ISRCTN ISRCTN07444684
DOI https://doi.org/10.1186/ISRCTN07444684
Secondary identifying numbers N/A
Submission date
08/08/2005
Registration date
10/08/2005
Last edited
07/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Wim Weber
Scientific

Dept. Neurology
University Hospital Maastricht
P.O. Box 5800
Maastricht
6202 AZ
Netherlands

Phone +31 (0)43 3875117
Email wweb@neurologie.azm.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleInvasive Therapy for Cervicogenic Headache
Study acronymITCH
Study objectivesA 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCervicogenic headache
InterventionRadiofrequency 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Methylprednisolone
Primary outcome measureMean visual analogue scores of pain at 8 weeks, 3-months, 6-months and 1 year
Secondary outcome measuresGlobal 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 study start date01/09/1997
Completion date01/07/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants30
Total final enrolment30
Key inclusion criteriaThe 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
Key exclusion criteriaExcluded 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.
Date of first enrolment01/09/1997
Date of final enrolment01/07/2002

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Dept. Neurology
Maastricht
6202 AZ
Netherlands

Sponsor information

University Hospital Maastricht, Pain Centre (The Netherlands)
University/education

P.O. Box 5800
Maastricht
6202 AZ
Netherlands

Phone +31 (0)43 3876543
Email pijn@sane.azm.nl
Website http://www.pijn.com
ROR logo "ROR" https://ror.org/02d9ce178

Funders

Funder type

University/education

University Hospital Maastricht, Pain Centre (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 16/02/2006 Yes No

Editorial Notes

07/01/2021: Total final enrolment added.