NCT00896688

Brief Summary

The diagnostic cervical branch block for neck pain due to cervical facet joint pain has been traditionally done under fluoroscopic guidance. Its diagnostic value and technique have been well established. However, recently some studies have shown that the diagnostic cervical and lumbar medial branch block can be done under ultrasound guidance.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

April 30, 2009

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
7.6 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 14, 2018

Status Verified

December 1, 2018

Enrollment Period

11 months

First QC Date

April 30, 2009

Last Update Submit

December 13, 2018

Conditions

Keywords

cervical branch blockfluoroscopic guidanceultrasound guidance

Outcome Measures

Primary Outcomes (1)

  • To determine the efficacy of the use of ultrasound for diagnostic cervical medial branch block on pain patients who have developed neck pain, cervicogenic headache, or shoulder pain.

    At time of procedure

Secondary Outcomes (1)

  • Interventional pain procedure studies on chronic pain patients

    At time of procedure

Study Arms (2)

Healthy Volunteers

It will involve 5 volunteers and they will undergo C arm fluoroscopic guided cervical medial branch blocks (C2-C7) on unilateral position and then followed by the 3D ultrasound machine for visualization of needle position.

Procedure: cervical medial branch blocks using the Quincke spinal needle

Candidates for upper and lower cervial medical branch blocks

This will involve 25 patients and they will follow the same procedures as the healthy volunteers.

Procedure: cervical medial branch blocks using the Quincke spinal needle

Interventions

#25 gauge 1 and 1/2 inch long needle and #25 gauge 10cm long Quincke spinal needle will be used for placement.

Candidates for upper and lower cervial medical branch blocksHealthy Volunteers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • healthy volunteers
  • patients who have headache, neck pain, and shoulder pain due to possible facet joint disease

You may not qualify if:

  • patients/volunteers with BMI \> 35
  • patients/volunteers with short thick neck
  • coagulopathy
  • allergy to local anesthetic, ultrasound gel
  • patient unable to fill out post procedure pain diary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (2)

  • Fishman SM, Smith H, Meleger A, Seibert JA. Radiation safety in pain medicine. Reg Anesth Pain Med. 2002 May-Jun;27(3):296-305. doi: 10.1053/rapm.2002.32578. No abstract available.

    PMID: 12016604BACKGROUND
  • Greher M, Scharbert G, Kamolz LP, Beck H, Gustorff B, Kirchmair L, Kapral S. Ultrasound-guided lumbar facet nerve block: a sonoanatomic study of a new methodologic approach. Anesthesiology. 2004 May;100(5):1242-8. doi: 10.1097/00000542-200405000-00028.

    PMID: 15114223BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph Park, MD

    Hamilton Health Sciences Corporation

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2009

First Posted

May 12, 2009

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 14, 2018

Record last verified: 2018-12

Locations