Conventional Radiofrequency Thermocoagulation Application to the Articular Branches of the Femoral and Obturator NerveNCT06751472
Long-Term Follow-up of Radiofrequency to Articular Branches of the Femoral and Obturator Nerve in Chronic Hip Pain
An observational study of Conventional Radiofrequency Thermocoagulation Application to the Articular Branches of the Femoral and Obturator Nerve and Chronic Hip Pain, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
It has been observed that the deterioration in the physical performance of the hip, the medical need before the specialist consultation and the deterioration in the health status can progress treatment[3]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conventional Radiofrequency Thermocoagulation Application to the Articular Branches of the Femoral and Obturator Nerve, Chronic Hip Pain
- What is being tested?
- VPS (Verbal Pain Score) and WOMAC (Western Ontario and McMaster Universities Arthritis Index) scale
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2025to 20 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients who underwent conventional RF will be included in the prospective studies titled "Treatment of chronic hip pain with conventional radiofrequency thermocoagulation to the articular branches of the femoral and obturator nerves" and "Comparison of conventional radiofrequency thermocoagulation to the articular branches of the femoral and obturator nerves with intra-articular steroid injection and pericapsular nerve group (PENG) block in chronic hip pain" (theses of assistant Sevilay Şimşek Karaoğlu and Bilge Ergün, respectively) conducted in our clinic.
Who may be able to join
- Being over 18 years of age
- Having received written consent
- Those with chronic hip pain lasting longer than 3 weeks
Who cannot join
- Major psychiatric disease
- Patients with lumbar pressure pain or referred pain
- Patients using anticoagulant agents
- Patients with infection in the area to be treated
- Those with local anesthetic allergy
- Those with betamethasone allergy
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Adnan Menderes University, Research hospital
Aydin, 09100
Sinem Sarı, Prof, MD, sarisinem@yahoo.com
About this study
Official title: Long-Term Follow-up of the Effect of Conventional Radiofrequency Thermocoagulation Application to the Articular Branches of the Femoral and Obturator Nerve on Pain and Functional Capacity in Patients With Chronic Hip Pain
It has been observed that the deterioration in the physical performance of the hip, the medical need before the specialist consultation and the deterioration in the health status can progress treatment[3]. When conservative treatment methods such as physical therapy and weight change, the use of walking aids (such as a cane) and analgesic agents are used, these interruptions usually provide short-term and partial benefits. After the application of medical treatment procedures, hip prostheses are usually separated. However, the additional diseases of the patients, the fact that the surgery is a major surgery and the mortality rate is high, and the life of the prostheses used are limited have led to the search for alternative pain palliation.
Hip joint radiofrequency thermocoagulation is a procedure performed in our clinic. In this study, we aimed to examine the long-term effects of hip RFT on pain and functional capacity changes in patients.
Read the detailed description
After obtaining hospital ethics committee approval, it was planned to retrospectively examine adult patients over the age of 18 who applied to the outpatient clinic of the Department of Algology, ADÜTF, between May 2021 and September 2023 and who underwent elective conventional radiofrequency thermocoagulation (RFT) procedure to the articular branches of the femoral and obturator nerves due to chronic hip pain. The prospective studies conducted in our clinic titled "Treatment of chronic hip pain with conventional radiofrequency thermocoagulation to the articular branches of the femoral and obturator nerve" and "Comparison of Conventional Radiofrequency Thermocoagulation to the Articular Branches of the Femoral and Obturator Nerve in Chronic Hip Pain with Intra-Articular Steroid Injection and Pericapsular Nerve Group (PENG) Block" (theses of assistants Sevilay Şimşek Karaoğlu and Bilge Ergün, respectively) will include patients who underwent conventional RF. In the studies, patients who underwent elective conventional radiofrequency thermocoagulation (RFT) to the articular branches of the femoral and obturator nerve were followed up for up to 6 months. The follow-up of the patients in our clinic is ongoing. In our study, the long-term follow-up of these patients will be evaluated retrospectively at 12 months and 24 months.
- Conditions
- Conventional Radiofrequency Thermocoagulation Application to the Articular Branches of the Femoral and Obturator Nerve, Chronic Hip Pain
- Being tested
- VPS (Verbal Pain Score), WOMAC (Western Ontario and McMaster Universities Arthritis Index) scale
- Keywords
- chronic hip pain, radiofrequency thermocoagulation, Articular Branches of the Femoral and Obturator Nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPS (Verbal Pain Score)Diagnostic test
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
WOMAC (Western Ontario and McMaster Universities Arthritis Index) scaleDiagnostic test
It includes 24 questions under three sub-headings as pain, stiffness and physical function
| Study group | Role | What they receive |
|---|---|---|
| RFT | Conventional radiofrequency thermocoagulation (RFT) procedure was applied to the femoral and obturator nerve joint branches electively due to chronic hip pain. Receives: Diagnostic Test: VPS (Verbal Pain Score); Diagnostic Test: WOMAC (Western Ontario and McMaster Universities Arthritis Index) scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
chronic pain assessment
Pain will be assessed with the SAS (Verbal Pain Score) score before surgery, at 12 and 24 months.
Measured: 12 month, 24 month
Secondary outcomes (1)
functional capacity assesment
Functional capacity will be assessed with the womac score before surgery, at 12 and 24 months.
Measured: 12 month, 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start5 Jan 2025 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion20 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conventional Radiofrequency Thermocoagulation Application to the Articular Branches of the Femoral and Obturator NerveStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 76 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
- NCT06751472
- Sponsor's protocol ID
- 2024-218
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-up of the Effect of Conventional Radiofrequency Thermocoagulation Application to the Articular Branches of the Femoral and Obturator Nerve on Pain and Functional Capacity in Patients With Chronic Hip Pain
- ClinicalTrials.gov ID
- NCT06751472
- Acronym / sponsor ID
- 2024-218
- Conditions
- Conventional Radiofrequency Thermocoagulation Application to the Articular Branches of the Femoral and Obturator Nerve, Chronic Hip Pain
- Keywords
- chronic hip pain, radiofrequency thermocoagulation, Articular Branches of the Femoral and Obturator Nerve
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 5 Jan 2025 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 20 Apr 2025 (estimated)
- First posted
- 30 Dec 2024 (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.
It has been observed that the deterioration in the physical performance of the hip, the medical need before the specialist consultation and the deterioration in the health status can progress treatment[3]. When conservative treatment methods such as physical therapy and weight change, the use of walking aids (such as a cane) and analgesic agents are used, these interruptions usually provide short-term and partial benefits. After the application of medical treatment procedures, hip prostheses are usually separated. However, the additional diseases of the patients, the fact that the surgery is a major surgery and the mortality rate is high, and the life of the prostheses used are limited have led to the search for alternative pain palliation.
Hip joint radiofrequency thermocoagulation is a procedure performed in our clinic. In this study, we aimed to examine the long-term effects of hip RFT on pain and functional capacity changes in patients.
Detailed description
After obtaining hospital ethics committee approval, it was planned to retrospectively examine adult patients over the age of 18 who applied to the outpatient clinic of the Department of Algology, ADÜTF, between May 2021 and September 2023 and who underwent elective conventional radiofrequency thermocoagulation (RFT) procedure to the articular branches of the femoral and obturator nerves due to chronic hip pain. The prospective studies conducted in our clinic titled "Treatment of chronic hip pain with conventional radiofrequency thermocoagulation to the articular branches of the femoral and obturator nerve" and "Comparison of Conventional Radiofrequency Thermocoagulation to the Articular Branches of the Femoral and Obturator Nerve in Chronic Hip Pain with Intra-Articular Steroid Injection and Pericapsular Nerve Group (PENG) Block" (theses of assistants Sevilay Şimşek Karaoğlu and Bilge Ergün, respectively) will include patients who underwent conventional RF. In the studies, patients who underwent elective conventional radiofrequency thermocoagulation (RFT) to the articular branches of the femoral and obturator nerve were followed up for up to 6 months. The follow-up of the patients in our clinic is ongoing. In our study, the long-term follow-up of these patients will be evaluated retrospectively at 12 months and 24 months.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RFT | – | Diagnostic Test: VPS (Verbal Pain Score), Diagnostic Test: WOMAC (Western Ontario and McMaster Universities Arthritis Index) scaleConventional radiofrequency thermocoagulation (RFT) procedure was applied to the femoral and obturator nerve joint branches electively due to chronic hip pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent conventional RF will be included in the prospective studies titled "Treatment of chronic hip pain with conventional radiofrequency thermocoagulation to the articular branches of the femoral and obturator nerves" and "Comparison of conventional radiofrequency thermocoagulation to the articular branches of the femoral and obturator nerves with intra-articular steroid injection and pericapsular nerve group (PENG) block in chronic hip pain" (theses of assistant Sevilay Şimşek Karaoğlu and Bilge Ergün, respectively) conducted in our clinic.
Key inclusion criteria (3 listed)
- Being over 18 years of age
- Having received written consent
- Those with chronic hip pain lasting longer than 3 weeks
Key exclusion criteria (7 listed)
- Major psychiatric disease
- Patients with lumbar pressure pain or referred pain
- Patients using anticoagulant agents
- Patients with infection in the area to be treated
- Those with local anesthetic allergy
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 |
|---|---|---|
| VPS (Verbal Pain Score)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 | Diagnostic test | RFT |
| WOMAC (Western Ontario and McMaster Universities Arthritis Index) scaleIt includes 24 questions under three sub-headings as pain, stiffness and physical function | Diagnostic test | RFT |
Primary outcome
chronic pain assessment
Time frame: 12 month, 24 month
Pain will be assessed with the SAS (Verbal Pain Score) score before surgery, at 12 and 24 months.
1 secondary outcome
functional capacity assesment
Time frame: 12 month, 24 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conventional Radiofrequency Thermocoagulation Application to the Articular Branches of the Femoral and Obturator Nerve and 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 7 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: opening soon, as of the sponsor's last update on 30 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sinem Sarı, Prof,MD (444 1 256 ext. 2108, sarisinem@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chronic pain assessment (time frame: 12 month, 24 month). 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 30 Dec 2024.