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
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