed 35627729Smith KM, Massey BJ, Young JL, Rhon DI. What are the unsupervised exercise adherence rates in clinical trials for knee osteoarthritis? A systematic review. Braz J Phys Ther. 2023 Jul-Aug;27(4):100533. doi: 10.1016/j.bjpt.2023.100533. Epub 2023 Aug 12.
PubMed 37597491Weng Q, Goh SL, Wu J, Persson MSM, Wei J, Sarmanova A, Li X, Hall M, Doherty M, Jiang T, Zeng C, Lei G, Zhang W. Comparative efficacy of exercise therapy and oral non-steroidal anti-inflammatory drugs and paracetamol for knee or hip osteoarthritis: a network meta-analysis of randomised controlled trials. Br J Sports Med. 2023 Aug;57(15):990-996. doi: 10.1136/bjsports-2022-105898. Epub 2023 Jan 2.
PubMed 36593092
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ecoguided Genicular Nerve Block in Patients With Knee Osteoarthritis by Local Anesthetic or by Combination of Local Anesthetic and Corticoid: Placebo-Controlled Randomized Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06619080
- Acronym / sponsor ID
- 22/149
- Conditions
- Osteoarthritis, Knee/Rehabilitation
- Keywords
- "Nerve Block"[MeSH Terms], "Exercise"[MeSH Terms], Ultrasound-guided infiltration, Genicular nerves
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hospital Universitario Fundación AlcorcónUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Nov 2024 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Block with 0.5% bupivacaine and corticosteroid (triamcinolone). | Active comparator | Drug: Genicular nerve block with bupivacaine and corticosteroidsInjection Doses: 2.5 mL of 0.5% bupivacaine + 20 mg of triamcinolone. |
| Group 2: Block with 0.5% bupivacaine. | Active comparator | Drug: Genicular nerve block with bupivacaineInjection Doses: 2.5 mL of 0.5% bupivacaine. |
| Group 3 (Control): Block with saline solution. | Placebo comparator | Drug: Genicular nerve block with salineInjection Doses: 2.5 mL of saline solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genicular nerve block with bupivacaine and corticosteroids- 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. | Drug | Group 1: Block with 0.5% bupivacaine and corticosteroid (triamcinolone). |
| Genicular nerve block with bupivacaine- 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. | Drug | Group 2: Block with 0.5% bupivacaine. |
| Genicular nerve block with saline- 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. | Drug | Group 3 (Control): Block with saline solution. |
Primary outcome
Reduction in Pain
Time frame: 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.
18 secondary outcomes
Mood Evaluation
Time frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure
Physical Examination
Time frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure
Functionality Improvement
Time frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure
Functionality improvement
Time frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure
Functionality Improvement
Time frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure
Incidence of Adverse Events
Time frame: Through study completion, an average of 1 year
Demographic and clinical variables
Time frame: Baseline
Demographic and Clinical Variables
Time frame: Baseline
Demographic and clinical variables
Time frame: Baseline
Demographic and clinical variables
Time frame: Baseline
Demographic and clinical variables
Time frame: Baseline
Demographic and clinical variables
Time frame: Baseline
Demographic and clinical variables
Time frame: Baseline
Demographic and clinical variables
Time frame: Baseline
Demographic and clinical variables
Time frame: Baseline
Analgesic Medication Use
Time frame: Through study completion, an average of 1 year
Demographic and clinical variables
Time frame: Baseline
Analgesic Medication Use
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Results publication: PubMed 35091326Luan L, El-Ansary D, Adams R, Wu S, Han J. Knee osteoarthritis pain and stretching exercises: a systematic review and meta-analysis. Physiotherapy. 2022 Mar;114:16-29. doi: 10.1016/j.physio.2021.10.001. Epub 2021 Oct 11.
- Results publication: PubMed 38317328Marriott KA, Hall M, Maciukiewicz JM, Almaw RD, Wiebenga EG, Ivanochko NK, Rinaldi D, Tung EV, Bennell KL, Maly MR. Are the Effects of Resistance Exercise on Pain and Function in Knee and Hip Osteoarthritis Dependent on Exercise Volume, Duration, and Adherence? A Systematic Review and Meta-Analysis. Arthritis Care Res (Hoboken). 2024 Jun;76(6):821-830. doi: 10.1002/acr.25313. Epub 2024 Apr 15.
- Results publication: PubMed 33591346Messier SP, Mihalko SL, Beavers DP, Nicklas BJ, DeVita P, Carr JJ, Hunter DJ, Lyles M, Guermazi A, Bennell KL, Loeser RF. Effect of High-Intensity Strength Training on Knee Pain and Knee Joint Compressive Forces Among Adults With Knee Osteoarthritis: The START Randomized Clinical Trial. JAMA. 2021 Feb 16;325(7):646-657. doi: 10.1001/jama.2021.0411.
- Results publication: PubMed 37346776Mo L, Jiang B, Mei T, Zhou D. Exercise Therapy for Knee Osteoarthritis: A Systematic Review and Network Meta-analysis. Orthop J Sports Med. 2023 Jun 5;11(5):23259671231172773. doi: 10.1177/23259671231172773. eCollection 2023 May.
- Results publication: PubMed 36562820Patterson BE, Girdwood MA, West TJ, Bruder AM, Oiestad BE, Juhl C, Culvenor AG. Muscle strength and osteoarthritis of the knee: a systematic review and meta-analysis of longitudinal studies. Skeletal Radiol. 2023 Nov;52(11):2085-2097. doi: 10.1007/s00256-022-04266-4. Epub 2022 Dec 23.
- Results publication: PubMed 37358362Puts S, Liberman K, Leysen L, Forti L, Muyldermans E, Vaes P, Nijs J, Beckwee D, Bautmans I. Exercise-induced effects on inflammatory markers and brain-derived neurotrophic factor in patients with knee osteoarthritis. A systematic review with meta-analysis. Exerc Immunol Rev. 2023;29:22-53.
- Results publication: PubMed 33666347Raposo F, Ramos M, Lucia Cruz A. Effects of exercise on knee osteoarthritis: A systematic review. Musculoskeletal Care. 2021 Dec;19(4):399-435. doi: 10.1002/msc.1538. Epub 2021 Mar 5.
- Results publication: PubMed 34826572Reichenbach S, Juni P, Hincapie CA, Schneider C, Meli DN, Schurch R, Streit S, Lucas C, Mebes C, Rutjes AWS, da Costa BR. Effect of transcutaneous electrical nerve stimulation (TENS) on knee pain and physical function in patients with symptomatic knee osteoarthritis: the ETRELKA randomized clinical trial. Osteoarthritis Cartilage. 2022 Mar;30(3):426-435. doi: 10.1016/j.joca.2021.10.015. Epub 2021 Nov 23.
- Results publication: PubMed 32776763Rezasoltani Z, Azizi S, Najafi S, Sanati E, Dadarkhah A, Abdorrazaghi F. Physical therapy, intra-articular dextrose prolotherapy, botulinum neurotoxin, and hyaluronic acid for knee osteoarthritis: randomized clinical trial. Int J Rehabil Res. 2020 Sep;43(3):219-227. doi: 10.1097/MRR.0000000000000411.
- Results publication: PubMed 33093712Rocha TC, Ramos PDS, Dias AG, Martins EA. The Effects of Physical Exercise on Pain Management in Patients with Knee Osteoarthritis: A Systematic Review with Metanalysis. Rev Bras Ortop (Sao Paulo). 2020 Oct;55(5):509-517. doi: 10.1055/s-0039-1696681. Epub 2019 Sep 23.
- Results publication: PubMed 38894836Santos ACG, Caiado VDS, Moreira-Marconi E, Teixeira-Silva Y, De Meirelles AG, Seixas A, Lacerda ACR, Sonza A, Mendonca VA, Bernardo-Filho M, De Sa-Caputo DDC. The Influence of Physical Exercises on the Flexibility of Older Individuals with Knee Osteoarthritis: A Systematic Review. Iran J Public Health. 2024 Feb;53(2):255-267. doi: 10.18502/ijph.v53i2.14911.
- Results publication: PubMed 37461112Si J, Sun L, Li Z, Zhu W, Yin W, Peng L. Effectiveness of home-based exercise interventions on pain, physical function and quality of life in individuals with knee osteoarthritis: a systematic review and meta-analysis. J Orthop Surg Res. 2023 Jul 17;18(1):503. doi: 10.1186/s13018-023-04004-z.
- Individual participant dataSharing planned: No. Plan Description: Individual participant data (IPD) collected in this study will not be shared. The reasons for this decision include: * Privacy Concerns: Protecting participant confidentiality is paramount. Sharing IPD could potentially compromise participant privacy * Proprietary Information: The data collected includes proprietary information that cannot be disclosed due to legal or contractual reasons * Data Quality and Integrity: To maintain the accuracy and integrity of the data, sharing IPD might lead to misuse or misinterpretation * Institutional Policies: Institutional policies restrict the sharing of data to comply with ethical and regulatory standards * Resource Limitations: The study team lacks the resources to manage and facilitate IPD sharing effectively Access Criteria: As IPD will not be shared, there are no access criteria.
Related trials for Osteoarthritis, Knee/Rehabilitation
Not yet recruiting
Robotic-Assisted Versus Conventional Total Knee Arthroplasty With Virtual Home-Based Rehabilitation
Osteoarthritis, Knee
Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Effects of Visual and Vestibular Rehabilitation in Individuals With Knee Osteoarthritis
Knee Osteoarthritis, Visual Rehabilitation
Not yet recruitingObservational study
Person-Centred Digital Rehabilitation for Knee Osteoarthritis
Knee Osteoarthritis, Physical Activity Behaviour
Not yet recruiting
Wearable Knee-Assisted Rehabilitation for Range of Motion and Muscle Strength After Total Knee Arthroplasty
Total Knee Arthroplasty Recovery, Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genicular nerve block with bupivacaine and corticosteroids, Genicular nerve block with bupivacaine and Genicular nerve block with saline in people with Osteoarthritis, Knee/Rehabilitation, run by Hospital Universitario Fundación Alcorcón 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 27 Apr 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Pain (time frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06619080, which also lists 57 linked publications.
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 27 Apr 2025.