Condition category
Signs and Symptoms
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
17/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Turo Nurmikko

ORCID ID

Contact details

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

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes