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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleThe effect of spinal cord stimulation (SCS) on allodynia in patients with neuropathic pain
Study objectivesThis 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) studiedSigns and Symptoms: Allodynia
InterventionWe 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/2004
Completion date01/03/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants25
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/04/2004
Date of final enrolment01/03/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Department of Health
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan