Chronic Hip PainNCT05822310
Comparison of Femoral and Obturatory Nerve Joint Branches Conventional Radiofrequency Thermocoagulation ,Intraarticular Steroid Injection and Pericapsular Nerve Group (PENG) Block in Chronic Hip Pain
A study testing radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves, intraairticular steroid injection and pericapsular nerve group (PENG) block in people with Chronic Hip Pain, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hip Pain
- What is being tested?
- radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves, intraairticular steroid injection and pericapsular nerve group (PENG) block
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be over 18 years old
- Written consent has been obtained
- Those with chronic hip pain for more than 3 weeks
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Adnan Menderes University Faculty of Medicine
Aydin, 09010
About this study
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.
Read the 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.
- Conditions
- Chronic Hip Pain
- Being tested
- radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves, intraairticular steroid injection, pericapsular nerve group (PENG) block
- Keywords
- femoral and obturatuar nerve, chronic hip pain, Radiofrequency thermocoagulation, intraartıcular steroid injection, pericapsular nerve group (PENG) block
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nervesProcedure or surgery
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.
intraairticular steroid injectionProcedure or surgery
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.
pericapsular nerve group (PENG) blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves | Experimental | radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves applied Receives: Procedure: radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves |
| intraairticular steroid injection | Active comparator | intraairticular steroid injection applied Receives: Procedure: intraairticular steroid injection |
| pericapsular nerve group (PENG) block | Active comparator | pericapsular nerve group (PENG) block applied Receives: Procedure: pericapsular nerve group (PENG) block |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS(Numerating Rating Scale) for chronic pain
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
Measured: preoperative
NRS(Numerating Rating Scale) for chronic pain
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
Measured: Postoperative first month
NRS(Numerating Rating Scale) for chronic pain
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
Measured: Postoperative third month
Secondary outcomes (3)
WOMAC (Western OntarioandMcMasterUniversitiesArthritisIndex )
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
Measured: Preoperative
WOMAC (Western OntarioandMcMasterUniversitiesArthritisIndex )
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
Measured: Postoperative first month
WOMAC (Western OntarioandMcMasterUniversitiesArthritisIndex )
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
Measured: Postoperative third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start15 Apr 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hip PainStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SINEM SARI, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822310
- Sponsor's protocol ID
- 2022/07
- Status last verified
- Apr 2023
- First submitted
- 19 Jan 2023
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Femoral and Obturatory Nerve Joint Branches Conventional Radiofrequency Thermocoagulation ,Intraarticular Steroid Injection and Pericapsular Nerve Group (PENG) Block in Chronic Hip Pain
- ClinicalTrials.gov ID
- NCT05822310
- Acronym / sponsor ID
- 2022/07
- Conditions
- Chronic Hip Pain
- Keywords
- femoral and obturatuar nerve, chronic hip pain, Radiofrequency thermocoagulation, intraartıcular steroid injection, pericapsular nerve group (PENG) block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves | Experimental | Procedure: radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nervesradiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves applied |
| intraairticular steroid injection | Active comparator | Procedure: intraairticular steroid injectionintraairticular steroid injection applied |
| pericapsular nerve group (PENG) block | Active comparator | Procedure: pericapsular nerve group (PENG) blockpericapsular nerve group (PENG) block applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- be over 18 years old
- Written consent has been obtained
- Those with chronic hip pain for more than 3 weeks
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nervesPatients 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. | Procedure or surgery | radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves |
| intraairticular steroid injectionThe 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. | Procedure or surgery | intraairticular steroid injection |
| pericapsular nerve group (PENG) blockThe 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. | Procedure or surgery | pericapsular nerve group (PENG) block |
Primary outcome
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
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
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
3 secondary outcomes
WOMAC (Western OntarioandMcMasterUniversitiesArthritisIndex )
Time frame: Preoperative
WOMAC (Western OntarioandMcMasterUniversitiesArthritisIndex )
Time frame: Postoperative first month
WOMAC (Western OntarioandMcMasterUniversitiesArthritisIndex )
Time frame: Postoperative third month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves, intraairticular steroid injection and pericapsular nerve group (PENG) block in people with Chronic Hip Pain, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BİLGENUR ERGÜN DEMİRÖZ, RESİDENT DOCTOR (+902564441256, bilgenurergunn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS(Numerating Rating Scale) for chronic pain (time frame: preoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.