NCT05136248

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 30, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 29, 2021

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

April 4, 2023

Status Verified

April 1, 2023

Enrollment Period

1.3 years

First QC Date

September 30, 2021

Last Update Submit

April 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    change from baseline to day 1, week 2, 4, 8 after the block

Secondary Outcomes (1)

  • Quality of Life (WOMAC)

    baseline to 8 weeks

Other Outcomes (1)

  • Change in Harris Hip Score (HHS)

    baseline to 8 weeks

Study Arms (2)

intraarticular injection

EXPERIMENTAL

intra-articular steroid injection with the ultrasound guidance technique,

Procedure: intraarticular injection

peng block

ACTIVE COMPARATOR

Ultrasound guided drug injection between to iliopubic eminentia and psoas tendon

Procedure: peng block

Interventions

Ultrasound-guided intraarticular injection

intraarticular injection
peng blockPROCEDURE

Ultrasound-guided PENG block

peng block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hip pain NRS \> 4
  • No pathologies in the laboratory and coagulation parameters

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Yildirim Beyazit Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Injections, Intra-Articular

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

InjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • selin guven kose

    Diskapi Teaching and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal Investigator

Study Record Dates

First Submitted

September 30, 2021

First Posted

November 29, 2021

Study Start

April 25, 2020

Primary Completion

August 20, 2021

Study Completion

December 20, 2021

Last Updated

April 4, 2023

Record last verified: 2023-04

Locations