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An open prospective randomized long-term effectiveness study, comparing best medical practice with or without adjunctive spinal cord stimulation in patients with chronic diabetic neuropathic pain. (SCS 001)


- candidate number2369
- NTR NumberNTR842
- ISRCTNISRCTN03269533
- Date ISRCTN created22-jan-2007
- date ISRCTN requested12-jan-2007
- Date Registered NTR14-dec-2006
- Secondary IDs001 
- Public TitleAn open prospective randomized long-term effectiveness study, comparing best medical practice with or without adjunctive spinal cord stimulation in patients with chronic diabetic neuropathic pain. (SCS 001)
- Scientific TitleAn open prospective randomized long-term effectiveness study, comparing best medical practice with or without adjunctive spinal cord stimulation in patients with chronic diabetic neuropathic pain. (SCS 001)
- ACRONYMSCS 001
- hypothesisTo demonstrate superiority over time in treatment of pain of best medical practice with adjunctive SCS Therapy compared to best medical practice without SCS Therapy in patients with chronic diabetic neuropathic pain as measured by VAS score.
- Healt Condition(s) or Problem(s) studiedDiabetic neuropathy
- Inclusion criteria1. Chronic, diabetic, peripheral neuropathic pain that exists for more than one year; 2. Patient cannot be treated further otherwise according to patientsí medical specialist; 3. The pain-sensation on a VAS-scale is minimal 5 (recording both for day and night time).
- Exclusion criteria1. Age < 18 years; 2. Psychological problems; 3. Neuropathic pain in upper extremities.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupFactorial
- Type-
- Studytypeintervention
- planned startdate 1-aug-2006
- planned closingdate1-aug-2008
- Target number of participants45
- InterventionsAfter a baseline period patients will be randomized to either the best medical practice with adjunctive SCS therapy arm or the best emdical practice without adjunctive SCS therapy arm. The control group will be followed simultanously with the SCS-treatment group.
- Primary outcomeVAS score. Measured at baseline and 1, 3, 6, 9 and 12 months after inclusion.
- Secondary outcome1. Response rates (greater than or equal to 50% reduction in pain intensity) at all visits; 2. Percent of patients that are pain free (>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 1, 3, 6, 9 and 12 months after inclusion.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESIr. C.C. Vos, de
- CONTACT for SCIENTIFIC QUERIESIr. C.C. Vos, de
- Sponsor/Initiator Medisch Spectrum Twente, Twente Institute for Neuromodulation (TWIN), Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Medisch Spectrum Twente, Enschede, Stichting TWIN
- PublicationsN/A
- Brief summaryBackground: Spinal Cord Stimulation (SCS) is an established and safe treatment for patients with certain types of chronic intractable pain. A few uncontrolled trials, including our own study with nine diabetic patients, have shown that patients with chronic diabetic neuropathic pain might respond well to SCS treatment. Study goal: What is the long-term clinical benefit of best medical practice with and without adjunctive SCS therapy in patients with chronic diabetic neuropathic pain? Study Design: The SCS-001 study is an open, prospective, long-term effectiveness study comparing best medical practice with or without adjunctive SCS therapy in patients with chronic diabetic neuropathic pain. Medisch Spectrum Twente is officially certified to perform this therapy. The treatment contains an intake and baseline period, trial stimulation and possibly surgical implantation of the SCS system and follow-up. Population: Approximately 45 diabetic patients with chronic neuropathic pain in the lower extremities will be randomized to either the best medical practice with adjunctive SCS therapy or best medical practice without SCS therapy. Study Endpoints: The primary objective of the SCS-001 study is to demonstrate superiority over time in treatment of pain of best medical practice with adjunctive SCS therapy compared to best medical practice without SCS therapy in patients with chronic diabetic neuropathic pain as measured by VAS score. The most important secondary objectives of the SCS-001 study are the evaluation of the effect of SCS therapy over time and the evaluation of the reported pain (like pain intensity, pain duration, pain pattern), pain medication, quality of live (SF-36) and safety and tolerability of the SCS system in this patient population Risk: The risk of best medical practice with or without adjunctive SCS therapy for the treatment of chronic pain is small. SCS therapy is an established treatment and Medisch Spectrum Twente is officially certified to perform this therapy.
- Main changes (audit trail)
- RECORD14-dec-2006 - 23-jan-2007


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