Comparison of Intra-articular Steroid Injection and Radiofrequency Thermocoagulation in Coxarthrosis Patients
Primary Purpose
Pain Hip Burning
Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Radiofrequency thermocoagulation of sensory branches of hip joint
Intraarticular steroid injection of hip joint
Sponsored by
About this trial
This is an interventional supportive care trial for Pain Hip Burning
Eligibility Criteria
Inclusion Criteria:
- - 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.
Exclusion Criteria:
- 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
Sites / Locations
- Halil Cetingok
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Radiofrequency thermocoagulation of sensory branches of hip joint
Intraarticular steroid injection of hip joint
Arm Description
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.
Fluoroscopy guided percutaneous intra articular steroid injection of hip joint will be performed
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05564065
First Posted
September 30, 2022
Last Updated
September 30, 2022
Sponsor
Istanbul University
1. Study Identification
Unique Protocol Identification Number
NCT05564065
Brief Title
Comparison of Intra-articular Steroid Injection and Radiofrequency Thermocoagulation in Coxarthrosis Patients
Official Title
Comparison of Intra-articular Steroid Injection and Radiofrequency Thermocoagulation of the Sensory Branches of the Femoral and Obdurator Nerves in Coxarthrosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Hip Burning
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radiofrequency thermocoagulation of sensory branches of hip joint
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intraarticular steroid injection of hip joint
Arm Type
Active Comparator
Arm Description
Fluoroscopy guided percutaneous intra articular steroid injection of hip joint will be performed
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency thermocoagulation of sensory branches of hip joint
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intraarticular steroid injection of hip joint
Intervention Description
Fluoroscopy guided percutaneous intra articular steroid injection of hip joint will be performed
Primary Outcome Measure Information:
Title
Visual Analog Scale comparison
Description
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.
Time Frame
Baseline
Title
Visual Analog Scale comparison
Description
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.
Time Frame
1.month
Title
Visual Analog Scale comparison
Description
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.
Time Frame
3.month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halil Cetingok, Ass. Prof
Organizational Affiliation
Istanbul University
Official's Role
Study Director
Facility Information:
Facility Name
Halil Cetingok
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Intra-articular Steroid Injection and Radiofrequency Thermocoagulation in Coxarthrosis Patients
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