- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07700784
Radiofrequency in Knee Osteoarthritis
Efficacy of Ultrasound Guided Laser Genicular Nerves Ablation Versus Conventional Radiofrequancy For Chronic Knee Osteoarthritis Pain
Knee osteoarthritis is one of the most common causes of chronic pain and disability worldwide, particularly in middle-aged and elderly populations. It is characterised by progressive cartilage degeneration, subchondral bone remodelling, and synovial inflammation.
There were many trails to provide pain relief by using systemic opioids or Non steroidal anti inflammatory drugs (with side effects such as peptic ulcer and hepatic, renal impairment)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Knee osteoarthritis is one of the most common causes of chronic pain and disability worldwide, particularly in middle-aged and elderly populations. It is characterized by progressive cartilage degeneration, subchondral bone remodeling, and synovial inflammation.
There were many trails to provide pain relief by using systemic opioids or non steroidal anti inflammatory drugs (with side effects such as peptic ulcer and hepatic, renal impairment) In knee osteoarthritis .these nerves are believed to be sensitised, leading to increased pain signalling . This can result in chronic pain and discomfort in patients with knee osteoarthritis.
Radiofrequency targeting these nerves aims to provide pain relief by disrupting the pain signals transmitted through these nerves .
By selectively targeting the articular branches, these interventions can alleviate pain and improve the physical function and quality of life of patients with knee osteoarthritis. The positive therapeutic effect of radiofrequency on genicular nerves has been reported in many previous studies . However, little is known about its effects on patients with intractable knee pain.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- American society of anesthesiologist's physical status class I, II- Body mass index (BMI): 18.5 - 29.9 kg/m2- Confirmation of knee OA on radiograph- Chronic knee pain ≥ 3 months.
Exclusion Criteria:
- History of clinically significant cardiac, hepatic, renal or neurological disease- Allergy to study medication- Coagulopathy- Infection at injection site
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Laser genicular nerve ablation
Laser genicular nerve ablation Using ultrasound
|
Ultrasoud guided Laser genicular nerve ablation for pain relief in knee osteoarthritis
|
|
Active Comparator: Conventional Radiofrequency genicular nerve ablation
Conventional Radiofrequency genicular nerve ablation using ultrasound
|
Conventional radiofrequency genicular nerve ablation for pain relief in knee osteoarthritis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue scale pain score
Time Frame: 24 hour
|
To assess pain intensity using Visual Analogue Scale score between laser and radiofrequency group with score 10 indicates worst pain and score 0 indicates no pain.
|
24 hour
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Analgesia
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.
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