Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0259139017
Study information
Scientific title
The effect of spinal cord stimulation (SCS) on allodynia in patients with neuropathic pain
Acronym
Study hypothesis
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
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
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
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2004
Overall trial end date
01/03/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
25
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/2004
Recruitment end date
01/03/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Walton Centre for Neurology and Neurosurgery
Liverpool
L9 7LJ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Walton Centre for Neurology and Neurosurgery NHS Trust (UK)
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