Vidian neurectomy for management of chronic cluster headache

ISRCTN	ISRCTN15975015
DOI	https://doi.org/10.1186/ISRCTN15975015
Secondary identifying numbers	20170425-VN

Submission date: 25/04/2017
Registration date: 23/05/2017
Last edited: 23/05/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
Cluster headaches are a type of headache which involves excruciating attacks of pain on one side of the head. They can affect people of any age, but tend to be more common in men and people over the age of 20. Attacks can be described as stabbing and of the most severe intensity “like a knife penetrating behind the eye”. Cluster headaches can be difficult to treat with 15-20% of patients not responding to drug treatment. The severity of pain and the frequency of attacks seriously degrade patients’ quality of life, justifying the consideration of other, more drastic therapies. Trans-nasal endoscopic vidian neurectomy is a surgical technique is a surgical technique which involves severing or removing the vidian nerve (a nerve in the head). The aim of this study is to find out whether this procedure is an effective treatment for long-term (chronic) cluster headaches.

Who can participate?
Adults who have been suffering from daily cluster headaches for three years.

What does the study involve?
All participants undergo a trans-nasal endoscopic vidian neurectomy while under general anesthesia (put to sleep). After this procedure, most patients can leave the hospital at the same day and without other discomforts except a feeling of fullness in the nose. At the start of the study and then one week and one, three and six months after the surgery, patients are interviewed and complete a questionnaire to find out if their symptoms have improved.

What are the possible benefits and risks of participating?
Participants nay benefit from an improvement to their cluster headache symtpoms. There is a risk of developing dry eyes, a dry nose or numbness in the palate (roof of the mouth).

Where is the study run from?
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation (Taiwan)

When is the study starting and how long is it expected to run for?
August 2011 to December 2016

Who is funding the study?
Investigator initiated and funded (Taiwan)

Who is the main contact?
Dr Shao-Cheng Liu
m871435@ndmctsgh.edu.tw

Contact information

Dr Shao-Cheng Liu
Scientific

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
No.289, Jianguo Road
Xindian District
New Taipei City
23142
Taiwan

ORCID ID	0000-0001-9730-1798
Phone	+886 2 8792 7192
Email	m871435@ndmctsgh.edu.tw

Study information

Study design	Single-centre non randomised interventional study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Surgical role of vidian neurectomy in treating chronic cluster headache
Study hypothesis	Precise vidian neurectomy (VN) with maximal preservation of SPG activity is both effective and safe in patients with chronic cluster headache with failed pharmacological management.
Ethics approval(s)	Institutional Review Board of Buddhist Tzu Chi General Hospital-Taipei Branch
Condition	Chronic cluster headache
Intervention	All participants undergo a trans-nasal endoscopic vidian neurectomy with maximal preservation of spheno-palatine ganglion activity. This involves precisely nerve transect via an endoscopic trans-naasl approach and no cauterization was used over the distal stump of the vidian nerve to avoid thermal injury of spheno-palatine ganglion. At baseline, one week, and one, three, six and twelve months post procedure, participants undergo a range of assessments to measure the change of their headache pattern, including mean attack frequency, mean attack intensity, and pain disability index, by patient interviews and medical tests.
Intervention type
Primary outcome measure	Headache pattern is measured by patient interviews, to obtain the change of the mean attack frequency (numbers of attacks per week) and mean attack intensity (using the visual analogue scale (VAS)) at baseline, one week, and one, three, six and twelve months post procedure.
Secondary outcome measures	The degree participants’ daily lives disrupted by cluster headache is obtained by patient interviews and questionnaire: the pain disability index (PDI) at baseline, one week, and one, three, six and twelve months post procedure.
Overall study start date	31/08/2011
Overall study end date	31/12/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	9
Participant inclusion criteria	1. Diagnosis of CCH according to the criteria of International Classification of Headache Disorders 2nd edition (ICHD-II) 2. Duration of CH exceeding three years 3. Daily attacks 4. Resistance to more than two pharmacological prophylactic treatments with adequate trials including rizatriptan or other available drugs in Taiwan (verapamil, lithium or steroid) 5. Treatment by vidian neurectomy ranked as a precise cut, with follow-up exceeding one year 6. Aged 17 years and over
Participant exclusion criteria	Patients with cluster headache who show good response to pharmacological treatments.
Recruitment start date	01/03/2013
Recruitment end date	31/12/2015

Locations

Countries of recruitment

Taiwan

Study participating centre

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

No.289, Jianguo Road
Xindian District
New Taipei City
23142
Taiwan

Sponsor information

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hospital/treatment centre

No.289, Jianguo Road
Xindian District
New Taipei City
23142
Taiwan

Phone	+886 2 8792 7192
Email	m871435@ndmctsgh.edu.tw
"ROR"	https://ror.org/037r57b62

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	31/12/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication of study results in a high-impact peer reviewed journal (such as Scientific Reports).
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Shao-Cheng Liu (m871435@ndmctsgh.edu.tw)