Contact information
Type
Scientific
Primary contact
Dr Wim Weber
ORCID ID
Contact details
Dept. Neurology
University Hospital Maastricht
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
+31 (0)43 3875117
wweb@neurologie.azm.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
ITCH
Study hypothesis
A sequence of cervical radiofrequency lesions (directed at the cervical facet joints, eventually followed by dorsal root ganglion lesions) is more effective than conservative therapy (local injections with anaesthetic and methylprednisolone of the greater occipital nerve, eventually followed by transcutaneous nerve stimulation) in alleviating headache in patients with cervicogenic headache
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cervicogenic headache
Intervention
Radiofrequency neurotomy of the cervical facet joint, eventually followed by a radiofrequency lesion of a cervical dorsal root ganglion versus conservative therapy (local injections with anaesthetic and methylprednisolone of the greater occipital nerve, eventually followed by transcutaneous nerve stimulation)
Intervention type
Drug
Phase
Not Specified
Drug names
methylprednisolone
Primary outcome measure
Mean visual analogue scores of pain at 8 weeks, 3-months, 6-months and 1 year
Secondary outcome measures
Global perceived effect by patient at the above-mentioned timepoints. The number of headache days, the medicine use and the headache intensity during a week were also recorded.
Overall trial start date
01/09/1997
Overall trial end date
01/07/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
The study group was recruited from patients with cervicogenic headache (CH) according to the diagnostic criteria of Sjaastad. The other following inclusion criteria had to be fulfilled:
1. Age between 20 and 65 years; chronic cervicogenic headache of more than 2 years' duration
2. An initial visual analogue scale (VAS) score of more than 50 mm during a pain period
3. A significant pain during at least two days per week
4. At least one of the following symptoms on physical examination of the neck: paravertebral tenderness on palpation of the cervical spine and/or positive tender points at specific points indicating the involvement of segmental nerves and/or reduction of range of motion in the cervical spine
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
Excluded from the study were patients who had previous surgical procedures of the cervical spine; who had coagulation disturbances; who were pregnant; who had multilevel severe degenerative changes; who were diagnosed with post-whiplash syndrome and in whom none of the symptoms on physical examination described above were present.
Recruitment start date
01/09/1997
Recruitment end date
01/07/2002
Locations
Countries of recruitment
Netherlands
Trial participating centre
Dept. Neurology
Maastricht
6202 AZ
Netherlands
Sponsor information
Organisation
University Hospital Maastricht, Pain Centre (The Netherlands)
Sponsor details
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
+31 (0)43 3876543
pijn@sane.azm.nl
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University Hospital Maastricht, Pain Centre (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
van Suijlekom HA, van Kleef M, Barendse GA, Sluijter ME, Sjaastad O, Weber WE: Radiofrequency cervical zygapophyseal joint neurotomy for cervicogenic headache: a prospective study of 15 patients. Funct Neurol 1998, 13(4):297-303.
<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9934574&query_hl=3"; target="_blank">http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9934574&query_hl=3</a>;
van Suijlekom HA, Weber WE, van Kleef M, Barendse GA, Sluijter ME: Radiofrequency cervical zygapophyseal joint neurotomy for cervicogenic headache: a short term follow-up study. Funct Neurol 1998, 13(1):82-83
<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9584881&query_hl=3"; target="_blank">http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9584881&query_hl=3</a>;
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16483374&query_hl=1&itool=pubmed_DocSum
Publication citations
-
van Suijlekom HA, van Kleef M, Barendse GA, Sluijter ME, Sjaastad O, Weber WE, Radiofrequency cervical zygapophyseal joint neurotomy for cervicogenic headache: a prospective study of 15 patients., Funct. Neurol., 13, 4, 297-303.
-
van Suijlekom HA, van Kleef M, Barendse GA, Sluijter ME, Sjaastad O, Weber WE, Radiofrequency cervical zygapophyseal joint neurotomy for cervicogenic headache: a prospective study of 15 patients., Funct. Neurol., 13, 4, 297-303.
-
van Suijlekom HA, Weber WE, van Kleef M, Barendse GA, Sluijter ME, Radiofrequency cervical zygapophyseal joint neurotomy for cervicogenic headache: a short term follow-up study., Funct. Neurol., 13, 1, 82-83.
-
van Suijlekom HA, Weber WE, van Kleef M, Barendse GA, Sluijter ME, Radiofrequency cervical zygapophyseal joint neurotomy for cervicogenic headache: a short term follow-up study., Funct. Neurol., 13, 1, 82-83.
-
Haspeslagh SR, Van Suijlekom HA, Lamé IE, Kessels AG, van Kleef M, Weber WE, Randomised controlled trial of cervical radiofrequency lesions as a treatment for cervicogenic headache [ISRCTN07444684]., BMC Anesthesiol, 2006, 6, 1, doi: 10.1186/1471-2253-6-1.