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Capsaicin in Treatment of Rhinogenic Headache

Primary Purpose

Headache Disorders

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Capsaicin
Placebo
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache Disorders

Eligibility Criteria

19 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Consenting Adults aged 19-100 presenting to the Otolaryngology DepartmentofUniversityof Nebraska Medical center complaining of headaches/ facial pain and pressure Diagnosis of a primary rhinogenic headache disorder by the senior authors.

Exclusion Criteria:

  • Exclusion criteria include: pregnancy, age less than 19, active history of smoking, presence of confirmed sinonasal disease, fibromyalgia, poorly controlled chronic health problems, allergies to chili peppers or any ingredient in the nasal spray, or confirmed Temporal Mandibular Joint (TMJ) arthralgia as the etiology of primary headache.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Experimental Group

    Placebo Group

    Arm Description

    This group will receive the capsaicin. The Study Drug ICX72 or sinus buster which is a homeopathic blend of capsicum annum and eucalyptol, that is readily available over the counter.

    This group will receive saline. The Placebo formulation contained saline and eucalyptol in a concentration that matched the control.

    Outcomes

    Primary Outcome Measures

    headache medication use
    We will track the amount of headache medication used during the study period

    Secondary Outcome Measures

    number of patients with treatment related adverse events
    patients will be asked to report any adverse reactions or events during the study period.
    headache frequency and severity
    Patient will be asked to record the number of headaches during the study period, and record the severity from 1-10 on the Visual Analog Scale (VAS)

    Full Information

    First Posted
    July 27, 2017
    Last Updated
    August 16, 2023
    Sponsor
    University of Nebraska
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03330639
    Brief Title
    Capsaicin in Treatment of Rhinogenic Headache
    Official Title
    The Role of Topical Capsaicin in Treatment of Rhinogenic Headache
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Grant funding for study was not obtained.
    Study Start Date
    July 2017 (Anticipated)
    Primary Completion Date
    June 23, 2020 (Actual)
    Study Completion Date
    June 23, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Nebraska

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Description: Capsaicin (8- methyl-N-vanillyl-6-nonenamide) has been demonstrated to have a therapeutic effect in idiopathic rhinitis. We hypothesize that capsaicin has a therapeutic effect on rhinogenic headaches, in addition to the previously studied decongestive effects. This study aims to evaluate capsaicin impact on headaches attributed to V1, V2 distribution of the sinonasal cavity. This study is a randomized, double-blinded, parallel trial.
    Detailed Description
    Title: The role of capsaicin in treatment of rhinogenic headache Description: Capsaicin (8- methyl-N-vanillyl-6-nonenamide) has been demonstrated to have a therapeutic effect in idiopathic rhinitis, migraines and cluster headaches. We hypothesize that capsaicin has a therapeutic effect on rhinogenic headaches as well. This study aims to evaluate capsaicin impact on headaches attributed to the nose and paranasal sinus distribution. Interventions, evaluations, and follow-up: Subjects are recruited from an Otolaryngology clinic, where a formal headache questionnaire is administered in-office, and standard endoscopy is performed in office to rule out confounding causes of headache and sinonasal disease. Written instructions are provided and consent obtained. A symptom journal is provided. Subjects are randomly selected to receive two bottles of either eucalyptol spray (placebo) or sinus buster (capsaicin) spray and are blinded to the content of the spray bottle. They are instructed to use the nasal spray one to two times daily. Subjects are permitted to continue to take headache medication as needed, but it must be recorded in their symptom journal. The journal is completed daily, and includes medication use, a headache pain score, and side effect log. Additionally, subjects fill out SinoNasal Outcome test (SNOT)22 at 2 weeks, 4 weeks, and 8 weeks. Weekly emails are sent to remind subject to fill out their journal. A phone call is made to the subject to survey them on progress at 2 and 6 weeks. Follow up visits are scheduled at 4 weeks and 8 weeks, or sooner if problems arise. A standard nasal endoscopy is performed at the first and last visit. Additional data that would be tracked: Quality of life score as measured by SNOT-22 scores, treatment failure and drop-outs, and objective changes in sinus endoscopy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Headache Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized parallel group
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    This group will receive the capsaicin. The Study Drug ICX72 or sinus buster which is a homeopathic blend of capsicum annum and eucalyptol, that is readily available over the counter.
    Arm Title
    Placebo Group
    Arm Type
    Placebo Comparator
    Arm Description
    This group will receive saline. The Placebo formulation contained saline and eucalyptol in a concentration that matched the control.
    Intervention Type
    Other
    Intervention Name(s)
    Capsaicin
    Intervention Description
    Capsaicin is a homeopathic medication and there for this drug is not subject to the requirements of the FDA.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    This group will receive the saline placebo solution.
    Primary Outcome Measure Information:
    Title
    headache medication use
    Description
    We will track the amount of headache medication used during the study period
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    number of patients with treatment related adverse events
    Description
    patients will be asked to report any adverse reactions or events during the study period.
    Time Frame
    1 year
    Title
    headache frequency and severity
    Description
    Patient will be asked to record the number of headaches during the study period, and record the severity from 1-10 on the Visual Analog Scale (VAS)
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Consenting Adults aged 19-100 presenting to the Otolaryngology DepartmentofUniversityof Nebraska Medical center complaining of headaches/ facial pain and pressure Diagnosis of a primary rhinogenic headache disorder by the senior authors. Exclusion Criteria: Exclusion criteria include: pregnancy, age less than 19, active history of smoking, presence of confirmed sinonasal disease, fibromyalgia, poorly controlled chronic health problems, allergies to chili peppers or any ingredient in the nasal spray, or confirmed Temporal Mandibular Joint (TMJ) arthralgia as the etiology of primary headache.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christie Barnes, MD
    Organizational Affiliation
    University of Nebraska
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26171907
    Citation
    Gevorgyan A, Segboer C, Gorissen R, van Drunen CM, Fokkens W. Capsaicin for non-allergic rhinitis. Cochrane Database Syst Rev. 2015 Jul 14;(7):CD010591. doi: 10.1002/14651858.CD010591.pub2.
    Results Reference
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    Capsaicin in Treatment of Rhinogenic Headache

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