NCT05487313

Brief Summary

The primary endpoint of this study was to identify if the ESPB in the patients of cervical radiculopathy has the effect of pain relief. The secondary endpoint of this study was to identify the spread level in the craniocaudal direction when performed at the T2 level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

August 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

August 12, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2023

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

August 1, 2022

Last Update Submit

March 28, 2023

Conditions

Pain, Chronic

Keywords

Pain, Cervical, Spread

Outcome Measures

Primary Outcomes (2)

  • numerical rating scale changes among 5 times period

    numerical rating scale changes after T2 ESPB among 5 times period

    baseline, 10 minutes after ESPB, 1 week after ESPB, 2 weeks after ESPB, 4 weeks after ESPB, 8 weeks after ESPB

  • Neck disability scale changes

    Neck disability scale changes after T2 ESPB among 2 times period

    baseline, 8 weeks after ESPB

Secondary Outcomes (1)

  • spread level in the cranio-caudal direction

    baseline, 1 minute after erector spinae plane block

Study Arms (2)

10 ml ESP group

ACTIVE COMPARATOR

ESP group using 10 ml mixture of local anesthetics and contrast medium

Procedure: Erector spinae plane block

20 ml ESP group

ACTIVE COMPARATOR

ESP group using 20 ml mixture of local anesthetics and contrast medium

Procedure: Erector spinae plane block

Interventions

Erector spinae plane blockPROCEDURE

fascial plane injection guided by fluoroscopic device after ultrasound guidance

10 ml ESP group20 ml ESP group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cervical facet joint arthrosis
  • cervical foraminal stenosis
  • cervical herniated intervertebral disc
  • myofascial pain syndrome of upper back muscle

You may not qualify if:

  • Allergy to local anesthetics or contrast medium
  • pregnancy
  • prior history of cervical spine surgery
  • coagulation abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong ji HEE

Daegu, 42601, South Korea

Location

MeSH Terms

Conditions

Chronic PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ji H Hong, Ph.D

    Keimyung University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 1, 2022

First Posted

August 4, 2022

Study Start

August 12, 2022

Primary Completion

March 21, 2023

Study Completion

March 21, 2023

Last Updated

March 30, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)