- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07190339
- Original Trial
Femoral and Obturator Nerve Articular Branches Prf
A Study on the Effectiveness of Pulsed Radiofrequency Treatment Applied to the Femoral and Obturator Nerve Articular Branches Under Ultrasound Guidance in Chronic Hip Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gevher Rabia Genc Perdecioglu, TR
- Phone Number: +905332009184
- Email: gevhergenc@gmail.com
Study Contact Backup
- Name: Emine Yuksel, TR
- Phone Number: +905453489378
- Email: eminecan_02@hotmail.com
Study Locations
-
-
-
Ankara, Turkey (Türkiye)
- Recruiting
- Ankara Etlik City Hospital
-
Contact:
- Ankara Etlik City Hospital Etlik City Hospital
- Phone Number: (0312) 797 00 00
- Email: eminecan_02@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1. Patients with hip and groin pain who have been diagnosed with hip osteoarthritis by direct radiography
- 2. Patients who have had hip pain above VAS 5 for more than 6 weeks
- 3. Failure of pain treatment with conservative methods such as analgesics and physical therapy
Exclusion Criteria:
- 1. Patients with lumbar radiculopathy and axial back pain, sacroiliac joint, connective tissue disease
- 2. Patients who do not attend follow-up appointments regularly or cannot be reached by phone
- 3. Patients who started additional analgesic medication or underwent additional interventional procedures after the initial interventional procedure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: pulsed radiofrequency group
femoral and obturator nerve articular branches pulsed radiofrequency for hip osteoartritis
|
Hemodynamic monitoring is provided. The hip joint where the procedure will be performed is cleaned with povidone-iodine. Sterile draping is performed. For PRF application to the articular branches of the femoral nerve, a convex ultrasound probe is first used to locate the articular branches of the femoral nerve in the groin area, followed by the articular branches of the obturator nerve. The radiofrequency cannula is inserted sequentially into the target points and sensory feedback is obtained. Then, a pulsed radiofrequency current, which has therapeutic properties for chronic pain and does not damage tissues by exceeding a temperature of 42 degrees, is applied to the relevant nerve root for 240 seconds. Subsequently, an injectate consisting of 2 cc of 5% bupivacaine, 4 mg of dexamethasone, and 2 cc of physiological saline is administered to the same nerve. Translated with DeepL.com (free version) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
numeric rating scale
Time Frame: Change from baseline to 2nd 6 th and 12th weeks after treatment
|
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
|
Change from baseline to 2nd 6 th and 12th weeks after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
oxford hip score
Time Frame: Change from baseline to 2nd 6th and 12th weeks after treatment
|
The Oxford Hip Score (OHS) is a joint-specific, patient-reported outcome measure designed to assess disability in patients witth hip osteoarthritis
|
Change from baseline to 2nd 6th and 12th weeks after treatment
|
Collaborators and Investigators
Investigators
- Study Chair: Gevher Rabia Genc Perdecioğlu, Diskapi TRH
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- hip pericapsular nerve pRF
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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