"Comparison of the Effectiveness of Conventional Radiofrequency Thermocoagulation and Chemical Ablation With Phenol on Articular Branches of Femoral and Obturator Nerves in Chronic Hip Pain"
Study Overview
Detailed Description
"Our study is designed as a double-blind, prospective randomized controlled trial. Blinding will be ensured by keeping the researcher performing pain diary follow-ups unaware of which procedure was applied to each patient.
Patients will be randomized using computer-assisted methods. Following approval from the hospital ethics committee, clinical trial registration will be conducted. From 2024 to 2025, patients presenting with chronic hip pain to the Department of Algology at ADU Faculty of Medicine will be divided into two groups. In Group 1, chemical ablation of the femoral and obturator nerve branches with phenol under ultrasound guidance will be performed. In Group 2, conventional radiofrequency thermocoagulation of the articular branches of the femoral and obturator nerves under ultrasound guidance will be applied.
During the study, pain intensity will be assessed using the Numerical Rating Scale (NRS) at baseline, 2 hours post-procedure, and at 1 month and 3 months post-procedure for both Group 1 and Group 2. The WOMAC scale will be used to evaluate their functional capacity."
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Akylai Dosieva, Resident doctor
- Phone Number: +905365088993
- Email: akylaidosieva@mail.ru
Study Contact Backup
- Name: osman nuri aydın, Professor
- Phone Number: 905325125124
- Email: onaydin@superonline.com
Study Locations
-
-
-
Aydın, Turkey, 09010
- Adnan Menderes University Faculty of Medicine
-
Contact:
- akylai dosieva
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Be older than 18 years old. Written consent must be obtained. Have had chronic hip pain for more than 3 weeks. -
Exclusion Criteria:
Major psychiatric illness Presence of lumbar radicular pain or referred pain in the patient Patients using anticoagulant agents Patients with infection in the area where the procedure will be performed Those with allergy to local anesthetics Those allergic to phenol or betamethasone Pregnant women Scheduled for surgery
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves
Patients are operated under sedation in the operating room.
C-arm fluoroscopy device is used for imaging purposes for radiofrequency thermocoagulation process.
In order to prevent vascular injury the needle is advanced under the guidance of ultrasonography.
There are target points determined in fluoroscopy for the femoral nerve and the obturatory nerve.
Before the thermocoagulation procedure, local anesthetic and steroid are injected into each of the target points.
|
Sedation is applied before the procedure
|
|
Active Comparator: Chemical ablation with phenol
Patients are operated under sedation in the operating room.
C-arm fluoroscopy device is used for imaging purposes for radiofrequency thermocoagulation process.
In order to prevent vascular injury the needle is advanced under the guidance of ultrasonography.
There are target points determined in fluoroscopy for the femoral nerve and the obturatory nerve.
Before the thermocoagulation procedure, local anesthetic and steroid are injected into each of the target points.
Before the procedure, the femoral artery was visualized with a linear ultrasound probe to prevent arterial injury by entering 2 cm lateral to the femoral artery.
Following this, a mixture of 2.5 cc of 0.05% bupivacaine and 2.5 cc of 6% phenol was applied, and a lesion was created for 90 seconds at 80°.
|
Sedation is applied before the procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NRS (Numerical Rating Scale)
Time Frame: preoperative
|
We will assess NRS (Numerical Rating Scale) scores at 1 month and 3 months.
A 50% reduction in NRS will be considered statistically significant
|
preoperative
|
|
NRS (Numerical Rating Scale)
Time Frame: postoperative first month
|
We will assess NRS (Numerical Rating Scale) scores at 1 month and 3 months.
A 50% reduction in NRS will be considered statistically significant
|
postoperative first month
|
|
NRS (Numerical Rating Scale)
Time Frame: postoperative third month
|
We will assess NRS (Numerical Rating Scale) scores at 1 month and 3 months.
A 50% reduction in NRS will be considered statistically significant
|
postoperative third month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
WOMAC (Western OntarioandMcMasterUniversitiesArthritis Index )
Time Frame: preoperative
|
To assess functional capacity preoperatively, we will evaluate the WOMAC (Western Ontario and McMaster Universities Arthritis Index) scale at 1 month and 3 months post-procedure in patients.
|
preoperative
|
|
WOMAC (Western OntarioandMcMasterUniversitiesArthritis Index )
Time Frame: postoperative first month
|
To assess functional capacity preoperatively, we will evaluate the WOMAC (Western Ontario and McMaster Universities Arthritis Index) scale at 1 month and 3 months post-procedure in patients.
|
postoperative first month
|
|
WOMAC (Western OntarioandMcMasterUniversitiesArthritis Index )
Time Frame: postoperative third month
|
To assess functional capacity preoperatively, we will evaluate the WOMAC (Western Ontario and McMaster Universities Arthritis Index) scale at 1 month and 3 months post-procedure in patients.
|
postoperative third month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: akylai dosieva, Aydin Adnan Menderes 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024 (Other Grant/Funding Number: Rome Foundation)
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.