NCT05723367

Brief Summary

The primary endpoint of this study was to identify that Perfusion index (PI) has any predictive value for the treatment outcome of cervical radiculopathy

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
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

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

February 3, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

February 13, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

February 3, 2023

Last Update Submit

February 13, 2023

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (5)

  • Perfusion index changes among 4 time periods

    Perfusion index changes among 4 time periods

    baseline, 10 minutes after erector spinae plane block, 20 minutes after erector spinae plane block, 30 minutes after erector spinae plane block

  • Number of patients showing numerical rating scale reduction more than 50%

    Number of patients showing numerical rating scale reduction more than 50%

    1 month after erector spinae plane block

  • Number of patients showing numerical rating scale reduction less than 50%

    Number of patients showing numerical rating scale reduction less than 50%

    1 month after erector spinae plane block

  • Number of patients showing no reduction in numerical rating scale

    Number of patients showing no reduction in numerical rating scale

    1 month after erector spinae plane block

  • Back pain functional scale between 2 time periods

    Back pain functional scale between 2 time periods

    baseline, 1 month after erector spinae plane block

Interventions

lumbar ESPB group where ESPB is performed at L4 with local anesthetics 20mlPROCEDURE

ultrasound guided fascial plane injection

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who visit the pain clinic

You may qualify if:

  • Lumbar foraminal stenosis
  • Lumbar central stenosis
  • Lumbar disc herniation
  • Lumbar spondylolisthesis

You may not qualify if:

  • Infection
  • Pregnancy
  • allergy to local anesthetic agnets
  • Previous lumbar spine surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ji Hoon Park

Daegu, 42601, South Korea

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Central Study Contacts

Ji H Hong

CONTACT

01046794343swon13@daum.net

Ji Hoon Park

CONTACT

+82532587760cmjihoon@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 3, 2023

First Posted

February 10, 2023

Study Start

February 13, 2023

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)