HeadacheRHINONCT00580307
Rhinogenic Headache Improvement After Nasal Operation
A study testing Septoplasty and Septoplasty and endoscopic contact point correction in people with Headache, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Objective: To determine the efficacy of surgical correction of intranasal mucosal contact points in improving quality of life and decreasing medication use in patients with rhinogenic headaches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache
- What is being tested?
- Septoplasty and Septoplasty and endoscopic contact point correction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic (> 2 months) pain or pressure over nasal bridge, glabella, or forehead
- Unilateral or bilateral nasal septal deviation that is chronically symptomatic (e.g. nasal airway obstruction)
- Failure of standard medical therapy for headache
- Symptomatic contact points as demonstrated by physical examination, sinus CT and nasal endoscopy
- Relief of headache after application of topical anesthetic to contact points
- Contact points that remain after mucosal decongestion
- Absence of any other obvious cause of headaches after a thorough evaluation by a neurologist, ophthalmologist, dentist, internist, or other related specialist
Who cannot join
- Previous sinonasal surgery
- Active acute sinonasal disease:
- Seasonal allergic exacerbations with mucosal swelling
- Acute infectious rhino-sinusitis
- Chronic sinonasal problems:
- Severe nasal polyps mimicking contact points
Show all 9Show fewer
- Mucoceles protruding from sinuses into nasal cavity
- Nasal and sinus tumors
- General medical condition that precludes elective surgery (including pregnancy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Correction of Contact Point Headaches - Randomized Controlled Trial. [Rhinogenic Headache Improvement After Nasal Operation] Trial
Objective: To determine the efficacy of surgical correction of intranasal mucosal contact points in improving quality of life and decreasing medication use in patients with rhinogenic headaches.
Read the detailed description
Significance: Chronic, debilitating headaches that resist maximal medical treatment by various headache specialists are sometimes linked to structural anomalies within the nose that exert pressure on apposing mucosal surfaces. A number of otolaryngologists have reported success in alleviating rhinogenic headaches with contact point correction surgery. This practice is supported by anecdotal reports along with retrospective and observational studies; however, a prospective study with an appropriate surgical control group has not been conducted. Because the specific effect of contact point correction has not yet been differentiated from the placebo effect of surgery itself, many headache specialists are reluctant to recommend surgical evaluation for their patients. To demonstrate the efficacy of contact point correction surgery to both the headache and otolaryngology communities - and thus, to make this treatment option more widely available to rhinogenic headache sufferers - a randomized controlled trial is needed.
- Conditions
- Headache
- Being tested
- Septoplasty, Septoplasty and endoscopic contact point correction
- Keywords
- Headache, Rhinogenic, Nose, Nasal septum, Deviated septum, Surgery, Septoplasty, Turbinoplasty, Contact point, HIT-6
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeptoplastyProcedure or surgery
Surgical straightening of nasal septum
Septoplasty and endoscopic contact point correctionProcedure or surgery
Also called Turbinoplasty
Septoplasty (as previously described). Contact point correction: structures of the lateral nasal wall that impinge on the nasal septum are mobilized to a more lateral position under endoscopic guidance.
| Study group | Role | What they receive |
|---|---|---|
| Septoplasty | Placebo comparator | Septoplasty only Receives: Procedure: Septoplasty |
| Septoplasty and correction | Experimental | Septoplasty and endoscopic contact point correction Receives: Procedure: Septoplasty and endoscopic contact point correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group difference in patient-rated headache improvement at 10 days, 6 weeks, 6 months and 12 months post-intervention, as measured by a validated questionnaire, the Headache Impact Test - 6 (HIT-6™).
Measured: 12 months
Secondary outcomes (1)
Between-group differences in subject responses to a non-validated questionnaire so as to permit comparison with previous studies. Additionally, headache medication use will be examined as a secondary end-point.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew P Page, MD, Principal investigator, Dept. OtoHNS, U. Missouri - ColumbiaAlvis L Barrier, MD, Study director, Dept. OtoHNS, U. Missouri- ColumbiaKaren H Calhoun, MD, FACS, Study chair, Dept. OtoHNS, U. Missouri - Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580307
- Sponsor's protocol ID
- 1089377
- Acronym
- RHINO
- Status last verified
- Sep 2016
- First submitted
- 12 Dec 2007
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Correction of Contact Point Headaches - Randomized Controlled Trial. [Rhinogenic Headache Improvement After Nasal Operation] Trial
- ClinicalTrials.gov ID
- NCT00580307
- Acronym / sponsor ID
- RHINO / 1089377
- Conditions
- Headache
- Keywords
- Headache, Rhinogenic, Nose, Nasal septum, Deviated septum, Surgery, Septoplasty, Turbinoplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To determine the efficacy of surgical correction of intranasal mucosal contact points in improving quality of life and decreasing medication use in patients with rhinogenic headaches.
Detailed description
Significance: Chronic, debilitating headaches that resist maximal medical treatment by various headache specialists are sometimes linked to structural anomalies within the nose that exert pressure on apposing mucosal surfaces. A number of otolaryngologists have reported success in alleviating rhinogenic headaches with contact point correction surgery. This practice is supported by anecdotal reports along with retrospective and observational studies; however, a prospective study with an appropriate surgical control group has not been conducted. Because the specific effect of contact point correction has not yet been differentiated from the placebo effect of surgery itself, many headache specialists are reluctant to recommend surgical evaluation for their patients. To demonstrate the efficacy of contact point correction surgery to both the headache and otolaryngology communities - and thus, to make this treatment option more widely available to rhinogenic headache sufferers - a randomized controlled trial is needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septoplasty | Placebo comparator | Procedure: SeptoplastySeptoplasty only |
| Septoplasty and correction | Experimental | Procedure: Septoplasty and endoscopic contact point correctionSeptoplasty and endoscopic contact point correction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronic (> 2 months) pain or pressure over nasal bridge, glabella, or forehead
- Unilateral or bilateral nasal septal deviation that is chronically symptomatic (e.g. nasal airway obstruction)
- Failure of standard medical therapy for headache
- Symptomatic contact points as demonstrated by physical examination, sinus CT and nasal endoscopy
- Relief of headache after application of topical anesthetic to contact points
Key exclusion criteria (9 listed)
- Previous sinonasal surgery
- Active acute sinonasal disease:
- Chronic sinonasal problems:
- General medical condition that precludes elective surgery (including pregnancy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeptoplastySurgical straightening of nasal septum | Procedure or surgery | Septoplasty |
| Septoplasty and endoscopic contact point correctionAlso: TurbinoplastySeptoplasty (as previously described). Contact point correction: structures of the lateral nasal wall that impinge on the nasal septum are mobilized to a more lateral position under endoscopic guidance. | Procedure or surgery | Septoplasty and correction |
Primary outcome
Between-group difference in patient-rated headache improvement at 10 days, 6 weeks, 6 months and 12 months post-intervention, as measured by a validated questionnaire, the Headache Impact Test - 6 (HIT-6™).
Time frame: 12 months
1 secondary outcome
Between-group differences in subject responses to a non-validated questionnaire so as to permit comparison with previous studies. Additionally, headache medication use will be examined as a secondary end-point.
Time frame: 12 months
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew P Page, MD principal investigator
Dept. OtoHNS, U. Missouri - Columbia
Alvis L Barrier, MD study director
Dept. OtoHNS, U. Missouri- Columbia
Karen H Calhoun, MD, FACS study chair
Dept. OtoHNS, U. Missouri - Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Septoplasty and Septoplasty and endoscopic contact point correction in people with Headache, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group difference in patient-rated headache improvement at 10 days, 6 weeks, 6 months and 12 months post-intervention, as measured by a validated questionnaire, the Headache Impact Test - 6 (HIT-6™). (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.