Ultra-Low Energy Cycled Burst Spinal Cord Stimulation Yields Robust Outcomes in Pain, Function, and Affective Domains: A Subanalysis From Two Prospective, Multicenter, International Clinical Trials.

INTRODUCTION: DeRidder's burst stimulation design has become a key spinal cord stimulation (SCS) waveform because it reduces the intensity of pain as well as its associated emotional distress. The brain pathways underlying these outcomes may also allow for the effects of stimulation to carry over after stimulation is turned off, making it amenable to intermittent application. Here, the utility of intermittently cycled burst was evaluated using data from two large real-world prospective studies (TRIUMPH, REALITY). MATERIALS AND METHODS: Subjects used intermittent dosing in a 1:3 ratio (30 sec on, 90 sec off; N = 100) in TRIUMPH and 1:12 ratio in REALITY (30-sec on, 360-sec off; N = 95) for six months. Pain intensity (0-10 numeric rating scale), pain-related emotions on the pain catastrophizing scale (PCS), and physical function on PROMIS questionnaires were compared with preimplant baseline ratings and by group. RESULTS: In both groups, mean pain intensity decreased by nearly 50% relative to baseline, PCS scores significantly decreased, and physical function improved. Importantly, no differences between the 1:3 and 1:12 groups were identified. A high proportion, 80% and 77% of the 1:3 and 1:12 groups, respectively, were considered responders on a multiple measures. No adverse events were associated with intermittent stimulation. DISCUSSION: Intermittent cycling of burst SCS lowers the overall electric charge delivered to the spinal cord and preserves battery consumption, without compromising pain relief and associated symptoms.

Composite Score Is a Better Reflection of Patient Response to Chronic Pain Therapy Compared With Pain Intensity Alone.

OBJECTIVE: The pain Numeric Rating Scale (NRS) score became standard when pain was introduced as the fifth vital sign in the 1990s. Although plagued with issues, it remains the basis for primary outcome measures in clinical trials for chronic pain therapies. Multidimensional composite scoring that considers all aspects of the chronic pain experience may provide a more meaningful response measure. Herein we propose a multidimensional responder index. MATERIALS AND METHODS: Data were extracted from an ongoing prospective, multicenter study on DeRidder Burst spinal cord stimulation (B-SCS) for chronic back and/or leg pain (NCT03082261). The analysis cohort consisted of subjects who completed the NRS, Pain Catastrophizing Scale (PCS), EuroQol-5D (EQ-5D), and eight-item Patient-Reported Outcomes Measurement Information System Physical Function preoperatively and at 12 months after implant. RESULTS: A principal component analysis showed that each of the four measures contributed equally to the variance in the data set, confirming that pain score should not be used alone. Subjects who failed to respond on NRS responded on both PCS and EQ-5D. Eighty-one percent of subjects responded on at least two measures. The responder algorithm yielded an 84% success rate at both 6- and 12-month time points. CONCLUSIONS: Our study suggests that therapeutic response, similar to the chronic pain experience, is multidimensional. Careful consideration should be made to incorporate composite endpoints in future SCS clinical trials.

Improved Psychosocial and Functional Outcomes and Reduced Opioid Usage Following Burst Spinal Cord Stimulation.

OBJECTIVE: Burst spinal cord stimulation (B-SCS) has been shown to reduce neuronal firing in the anterior cingulate cortex through selective modulation of the medial pain pathway tract. This pain pathway communicates the affective component of pain processing. The purpose of this study was to assess the effect of B-SCS on psychosocial functioning and its influence on pain and quality of life. MATERIALS AND METHODS: Eligible patients with chronic, intractable pain of the trunk, and/or lower limbs were enrolled. After a successful trial period, subjects received a permanent implant and returned for follow-up at 6- and 12-months. RESULTS: In total, 269 patients were enrolled at 22 centers. Trial success rate was 90%. Significant improvements in pain, physical, mental, and emotional functioning were observed from baseline to the 6- and 12-month follow-up (p < 0.001). Overall, patients had improved quality of life, became more active, and the negative impact of pain on daily life was decreasing. At one year, 81% of subjects were satisfied or very satisfied with their therapy. Subjects showing significant improvements on mental health outcomes reported enhanced pain relief and quality of life scores compared with subjects with continued impaired mental health at follow-up. At one year, 89% of subjects who were taking opioids at baseline decreased or stayed at the same level of opioid use; 19% stopped taking any opioids. No unanticipated adverse events have been reported. CONCLUSIONS: One-year outcomes after B-SCS show improvements across all evaluated psychological measures with the largest impact observed on catastrophizing and depression (the affective component of pain processing). These pain-related beliefs and behaviors, and not pain intensity, have been shown to put patients at greatest risk of a poor prognosis and quality of life.

Anatomic Lead Placement Without Paresthesia Mapping Provides Effective and Predictable Therapy During the Trial Evaluation Period: Results From the Prospective, Multicenter, Randomized, DELIVERY Study.

OBJECTIVE: The purpose of this study was to compare the trial success rate between anatomic lead placement (AP) and paresthesia-mapped (PM) lead placement techniques for spinal cord stimulation (SCS) using a nonlinear burst stimulation pattern. MATERIALS AND METHODS: Eligible patients with back and/or leg pain with a Numeric Rating Scale (NRS) score of ≥6 who had not undergone previous SCS were enrolled in the study. A total of 270 patients were randomized in a 1:1 ratio to each treatment arm. In the AP group, one lead tip was placed at the mid-body of T8, and the other at the superior endplate of T9. In the PM group, physicians confirmed coverage of the patient's primary pain location. Trial success was a composite of the following: ≥50% patient-reported pain relief at the end of the minimum three-day trial period, physician's recommendation, and patient's interest in a permanent implant. RESULTS: Trial success for AP vs. PM groups was equivalent to 84.4% and 82.3%, respectively. Physicians who performed both techniques preferred AP technique (70% vs. 30%). Procedure times for placement of two leads were 31% shorter in the AP group (p < 0.0001). Decrease in the mean NRS pain score was similar between groups (53.2%, AP group; 53.8%, PM group, p = 0.79). Trial success for patients who went on to an extended trial with tonic stimulation was 50% (5/10) vs. 79% (11/14) for AP group and PM group, respectively (p = 0.2). A total of 13 adverse events were observed (4.5%), most commonly lead migrations and pain around implant site, with no difference between groups. CONCLUSIONS: When using a nonlinear burst stimulation pattern, anatomic or PM lead placement technique may be used. Nonresponders to subthreshold stimulation had a higher conversion rate when a PM technique was used. AP resulted in shorter procedure times with a similar safety profile and was strongly preferred by trialing physicians.

Effectiveness and Safety of Dorsal Root Ganglion Stimulation for the Treatment of Chronic Pain: A Pooled Analysis.

INTRODUCTION: Since it became available in the mid-2010s, dorsal root ganglion (DRG) stimulation has become part of the armamentarium to treat chronic pain. To date, one randomized controlled trial, and several studies of moderate sample size and various etiologies have been published on this topic. We conducted a pooled analysis to investigate the generalizability of individual studies and to identify differences in outcome between chronic pain etiologic subgroups and/or pain location. MATERIALS AND METHODS: One prospective, randomized comparative trial and six prospective, single-arm, observational studies were identified that met pre-defined acceptance criteria. Pain scores and patient-reported outcome (PRO) measures were weighted by study sample sizes and pooled. Safety data are reported in aggregate form. RESULTS: Our analysis included 217 patients with a permanent implant at 12-month follow-up. Analysis of pooled data showed an overall weighted mean pain score of 3.4, with 63% of patients reporting ≥50% pain relief. Effectiveness sub-analyses in CRPS-I, causalgia, and back pain resulted in a mean reduction in pain intensity of 4.9, 4.6, and 3.9 points, respectively. Our pooled analysis showed a pain score for primary affected region ranging from 1.7 (groin) to 3.0 (buttocks) and responder rates of 80% for foot and groin, 75% for leg, and 70% for back. A substantial improvement in all PROs was observed at 12 months. The most commonly reported procedural or device complications were pain at the IPG pocket site, lead fracture, lead migration, and infection. CONCLUSIONS: DRG stimulation is an effective and safe therapy for various etiologies of chronic pain.

Self-massage prior to stretching improves flexibility in young and middle-aged adults.

We examined the influence of stretching alone (SS) or combined with self-massage (SM) on maximal ankle dorsiflexion angle, maximal voluntary contraction (MVC) torque and calf muscle activity, and subcutaneous tissue thickness in 15 young (25 ± 3 years) and 15 middle-aged (45 ± 5 years) adults. Participants performed two sessions of calf muscle stretches (3x 30-s stretches, 30-s rest): stretch after a 60-s control condition (SS) and stretch after 60 s of self-massage with therapy balls (SM). Evaluations were performed before and 5 min after the intervention. Linear mixed effects model revealed no main effect for age on ROM or MVC and significant main effects for treatment and time. Change in ankle angle was greater after SM: SS = 3.1 ± 2°, SM = 6.2 ± 3.3° (Hedges' g = 0.98, p < 0.001). Similar results were observed for MVC torque: SS = -4 ± 16%, SM = 12 ± 16% (Hedges' g = 0.97, p = 0.0001). Changes in MVC torque and absolute EMG amplitude were correlated, but subcutaneous tissue thickness was not altered by treatment. The gains in ROM were more pronounced in less flexible middle-aged adults, underscoring the need to include flexibility exercises in their training.

Is sacroiliac joint pain associated with changes in the pubic symphysis? A radiographic pilot study.

BACKGROUND CONTEXT: Disorders of the sacroiliac joint are challenging to diagnose. This is partially due to similarity in symptom presentation to other lumbar spinal disorders and poor visibility of the joint on imaging studies. The pubic symphysis is clearly visualized in the anteroposterior view on plain film radiographs. As a closed ring, changes in the anterior and posterior portion of the pelvis may be reciprocal. The purpose of this study was to assess the correlation between pubic symphyseal changes observed on X-ray and SI joint disorders. METHODS: Thirty patients with a confirmed diagnosis of SI joint disorders were compared with 30 patients with low back pain without the evidence of SI joint involvement. Plain film radiographs were blinded and independently reviewed by two orthopedic surgeons. Changes in the pubic symphysis were classified as (0) no change, (1) osteoarthritic degeneration, (2) vertical displacement, or (3) ligament ossification. RESULTS: There was no significant difference between groups in age, gender, or parturition status. The majority of both groups were female. Mean (±SD) subject age was 61 (±11) and 59 (±9) years, and parity was 44% and 39% for the study and control groups, respectively. The prevalence of observable changes in the pubic symphysis was 97% in the study group and 30% in the control group (p < 0.001). CONCLUSION: Results of this study suggest that pubic symphyseal changes in the presence of low back pain and positive provocative maneuvers could serve as a marker for SI joint disease. Further investigation of the potential relationship between SI joint symptoms and symphyseal changes should be examined.

Estimating the Cost of Spinopelvic Complications After Adult Spinal Deformity Surgery.

Objective: Reoperations for spinopelvic failure after adult spinal deformity (ASD) surgery are common. We sought to determine the added costs of ASD surgery attributable to reoperations for spinopelvic construct failures. Methods: We constructed a Markov process model to calculate the expected discounted 5-year costs of spinopelvic construct failures after ASD surgery. The Nationwide Inpatient Sample (NIS) was queried to estimate the number of ASD surgeries. Model inputs were based on literature review and expert opinion. ASD surgery was defined as thoracolumbar fusion of 4 or more levels with pelvic fixation. The following pelvic fixation failures were included: 1) rod fracture or pseudarthrosis from L4-S1, 2) iliac screw failure or set plug dislodgment, 3) iliac screw prominence, and 4) sacroiliac (SI) joint pain. The number of patients undergoing ASD surgery annually in the US was determined using a commercial claims database. Results: The net present value 5-year cost per patient for spinopelvic complications was $35,265, equal to 29% of index surgery costs. Given an estimated 27,580 cases annually in the US, the additional cost to address spinopelvic complications reach nearly $1 billion over 5-years. A sensitivity analysis showed that these costs were most sensitive to the rate of rod fracture/pseudarthrosis, iliac screw prominence, and reoperation. Conclusion: A conservative estimate of the cost of spinopelvic failures after ASD surgery is substantial, nearly $1 billion over 5-years. We propose a method of capturing spinopelvic fixation failures for use in future clinical studies and cost analyses.

Minimally Invasive SI Joint Fusion Procedures for Chronic SI Joint Pain: Systematic Review and Meta-Analysis of Safety and Efficacy.

BACKGROUND: Sacroiliac (SI) joint fusion is increasingly used to treat chronic SI joint pain. Multiple surgical approaches are now available. METHODS: Data abstraction and random effects meta-analysis of safety and efficacy outcomes from published patient cohorts. Patient-reported outcomes (PROs) and safety measures were stratified by surgical technique: transiliac, including lateral transiliac (LTI) and posterolateral transiliac (PLTI), and posterior interpositional (PI) procedures. RESULTS: Fifty-seven cohorts of 2851 patients were identified, including 43 cohorts (2126 patients) for LTI, 6 cohorts (228 patients) for PLTI, and 8 cohorts (497 patients) for PI procedures. Randomized trials were only available for LTI. PROs were available for pain (numeric rating scale) in 57 cohorts (2851 patients) and disability (Oswestry Disability Index [ODI]) in 37 cohorts (1978 patients).All studies with PROs showed improvement from baseline after surgery. Meta-analytic improvements in pain scores were highest for LTI (4.8 points [0-10 scale]), slightly lower for PLTI (4.2 points), and lowest for PI procedures (3.8 points, P = 0.1533). Mean improvements in ODI scores were highest for LTI (25.9 points), lowest for PLTI procedures (6.8 points), and intermediate for PI (16.3 points, P = 0.0095).For safety outcomes, acute symptomatic implant malposition was 0.43% for LTI, 0% for PLTI, and 0.2% for PI procedures. Wound infection was reported in 0.15% of LTI, 0% of PLTI, and 0% of PI procedures. Bleeding requiring surgical intervention was reported in 0.04% of LTI procedures and not reported for PLTI or PI. Breakage and migration were not reported for any device. Radiographic imaging evaluation reporting implant placement accuracy and fusion was only available for LTI. DISCUSSION: Literature support for SI joint fusion is growing. The LTI procedure contains the largest body of available evidence and shows the largest improvements in pain and ODI. Only LTI procedures have independent radiographic evidence of fusion and implant placement. The adverse event rate for all procedures was low.

Burst spinal cord stimulation can attenuate pain and its affective components in chronic pain patients with high psychological distress: results from the prospective, international TRIUMPH study.

BACKGROUND CONTEXT: Psychological characteristics such as catastrophizing and depression have been shown to negatively impact outcome prognosis after spinal interventions. PURPOSE: To evaluate whether high psychological distress, defined as clinically elevated levels of catastrophizing and depression, is associated with poorer outcomes after spinal cord stimulation utilizing a passive recharge burst stimulation design. This proprietary waveform may uniquely attenuate the emotional aspects of chronic pain given its affects on the medial pain pathway projecting to the dorsal anterior cingulate cortex and anterior insula. STUDY DESIGN/SETTINGS: Data were extracted from the prospective, multi-center, single-arm, international TRIUMPH study. The purpose of TRIUMPH was to assess long-term (2 years) safety and effectiveness of spinal cord stimulation for chronic pain in the trunk and/or limbs using a passive recharge enabled burst spinal cord stimulation (B-SCS) system. PATIENT SAMPLE: Two subsets of study patients were identified; those with (n=31) and those without (n=54) high psychological distress. OUTCOME MEASURES: Psychological and functional outcomes as well as pain intensity and impact of pain on life were administered at baseline and all follow intervals. Additionally, patient satisfaction and patient global impression of change were assessed at all follow-up intervals. METHODS: Psychological distress (PD) was defined as a baseline score of ≥ 30 on the Pain Catastrophizing Scale (PCS) and ≥ 10 on the Patient Health Questionnaire Depression scale (PHQ-9). Nondistressed (ND) patients had scores below these thresholds on both scales. All patients were implanted with a B-SCS system and completed data collection for the 24-month follow-up visit. This study was funded by Abbott. JMH is a consultant for Abbott and has received <$20,000 in lifetime consulting fees from Abbott. SMF is a consultant for Abbott and has received >$50,000 in lifetime consulting fees from Abbott. BB is an Abbott employee. RAC is a former Abbott employee. JJY is a consultant for Abbott and has received <$2,500 in lifetime consulting fees from Abbott. RESULTS: Of the 128 participants with 24-month data, 31 (24%) and 54 (35%) met the criteria for PD and ND, respectively. Baseline measures indicated a more severe chronic pain profile and worse quality of life in the PD group. Two years after implant, 71% were no longer clinically catastrophizing and 58% were no longer clinically depressed. Notably, more than half of the PD patients on antidepressants discontinued or decreased their medication. Health-related quality of life was 82% higher in the PD group at 24 months, reaching levels similar to the ND group. Psychological distress did not impact outcomes after SCS therapy; composite multi-responder rates were similar in the 2 groups throughout the follow-up period. Patient reported pain relief (58% PD vs. 61% ND) was equivalent in each group. In both groups, 81% were satisfied or very satisfied with the pain relief provided. CONCLUSIONS: Our results showed that B-SCS appears to be as effective in a chronic pain population with high psychological distress as in those without distress. This may be due to the unique mechanism of action with the stimulation design involving the emotional-affective medial pain pathway in the brain.

Revision of Failed Sacroiliac Joint Posterior Interpositional Structural Allograft Stabilization with Lateral Porous Titanium Implants: A Multicenter Case Series.

Background: Distraction arthrodesis (DA) and stabilization of the sacroiliac (SI) joint by placing standalone structural allograft (SA) into the joint from a posterior trajectory has recently been introduced as a surgical procedure for chronic SI joint pain refractory to non-operative care. Methods: Retrospective case series of patients with recurrent and/or persistent pain after placement of one or more interpositional/intraarticular standalone SAs between the ilium and sacrum using a posterior procedure to treat SI joint pain/dysfunction. Patients subsequently underwent surgical revision with porous titanium fusion implants using a lateral transfixing procedure. The demographic, clinical, and radiographic features of these cases are described. Results: Data were available for 37 patients. The average (SD) age was 57 (13) years, 62% were female, and the average BMI was 31 (5.4). On average, two SA implants were placed per joint; 46% of cases were bilateral. At follow-up, two common themes were identified: lucencies around the implants and suboptimal implant position. None of the cases showed radiographic fusion of the SI joint prior to revision. One patient had an inflammatory reaction to the SA. All patients presented for revision due to either continued (49%) or recurrence (51%) of pain. In one revision case, the SA was forced ventrally, resulting in a sacral fracture, which was treated conservatively without sequelae. Conclusions: The popularity of standalone SA for SI joint stabilization/fusion with a posterior procedure is increasing. This case series demonstrates that clinical failures from this procedure may require surgical revision. The proposed fusion strategy (DA) for these products is unproven in the SI joint, and, therefore, properly conducted prospective randomized clinical trials with long-term clinical and radiographic follow-up are important to establish the safety and efficacy of this approach. In the meantime, the placement of lateral titanium implants appears to be an effective revision strategy.

Passive Recharge Burst Spinal Cord Stimulation Provides Sustainable Improvements in Pain and Psychosocial Function: 2-year Results From the TRIUMPH Study.

STUDY DESIGN: Prospective, international, multicenter, single-arm, post-market study. OBJECTIVE: The aim of this study was to assess long-term safety and effectiveness of spinal cord stimulation using a passive recharge burst stimulation design for chronic intractable pain in the trunk and/or limbs. Herein we present 24-month outcomes from the TRIUMPH study (NCT03082261). SUMMARY OF BACKGROUND DATA: Passive recharge burst spinal cord stimulation (B-SCS) uniquely mimics neuronal burst firing patterns in the nervous system and has been shown to modulate the affective and attentional components of pain processing. METHODS: After a successful trial period, subjects received a permanent SCS implant and returned for follow-up at 6, 12, 18, and 24 months. RESULTS: Significant improvements in physical, mental, and emotional functioning observed after 6 months of treatment were maintained at 2 years. Pain catastrophizing scale (PCS) scores dropped below the population norm. Health-related quality of life on EQ-5D improved across all domains and the mean index score was within one standard deviation of norm. Pain reduction (on NRS) was statistically significant (P < 0.001) at all timepoints. Patient reported pain relief, a stated percentage of improvement in pain, was consistent at all timepoints at 60%. Patients reported significant improvements across all measures including activity levels and impact of pain on daily life. At 24 months, 84% of subjects were satisfied and 90% would recommend the procedure. Subjects decreased their chronic pain medication intake for all categories; 38% reduced psychotropic and muscle relaxants, 46% reduced analgesic, anti-convulsant and NSAIDs, and 48% reduced opioid medication. Adverse events occurred at low rates without unanticipated events. CONCLUSION: Early positive results with B-SCS were maintained long term. Evidence across multiple assessment tools show that B-SCS can alleviate pain intensity, psychological distress, and improve physical function and health-related quality of life.Level of Evidence: 3.

Sensory nerve stimulation causes an immediate improvement in motor function of persons with multiple sclerosis: A pilot study.

BACKGROUND: Multiple sclerosis (MS) symptoms reported in the first year of the disease include sensory impairment, fatigue, reduced mobility, and declines in hand function. The progressive reduction in motor function experienced by persons living with MS is invariably preceded by changes in sensory processing, which are strongly associated with the declines in both walking performance and manual dexterity. AIMS: To assess the influence of concurrent sensory stimulation using augmented transcutaneous electrical nerve stimulation (aTENS) applied to leg and hand muscles on clinical tests of motor function in individuals whose mobility was compromised by MS. METHODS: Thirteen persons with MS (52 ±â€¯8 years; 6 women) and 12 age- and sex-matched healthy adults (52 ±â€¯9 years) met the inclusion criteria. Participants visited the lab on two occasions with one week between visits. Each visit involved the participant performing four tests of motor function and completing two health-related questionnaires (PDDS and MSWS-12). The tests assessed walking performance (6-min test and 25-ft test), dynamic balance (chair-rise tes, and manual dexterity (grooved pegboard test). aTENS was applied through pads attached to the limbs over the tibialis anterior and rectus femoris muscles of the affected leg, and over the median nerve and the thenar eminence of the dominant hand. The pads were attached during both visits, but the current was only applied during the second visit. The stimulation comprised continuous asymmetrical biphasic pulses (0.2 ms) at a rate of 50 Hz and an intensity that elicited slight muscle contractions. RESULTS: At baseline and during both treatment sessions, the performance on all four tests of motor function was worse for the MS group than the Control group. The MS group experienced significant improvements in all outcomes during the aTENS session with medium-to-large effect sizes. PDDS ratings improved (from 2.8 ±â€¯1.3 to 2.0 ±â€¯1.5; effect size d = -0.70) and the MSWS-12 scores declined (from 36 ±â€¯11 to 28 ±â€¯12; effect size d = -1.52). The concurrent application of aTENS enabled the MS group to walk further during the 6-min test (from 397 ±â€¯174 m to 415 ±â€¯172 m; effect size d = 0.81), to complete the 25-ft test in less time (6.7 ±â€¯3.0 s to 6.3 ±â€¯2.9 s; effect size d = -0.76), to increase the counts in the chair-rise test (from 11.2 ±â€¯3.8 to 13.6 ±â€¯4.8; effect size d = 1.52), and to perform the grooved pegboard test more quickly (from 110 ±â€¯43 s to 99 ±â€¯37 s; effect size d = -0.98). The only significant effect for the Control group was a significant increase in the 6-min walk distance (from 725 ±â€¯79 to 740 ±â€¯82 m; effect size d = 0.87). CONCLUSIONS: Stimulation of sensory fibers with aTENS evoked clinically significant improvements in four tests of motor function and the self-reported level of walking limitations in persons who were moderately disabled by MS. Moreover, the improvements in function elicited by the concurrent application of aTENS were immediate.

Manipulation of sensory input can improve stretching outcomes.

The primary purpose of our study was to assess the influence of modulating sensory input with either transcutaneous electrical nerve stimulation (TENS) or self-massage with therapy balls on the maximal range of motion (ROM) about the ankle joint when stretching the calf muscles. We also investigated the influence of these two conditions on the force capacity and force control of plantar flexor muscles. Twenty healthy adults (25 ± 3 yr) performed three sessions of ankle plantar flexor stretching (three stretches of 30 s each): stretching alone (SS), stretching with concurrent TENS (TENS), and stretching after self-massage using therapy balls (SM). TENS was applied for 60 s prior to and during each stretch, and SM was performed for 60 s prior to each of the three stretches. Maximal voluntary contraction (MVC) torque and force steadiness at 20% MVC were recorded before and at 15 min after the final stretch. Ankle dorsiflexion ROM was assessed before, after, and at 5, 10, and 15 min after the last stretch. The increase in ROM was greater after SM (24%) than after SS (13%) and TENS (9%; p < .001). Maximal discomfort level (0-10 VAS) during stretching was similar for all conditions. MVC torque increased after SM only (p < .001, Cohen's D = 1.5): SM, 16%; SS, -1%; TENS, -3%. Force steadiness did not change. The sensory fibres that contribute to stretch tolerance were engaged by self-massage but not by TENS, resulting in greater increases in flexibility and MVC torque after self-massage.

Individuals with sacroiliac joint dysfunction display asymmetrical gait and a depressed synergy between muscles providing sacroiliac joint force closure when walking.

Walking is often compromised in individuals with low back and hip disorders, such as sacroiliac joint dysfunction (SIJD). The disorder involves reduced coactivation of the gluteus maximus and contralateral latissimus dorsi, which together provide joint stability during walking. The purpose of our study was to compare the kinematics and contributions of selected muscles to identified synergies during walking between healthy individuals and those with SIJD. Six women with unilateral SIJD and six age-matched healthy controls walked on a force-measuring treadmill at 1 m/s while we recorded kinematics and the activity of 16 muscles with surface EMG. Non-negative matrix factorization was used to identify patterns of EMG activity (muscle synergies). Individuals with SIJD exhibited less hip extension and lower peak vertical ground reaction forces on the affected side than the unaffected side. In contrast to controls, the SIJD group also displayed a depressed muscle synergy between gluteus maximus on the affected side and the contralateral latissimus dorsi. The results indicate that individuals with SIJD exhibited both reduced activation of gluteus maximus during a loading synergy present in walking and greater asymmetry between legs when walking compared with age-matched controls.

Patients with sacroiliac joint dysfunction exhibit altered movement strategies when performing a sit-to-stand task.

OF BACKGROUND DATA: The ability to rise from a chair is a basic functional task that is frequently compromised in individuals diagnosed with orthopedic disorders in the low back and hip. There is no published literature that describes how this task is altered by sacroiliac joint dysfunction (SIJD). PURPOSE: The objective of this study was to compare lower extremity biomechanics and the onset of muscle activity when rising from a chair in subjects with SIJD and in healthy persons. STUDY DESIGN: Six women with unilateral SIJD and six age-matched healthy controls performed a sit-to-stand task while we measured kinematics, kinetics, and muscle activity. MATERIALS AND METHODS: Subjects stood up at a preferred speed from a seated position on an armless and backless adjustable stool. We measured kinematics with a 10-camera motion capture system, ground reaction forces for each leg with force plates, and muscle activity with surface electromyography. Joint angles and torques were calculated using inverse dynamics. Leg-loading rate was quantified as the average slope of vertical ground reaction (VGRF) force during the 500-millisecond interval preceding maximal knee extension. RESULTS: Between-leg differences in loading rates and peak VGRFs were significantly greater for the SIJD group than for the control group. Maximal hip angles were significantly less for the SIJD group (p=.001). Peak hip moment in the SIJD group was significantly greater in the unaffected leg (0.75±0.22 N⋅m/kg) than in the affected leg (0.47±0.29 N⋅m/kg, p=.005). There were no between-leg or between-group differences for peak knee or ankle moments. The onset of activity in the latissimus dorsi muscle on the affected side was delayed and the erector spinae muscles were activated earlier in the SIJD group than in the control group. CONCLUSIONS: Subjects with SIJD have a greater VGRF on the unaffected leg, generate a greater peak hip moment in the unaffected leg, use a smaller range of motion at the hip joint of the affected leg, and delay the onset of a key muscle on the affected side when rising from a seated position.

Safety and effectiveness of minimally invasive sacroiliac joint fusion in women with persistent post-partum posterior pelvic girdle pain: 12-month outcomes from a prospective, multi-center trial.

Postpartum posterior pelvic girdle pain (PPGP) affects nearly 20 % of women who experience back pain in the peripartum period. The sacroiliac joint is a source of this pain in 75 % of women with persistent PPGP. A subset of women will fail to obtain acceptable pain relief from the current array of non-surgical treatment options. The purpose of this study is to assess the safety and effectiveness of minimally invasive sacroiliac (SI) joint fusion in women with chronic SI joint dysfunction whose pain began in the peri-partum period whose symptoms were recalcitrant to non-surgical management. A sub-group analysis of subjects with sacroiliac joint disruption and/or degenerative sacroiliitis enrolled in a prospective, multi-center trial of SI joint fusion was performed. Subjects with PPGP were identified and compared with women without PPGP and with men. Of 172 enrolled subjects, 52 were male, 100 were females without PPGP and 20 females had PPGP. PPGP subjects were significantly younger (43.3 years, vs. 52.8 for females without PPGP and 50.5 for men, p = 0.002). There were no differences in any other demographic or baseline clinical measure. Women with PPGP experienced a significant improvement in pain (-51 mm on VAS), function (-20.6 pts on ODI) and quality of life (SF-36 PCS +10.4, MCS +7.2, EQ-5D +0.31) at 12 months after surgery. These improvements were characteristic of the overall study results; no difference was detected between sub-groups. The sacroiliac joint can be a source of pain in women with persistent PPGP and should be investigated as a pain generator. In this study, women with carefully diagnosed chronic SI joint pain from PPGP recalcitrant to conservative therapies experienced clinically beneficially improvements in pain, disability and quality of life after minimally invasive SI joint fusion using a series of triangular porous plasma spray coated implants.

A systematic review of minimally invasive sacroiliac joint fusion utilizing a lateral transarticular technique.

BACKGROUND: A number of studies have been published regarding minimally invasive surgical (MIS) fusion of the sacroiliac (SI) joint using a lateral transarticular approach. Herein we report a systematic review and meta-analysis to summarize operative measures and clinical outcomes reported in published studies of MIS SI joint fusion. METHODS: The systematic review was done according to PRISMA standards. PubMed and EMBASE were searched using the terms sacroiliac joint AND fusion. Original peer-reviewed articles in the English language that reported clinical outcomes on at least 5 cases of MIS SI joint fusion using a lateral transarticular approach were included. Random effects meta-analysis (RMA) was performed on selected variables using the DerSimonian and Laird method, including operative measures, VAS SI joint pain ratings (0-10 scale) and Oswestry Disability Index (ODI). Mean and 95% confidence intervals (CI) were calculated and heterogeneity was assessed. Other findings were summarized qualitatively. RESULTS: A total of 18 articles met the inclusion criteria. After accounting for overlapping cohorts, 12 unique cohorts from 4 countries were extracted for a total of 432 subjects. The RMA mean (range) was 59 minutes (27-78) for procedure time, 36.9cc (10-70) for estimated blood loss and 1.7 days (range 0-7) for length of stay (LOS). The RMA mean [95% CI] pain score dropped by 5.2 points at 6 months and 5.3 points at 12 months (baseline score of 8.1 [7.8-8.4], 12-month score of 2.7 [2.1-3.3]), and a 24-month score of 2.0(1.4-2.5). ODI decreased by 31 points at 12 months (baseline score of 56.2 [51.0-61.5], 6-month score of 30.7 [21.8-39.6], and 12-month score of 25.1 [12.3-37.9]). Some estimates showed significant variation across studies and between the types of implants used. Other reported outcomes were supportive of the positive effects of SI joint fusion. CONCLUSION: Published studies of MIS SI joint fusion using a lateral transarticular approach confirm its minimally invasive characteristics with minimal blood loss and short operating room times, and show consistent, rapid, sustained and clinically important improvements in patient reported SI joint pain, disability and quality of life scores.

Spine device clinical trials: design and sponsorship.

BACKGROUND CONTEXT: Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. PURPOSE: To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design. STUDY DESIGN: Analysis of data from a publicly available clinical trials database. METHODS: Clinical trials of spine devices registered on ClinicalTrials.gov, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models. RESULTS: One thousand six hundred thrity-eight studies were retrieved from ClinicalTrials.gov using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (p<.0001) and larger sample sizes. There were very few US-based multicenter randomized trials of spine devices not sponsored by the industry. CONCLUSIONS: Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose.