Comparison of Intra-articular Steroid Injection and Radiofrequency Thermocoagulation in Coxarthrosis Patients

Sponsor

Istanbul University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05564065

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Pain Hip Burning	Procedure: Radiofrequency thermocoagulation of sensory branches of hip joint Procedure: Intraarticular steroid injection of hip joint	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two groups: 1. intraarticular steroid injection of hip joint; 2. Radiofrequency thermocoagulation of femoral and obturator nerve terminal sensory branches of hip jointTwo 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)

Primary Purpose:

Supportive Care

Official Title:

Comparison of Intra-articular Steroid Injection and Radiofrequency Thermocoagulation of the Sensory Branches of the Femoral and Obdurator Nerves in Coxarthrosis Patients

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Radiofrequency thermocoagulation of sensory branches of hip joint 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.	Procedure: Radiofrequency thermocoagulation of sensory branches of hip joint 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.
Active Comparator: Intraarticular steroid injection of hip joint Fluoroscopy guided percutaneous intra articular steroid injection of hip joint will be performed	Procedure: Intraarticular steroid injection of hip joint Fluoroscopy guided percutaneous intra articular steroid injection of hip joint will be performed

Arm

Intervention/Treatment

Active Comparator: Radiofrequency thermocoagulation of sensory branches of hip joint

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.

Procedure: Radiofrequency thermocoagulation of sensory branches of hip joint

Active Comparator: Intraarticular steroid injection of hip joint

Fluoroscopy guided percutaneous intra articular steroid injection of hip joint will be performed

Procedure: Intraarticular steroid injection of hip joint

Fluoroscopy guided percutaneous intra articular steroid injection of hip joint will be performed

Outcome Measures

Primary Outcome Measures

Visual Analog Scale comparison [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Halil Cetingok	Istanbul	Fatih	Turkey	34093

Sponsors and Collaborators

Istanbul University

Investigators

Study Director: Halil Cetingok, Ass. Prof, Istanbul University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Halil Cetingok, Assistant professor, Istanbul University

ClinicalTrials.gov Identifier:

NCT05564065

Other Study ID Numbers:

2019/123

First Posted:

Oct 3, 2022

Last Update Posted:

Oct 3, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoarthritis, Hip

Study Results

No Results Posted as of Oct 3, 2022