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Clinical Trials/NCT02686983
NCT02686983
Unknown
Phase 4

Greater Occipital Nerve Blockade for the Treatment of Chronic Migraine: a Randomized, Double- Blind, Placebo-controlled Study

Jakob Møller Hansen, MD.1 site in 1 country34 target enrollmentMarch 2016

Overview

Phase
Phase 4
Intervention
Betamethasone and local anesthetic
Conditions
Chronic Migraine
Sponsor
Jakob Møller Hansen, MD.
Enrollment
34
Locations
1
Primary Endpoint
Number of migraine days
Last Updated
10 years ago

Overview

Brief Summary

Infiltration of the greater occipital nerve (GON) with local anaesthetics and corticosteroids is a treatment option for cluster headache. Corticosteroids may be helpful in reducing the pain intensity and frequency in chronic migrtaine. This RCT is set up to assess efficacy and safety of sub-occipital steroid injections with local anesthetic in patients with chronic migraine.

Detailed Description

Infiltration of the greater occipital nerve (GON) with local anaesthetics and corticosteroids is a treatment option for cluster headache. In general, there is a marked paucity of evidence concerning GON blocks in migraine. Corticosteroids may be helpful in reducing the pain intensity and frequency in these patients. This is an RCT to assess efficacy and safety of sub-occipital steroid injections with local anesthetic in patients with chronic migraine.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
July 2018
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Jakob Møller Hansen, MD.
Responsible Party
Sponsor Investigator
Principal Investigator

Jakob Møller Hansen, MD.

MD, PhD

Danish Headache Center

Eligibility Criteria

Inclusion Criteria

  • Chronic migraine

Exclusion Criteria

  • Medication overuse headache

Arms & Interventions

Active

Betamethasone and local anesthetic.

Intervention: Betamethasone and local anesthetic

Placebo

Saline with local anesthetic.

Intervention: Betamethasone and local anesthetic

Outcomes

Primary Outcomes

Number of migraine days

Time Frame: 8 weeks

Number of days fulfilling the ICHD criteria for migraine

Secondary Outcomes

  • Responder rate(8 weeks)
  • Number of days with severe headache days(8 weeks)
  • Medication use(8 weeks)
  • Number of migraine attacks(8 weeks)

Study Sites (1)

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