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

ISRCTN	ISRCTN03269533
DOI	https://doi.org/10.1186/ISRCTN03269533
Secondary identifying numbers	NL829, NTR842

Submission date: 22/01/2007
Registration date: 22/01/2007
Last edited: 14/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr C C de Vos
Scientific

Medisch Spectrum Twente
Department of Neurosurgery
P.O. Box 50000
Enschede
7500 KA
Netherlands

Phone	+31 (0)53 487 3532
Email	c.devos@ziekenhuis-mst.nl

Study information

Study design	Randomised, controlled, factorial trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Study acronym	SCS 001
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
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 study start date	01/08/2006
Completion date	01/08/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	45
Total final enrolment	11
Key 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)
Key exclusion criteria	1. Aged less than 18 years 2. Psychological problems 3. Neuropathic pain in upper extremities
Date of first enrolment	01/08/2006
Date of final enrolment	01/08/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Medisch Spectrum Twente

Enschede
7500 KA
Netherlands

Sponsor information

Medisch Spectrum Twente (The Netherlands)
Hospital/treatment centre

P.O. Box 50000
Enschede
7500 KA
Netherlands

Website	http://www.ziekenhuis-mst.nl/
"ROR"	https://ror.org/033xvax87

Funders

Funder type

Hospital/treatment centre

Medisch Spectrum Twente (The Netherlands)

No information available

Stichting TWIN (The Netherlands)

No information available

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2009	14/01/2021	Yes	No

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.