The effect of spinal cord stimulation (SCS) on allodynia in patients with neuropathic pain

ISRCTN	ISRCTN51597459
DOI	https://doi.org/10.1186/ISRCTN51597459
Protocol serial number	N0259139017
Sponsor	Department of Health
Funder	The Walton Centre for Neurology and Neurosurgery NHS Trust (UK)

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

The Walton Centre for Neurology and Neurosurgery
Lower Lane
Fazakerley
Liverpool
L9 7LJ
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/03/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

United Kingdom
England

Study participating centre

The Walton Centre for Neurology and Neurosurgery

Liverpool
L9 7LJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan