NCT05487326

Brief Summary

The primary endpoint of this study was to identify whether there is a pain improving effect of high thoracic eretor spinae plane block (ESPB) when compared with cervical epidural injection

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
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
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

August 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

August 7, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

April 5, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

August 1, 2022

Last Update Submit

April 2, 2023

Conditions

Pain, Chronic

Keywords

Pain, lumbar

Outcome Measures

Primary Outcomes (1)

  • Changes of numerical rating scale

    Changes of 11-point numerical rating scale (0-10)

    baseline, 10 min after injection, 1wk after injection, 2 wks after injection, 4 wks after injection, 8 wks after injection

Secondary Outcomes (1)

  • Changes of neck disability index

    baseline, 8 wks after injection

Study Arms (2)

high thoracic ESPB group

ACTIVE COMPARATOR

Group where ESPB is performed at T2 with local anesthetic mixture 20 ml

Procedure: Erector spinae plane block

cervical epidural group

ACTIVE COMPARATOR

Group where cervical epidural injection is performed at C6-7 or C7-T1 level

Procedure: cervical epidural injection

Interventions

Erector spinae plane blockPROCEDURE

fascial plane injection guided by ultrasound guidance

high thoracic ESPB group
cervical epidural injectionPROCEDURE

cervical epidural injection by fluoroscopy

cervical epidural group

Eligibility Criteria

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

You may qualify if:

  • cervical spinal stenosis
  • cervical intervertebral disc herniation
  • cervical facet arthropathy
  • cervical foraminal stenosis

You may not qualify if:

  • Allergy to local anesthetics or contrast medium
  • Pregnancy
  • Spine deformity
  • Patients with coagulation abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong ji HEE

Daegu, 42601, South Korea

RECRUITING

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

Central Study Contacts

Ji H Hong, Ph.D

CONTACT

01046794343swon13@daum.net

Sung W Jung

CONTACT

01021064343swon12@daum.net

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 7, 2022

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

April 5, 2023

Record last verified: 2023-04

Locations

KR(1)