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

ISRCTN	ISRCTN36818685
DOI	https://doi.org/10.1186/ISRCTN36818685
Protocol serial number	4891
Sponsor	Walton Centre for Neurology and Neurosurgery (UK)
Funder	Multiple Sclerosis Society (UK)

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

Primary study design	Interventional
Study design	Non-randomised interventional treatment trial
Secondary study design	Non randomised controlled trial
Study type	Participant 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(s)	Changes in pain scores measured by daily pain diaries, measured on day 7 of the trial
Key secondary outcome measure(s)	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
Completion date	30/06/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	30
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

United Kingdom
England

Study participating centre

Pain Research Institute

Liverpool
L9 7AL
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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