- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05136248
Comparison of the Effect of Intra Articular Steroid Injection and Pericapsular Nerve Group Block for Hip Osteoarthritis
April 2, 2023 updated by: Selin Guven Kose, Diskapi Teaching and Research Hospital
Comparison of Ultrasound Guided Intra-articular Steroid Injection and Pericapsular Nerve Group Block (PENG) in Patients With Chronic Hip Pain
The most common cause of hip joint dysfunction in the elderly is degenerative osteoarthritis of the hip.
Innervation of the hip joint capsule is provided by the obturator nerve, the accessory obturator nerve, and the femoral nerve.
With pericapsular nerve group block (PENG), by blocking the femoral nerve and the accessory obturator nerve, analgesia is successfully provided for the hip joint.
Intra-articular injection of corticosteroids; It is used as an alternative to surgical interventions because it reduces inflammation and short-term pain and is a minimally invasive method.
The investigators aim to compare and report patients who underwent ultrasound-guided intra-articular steroid injection and PENG block in terms of post-procedural pain scores and patient satisfaction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
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 Locations
-
-
-
Ankara, Turkey, 06110
- Diskapi Yildirim Beyazit Training and Research Hospital
-
-
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 to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Hip pain NRS > 4
- No pathologies in the laboratory and coagulation parameters
Exclusion Criteria:
- Rheumatological disease with hip involvement
- Systemic active infection
- Malignancy
- History of hip joint surgery
- History of traumatic hip injury
- Platelets values < 150.000 / µl
- History of bleeding disorder
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intraarticular injection
intra-articular steroid injection with the ultrasound guidance technique,
|
Ultrasound-guided intraarticular injection
|
|
Active Comparator: peng block
Ultrasound guided drug injection between to iliopubic eminentia and psoas tendon
|
Ultrasound-guided PENG block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
numerical rating scale (NRS) pain score
Time Frame: change from baseline to day 1, week 2, 4, 8 after the block
|
The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain."
The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
|
change from baseline to day 1, week 2, 4, 8 after the block
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life (WOMAC)
Time Frame: baseline to 8 weeks
|
The Western Ontario and McMaster Universities (WOMAC) is a self-administered health status measure and consists of 24 items divided into three domains, which are pain, stiffness, and physical function, validated to patients with hip or knee osteoarthritis
|
baseline to 8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Harris Hip Score (HHS)
Time Frame: baseline to 8 weeks
|
The Harris Hip Score (HHS) is a joint-specific measure, and it consists of two sections: questions and a physical examination, including a range of motion and deformity items.
The score has a maximum of 100 points with a maximum of 44 points for pain, 47 for function, 4 points for absence of deformity, and 5 points for a range of motion.
The highest score of 100 points indicates the best function and no pain.
|
baseline to 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: selin guven kose, Diskapi Teaching and Research Hospital
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)
April 25, 2020
Primary Completion (Actual)
August 20, 2021
Study Completion (Actual)
December 20, 2021
Study Registration Dates
First Submitted
September 30, 2021
First Submitted That Met QC Criteria
November 25, 2021
First Posted (Actual)
November 29, 2021
Study Record Updates
Last Update Posted (Actual)
April 4, 2023
Last Update Submitted That Met QC Criteria
April 2, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 84/18
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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