Onderzoek naar ruggenmergstimulatie voor de behandeling van diabetische neuropathische pijn, een evaluatie studie

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.

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.

After baseline and implantation, patients will have study visits after 3,6,9, and 12 weeks and a final study visit at 6 months

Implantation of spinal cord stimulator and stuctured evaluation of various stimulation settings (tonic, high amplitude burst, low amplitude burst, placebo)