Condition category
Signs and Symptoms
Date applied
08/08/2005
Date assigned
10/08/2005
Last edited
14/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.pijn.com

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Additional files

Editorial Notes