Invasive Therapy for Cervicogenic Headache
| 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
Scientific
Dept. Neurology
University Hospital Maastricht
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
| Phone | +31 (0)43 3875117 |
|---|---|
| wweb@neurologie.azm.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Invasive Therapy for Cervicogenic Headache |
| Study acronym | ITCH |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/09/1997 |
| Completion date | 01/07/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/09/1997 |
| Date of final enrolment | 01/07/2002 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Dept. Neurology
Maastricht
6202 AZ
Netherlands
6202 AZ
Netherlands
Sponsor information
University Hospital Maastricht, Pain Centre (The Netherlands)
University/education
University/education
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
| Phone | +31 (0)43 3876543 |
|---|---|
| pijn@sane.azm.nl | |
| Website | http://www.pijn.com |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
