This trial is examining the effectiveness of spinal cord stimulation (SCS) on improving nerve function and pain in patients with diabetic nerve disease. The main outcome to be measured will be a change in pain levels, symptoms, and functions. This study is being conducted at the Mayo Clinic in Rochester, Minnesota, United States.
The details
Spinal cord stimulation (SCS) is an FDA approved treatment for nerve pain in diabetic nerve disease (neuropathy). A wire is placed in the spine and the spinal cord is stimulated to interrupt pain signaling coming from the legs. The spinal cord stimulator is similar to a pacemaker device, which treats abnormal rhythms of the heart. Recent studies have suggested that SCS can improve nerve function in patients with peripheral nerve disease.
This study aims to measure the changes in nerve function and pain after SCS in painful diabetic nerve disease. Changes in pain levels and symptoms will be measured using questionnaires. Changes in leg function will be measured by testing ability to walk on toes, walk on heels and arising from a kneeled position.
Who are they looking for?
This study is looking for 20 participants with type 2 diabetes. Patients must have nerve pain in their legs for more than 1 year which scores greater than or equal to 5 on a pain scale from 0 (no pain) to 10 (worst pain imaginable). Patients must have tried and failed or cannot take specific nerve pain medications such as gabapentin, pregabalin, tricyclic antidepressants, venlafaxine or duloxetine. Patients must also be suitable for surgery for the spinal cord stimulator.
Patients must not have severe autonomic nerve disease, severe peripheral artery disease and must not have had previous surgery for cutting or clamping a nerve (sympathectomy). They must not have a HbA1c (blood test for blood glucose control) of greater than 8% or must not be regularly taking opioid drugs or have a psychiatric disorder. Women of childbearing age must be willing to use contraception.
How will it work
All patients will receive the SCS implant according to the FDA approved indications. Two leads will be placed in the spine under guided imaging and will be attached to either an external stimulator or a pulse generator implanted under the skin. Patients will receive small electrical currents that are optimized for pain relief. Programming for the amplitude of the currents will be carried out after the operation based on each patients’ individual needs.
Changes in pain and symptoms will be regularly evaluated using questionnaires. A change in nerve function will be measured by testing the ability of the patient to walk on their toes, walk on their heels and arise from a kneeling position. Patients will be followed up for 1 year.
