Epidural Laterality and Pain Relief With Burst Spinal Cord Stimulation.

INTRODUCTION: Burst spinal cord stimulation (SCS) can achieve excellent clinical reduction of pain, alongside improvements in function, quality of life, and related outcomes. Good outcomes likely depend on good lead placement, thereby enabling recruitment of the relevant neural targets. Several competing approaches exist for lead implantation, such as the use of single vs bilateral leads and leads lateralized vs placed at midline. The objective of this study was to examine the relationship between paresthesia locations and pain relief with burst SCS in a prospective double-blind crossover design. MATERIALS AND METHODS: All participants had bilateral back and leg pain, with more intense pain experienced on one side of the body. A trial SCS system was placed, during which brief intraoperative mapping with conventional stimulation was used to characterize paresthesia locations. Two programs for subperception burst SCS treatment were then applied for two days each, in random order: bilateral paresthesia coverage vs unilateral paresthesia coverage contralateral to the side of the body with more intense pain. Pain ratings (visual analog scale [VAS]) and pain reductions (scaling pain relief [SPR]) were reported for each. RESULTS: Of the 30 participants who completed the study, 24 (80%) had good pain relief with at least one program. A baseline VAS score of 8.75 was reduced to 5.98 with contralateral stimulation and to 2.88 with bilateral stimulation; with SPR, this equated to 31.25% and 67.50% improvement, respectively. The incremental benefit of bilateral stimulation over contralateral stimulation was statistically significant (p < 0.001). Of the 24 participants, 87.5% preferred bilateral stimulation, whereas 12.5% preferred unilateral stimulation. The six participants who failed the trial had no preference. DISCUSSION: When burst stimulation is delivered to spinal targets that can generate paresthesias contralateral to the side of worst pain, suboptimal therapy is achieved. Thus, attention to laterality and pain coverage is critical for successful therapy, and it may be important to carefully consider lead implantation techniques.

Evaluation of Patient's Quality of Life before and after Implantation of Abbott's Proclaim™ XR Spinal Cord Stimulator with BurstDR™ Stimulation in Chronic Pain Syndrome.

Background and Objectives: In case of the ineffectiveness of pharmacological and non-pharmacological treatments in managing chronic neuropathic pain, spinal cord stimulation (SCS) with BurstDR™ stimulation may reduce pain and increase the quality of life. The term "burst" refers to a series of stimulation impulses that are compressed into small packets and separated by intervals of latency. Materials and Methods: A group of 30 consecutive patients who received the BurstDR™ stimulator using the minimally invasive percutaneous method was selected. Patients selected for our study underwent numerous spinal surgeries before SCS implantation. In the study, analgesics and co-analgesics and their doses used by patients before and 6 months after SCS implantation were examined and compared. Using the visual analogue scale (VAS), pain was compared before and after the procedure. Patients` quality of life was assessed using the Oswestry Disability Index (ODI). Results: We observed a significant reduction in opioid daily doses by an average of 32.4% (±36.1%) and a reduction in paracetamol daily doses by an average of 40% (±33.4%). There was a reduction in pregabalin doses as well. Ketoprofen daily dose reduction was 85.4 mg. The mean VAS difference before and after procedure was 3.9 (±2.3), and the mean difference in ODI was 12.9 (±9), which benefits operative treatment. The VAS and ODI results were statistically significant as well. Conclusions: According to our research, BurstDR™ stimulation improves the quality of life by reducing doses of analgesics and the level of pain.

Burst SCS Microdosing Is as Efficacious as Standard Burst SCS in Treating Chronic Back and Leg Pain: Results From a Randomized Controlled Trial.

INTRODUCTION: The burst waveform, a recent innovation in spinal cord stimulation (SCS), can achieve better outcomes than conventional tonic SCS, both for de novo implants and as a salvage therapy. Burst stimulation delivers more energy per second than tonic stimulation, which is a consideration for battery consumption. The clinical effectiveness of an energy-conserving strategy was investigated. METHODS: Subjects were experienced users of BurstDR SCS for back and leg pain. Three 2-week stimulation paradigms were presented in blinded random order: standard (continuously delivered) BurstDR, microdosing A: 5 sec of BurstDR alternating with 5 sec of no stimulation, and microdosing B: 5 sec of BurstDR alternating with 10 sec of no stimulation. The primary outcome for each paradigm was change in pain ratings, and secondary outcomes included changes in scores for quality of life, satisfaction, and preference. RESULTS: Twenty-five subjects assessed all three stimulation paradigms. There were no significant differences in pain (visual analog scale) or quality of life (EQ-5D) when comparing standard burst outcomes with those of microdosing A and, separately, microdosing B. Microdosing paradigms were graded with slightly higher level of satisfaction and were generally preferred above standard burst stimulation. DISCUSSION: These results suggest that the use of energy-efficient burst microdosing stimulation paradigms with alternating stimulation-on and stimulation-off periods can provide clinically equivalent results to standard burst stimulation. This is important for extending SCS battery life. Further research is needed to comprehensively characterize the clinical utility of this approach and the neurophysiological mechanisms for the maintenance of pain relief during stimulation-off periods.

Successful relief of central poststroke pain with BurstDR spinal cord stimulation: A case series.

Background: Central poststroke pain (CPSP) is a commonly undertreated condition that can negatively impact a patient's quality of life. The efficacy of spinal cord stimulation (SCS) for the treatment of CPSP is not established due to limited studies. Case Description: Here, two patients, ages 42 and 75, sustained strokes resulting in CPSP. After failed medical management, both underwent placement of paddle-lead SCS systems utilizing BurstDR stimulation that successfully resulted in pain resolution. Conclusion: Two patients with CPSP were successfully treated with paddle lead SCS with BurstDR programming.

Surgical treatment of refractory low back pain using implanted BurstDR spinal cord stimulation (SCS) in a cohort of patients without options for corrective surgery: Findings and results from the DISTINCT study, a prospective randomized multi-center-controlled trial.

Background: Low back pain (LBP) is a highly prevalent, disabling condition affecting millions of people. Patients with an identifiable anatomic pain generator and resulting neuropathic lower extremity symptoms often undergo spine surgery, but many patients lack identifiable and/or surgically corrective pathology. Nonoperative treatment options often fail to provide sustained relief. Spinal cord stimulation (SCS) is sometimes used to treat these patients, but the lack of level 1 evidence limits its widespread use and insurance coverage. The DISTINCT RCT study evaluates the efficacy of passive recharge burst SCS compared to conventional medical treatment (CMM) in alleviating chronic, refractory axial low back pain. Methods: This prospective, multicenter, randomized, study with an optional 6-month crossover involved patients who were not candidates for lumbar spine surgery. The primary and secondary endpoints evaluated improvements in low back pain intensity (NRS), back pain-related disability (ODI), pain catastrophizing (PCS), and healthcare utilization. Patients were randomized to SCS therapy or CMM at 30 US study sites. Results: The SCS arm reported an 85.3% NRS responder rate (≥ 50% reduction) compared to 6.2% (5/81) in the CMM arm. After the 6M primary endpoint, SCS patients elected to remain on assigned therapy and 66.2% (49/74) of CMM patients chose to trial SCS (crossover). At the 12M follow-up, SCS and crossover patients reported 78.6% and 71.4% NRS responder rates. Secondary outcomes indicated significant improvements in ODI, PCS, and reduced healthcare utilization. Six serious adverse events were reported and resolved without sequelae. Conclusion: DISTINCT chronic low back pain patients with no indication for corrective surgery experienced a significant and sustained response to burst SCS therapy for up to 12 months. CMM patients who crossed over to the SCS arm reported profound improvements after 6 months. This data advocates for a timely consideration of SCS therapy in patients unresponsive to conservative therapy.

Comparing Conventional Medical Management to Spinal Cord Stimulation for the Treatment of Low Back Pain in a Cohort of DISTINCT RCT Patients.

Aim: Low Back Pain (LBP) is a prevalent condition. Spinal cord stimulation (SCS) has emerged as a more effective, long-term treatment compared to conventional medical management (CMM). The DISTINCT study enrolled and randomized chronic LBP patients with no indication of traditional spine surgery. This analysis focuses comparing study outcomes on patients initially randomized to receive CMM treatment and subsequently crossed over to SCS after 6 months. Purpose: To compare the therapeutic effectiveness and cost-efficiency of passive recharge burst SCS to CMM. Patients and Methods: A total of 269 patients were enrolled with 162 randomly assigned to SCS and 107 to CMM. The DISTINCT study design allowed a crossover to the alternative treatment arm after 6 months. Patients underwent a trial and received a permanent implant if they reported ≥50% pain reduction. Outcome analysis included pain (NRS), disability (ODI), catastrophizing (PCS), quality of life (PROMIS-29) and health care utilization. Results: Seventy out of eighty-one patients opted to cross over to trial SCS at 6M with 94% (66/70) undergoing a trial. Among those, 88% (58/66) reported a ≥50% or more pain relief and 55 received a permanent implant. At 12M visit, 71.4% reported a ≥50% pain improvement sustained at the 18M visit, with 24.5% (12/49) indicating a ≥80% improvement. Disability reductions (79% meeting the minimally important difference of a 13-point decrease), decreased catastrophizing, and significant improvements in all PROMIS-29 domains were noted. Furthermore, 42% of the patients reported decreased or discontinued opioid usage. Clinical benefits at the 12M visit were sustained through the 18M visit accompanied by a significant reduction in healthcare utilization and a $1214 cost savings. Conclusion: SCS demonstrates superior, long-term performance and safety outcomes compared to CMM therapy in LBP patients who received both CMM and SCS therapy. Additionally, SCS patients experienced reduced healthcare resource utilization and lower costs compared to those receiving CMM.

Analysis of Somatosensory Profiles Using Quantitative Sensory Testing During Tonic and BurstDR Stimulation for the Treatment of Chronic Pain.

BACKGROUND: In the presence of neuropathic pain, other sensory qualities, such as touch or pressure, which are a sign of nerve damage, are almost always affected. However, it is unclear to which extent spinal cord stimulation (SCS) influences these simultaneously damaged sensory pathways or possibly contributes to their regeneration. OBJECTIVES: The aim of this study was to investigate the effects and possible differences of tonic and BurstDR (Abbott, Austin, TX) SCS on somatosensory profiles of patients with chronic neuropathic pain, using quantitative sensory testing (QST). STUDY DESIGN: A randomized, single-blinded, single-center study. SETTING: University medical center. METHODS: After a washout phase of 4 hours and having done the basic QST measurement, either tonic or BurstDR stimulation was performed for 30 minutes in a randomized fashion. Then, the second measurement was taken. The third measurement followed after using the remaining stimulation mode for 30 minutes. Mean values of all QST parameters were calculated and compared. We also computed Z-values using standard data. RESULTS: We examined 14 patients (9 women, 5 men, mean age 58.4 years) with previously implanted SCS systems for chronic neuropathic pain, using QST (7 tests, 13 parameters).The QST raw data showed a statistically significant improved vibration sensation (A-Beta) (P = 0.019) and lower mechanical pain threshold (A-Delta) (P = 0,031) when testing BurstDR in comparison to tonic SCS. We found a significant improvement in the vibration sensation and also A-Beta fiber function during BurstDR when we used the Z-value analysis (P = 0.023). With regard to Z-values, BurstDR seemed to be superior regarding the normalization tendency of the A-Delta fiber function in the mechanical pain threshold (P = 0.082), and tonic SCS seemed superior regarding heat detection threshold (C) and cold pain threshold (C and A-Delta) (P = 0.093). LIMITATIONS: The study is limited by its small number of cases. CONCLUSIONS: In this study, it could be shown that, in some QST parameters and tested fiber functions, normalization tendencies were recognizable by using BurstDR or tonic SCS. However, BurstDR SCS seemed to be superior to tonic stimulation in this regard.

BurstDR spinal cord stimulation in the treatment of chronic visceral pain.

Background:Visceral pain can be disabling for patients and challenging to treat in the clinic. Spinal cord stimulation is a NICE approved treatment for chronic neuropathic pain, presenting potential advantages over conventional therapies for managing chronic visceral pain. Results: A retrospective study revealed that a specific type of spinal cord stimulation, BurstDRTM (Abbott, TX, USA), was effective at improving pain and quality of life in patients with chronic visceral pain. Baseline pain scores significantly correlated with change at follow-up, suggesting it may be possible to identify potential responders from the outset. BurstDR was safe: rates of revision, explantation and complications were low. Conclusion: Clinical trials exploring the long-term effects of BurstDR including a control arm are needed. Findings could have the potential to inform best practice and improve outcomes for individuals with chronic visceral pain.

New mode of burst spinal cord stimulation improved mental status as well as motor function in a patient with Parkinson's disease.

Traditional tonic spinal cord stimulation has been shown to improve locomotor behaviour of Parkinson's disease (PD), but may induce paresthesia. Recently developed new stimulation mode, called BurstDR, improved pain, gait and posture of later developed PD patients without inducing paresthesia, in addition to improve emotional symptoms.