NCT01648543

Brief Summary

Lumbar sympathetic ganglion block is used for several neuropathic pain syndromes. The best method of lumbar sympathetic ganglion block is not established. The investigators would compare two methods of lumbar sympathetic ganglion block. One is modified Reid method which's entry point is 7\~7.5cm from midline of spinous process of lumbar spine. The other is angular method which's entry angle is 30 degree from anterior-posterior view of C-arm. Comparison modified Reid method with angular method would be helpful for finding best method of lumbar sympathetic ganglion 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
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

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

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 24, 2012

Status Verified

July 1, 2012

Enrollment Period

6 months

First QC Date

July 19, 2012

Last Update Submit

July 23, 2012

Conditions

Lumbar Sympathetic Ganglion Block Indication: Neuropathic Pain, CRPS, Hyperhydrosis Etc.

Outcome Measures

Primary Outcomes (2)

  • temperature change

    30min

  • muscle or vessel shadow

    30min

Study Arms (2)

block method: angle

ACTIVE COMPARATOR

The entry angle of angular method which is one method of lumbar sympathetic ganglion block is 30 degree of anterior-posterior view of C-arm.

Procedure: lumbar sympathetic ganglion block

block method: distance

ACTIVE COMPARATOR

The entry point of modified Reid method which is popular method of lumbar sympathetic ganglion block is 7\~7.5cm from midline of spinous process of lumbar spine.

Procedure: lumbar sympathetic ganglion block

Interventions

lumbar sympathetic ganglion blockPROCEDURE
block method: angleblock method: distance

Eligibility Criteria

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

You may qualify if:

  • Adults above age of 20
  • Undergoing lumbar sympathetic ganglion block indication

You may not qualify if:

  • Infection
  • Bleeding tendency
  • Previous spinal surgery history
  • Pregnancy
  • Illiteracy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

Study Officials

  • Jong Bum Choi

    Yonsei University

    STUDY DIRECTOR

Central Study Contacts

Jong Bum Choi

CONTACT

+82-2-2019-6093ROMEOJB@yuhs.ac

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
Yonsei University College of Medicine

Study Record Dates

First Submitted

July 19, 2012

First Posted

July 24, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 24, 2012

Record last verified: 2012-07

Locations

KR(1)