Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/01/2007
Date assigned
22/01/2007
Last edited
14/01/2021
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Not provided at time of registration

Trial website

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

NL829, NTR842

Study information

Scientific title

An open prospective randomised long-term effectiveness study, comparing best medical practice with or without adjunctive Spinal Cord Stimulation in patients with chronic diabetic neuropathic pain

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 measure

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 (if study stopped)

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

Total final enrolment

11

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

http://www.ziekenhuis-mst.nl/

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

Basic results (scientific)

Publication list

2009 results in https://pubmed.ncbi.nlm.nih.gov/18413161/ (added 14/01/2021)

Publication citations

Additional files

Editorial Notes

14/01/2021: The following changes have been made: 1. Publication reference added. 2. The final enrolment number has been added from the reference. 3. The NTR numbers have been added.