Spinal cord stimulation for the treatment of central pain in Multiple Sclerosis

ISRCTN	ISRCTN36818685
DOI	https://doi.org/10.1186/ISRCTN36818685
Secondary identifying numbers	4891

Submission date: 23/04/2010
Registration date: 23/04/2010
Last edited: 24/01/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

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

Ms K Maciver
Scientific

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

Study information

Study design	Non-randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	South Sefton LREC, 08/08/2008, ref: 08/H1001/103
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/07/2008
Completion date	30/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 302) MS central neuropathic pain3) Peripheral nerve injury pain
Key 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
Key exclusion criteria	1. Unsuitable for spinal cord stimulation 2. High intake of opiates 3. High levels of psychological distress
Date of first enrolment	01/07/2008
Date of final enrolment	30/06/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Pain Research Institute

Liverpool
L9 7AL
United Kingdom

Sponsor information

Walton Centre for Neurology and Neurosurgery (UK)
Hospital/treatment centre

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

Website	http://www.thewaltoncentre.nhs.uk/
"ROR"	https://ror.org/05cvxat96

Funders

Funder type

Charity

Multiple Sclerosis Society (UK)
Private sector organisation / Associations and societies (private and public)

Alternative name(s): Multiple Sclerosis Society of Great Britain and Northern Ireland, The MS Society, MS Society UK, Multiple Sclerosis Society UK, MS Society
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

24/01/2018: No publications found in PubMed, verifying study status with principal investigator.