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Comparison of the Effect of Intra Articular Steroid Injection and Pericapsular Nerve Group Block for Hip Osteoarthritis

Primary Purpose

Hip Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
intraarticular injection
peng block
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Diskapi Yildirim Beyazit Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intraarticular injection

peng block

Arm Description

intra-articular steroid injection with the ultrasound guidance technique,

Ultrasound guided drug injection between to iliopubic eminentia and psoas tendon

Outcomes

Primary Outcome Measures

numerical rating scale (NRS) pain score
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.

Secondary Outcome Measures

Quality of Life (WOMAC)
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

Full Information

First Posted
September 30, 2021
Last Updated
April 2, 2023
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05136248
Brief Title
Comparison of the Effect of Intra Articular Steroid Injection and Pericapsular Nerve Group Block for Hip Osteoarthritis
Official Title
Comparison of Ultrasound Guided Intra-articular Steroid Injection and Pericapsular Nerve Group Block (PENG) in Patients With Chronic Hip Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 25, 2020 (Actual)
Primary Completion Date
August 20, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intraarticular injection
Arm Type
Experimental
Arm Description
intra-articular steroid injection with the ultrasound guidance technique,
Arm Title
peng block
Arm Type
Active Comparator
Arm Description
Ultrasound guided drug injection between to iliopubic eminentia and psoas tendon
Intervention Type
Procedure
Intervention Name(s)
intraarticular injection
Intervention Description
Ultrasound-guided intraarticular injection
Intervention Type
Procedure
Intervention Name(s)
peng block
Intervention Description
Ultrasound-guided PENG block
Primary Outcome Measure Information:
Title
numerical rating scale (NRS) pain score
Description
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.
Time Frame
change from baseline to day 1, week 2, 4, 8 after the block
Secondary Outcome Measure Information:
Title
Quality of Life (WOMAC)
Description
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
Time Frame
baseline to 8 weeks
Other Pre-specified Outcome Measures:
Title
Change in Harris Hip Score (HHS)
Description
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.
Time Frame
baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
selin guven kose
Organizational Affiliation
Diskapi Teaching and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diskapi Yildirim Beyazit Training and Research Hospital
City
Ankara
ZIP/Postal Code
06110
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Comparison of the Effect of Intra Articular Steroid Injection and Pericapsular Nerve Group Block for Hip Osteoarthritis

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