- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05822310
Comparison of Femoral and Obturatory Nerve Joint Branches Conventional Radiofrequency Thermocoagulation ,Intraarticular Steroid Injection and Pericapsular Nerve Group (PENG) Block in Chronic Hip Pain
April 19, 2023 updated by: SINEM SARI, Aydin Adnan Menderes University
In this study ,the investigators aimed to show the decrease in pain levels and the effect on quality of life of patients who underwent chronic hip painRFT , intraartıcular steroid injection and Peng block.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Hip pain is a common medical condition with increasing age.The effectiveness of conservative methods used in hip pain is limited.Since the lifespan of prostheses used in hip surgery is limited, new methods are needed in the treatment of pain.The anterior sensory innervation of the hip joint is provided by the articular branches of the femoral and obturatory nerve.
Today, the most commonly used techniques for hip pain are corticosteroid administration into the hip joint, pericapsular nerve group (PENG) block application, and radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves.
The aim of this study is to compare the effects of these three procedures in hip pain.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: BİLGENUR ERGÜN DEMİRÖZ, RESİDENT DOCTOR
- Phone Number: +902564441256
- Email: bilgenurergunn@gmail.com
Study Contact Backup
- Name: Sinem Sarı Öztürk, Associate professor
- Phone Number: +902564441256
- Email: sinemsari@yahoo.com
Study Locations
-
-
-
Aydın, Turkey, 09010
- Recruiting
- Adnan Menderes University Faculty of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- be over 18 years old
- Written consent has been obtained
- Those with chronic hip pain for more than 3 weeks
Exclusion Criteria:
- Major psychiatric illness
- The patient has lumbar compression pain or referred pain
- Patients using anticoagulant agents
- Patients with infection in the area to be treated
- Those who are allergic to local anesthetics
- Those who are allergic to betamethasone
- Pregnancy
- Patients who underwent hip surgery during the 3-month follow-up period during the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves applied
|
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.
|
Active Comparator: intraairticular steroid injection
intraairticular steroid injection applied
|
The patients were placed in the supine position in the operating room.
The patient was stained sterile with povidone iodide.
The femoral neck was detected under ultrasonography and the joint capsule was entered with a 22G 9 cm spinal needle.
Then, 5 cc bupivacaine and 5 mg betamethasone were given and the procedure was terminated.
|
Active Comparator: pericapsular nerve group (PENG) block
pericapsular nerve group (PENG) block applied
|
The patients were placed in the supine position in the operating room.
The patient was stained sterile with povidone iodide.
The high-frequency linear ultrasonography probe was placed on the anterior superior iliacspina (ASIS).
Later, the anterior inferior iliac spine (AIIS) was detected by descending caudally.
Afterwards, the probe was brought to the oblique position and AIIS, iliopubikeminence, psoas muscle and tendon were seen.
Using a 22G 90-mm Quinckespinal needle, the tendon of the iliopsoas muscle was entered in the lateral-medial direction in the in-plane plane and bone contact was achieved.
After negative aspiration, 15 ml of 0.5% bupivacaine were administered by seeing the appropriate drug distribution.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NRS(Numerating Rating Scale) for chronic pain
Time Frame: preoperative
|
İt is a pain intensity determination system based on the system where there person tells a point between 0=(no pain) 10=( unbearable pain) and to describe their pain
|
preoperative
|
NRS(Numerating Rating Scale) for chronic pain
Time Frame: Postoperative first month
|
İt is a pain intensity determination system based on the system where there person tells a point between 0=(no pain) 10=( unbearable pain) and to describe their pain
|
Postoperative first month
|
NRS(Numerating Rating Scale) for chronic pain
Time Frame: Postoperative third month
|
İt is a pain intensity determination system based on the system where there person tells a point between 0=(no pain) 10=( unbearable pain) and to describe their pain
|
Postoperative third month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WOMAC (Western OntarioandMcMasterUniversitiesArthritisIndex )
Time Frame: Preoperative
|
It includes 24 questions under three sub-headings as pain, stiffness and physical function.
Each question was scored according to the Likert scale as 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe.minimum
score is 0=good maximum score is 96 = bad functional capacity
|
Preoperative
|
WOMAC (Western OntarioandMcMasterUniversitiesArthritisIndex )
Time Frame: Postoperative first month
|
It includes 24 questions under three sub-headings as pain, stiffness and physical function.
Each question was scored according to the Likert scale as 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe.minimum
score is 0=good maximum score is 96 = bad functional capacity
|
Postoperative first month
|
WOMAC (Western OntarioandMcMasterUniversitiesArthritisIndex )
Time Frame: Postoperative third month
|
It includes 24 questions under three sub-headings as pain, stiffness and physical function.
Each question was scored according to the Likert scale as 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe.minimum
score is 0=good maximum score is 96 = bad functional capacity
|
Postoperative third month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NRS(Numerating Rating Scale) for acute pain
Time Frame: postoperative second hour
|
İt is a pain intensity determination system based on the system where there person tells a point between 0=(no pain) 10=( unbearable pain) and to describe their pain
|
postoperative second hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2023
Primary Completion (Anticipated)
April 1, 2024
Study Completion (Anticipated)
April 1, 2024
Study Registration Dates
First Submitted
January 19, 2023
First Submitted That Met QC Criteria
April 19, 2023
First Posted (Actual)
April 20, 2023
Study Record Updates
Last Update Posted (Actual)
April 20, 2023
Last Update Submitted That Met QC Criteria
April 19, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2022/07
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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