Subcutaneous stimulation as add on therapy to spinal cord stimulaion to treat low back pain in FBSS. - SubQ study

niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 90 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Male/female >= 18 and <= 75 years
•Chronic neuropathic pain secondary to FBSS
•Pain radiating in lumbar segments L4 and/or L5 and/or S1 for at least 6 months
•Pain intensity assessed by VAS >= 5 scored separately for leg and back
•. Insufficient pain reduction after medication, invasive pain therapy, TENS, etc.
•Willing to provide informed consent

•Presence of any other clinically significant or disabling chronic pain condition
•Expected inability of patients to properly operate the neurostimulation system
•History of coagulation disorders, lupus erythematosus, diabetes mellitus, rheumatoid arthritis or morbus Bechterew
•Active malignancy
•Current use of medicines affecting coagulation which cannot be temporarily stopped
•Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
•Life expectancy of less than 1 year
•Existing or planned pregnancy

发起方

niversitair Medisch Centrum Sint Radboud