|- candidate number||27916|
|- NTR Number||NTR6704|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-sep-2017|
|- Secondary IDs||NL60465.044.17 ABR|
|- Public Title||Onderzoek naar ruggenmergstimulatie voor de behandeling van diabetische neuropathische pijn, een evaluatie studie|
|- Scientific Title||Spinal Cord Stimulation
for treating diabetic neuropathic pain;
a validation study
|- hypothesis||A study to validate the results from two RCTs that SCS is indeed capable of treating otherwise refractory diabetic neuropathic pain. In addition, we will evaluate the effects of burst stimulation settings in this patient group.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus, Diabetic neuropathy, Spinal cord stimulation|
|- Inclusion criteria||- Peripheral neuropathic pain that exists for more than 6 months and is due to diabetes mellitus.|
- Patient cannot be treated further otherwise according to patientsí medical specialist.
- The pain-sensation on a visual analogue scale is 5 or more
|- Exclusion criteria||- Age < 18 years.|
- Psychological problems that requires treatment.
- Addiction (i.e. compulsory) to: drugs, alcohol, medication.
- Insufficient cooperation by patient (motivation, insight or communication).
- Coagulation irregularities/ Anti-coagulants.
- Immune compromised.
- Life expectancy less than 1 year.
- Local infection at the site of the incision
- Implanted pacemaker, ICD or other neuromodulation system
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||8-jun-2017|
|- planned closingdate||31-dec-2019|
|- Target number of participants||20|
|- Interventions||Implantation of spinal cord stimulator and stuctured evaluation of various stimulation settings (tonic, high amplitude burst, low amplitude burst, placebo)|
|- Primary outcome||Primary outcome measure is the change in neuropathic pain as measured by visual analogue scale (VAS) score after 6 months of SCS.|
|- Secondary outcome||- evaluation of patient preference of stimulation settings, |
- satisfaction with SCS treatment (PGIC),
- evaluation of the efficacy of SCS treatment in patients with diabetic neuropathic pain as measured by mean and median percent change in pain intensity at all visits,
|- Timepoints||After baseline and implantation, patients will have study visits after 3,6,9, and 12 weeks and a final study visit at 6 months|
|- Trial web site||NA|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Ir. C.C. Vos, de|
|- CONTACT for SCIENTIFIC QUERIES||Ir. C.C. Vos, de|
|- Sponsor/Initiator ||Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|Medisch Spectrum Twente|
|- Brief summary||Two Randomised Clinical Trials have shown that in many patients refractory painful diabetic neuropathy can be treated effectively with Spinal Cord Stimulation (SCS). It has also been suggested that novel stimulation settings might be even more effective in this patient population than the standard tonic stimulation settings that have been used in the two RCTs. A validation study to confirm the effects of SCS in diabetic neuropathic pain and to evaluate the effects of burststimulation will be relevant.|
The study is a prospective, double-blind validation study.
20 patients with refractory diabetic neuropathic pain will be included. They should be eligible for spinal cord stimulation and have VAS scores for pain > 5. All patients will have a trial stimulation period with an external SCS pulse generator. If the trial is successful ( > 25% pain reduction) an SCS system will be implanted. - During the first 12 weeks, SCS settings are adjusted and evaluated by the patients. Settings include 3 weeks of tonic, high burst, low burst stimulation settings and SCS off, in random order. Principal investigator and patients will be blind for the stimulation setting. - After completion of the 6 months study treatment period, all patients will be followed in accordance with standard medical care.
Primary outcome measure is the change in neuropathic pain as measured by VAS score after 6 months of SCS.
|- Main changes (audit trail)|
|- RECORD||14-sep-2017 - 1-okt-2017|