NCT05822310

Brief Summary

In this study ,the investigators aimed to show the decrease in pain levels and the effect on quality of life of patients who underwent chronic hip painRFT , intraartıcular steroid injection and Peng block.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

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

First Submitted

Initial submission to the registry

January 19, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

April 15, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

12 months

First QC Date

January 19, 2023

Last Update Submit

April 19, 2023

Conditions

Keywords

femoral and obturatuar nervechronic hip painRadiofrequency thermocoagulationintraartıcular steroid injectionpericapsular nerve group (PENG) block

Outcome Measures

Primary Outcomes (3)

  • NRS(Numerating Rating Scale) for chronic pain

    İt is a pain intensity determination system based on the system where there person tells a point between 0=(no pain) 10=( unbearable pain) and to describe their pain

    preoperative

  • NRS(Numerating Rating Scale) for chronic pain

    İt is a pain intensity determination system based on the system where there person tells a point between 0=(no pain) 10=( unbearable pain) and to describe their pain

    Postoperative first month

  • NRS(Numerating Rating Scale) for chronic pain

    İt is a pain intensity determination system based on the system where there person tells a point between 0=(no pain) 10=( unbearable pain) and to describe their pain

    Postoperative third month

Secondary Outcomes (3)

  • WOMAC (Western OntarioandMcMasterUniversitiesArthritisIndex )

    Preoperative

  • WOMAC (Western OntarioandMcMasterUniversitiesArthritisIndex )

    Postoperative first month

  • WOMAC (Western OntarioandMcMasterUniversitiesArthritisIndex )

    Postoperative third month

Other Outcomes (1)

  • NRS(Numerating Rating Scale) for acute pain

    postoperative second hour

Study Arms (3)

radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves

EXPERIMENTAL

radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves applied

Procedure: radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves

intraairticular steroid injection

ACTIVE COMPARATOR

intraairticular steroid injection applied

Procedure: intraairticular steroid injection

pericapsular nerve group (PENG) block

ACTIVE COMPARATOR

pericapsular nerve group (PENG) block applied

Procedure: pericapsular nerve group (PENG) block

Interventions

Patients are operated under sedation in the operating room. C-arm fluoroscopy device is used for imaging purposes for radiofrequency thermocoagulation process. In order to prevent vascular injury, the needle is advanced under the guidance of ultrasonography. There are target points determined in fluoroscopy for the femoral nerve and the obturatory nerve. Before the thermocoagulation procedure, local anesthetic and steroid are injected into each of the target points.

radiofrequency thermocoagulation to the articular branches of the femoral and obturatory nerves

The patients were placed in the supine position in the operating room. The patient was stained sterile with povidone iodide. The femoral neck was detected under ultrasonography and the joint capsule was entered with a 22G 9 cm spinal needle. Then, 5 cc bupivacaine and 5 mg betamethasone were given and the procedure was terminated.

intraairticular steroid injection

The patients were placed in the supine position in the operating room. The patient was stained sterile with povidone iodide. The high-frequency linear ultrasonography probe was placed on the anterior superior iliacspina (ASIS). Later, the anterior inferior iliac spine (AIIS) was detected by descending caudally. Afterwards, the probe was brought to the oblique position and AIIS, iliopubikeminence, psoas muscle and tendon were seen. Using a 22G 90-mm Quinckespinal needle, the tendon of the iliopsoas muscle was entered in the lateral-medial direction in the in-plane plane and bone contact was achieved. After negative aspiration, 15 ml of 0.5% bupivacaine were administered by seeing the appropriate drug distribution.

pericapsular nerve group (PENG) block

Eligibility Criteria

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

You may qualify if:

  • be over 18 years old
  • Written consent has been obtained
  • Those with chronic hip pain for more than 3 weeks

You may not qualify if:

  • Major psychiatric illness
  • The patient has lumbar compression pain or referred pain
  • Patients using anticoagulant agents
  • Patients with infection in the area to be treated
  • Those who are allergic to local anesthetics
  • Those who are allergic to betamethasone
  • Pregnancy
  • Patients who underwent hip surgery during the 3-month follow-up period during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adnan Menderes University Faculty of Medicine

Aydin, 09010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Bites and Stings

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Central Study Contacts

BİLGENUR ERGÜN DEMİRÖZ, RESİDENT DOCTOR

CONTACT

Sinem Sarı Öztürk, Associate professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 19, 2023

First Posted

April 20, 2023

Study Start

April 15, 2023

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

April 20, 2023

Record last verified: 2023-04

Locations