Pain Hip BurningNCT05564065
Comparison of Intra-articular Steroid Injection and Radiofrequency Thermocoagulation in Coxarthrosis Patients
A study testing Radiofrequency thermocoagulation of sensory branches of hip joint and Intraarticular steroid injection of hip joint in people with Pain Hip Burning, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed that the Comparison of effectiveness of the intra-articular steroid injection and radiofrequency thermocoagulation of the sensory branches of the femoral and obdurator nerves in coxarthrosis patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Hip Burning
- What is being tested?
- Radiofrequency thermocoagulation of sensory branches of hip joint and Intraarticular steroid injection of hip joint
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2021to 1 Dec 2022
- 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
- - Older than 18-year-old
- Clincal, radiological (Grade 3-4) and laboratory examinations ara related with diagnosis of hip joint osteoarthirtis
- Despite of previous medical and physical treatment, VAS score > 5 and above
- Norological examination without critical motor and sensory deficency
- Patients who sign informed consent.
Who cannot join
- Coagulation disorders (bleeding diathesis)
- Usage of antitrombotic, anticoagulant medications
- Sepsis and local infection on intervention area
- Allergic to any of drugs which is used in intervention
- Without informed consent approval
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intra-articular Steroid Injection and Radiofrequency Thermocoagulation of the Sensory Branches of the Femoral and Obdurator Nerves in Coxarthrosis Patients
The investigators aimed that the Comparison of effectiveness of the intra-articular steroid injection and radiofrequency thermocoagulation of the sensory branches of the femoral and obdurator nerves in coxarthrosis patients
Read the detailed description
Osteoarthirtis is a deficency of articular cartilge which is caused by genetic, metabolic and biochemical factors. This is a pathologic period with cartilage, bone and sinovium destruction.
Pharmacological treatments and/or phsiycal medicine may not be enough to reduce pain in patients with chronic pain of osteoarthiritis. Intraarticular steroid injection is the most common used intervention method in analgesia of hip osteoarthirtis. Thus; cartilage inflammation can be decelerated and osteophyte formation can be prevented. On the other hand; because of less vascularity of hip joint, frequent steroid injections may cause aseptic necrosis.
In past decades, treatment to pain of hip joint pain caused by ostheoarthrits, radiofrequency ablation treatment is used to sensory nerves which cause pain. Especially, it can be a solution in patients who do not want to undergo a surgery.
Patients diagnosed with coxarthrosis will be randomly divided into two groups. One group will receive intra-articular steroid injection and the other group will receive radiofrequency thermocoagulation to the hip sensory nerve branches (femoral and obdurator). It was planned to compare the vas scores of the patients before and 1-3 months after the procedure with their effectiveness.
- Conditions
- Pain Hip Burning
- Being tested
- Radiofrequency thermocoagulation of sensory branches of hip joint, Intraarticular steroid injection of hip joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency thermocoagulation of sensory branches of hip jointProcedure or surgery
There are two main nerves that carry the pain sensation of the hip joint. These nerves are the femoral and obturator nerves. The sensory branches of these nerves going to the hip joint will be detected with a radiofrequency device under fluoroscopy and percutaneous ablation will be performed.
Intraarticular steroid injection of hip jointProcedure or surgery
Fluoroscopy guided percutaneous intra articular steroid injection of hip joint will be performed
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency thermocoagulation of sensory branches of hip joint | Active comparator | There are two main nerves that carry the pain sensation of the hip joint. These nerves are the femoral and obturator nerves. The sensory branches of these nerves going to the hip joint will be detected with a radiofrequency device under fluoroscopy and percutaneous ablation will be performed. Receives: Procedure: Radiofrequency thermocoagulation of sensory branches of hip joint |
| Intraarticular steroid injection of hip joint | Active comparator | Fluoroscopy guided percutaneous intra articular steroid injection of hip joint will be performed Receives: Procedure: Intraarticular steroid injection of hip joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale comparison
VAS is the most common pain scale. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: Baseline
Visual Analog Scale comparison
VAS is the most common pain scale. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: 1.month
Visual Analog Scale comparison
VAS is the most common pain scale. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: 3.month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start1 Aug 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Hip BurningStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: 1. intraarticular steroid injection of hip joint; 2. Radiofrequency thermocoagulation of femoral and obturator nerve terminal sensory branches of hip joint
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Cetingok, Istanbul University
- Investigators
- Halil Cetingok, Ass. Prof, Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564065
- Sponsor's protocol ID
- 2019/123
- Status last verified
- Sep 2022
- First submitted
- 30 Sep 2022
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intra-articular Steroid Injection and Radiofrequency Thermocoagulation of the Sensory Branches of the Femoral and Obdurator Nerves in Coxarthrosis Patients
- ClinicalTrials.gov ID
- NCT05564065
- Acronym / sponsor ID
- 2019/123
- Conditions
- Pain Hip Burning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 3 Oct 2022 (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.
The investigators aimed that the Comparison of effectiveness of the intra-articular steroid injection and radiofrequency thermocoagulation of the sensory branches of the femoral and obdurator nerves in coxarthrosis patients
Detailed description
Osteoarthirtis is a deficency of articular cartilge which is caused by genetic, metabolic and biochemical factors. This is a pathologic period with cartilage, bone and sinovium destruction.
Pharmacological treatments and/or phsiycal medicine may not be enough to reduce pain in patients with chronic pain of osteoarthiritis. Intraarticular steroid injection is the most common used intervention method in analgesia of hip osteoarthirtis. Thus; cartilage inflammation can be decelerated and osteophyte formation can be prevented. On the other hand; because of less vascularity of hip joint, frequent steroid injections may cause aseptic necrosis.
In past decades, treatment to pain of hip joint pain caused by ostheoarthrits, radiofrequency ablation treatment is used to sensory nerves which cause pain. Especially, it can be a solution in patients who do not want to undergo a surgery.
Patients diagnosed with coxarthrosis will be randomly divided into two groups. One group will receive intra-articular steroid injection and the other group will receive radiofrequency thermocoagulation to the hip sensory nerve branches (femoral and obdurator). It was planned to compare the vas scores of the patients before and 1-3 months after the procedure with their effectiveness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups: 1. intraarticular steroid injection of hip joint; 2. Radiofrequency thermocoagulation of femoral and obturator nerve terminal sensory branches of hip joint
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency thermocoagulation of sensory branches of hip joint | Active comparator | Procedure: Radiofrequency thermocoagulation of sensory branches of hip jointThere are two main nerves that carry the pain sensation of the hip joint. These nerves are the femoral and obturator nerves. The sensory branches of these nerves going to the hip joint will be detected with a radiofrequency device under fluoroscopy and percutaneous ablation will be performed. |
| Intraarticular steroid injection of hip joint | Active comparator | Procedure: Intraarticular steroid injection of hip jointFluoroscopy guided percutaneous intra articular steroid injection of hip joint will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - Older than 18-year-old
- Clincal, radiological (Grade 3-4) and laboratory examinations ara related with diagnosis of hip joint osteoarthirtis
- Despite of previous medical and physical treatment, VAS score > 5 and above
- Norological examination without critical motor and sensory deficency
- Patients who sign informed consent.
Key exclusion criteria (5 listed)
- Coagulation disorders (bleeding diathesis)
- Usage of antitrombotic, anticoagulant medications
- Sepsis and local infection on intervention area
- Allergic to any of drugs which is used in intervention
- Without informed consent approval
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 of sensory branches of hip jointThere are two main nerves that carry the pain sensation of the hip joint. These nerves are the femoral and obturator nerves. The sensory branches of these nerves going to the hip joint will be detected with a radiofrequency device under fluoroscopy and percutaneous ablation will be performed. | Procedure or surgery | Radiofrequency thermocoagulation of sensory branches of hip joint |
| Intraarticular steroid injection of hip jointFluoroscopy guided percutaneous intra articular steroid injection of hip joint will be performed | Procedure or surgery | Intraarticular steroid injection of hip joint |
Primary outcome
Visual Analog Scale comparison
Time frame: Baseline
VAS is the most common pain scale. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Visual Analog Scale comparison
Time frame: 1.month
VAS is the most common pain scale. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Visual Analog Scale comparison
Time frame: 3.month
VAS is the most common pain scale. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Individual participant dataSharing planned: No
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.
Halil Cetingok, Ass. Prof study director
Istanbul University
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 of sensory branches of hip joint and Intraarticular steroid injection of hip joint in people with Pain Hip Burning, run by Istanbul 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 5 inclusion and 5 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 3 Oct 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale comparison (time frame: Baseline). 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 3 Oct 2022.