"PUBLICATION INFORMATION","" "Author(s)","Shelden CH, Paul F, Jacques DB, Pudenz RH." "Title","Electrical stimulation of the nervous system." "Journal","Surg Neurol" "Volume, issue, pages","4(1):127-132" "Year","1975" "Full text link","" "PUBMED link","http://www.ncbi.nlm.nih.gov/pubmed/1080895" "STUDY DESCRIPTION","" "Study design","" "Study question","" "Population assessed","" "Model used if experimental study","" "Study dates","" "Follow-up duration","" "Follow-up intervals","" "Third-party follow-up","" "Other efforts to reduce bias","" "Patient protection","" "Outcome measures","" "Primary outcome","" "Secondary outcomes","" "Definition of success","" "Statistical significance","" "Statistical analyses performed","" "PATIENT SELECTION","" "Inclusion criteria","" "Exclusion criteria","" "Pre-op diagnostic imaging","" "Diagnosis required","" "Organic pain origin required","" "Psychological evaluation","" "DEMOGRAPHIC / PROGNOSTIC FACTORS","" "Sex (male/female)","" "Sex difference in outcome","" "Mean patient age in years (+/- SD, range)","" "Age difference in outcome","" "Race","" "Number prior surgeries difference in outcome","" "Time since last surgery difference in outcome","" "Pain onset time difference in outcome","" "Issues of secondary gain","" "Psychological difference in outcome","" "Other prognostic factors","" "PAIN LOCATION","" "Back only or predominant","" "Back and leg(s)","" "Leg(s)","" "Buttock and leg","" "Back and buttock","" "Back, buttock, leg","" "Knee","" "Foot","" "Upper extremity","" "Trunk (visceral and ischemic)","" "Other location","" "Unilateral","" "Bilateral","" "Mixed pain pattern","" "PAIN CHARACTERISTICS","" "Pain duration years (mean +/- SD, range)","" "Neuropathic","" "Nociceptive","" "Ischemic","" "Visceral","" "Mixed pain type","" "INDICATIONS","" "Failed back surgery syndrome","3" "Chronic low back pain","" "Radiculopathy","" "Phantom limb / post-amputation","" "Brachial plexitis / plexus avulsion","" "Complex regional pain syndrome","" "Spinal stenosis","" "Peripheral neuropathy","" "Diabetic neuropathy","" "Post-herpetic neuralgia","" "Arachnoiditis","" "Post-traumatic pain","" "Spinal cord injury","" "Multiple sclerosis","" "Angina pectoris","" "Syndrome X","" "Critical limb ischemia","" "Raynaud\'s","" "Abdominal disease","" "Visceral disease","" "Cancer","" "Repeat implantation","" "Other","" "SCREENING TRIAL","" "Number patients who underwent trial","" "Trial electrode type","" "Trial electrode manufacturer","" "Trial technique","" "Pain control during trial","" "Trial success criteria","" "Length of hospitalization","" "Trial risk reduction methods","" "Trial duration (days)","" "STIMULATION","" "Paresthesia coverage","" "Paresthesia threshold","" "Stimulation programming methods","" "Parameters","" "SYSTEM IMPLANTATION","" "Number implanted","27" "Type(s) of implanted electrode(s)","" "Manufacturer","" "Anesthesia","" "Electrode implantaton method","" "Electrode location(s)","" "Type of anchor","" "Anchoring method","" "Type of IPG","" "Location of IPG","" "Risk reduction","" "Length of hospitalization","" "Post-operative pain relief","" "OUTCOMES","" "Number in study","" "Number followed","" "Number lost to follow-up","" "Number with stimulation complication","" "Number died","" "Answer to study question","" "Rate of success if defined","" "Data presented disaggregated and summarized?","" "Outcomes reported as function of time?","" "Outcomes broken down by indication?","" "Implications of study results","" "OUTCOMES: PAIN","" "Mean pain reduction","" "Pain reduced back","" "Pain reduced legs","" "Stopped analgesics","" "Reduced analgesics","" "Excellent overall relief","67%" "Good overall relief","" "Good relief with occasional non-narcotics","" "Poor overall relief","" "Poor relief and use narcotics","" "Discontinued because pain-free","" "Discontinued no therapeutic benefit","" "New pain","" "Exacerbated pain","" "Adjunct pain treatment","" "OTHER BENEFICIAL OUTCOMES","" "Change in health care use","" "Change in function","" "Change in activities of daily life","" "Change in quality of life","" "Change in sleep","" "Reduced emotional depression","" "Patient satisfaction or impression of change","" "Physician-reported clinical benefits","" "Latency and persistence of therapeutic effect","" "Return to work","" "Limb survival","" "Ulcer healing","" "BIOLOGICAL COMPLICATIONS","" "Dural puncture","" "Infection","" "Infection leading to revision","" "Infection leading to system explant","" "Generator pocket hematoma","" "Skin erosion or wound dehiscence treated","" "Skin erosion or wound dehiscence leading to system explant","" "Seroma","" "Allergic reaction","" "IPG site pain requiring relocation","" "Spinal cord or nerve injury","" "Epidural hematoma","" "Epidural abscess","" "Scar tissue","" "Other biological complication","" "DEVICE COMPLICATIONS","" "Percutaneous electrode migration at trial","" "Laminotomy electrode migration at trial","" "Percutaneous electrode migration implant","" "Laminotomy electrode migration implant","" "Electrode migration and/or malposition","" "Lead and/or electrode failure or breakage","" "Generator failure","" "Generator migration","" "Connector repositioned","" "Battery depletion considered premature","" "Device interaction","" "Other hardware failure","" "STIMULATION SIDE EFFECTS","" "Extraneous paresthesia","" "Postural changes","" "Lost pain/paresthesia coverage","" "Over, under, or intermittent stimulation","" "Uncomfortable stimulation","" "Other stimulation side effects","" "COST EFFECTIVENESS","" "In FBSS","" "In CRPS","" "In ischemic diseases","" "In other indications","" "Optimizing","" "FACILITY AND STAFF","" "Physician training","" "Physician experience","" "Facility location","" "Facility type",""