Contact information
Type
Scientific
Primary contact
Dr C C de Vos
ORCID ID
Contact details
Medisch Spectrum Twente
Department of Neurosurgery
P.O. Box 50000
Enschede
7500 KA
Netherlands
+31 (0)53 487 3532
c.devos@ziekenhuis-mst.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
001
Study information
Scientific title
Acronym
SCS 001
Study hypothesis
To demonstrate superiority over time in treatment of pain of best medical practice with adjunctive Spinal Cord Stimulation (SCS) therapy compared to best medical practice without SCS therapy in patients with chronic diabetic neuropathic pain as measured by Visual Analogue Scale (VAS) score.
Ethics approval
Approval received from the local ethics committee (Medisch Ethische Toetsings Commissie of Medisch Spectrum Twente) on the 17th January 2007 (trial no: P06-34; approval letter: METC/07022.aa; approval letter: RvB/gh/0039-07/73.0).
Study design
Randomised, controlled, factorial trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Diabetic neuropathic pain
Intervention
After a baseline period patients will be randomised to:
1. Best medical practice with adjunctive SCS therapy arm, or
2. Best medical practice without adjunctive SCS therapy arm.
The control group will be followed simultaneously with the SCS-treatment group.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
VAS score: measured at baseline and one, three, six, nine and 12 months after inclusion.
Secondary outcome measures
1. Response rates (greater than or equal to 50% reduction in pain intensity) at all visits
2. Percent of patients that are pain free (more than 75% reduction in pain intensity) at all visits
3. Mean and median percent change in pain intensity at all visits
4. Pain free time during day and night
5. McGill Pain Questionnaire
6. Short Form 36
7. Changes in pain medication
8. Compliance rates
9. Emergent adverse events
10. Device complications
11. Premature study withdrawal
Measured at baseline and one, three, six, nine and 12 months after inclusion.
Overall trial start date
01/08/2006
Overall trial end date
01/08/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Chronic, diabetic, peripheral neuropathic pain that exists for more than one year
2. Patient cannot be treated further otherwise according to patients' medical specialist
3. The pain-sensation on a VAS-scale is minimal five (recording both for day and night time)
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
45
Participant exclusion criteria
1. Aged less than 18 years
2. Psychological problems
3. Neuropathic pain in upper extremities
Recruitment start date
01/08/2006
Recruitment end date
01/08/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Medisch Spectrum Twente
Enschede
7500 KA
Netherlands
Sponsor information
Organisation
Medisch Spectrum Twente (The Netherlands)
Sponsor details
P.O. Box 50000
Enschede
7500 KA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Medisch Spectrum Twente (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Stichting TWIN (The Netherlands)
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