Twelve-Month results from multicenter, open-label, randomized controlled clinical trial comparing differential target multiplexed spinal cord stimulation and traditional spinal cord stimulation in subjects with chronic intractable back pain and leg pain.

BACKGROUND: Spinal cord stimulation (SCS) is a well-established treatment for chronic intractable pain of the trunk and/or limbs; however, low back pain (LBP) is difficult to treat using traditional SCS. Differential Target Multiplexed spinal cord stimulation (DTM SCS) is an advanced approach inspired from animal studies demonstrating improved pain-related behavior and pain-relevant biological processes. OBJECTIVE: The purpose of this study was to compare the effectiveness of DTM SCS and traditional SCS in treating chronic LBP and leg pain (LP). METHODS: This prospective, postmarket randomized controlled trial compared DTM SCS to traditional SCS in patients with chronic LBP and LP. Primary end point was LBP responder rate (percentage of subjects with ≥ 50% relief) at 3 months. Noninferiority and superiority were assessed. Other outcomes included mean change in back and leg pain, responder rates, disability, global health, satisfaction, and safety profile throughout the 12-month follow-up. RESULTS: One hundred twenty-eight subjects were randomized across 12 centers (67 DTM SCS and 61 traditional SCS). Of the 94 patients implanted, 46 subjects in each group completed the 3-month assessment. LBP responder rate of 80.1% with DTM SCS was superior to 51.2% with traditional SCS (p = 0.0010). Mean LBP reduction (5.36 cm) with DTM SCS was greater than reduction (3.37 cm) with traditional SCS (p < 0.0001). These results were sustained at 6 months and 12 months. Safety profiles were similar between treatment groups. CONCLUSION: Superiority of DTM SCS compared with traditional SCS for chronic LBP was demonstrated. Clinical improvements provided by DTM SCS were sustained over 12 months and are expected to significantly impact the management of chronic LBP.

Rehabilitation outcomes after infection-related spinal cord disease: a retrospective analysis.

OBJECTIVES: To compare injury characteristics, demographics, and functional outcomes of patients with infection-related spinal cord disease (IR-SCD) vs. those with traumatic spinal cord injury (SCI). DESIGN: A 10-yr retrospective review of 34 consecutive patients with IR-SCD admitted to an SCI rehabilitation unit at a Level 1 tertiary university medical center. Outcome measures included length of stay (LOS), FIM motor scores, and home discharge rates. RESULTS: The cause of IR-SCD was most often spinal epidural abscess secondary to Staphylococcus aureus (74%). Weakness (90%) and neck/back pain (84%) were the most frequent initial admitting symptoms. Identifiable risk factors included history of recent infection (42%), diabetes mellitus (32%), and intravenous drug abuse (26%). SCD-related complications most commonly included pain (81%), urinary tract infection (52%), and spasticity (45%). When compared with traumatic SCI (n = 560), patients with IR-SCD comprised significantly less of the SCI/D rehabilitation admissions (3% vs. 61%), were older (53 vs. 40 yrs), and more often female (35% vs. 16%). Injuries were more commonly located in the thoracic region (48% vs. 38%). Patients with IR-SCD more often had incomplete injuries (94% vs. 57%). Thirty-two percent of IR-SCD patients had improvements in AIS impairment scale classification. LOS was longer on acute care (25 vs. 16 days), but similar on rehabilitation (36 vs. 34 days), and with lower FIM motor changes (16.2 vs. 22.8) during rehabilitation. Patients with IR-SCD were less often discharged to home (56% vs. 75%). CONCLUSIONS: Patients with infection-related SCD comprise a significant subset of SCI/D rehabilitation admissions and have differing demographic and injury characteristics compared with traumatic SCI. Despite less-severe injury characteristics and similar rehabilitation LOS, they achieve lower functional improvements and are less often discharged home, underscoring the importance of patient/family education and discharge planning.