- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07475793
Image Guided Genicular Nerve Radiofrequency Ablation for Chronic Knee Osteoarthritis
Efficacy of Ultrasound vs Fluoroscopy Guided Genicular Nerve Radiofrequency Ablation for Chronic Knee Osteoarthritis: A Randomized Controlled Trial
The goal of this prospective randomized control trial is to provide continued pain relief, classically long-lasting 3 to12 months, and enhanced function in patients following: both gender; male and female, age group; >50yr, healthy volunteers along with Radiographic diagnosis of knee OA with KL grade 3 and 4 in addition of Chronic knee pain ≥ 6 months and patients with ≥50% decrease in pain strength after diagnostic genicular nerve block. The main question it aims to answer is:
Is ultrasound-guided genicular nerve RFA more efficient in lowering pain intensity at six months contrasted with fluoroscopic guided method in patients with chronic knee osteoarthritis? Researchers will compare Group A (Fluoroscopic) to Group B (Ultrasound) to see comparison in efficiency of ultrasound guided against fluoroscopic guided genicular nerves block for decrease in pain intensity and functional improvement.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ali Sarfraz Siddiqui, MBBS-FCPS
- Phone Number: 4397 +92 021-38104397
- Email: sarfraz.siddiqui@aku.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both gender patients of age more than 50 years.
- Radiographic diagnosis of knee OA with KL level 3 and 4.
- Chronic knee pain for more than 6 months
- Patients with more than 50% reduction in pain intensity after diagnostic genicular nerve block
Exclusion Criteria:
- Lack of consent
- surgery of knee
- Patient with BMI more than 40kg/m2
- Intra-articular steroid injection or hyaluronic acid in last 3 months
- Localized infection at procedure site or knee.
- Patient unable to communicate properly (Severe psychiatric illness, severe dementia and cognitive impairment).
- Patients have moderate to severe low back pain (NRS ≥5)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group B
Intervention group in which genicular nerves radiofrequency ablation will be done with the help ultrasound guidance.
|
Genicular nerves radiofrequency ablation will be done with the help of ultrasound guidance.
|
|
Active Comparator: Group A
Control group in which genicular nerves radiofrequency ablation will be done with the help of fluoroscopic guidance.
|
Control group in which genicular nerves radiofrequency ablation will be done with the help of fluoroscopic guidance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness of Block
Time Frame: Post procedure 2 weeks, then follow up after 2, 4 and 6 months.
|
Block will be considered effective if decrease in pain score from baseline is >50% at six months.
And this will measure by using the 11-point Numeric Rating Scale (NRS) where 0 = no pain and 10 = worst imaginable pain.
|
Post procedure 2 weeks, then follow up after 2, 4 and 6 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Improvement after block
Time Frame: 6 months
|
Functional improvement after genicular nerve block is describe as > 20 % decrease in KOOS PS score from baseline at six months.
Functional condition will be assessed using the Knee injury and osteoarthritis outcomes score-Physical function short form (KOOS-PS) tool.
Minimum score is 0 and maximum is 20 which will then be converted into ratio from 0 to 100%, 0 means no functional impairment and 100 means maximum functional impairment.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ali Sarfraz Siddiqui, MBBS-FCPS, Aga Khan University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2026-12711-40401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Knee Osteoarthritis
-
Lucas R. Cusumano, MDNot yet recruitingKnee Osteoarthritis | Knee Discomfort | Knee Pain Chronic | Knee Swelling PainUnited States
-
Ankara City Hospital BilkentRecruitingChronic Knee OsteoarthritisTurkey
-
Poznan University of Medical SciencesCompletedOsteoarthritis, Knee | Arthropathy of Knee | Knee Pain ChronicPoland
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
Mansoura UniversityUnknownChronic Knee OsteoarthritisEgypt
-
Mansoura UniversityUnknownChronic Knee OsteoarthritisEgypt
-
University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)RecruitingChronic Pain | Chronic Knee Pain | Knee Osteoarthritis (OA)United States
-
Izmir Democracy UniversityNot yet recruitingKnee Osteoarthritis | Knee | Knee Arthropathy | Lipedema | Knee Acute and Chronic Pain | Knee Arthritis Osteoarthritis | Knee Cartilage Lesions | Knee Cartilage DefectsTurkey (Türkiye)
-
Ampio Pharmaceuticals. Inc.CompletedKnee Osteoarthritis | Osteoarthritis, Knee | Knee Arthritis | Knee Pain ChronicUnited States
-
FUSMobile Inc.RecruitingChronic Knee Pain | Osteoarthritis (OA) of the Knee | Knee Pain ArthritisCanada
Clinical Trials on Ultrasound Guided
-
Marmara UniversityCompletedAdhesive Capsulitis of the ShoulderTurkey
-
Abant Izzet Baysal UniversityRecruiting
-
Tri-Service General HospitalCompleted
-
Nanjing First Hospital, Nanjing Medical UniversityRecruitingNerve Block | Pulmonary NodulesChina
-
Al-Azhar UniversityCompletedPediatric | Infraclavicular | Ultrasound Guided | Venous Catheterization | Supraclavicular | SubclavianEgypt
-
Jose Antonio Garcia VidalUniversidad de MurciaCompleted
-
Bracco Diagnostics, IncBracco Imaging S.p.A.TerminatedProstate CancerItaly, Austria, France, Netherlands, Belgium, Germany, United Kingdom
-
Peking Union Medical College HospitalNot yet recruiting
-
Albert Einstein College of MedicineJacobi Medical CenterNot yet recruitingCentral Venous Catheter | Complication of Catheter | Midline CatheterUnited States
-
Diskapi Teaching and Research HospitalNot yet recruitingCardiac Surgery | Radial Artery Cannulation | Cardiac Surgery in Adult Patient | Arterial Cannulation | Radial Artery CatheterizationTurkey (Türkiye)