NCT05723354

Brief Summary

The primary endpoint of this study was to compare the clinical efficacy of axillary block in patients of cervical radiculopathy using 2 volumes of local anesthetics.

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
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

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

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 (2)

  • Numerical rating scale changes among 4 time periods

    Numerical rating scale changes among 4 time periods

    baseline, 2 weeks after injection, 4 weeks after injection, 8 weeks after injection

  • Neck disability injex changes between 2 time periods

    Neck disability injex changes between 2 time periods

    baseline, 8 weeks after injection

Study Arms (2)

5ml axillary block group

ACTIVE COMPARATOR

interfascial plane axillary block group using 5 ml local anesthetics

Procedure: axillary block guided by ultrasound

10ml axillary block group

ACTIVE COMPARATOR

interfascial plane axillary block group using 10 ml local anesthetics

Procedure: axillary block guided by ultrasound

Interventions

axillary block guided by ultrasoundPROCEDURE

axillary block using local anesthetics

10ml axillary block group5ml axillary block group

Eligibility Criteria

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

You may qualify if:

  • Cervical foraminal stenosis
  • Cervical central stenosis
  • Cervical disc herniation
  • Cervical spondylolisthesis
  • Prominent arm pain rather than neck pain

You may not qualify if:

  • Infection
  • Pregnancy
  • allergy to local anesthetic agents
  • previous cervical spine surgery
  • Prominent neck pain rather than arm pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong ji HEE

Daegu, 42601, South Korea

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ji H Hong

CONTACT

01046794343swon13@daum.net

Ji Hoon Park

CONTACT

+82532587760cmjihoon@gmail.com

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

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

Locations

KR(1)