NCT05564065

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

September 30, 2022

Last Update Submit

September 30, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    Baseline

  • 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.

    1.month

  • 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.

    3.month

Study Arms (2)

Radiofrequency thermocoagulation of sensory branches of hip joint

ACTIVE COMPARATOR

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

Intraarticular steroid injection of hip joint

ACTIVE COMPARATOR

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

Procedure: Intraarticular steroid injection of hip joint

Interventions

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.

Radiofrequency thermocoagulation of sensory branches of hip joint

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

Intraarticular steroid injection of hip joint

Eligibility Criteria

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

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halil Cetingok

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Study Officials

  • Halil Cetingok, Ass. Prof

    Istanbul University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two groups: 1. intraarticular steroid injection of hip joint; 2. Radiofrequency thermocoagulation of femoral and obturator nerve terminal sensory branches of hip joint
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 3, 2022

Study Start

August 1, 2021

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

October 3, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations