A randomised controlled trial of pulsed radio-frequency lesioning of the Gasserian ganglion for trigeminal neuralgia.
| ISRCTN | ISRCTN88952269 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88952269 |
| Secondary identifying numbers | N0259149058 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 10/04/2008
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Manohar Sharma
Scientific
Scientific
The Walton Centre for Neurology and Neurosurgery
Lower Lane
Fazakerley
Liverpool
L9 7LJ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Does Pulsed Radio frequency (RF) lesioning produce any neurological damage? Standard RF lesioning produces a lesion by electronically heating the tip of the electrode to a controllable temperature between 60 and 90 degrees C to deliberately partially damage the nerve tissue, thus reducing the pain. Pulsed RF is claimed to be an effective way of producing an analgesic effect without damaging the nerve in any way, because the average temperature at the tip of the electrode is 42 degrees. It is claimed that it affects function in an unexplained way, without any neurological damage. Nerve damage can produce numbness with pain persisting, or a further neuropathic pain developing as a result of the nerve damage. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nervous System Diseases: Neuralgia |
| Intervention | Parallel group, patient and assessor blind randomised controlled study. Patients would be checked as to their suitability for the study according to the entry criteria, and then receive a full assessment. Suitable patients would be investigated with an MRTA and a MRI of brain, together with laboratory investigation, neurophysiology and QST. Patients would be stratified as to typical or atypical forms of TGN, and randomised to receive either standard or pulsed RF lesion to the Gasserian Ganglion. Both patients and assessors would be blinded as to the treatment performed. The blinding would be maintained until return of pain, at which time a standard RF lesion or other clinically acceptable treatment such as balloon compression, stereotactic radiosurgery etc. will be performed. The pulsed or conventional RF lesion will be performed using the Radionics lesion generator. The patient will receive Midazolam sedation in the standard way. The RF needle (RDG Neurotherm cannula) will be positioned in the foramem ovale under X-ray control and the appropriate trigeminal root located with sensory thresholds of less than 0.5v29. A pain diary will be kept, using a pain logger, for the week preceding the RF lesion, together with a diary of interference with activities of daily living. This diary would continue after the procedure for 1 month, and will be re-introduced if pain relief follows the procedure and pain then returns at a later date. Time to return of pain will be noted. The patient will have specific instructions to notify the researchers when pain returns, and will be re-assessed at that time. Formal assessment will be done otherwise at 1-2 week(s), 1 month, 3 months, 6 months, 9 months and 12 months, 18 months and 2 years. |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/2004 |
| Completion date | 01/05/2008 |
| Reason abandoned (if study stopped) | Lack of time from trialist. Poor patient recruitment. |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Patients will be selected who have a diagnosis of trigeminal neuralgia with unilateral pain, failure of acceptable pharmacological control, failure of mirovascular decompression, or patients not otherwise suitable for surgery. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 01/05/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Walton Centre for Neurology and Neurosurgery
Liverpool
L9 7LJ
United Kingdom
L9 7LJ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
The Walton Centre for Neurology and Neurosurgery NHS Trust (UK)
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 |
