The effect of spinal cord stimulation (SCS) on allodynia in patients with neuropathic pain
| ISRCTN | ISRCTN51597459 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51597459 |
| Secondary identifying numbers | N0259139017 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 17/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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 Turo Nurmikko
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 | Treatment |
| Scientific title | The effect of spinal cord stimulation (SCS) on allodynia in patients with neuropathic pain |
| Study objectives | This study is designed to answer this research question: does spinal cord stimulation (SCS) reduce the intensity and area of mechanical and thermal allodynia in patients with neuropathic pain? It is a single-centre study, involving 25 patients, with neuropathic pain, of peripheral origin, and associated with mechanical and thermal allodynia (touch and heat/cold induced pain, respectively). While SCS is considered standard treatment for refractory neuropathic pain, only a few controlled studies have been published on its efficacy, and none systematically assessing allodynia. Our aim is to select patients with mechanical allodynia (most of whom have cold allodynia as well) and measure allodynia before, during and after stimulation to study this aspect further. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Allodynia |
| Intervention | We will recruit 25 patients with mechanical allodynia and neuropathic pain for this study. Patients are those in whom the clinical decision has been made either to (a) carry out a trial SCS, or (b) implant a permanent stimulator after the trial has been successful. In all these cases, due to clinical situation and routine testing, patients will spend some time without stimulation. We use this opportunity to compare the effect of stimulation on allodynia and pain in these patients. Measurements for intensity and area allodynia (using a brush, a 16 g or 26 g von Frey filament, thermal rollers and thermal stimulator applied to the skin) will be carried out with the stimulator ON and OFF. The level of pain during the two phases will be recorded as well. The patient will attend twice, once when on arrival the stimulator is switched off and a second time when on arrival the stimulator is switched on. The order of ON and OFF will be randomised, and allodynias always tested during both ON and OFF periods. |
| 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 | 01/04/2004 |
| Completion date | 01/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 25 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/2004 |
| Date of final enrolment | 01/03/2005 |
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
| 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 |
