Capsaicin in Treatment of Rhinogenic Headache

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

1. Title: The role of capsaicin in treatment of rhinogenic headache 2. 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. 3. 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. 4. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03330639
Study type	Interventional
Source	University of Nebraska
Contact
Status	Withdrawn
Phase	N/A
Start date	July 2017
Completion date	June 23, 2020

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT03632928` - Day to Day Variation of Pressure Pain Threshold and Muscle Hardness
Completed	`NCT00246350` - Spinal Manipulation for Treatment of Chronic Headaches	Phase 2
Completed	`NCT05404113` - Sustained Natural Apophyseal Glide and Deep Friction Massage in Patients With Cervicogenic Headache	N/A
Recruiting	`NCT03416114` - RegistRare: a Retro-prospective Registry of Rare Primary Headaches in Italian Tertiary Headache Centres	N/A
Enrolling by invitation	`NCT04976985` - Osteopathic Manipulative Treatment and Migraine Headaches	N/A
Recruiting	`NCT05153876` - An Open Internet-based Survey and Natural Language Processing Project Analysing Written Monologues by Headache Patients
Recruiting	`NCT06041997` - Smartphone Use Restriction as Treatment of Primary Headache	N/A
Active, not recruiting	`NCT04936321` - Intervention for Sleep and Pain in Youth: A Randomized Controlled Trial	N/A
Completed	`NCT04220580` - Multiomics After Cold Pressor Test of People Who Are Unable to Have Headache	N/A
Completed	`NCT03385174` - Carbon Monoxide Headache Triggering Properties as Well as Effects on the Brain's Vessels and Blood Flow	N/A
Completed	`NCT03137147` - Intervention for Sleep and Pain in Youth	N/A
Completed	`NCT02910921` - Individualized Prediction of Migraine Attacks Using a Mobile Phone App and Fitbit
Recruiting	`NCT05619354` - Validity and Reliability of the Dutch HDI
Recruiting	`NCT06206772` - Resting State Functional Connectivity in Cluster Headache
Completed	`NCT02662972` - Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.	Phase 1/Phase 2
Terminated	`NCT02624661` - Glycerol Block of the Trigeminal Ganglion in Trigeminal Neuralgia Using a New Neuronavigation-based Surgical Technique	Phase 1/Phase 2
Completed	`NCT05381012` - Fibromyalgia Syndrome on Patients With Chronic Migraine	N/A
Completed	`NCT04891848` - Assessment of Inflammation in Primary Headaches
Recruiting	`NCT04715685` - Mind Body Balance for Pediatric Migraine	N/A
Completed	`NCT00457496` - Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in Working Communities	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.