Condition category
Nervous System Diseases
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
09/10/2015
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

Ms K Maciver

ORCID ID

Contact details

Pain Research Institute
Clinical Sciences Centre
Fazakerley Hospital
Lower Lane
Liverpool
L9 7AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4891

Study information

Scientific title

Comparison of spinal cord stimulation and the clinical and quantitative sensory testing response in patients with MS pain versus patients with peripheral nerve injury pain

Acronym

Study hypothesis

We are measuring the effect of spinal cord stimulation on central pain in Multiple Sclerosis (MS), comparing the clinical and Quantitative Sensory Testing response in patients with MS pain and those with peripheral nerve injury pain. We hypothesise that MS pain patients will have a different sensory profile to peripheral nerve injury pain patients. We also hypothesise that spinal cord stimulation will benefit most of the peripheral nerve injury patients and some of the MS pain patients. We are collecting Quantitative Sensory Testing measurements from an age- and gender-matched group of healthy volunteers.

Ethics approval

South Sefton LREC approved on the 18th August 2008 (ref: 08/H1001/103)

Study design

Non-randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Neurological; Subtopic: Neurological (all Subtopics); Disease: Nervous system disorders

Intervention

Trial of spinal cord stimulation. A temporary electrode is inserted into the eipdural space and attached to an external radiofrequency transmitter, which when switched on gives a pleasant paraesthesia in the area of pain. This stimulator remains in situ for 7 days. Pain diaries are kept throughout the trial and Quantitative Sensory Testing is completed once with stimulation and once without, with the tester blinded.

Follow up length: 2 months

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Changes in pain scores measured by daily pain diaries, measured on day 7 of the trial

Secondary outcome measures

Comparison of QST measurements in MS patients with and without stimulation, measured on day 5 of the trial, when the second sensory testing is complete

Overall trial start date

01/07/2008

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Group 1: Confirmed MS with central pain
2. Group 2: Peripheral nerve injury pain
3. Both groups eligible for spinal cord stimulation
4. Group 3: Age- and gender-matched healthy controls
5. Male and female, aged 18 years or older

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 302) MS central neuropathic pain3) Peripheral nerve injury pain

Participant exclusion criteria

1. Unsuitable for spinal cord stimulation
2. High intake of opiates
3. High levels of psychological distress

Recruitment start date

01/07/2008

Recruitment end date

30/06/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Pain Research Institute
Liverpool
L9 7AL
United Kingdom

Sponsor information

Organisation

Walton Centre for Neurology and Neurosurgery (UK)

Sponsor details

Division of Neurological Science
Clinical Sciences Centre for Research and Education
Lower Lane
Liverpool
L9 7LJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.thewaltoncentre.nhs.uk/

Funders

Funder type

Charity

Funder name

Multiple Sclerosis Society (UK)

Alternative name(s)

MS Society

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

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