- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05022381
Treatment of Chronic Hip Pain by Application of Conventional Radiofrequency Thermocoagulation to the Articular Branches of the Femoral and Obturatory Nerve
August 25, 2021 updated by: sevilay şimşek, Aydin Adnan Menderes University
Radiofrequency Thermocoagulation to the Articular Branches of the Femoral and Obturatory Nerve in Chronic Hip Pain
The estimated prevalence of hip joint pain is 7% in men and 10% in women over the age of 45 years.Although physical therapy and weight loss, use of walking aids (such as walking sticks) and analgesic agents are used as conservative treatment methods, these methods usually provide short-term and partial benefits.The anterior sensory innervation of the hip joint is provided by the articular branches of the femoral and obturatory nerve.
Denervation of the articular branches of the femoral and obturator nerves with the radiofrequency thermocoagulation (RFT) method is a method used in chronic hip pain.
In this study, we aimed to show the decrease in pain levels and the effect on quality of life of patients who underwent hip RFT.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Denervation of the articular branches of the femoral and obturator nerves with the radiofrequency thermocoagulation (RFT) method is a method used in chronic hip pain.In previous studies with small groups, it was shown that radiofrequency thermocoagulation procedure caused 50% reduction in hip pain between 1-11 months.Hip joint radiofrequency thermocoagulation is a procedure applied in our clinic.
In this study, we aimed to show the decrease in pain levels and the effect on quality of life of patients who underwent hip RFT.
Study Type
Interventional
Enrollment (Anticipated)
55
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: sevilay şimşek karaoglu, Msc
- Phone Number: +902564441256
- Email: sevilaysimsek@yahoo.com
Study Contact Backup
- Name: sinem sari, Associate Professor
- Phone Number: +902564441256
- Email: sarisinem@yahoo.com
Study Locations
-
-
Province
-
Aydın, Province, Turkey, 09000
- Recruiting
- Adnan Menderes University Faculty of Medicine
-
Contact:
- sinem sari, Associate Professor
- Phone Number: +902564441256
- Email: sarisinem@yahoo.com
-
Contact:
- sevilay simsek karaoglu, resident doctor
- Phone Number: 4441256
- Email: sevilaysimsek@gmail.com
-
Aydın, Province, Turkey, 09000
- Not yet recruiting
- Adnan Menderes University Faculty of Medicine
-
Contact:
- sinem sari, Associate Professor
- Phone Number: +902564441256
- Email: sarisinem@yahoo.com
-
Contact:
- sevilay simsek karaoglu, resident doctor
- Phone Number: 4441256
- Email: sevilaysimsek@gmail.com
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Preoperative and Postoperative Pain Level
The preoperative pain level, hip function and quality of life of patients who underwent radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerve in chronic hip pain will be compared with the postoperative pain level, hip function and quality of life of these patients.
|
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.
Patients who do not have any complications after the procedure and who are mobilized are discharged in the 2nd hour.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chronic pain level
Time Frame: 1 month,3 month, 6 month
|
For this, the patients' preoperative, 1st month, 3rd month and 6th month VPS (Verbal Pain Score) scores will be checked.
A 50% reduction in the verbal pain score will be considered significant.
|
1 month,3 month, 6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hip functional capacity
Time Frame: 1month,3 month,6month
|
For this purpose, the WOMAC (Western Ontario and McMaster Universities Arthritis Index) scale will be checked at the 1st, 3rd, 6th, 6th months in order to evaluate the functional capacity before the procedure.
|
1month,3 month,6month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Life Quality
Time Frame: 1month, 3 month,6 month
|
For this purpose, patients will be subjected to the Short Form-12- test, which is a short scale of quality of life at 1st month, 3rd month and 6th month.
|
1month, 3 month,6 month
|
Acute pain
Time Frame: 1 week
|
Week 1 Verbal Pain Score will be checked to observe the improvement in acute pain in patients.
A 50% decrease in verbal pain score will be considered significant.
|
1 week
|
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)
June 1, 2021
Primary Completion (Anticipated)
June 30, 2022
Study Completion (Anticipated)
July 31, 2022
Study Registration Dates
First Submitted
August 25, 2021
First Submitted That Met QC Criteria
August 25, 2021
First Posted (Actual)
August 26, 2021
Study Record Updates
Last Update Posted (Actual)
August 26, 2021
Last Update Submitted That Met QC Criteria
August 25, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2021/04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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