NCT02031822

Brief Summary

Headache is one of the most common reasons for patients to access healthcare. Greater occipital nerve (GON) block with local anesthetic and steroid has been described for the management of primary headache refractory to conventional treatment. Two ultrasound (US)-guided techniques for greater occipital nerve (GON) block have been described for the management of refractory headache syndromes: a proximal technique performed at the level of the second cervical vertebra and a distal technique performed at the level of the superior nuchal line. Our airm is to compare the accuracy, efficacy and safety of these two techniques in patients with refractory headaches.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

January 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 30, 2018

Status Verified

October 1, 2017

Enrollment Period

3.3 years

First QC Date

January 7, 2014

Last Update Submit

May 29, 2018

Conditions

Primary Headache

Keywords

Primary HeadacheGreater Occipital NerveUltrasoundChronic PainCervicogenicOccipital NeuralgiaMigraineTension type headacheCluster headache

Outcome Measures

Primary Outcomes (1)

  • Numerical rating score (NRS) for headaches

    One month

Secondary Outcomes (3)

  • Efficacy-Related Outcomes

    24 hours and 3 months

  • Performance-Related Outcomes

    During procedure

  • Safety-Related Outcomes

    Immediate post-procedure and at 1 month

Study Arms (2)

US-guided Distal GON Block (Group D)

ACTIVE COMPARATOR

Needle placement for 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg will be performed under US guidance at the level of the superior nuchal line lateral to the external occipital protuberance, close to the occipital artery.

Procedure: US-guided Greater Occipital Nerve Injection

US-guided Proximal GON Block (Group P)

ACTIVE COMPARATOR

Needle placement for 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg will be performed under US guidance at the level of the bifid C2 spinous process laterally, between the inferior obliquus capitis and semispinalis capitis muscles.

Procedure: US-guided Greater Occipital Nerve Injection

Interventions

US-guided Greater Occipital Nerve InjectionPROCEDURE

Medication injected around the greater occipital nerve: 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg.

US-guided Distal GON Block (Group D)US-guided Proximal GON Block (Group P)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Features suggestive of occipital neuralgia: pain that begins in the upper neck and back of the head with radiation forward toward the eye and has an aching or burning character.
  • Diagnosis of refractory primary headache, any type
  • Baseline NRS headache score of \> 4 refractory to conventional oral analgesic therapy (anti-inflammatory drugs, migraine prophylaxis and treatment drugs, opioids).

You may not qualify if:

  • Ongoing litigation issues related to the patient's pain
  • Pregnancy
  • Allergy to steroids or local anesthetics
  • Multiple serious comorbidities
  • Age \< 18 or age ≥ 80 years
  • GON injection within last 3 months at time of entry into the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (1)

  • Flamer D, Alakkad H, Soneji N, Tumber P, Peng P, Kara J, Hoydonckx Y, Bhatia A. Comparison of two ultrasound-guided techniques for greater occipital nerve injections in chronic migraine: a double-blind, randomized, controlled trial. Reg Anesth Pain Med. 2019 May;44(5):595-603. doi: 10.1136/rapm-2018-100306. Epub 2019 Mar 18.

    PMID: 30886069DERIVED

MeSH Terms

Conditions

Chronic PainMigraine DisordersTension-Type HeadacheCluster Headache

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTrigeminal Autonomic Cephalalgias

Study Officials

  • Anuj Bhatia, MD FRCPC

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 9, 2014

Study Start

June 1, 2014

Primary Completion

September 1, 2017

Study Completion

May 1, 2018

Last Updated

May 30, 2018

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)