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Background Interspinous process decompression (IPD) with stand-alone spacers has demonstrated excellent long-term clinical benefit for patients with lumbar spinal stenosis (LSS). Methods IPD used the Superion® Indirect Decompression System (Vertiflex, Carlsbad, CA, USA). Perioperative and clinical data were captured via a registry for patients treated with IPD for LSS with intermittent neurogenic claudication. Three-hundred sixteen physicians at 86 clinical sites in the US participated. Patient data were captured from in-person interviews and a phone survey. Outcomes included intraoperative blood loss, procedural time, leg and back pain severity (100 mm VAS), patient satisfaction and treatment approval at 3 weeks, 6 and 12 months. Results The mean age of registry patients was 73.0 ± 9.1 years of which 54% were female. Mean leg pain severity decreased from 76.6 ± 22.4 mm preoperatively to 30.4 ± 34.6 mm at 12 months, reflecting an overall 60% improvement. Corresponding responder rates were 64% (484 of 751), 72% (1,097 of 1,523) and 75% (317 of 423) at 3 weeks, 6 and 12 months, respectively. Back pain severity improved from 76.8 ± 22.2 mm preoperatively to 39.9 ± 32.3 mm at 12 months (48% improvement); 12-month responder rate of 67% (297 of 441). For patient satisfaction at 3 weeks, 6 and 12 months, 89%, 80%, and 80% were satisfied or somewhat satisfied with their treatment and 90%, 75%, and 75% would definitely or probably undergo the same treatment again. In the phone survey, the rate of revision was 3.6% (51 of 1,426). Conclusion These registry findings support the clinical adoption of minimally invasive IPD in patients with neurogenic claudication associated with LSS.

Background Interspinous process decompression (IPD) with stand-alone spacers has demonstrated excellent long-term clinical benefit for patients with lumbar spinal stenosis (LSS). Methods IPD used the Superion® Indirect Decompression System (Vertiflex, Carlsbad, CA, USA). Perioperative and clinical data were captured via a registry for patients treated with IPD for LSS with intermittent neurogenic claudication. Three-hundred sixteen physicians at 86 clinical sites in the US participated. Patient data were captured from in-person interviews and a phone survey. Outcomes included intraoperative blood loss, procedural time, leg and back pain severity (100 mm VAS), patient satisfaction and treatment approval at 3 weeks, 6 and 12 months. Results The mean age of registry patients was 73.0 ± 9.1 years of which 54% were female. Mean leg pain severity decreased from 76.6 ± 22.4 mm preoperatively to 30.4 ± 34.6 mm at 12 months, reflecting an overall 60% improvement. Corresponding responder rates were 64% (484 of 751), 72% (1,097 of 1,523) and 75% (317 of 423) at 3 weeks, 6 and 12 months, respectively. Back pain severity improved from 76.8 ± 22.2 mm preoperatively to 39.9 ± 32.3 mm at 12 months (48% improvement); 12-month responder rate of 67% (297 of 441). For patient satisfaction at 3 weeks, 6 and 12 months, 89%, 80%, and 80% were satisfied or somewhat satisfied with their treatment and 90%, 75%, and 75% would definitely or probably undergo the same treatment again. In the phone survey, the rate of revision was 3.6% (51 of 1,426). Conclusion These registry findings support the clinical adoption of minimally invasive IPD in patients with neurogenic claudication associated with LSS.

BACKGROUND CONTEXT Interspinous process decompression (IPD) with stand-alone spacers has demonstrated excellent long-term clinical benefit for patients with lumbar spinal stenosis (LSS). PURPOSE Real-world experience with interspinous process decompression. The primary aim of the registry is to prospectively collect a set of perioperative and clinical outcomes among patients treated with stand-alone IPD for symptomatic LSS. STUDY DESIGN/SETTING Stand-alone IPD using the Superion Indirect Decompression System (Vertiflex, Carlsbad, CA USA). Perioperative and clinical data were captured via a registry for patients treated with IPD for LSS with intermittent neurogenic claudication. Seventy-five physicians at 53 clinical sites in the US participated. Outcomes included intraoperative blood loss, procedural time, leg and back pain severity, self-defined functional objective, and patient satisfaction at 3 weeks, 6 and 12 months. PATIENT SAMPLE To date, 722 patients have undergone IPD and enrolled in the PRESS registry with a mean age of 73.0 ± 10.7 years including 379 females (53%). The maximum number of patients providing pain severity data was 603, 521, 184 and 53 at baseline, 3 weeks, 6 and 12 months, respectively. OUTCOME MEASURES Patient-reported outcomes included leg and back pain severity by 100 mm Visual Analog Scale prior to IPD as well as at 3 weeks, 6 and 12 months, postoperatively. At each follow-up interval, patients were also asked to indicate the extent to which they had achieved their Self-Defined Functional Objective, on a 1 to 5 scale, with 1 indicating no progress at all, and 5 indicating complete achievement. Additionally, patient satisfaction with IPD was queried as satisfied, somewhat satisfied, somewhat dissatisfied, or dissatisfied. Treatment approval with IPD was characterized as definitely yes, probably yes, probably not or definitely not with respect to whether the patient would repeat the treatment. METHODS Perioperative and clinical data were captured via a registry for patients treated with IPD for LSS with intermittent neurogenic claudication. RESULTS To date, 722 patients have undergone IPD and enrolled in this registry with a mean age of 73.0 ± 10.7 years including 379 females (53%). Average intraoperative blood loss was 6.1 ± 7.7 mL; median operative duration was 39.0 minutes (range: 7.0 to 210.0 mins). Mean leg pain severity decreased from 67.3 ± 26.5 mm preoperatively to 28.7 ± 33.0 mm at 12 months, reflecting an overall 57% improvement. Corresponding responder rates were 64% (335 of 521), 61% (113 of 184) and 66% (35 of 53) at 3 weeks, 6 and 12 months, respectively. Back pain severity improved similarly from 67.9 ± 25.9 mm preoperatively to 28.6 ± 31.3 mm at 12 months (58% improvement); 12-month responder rate of 64% (34 of 53). Functional objective responder rates were 63%, 67% and 81% at 3 weeks, 6 and 12 months, respectively. For patient satisfaction at 3 weeks, 6 and 12 months, 89%, 84%, and 91% were satisfied or somewhat satisfied with their treatment and 91%, 80%, and 87% would definitely or probably undergo the same treatment again. In a phone survey, the rate of revision or reoperation was 4% (21 of 517). CONCLUSIONS These registry findings support the clinical adoption of IPD in patients considering minimally-invasive options to manage chronically recalcitrant LSS symptoms. FDA DEVICE/DRUG STATUS Superion Indirect Decompression System (Approved for this indication).

Background The aim of this study was to determine whether spinal cord stimulation (SCS) using 3D neural targeting provided sustained overall and low back pain relief in a broad routine clinical practice population. Study Design and Methods This was a multicenter, open-label observational study with an observational arm and retrospective analysis of a matched cohort. After IPG implantation, programming was done using a patient-specific, model-based algorithm to adjust for lead position (3D neural targeting) or previous generation software (traditional). Demographics, medical histories, SCS parameters, pain locations, pain intensities, disabilities, and safety data were collected for all patients. Results A total of 213 patients using 3D neural targeting were included, with a trial-to-implant ratio of 86%. Patients used seven different lead configurations, with 62% receiving 24 to 32 contacts, and a broad range of stimulation parameters utilizing a mean of 14.3 (±6.1) contacts. At 24 months postimplant, pain intensity decreased significantly from baseline (ΔNRS = 4.2, N = 169, P

Objective This case report calls attention to an alternative approach for management of a symptomatic facet joint synovial cyst. We describe a patient with a symptomatic facet joint synovial cyst who failed an attempted percutaneous rupture using a single-needle technique. This patient was subsequently successfully managed with percutaneous rupture using a 2-needle technique. Case Report A 60-year-old woman presented with low back pain, right lower extremity pain, and paresthesias. Magnetic resonance imaging revealed a right L5-S1 facet joint cyst, which compressed the right L5 nerve root. Before presentation, the patient failed an attempted single-needle percutaneous rupture. The decision was made to proceed with percutaneous rupture using a 2-needle technique. A 22-gauge needle was inserted into the right L5-S1 facet joint, and a Tuohy needle was inserted directly into the cyst through an interlaminar approach. A solution of methylprednisolone and hyaluronidase was simultaneously injected through both needles, and the cyst was continuously distended until rupture was achieved. Rupture was confirmed by injecting contrast into the facet joint and visualizing a normal epidurogram. The patient reported significant pain relief immediately after the procedure. At 4-month follow-up, the patient reported continued pain relief and denied any radicular symptoms. Conclusions Percutaneous rupture of a symptomatic facet joint synovial cyst using a single-needle technique has been validated as an efficacious form of management. In a select group of patients who fail single-needle percutaneous rupture, a 2-needle approach for percutaneous facet cyst rupture may be considered as an option for management.

Background : Patients with early acute inflammatory demyelinating polyradiculoneuropathy (AIDP) may not meet the current neurophysiologic criteria. Objective : To document neurophysiologic findings in early AIDP. Methods : Clinical and neurophysiologic data from 38 AIDP patients, assessed within 10 days of symptom onset were reviewed. Results : In addition to absent H reflexes and abnormal F-wave responses in the acute stage of AIDP, abnormalities of blink reflexes, upper limb sensory responses abnormalities with spared sural responses, presence of distal CMAP dispersion, and A-waves were frequently observed. Established demyelinating neurophysiologic parameters were infrequently seen. Conclusions : Abnormalities of H reflexes and F responses were most frequently noted in early AIDP. Additionally, distal temporal dispersion, prolonged or absent blink reflexes, and A-waves were often present in the acute stage of AIDP when classic diagnostic criteria of AIDP were not satisfied. Significance : Neurophysiologic studies in early AIDP frequently reveal abnormalities that are not specific of primary demyelinating neuropathy.

Objective: To characterize the association of poststroke urinary incontinence with disability progression in nursing home residents. Design: In this prospective cohort study, the Minimum Data Set from the State of New York between 1994 and 1997 was utilized. From a pool of over 240,000 potential subjects, 500 met inclusion/exclusion criteria. Previously continent, first-time stroke survivors were classified as being continent or incontinent immediately after their stroke and were followed for changes in activities of daily living status (disability) at quarterly intervals for a 1 yr. In addition, a post hoc analysis was performed examining changes in activities of daily living status from the prestroke condition and exploring the relationship between poststroke impairments in continence and limitations in mobility. Results: An almost 2-fold difference in level of disability was noted poststroke among those who were incontinent vs. those who were continent (P < 0.001). This difference in disability level remained unchanged for 1 yr. Through the post hoc analysis, it was determined that, although the onset of stroke produced significant elevations in disability for both continent and incontinent stroke survivors (P < 0.001), the presence of an impairment in urinary continence was associated with a significantly greater increase (94% vs. 13%) in disability (P < 0.001). In addition, incontinence occurred more frequently among those who had a loss in mobility function. Conclusion: Incontinence is a clinical factor after stroke that is associated with greater disability among nursing home residents. These findings have clinical implications for physiatrists and nursing home clinicians and provide a context in which future disability research can be conducted.

Both polypeptide growth factors and stem cell populations from bone marrow and umbilical cord blood hold promise as treatments to enhance neurologic recovery after stroke. Growth factors may exert their effects through stimulation of neural sprouting and enhancement of endogenous progenitor cell proliferation, migration, and differentiation in brain. Exogenous stem cells may exert their effects by acting as miniature "factories" for trophic substances in the poststroke brain. The combination of growth factors and stem cells may be more effective than either treatment alone. Stroke recovery represents a new and relatively untested target for stroke therapeutics. Whereas acute stroke treatments focus on agents that dissolve blot clots (thrombolytics) and antagonize cell death (neuroprotective agents), stroke recovery treatments are likely to enhance structural and functional reorganization (plasticity) of the damaged brain. Successful clinical trials of stroke recovery-promoting agents are likely to be quite different from trials testing acute stroke therapies. In particular, the time window of effective treatment to enhance stroke recovery is likely to be far longer than that for acute stroke treatments, perhaps days or weeks rather than minutes or hours after stroke. This longer time window means that time is available for careful screening and testing of potential subjects for stroke recovery trials, both in terms of size and location of cerebral infarcts and in type and severity of neurologic deficits. Detailed baseline information can be obtained for each patient against which eventual clinical outcome can be compared. Finally, separate and detailed outcome measures can be obtained in both the sensorimotor and cognitive neurologic spheres, because it is possible that these two kinds of function may recover differently or be differentially responsive to recovery-promoting treatments. Stroke recovery represents an important and underexplored opportunity for the development of new stroke treatments.

Improved device technology has caused a renewed interest in peripheral nerve field stimulation (PNfS). This study sought to obtain preliminary estimates of the safety and efficacy of PNfS in patients with localized chronic intractable pain of the back.This Institutional Review Board-approved, prospective, randomized, controlled, crossover study consisted of two phases. During phase I, patients rotated through four stimulation groups (minimal, subthreshold, low frequency, and standard stimulation). If a 50% reduction in pain was achieved during any of the three active stimulation groups (responder), the patient proceeded to phase II, which began with implant of the permanent system and lasted 52 weeks. The primary endpoint was a reduction in pain, assessed by the visual analog scale (VAS). Analysis of variance, including the effects of patient, treatment, and study period, was used for phase I results. Phase II results were analyzed by paired t-tests.A total of 44 patients were enrolled at five sites. Of these patients, 32 were implanted with a trial system and 30 completed phase I. During phase I, there were significant differences in mean VAS scores between minimal stimulation and subthreshold stimulation (p = 0.003), low frequency stimulation (p0.001), and standard stimulation (p0.001). Twenty-four patients were classified as responders to the therapy, and 23 patients received permanent system placement. Significant differences in VAS scores were observed between baseline and all follow-up visits during phase II (p0.001) CONCLUSIONS: The results provide evidence to support safety and effectiveness of PNfS as an aid in the management of chronic, localized back pain.

We describe a patient with locked-in syndrome who had minimal volitional motor function and severe spasticity in all four extremities. The patient showed a significant improvement in volitional motor function following intrathecal baclofen pump therapy to control spasticity. This case study suggests that intrathecal baclofen pump therapy might improve motor function in select patients with locked-in syndrome.

Peripheral nerve stimulation and, recently, peripheral nerve field stimulation are excellent options for the control of extremity pain in instances where conventional methods have failed and surgical treatment is ruled inappropriate. New techniques, ultrasound guidance, smaller generators, and task-specific neuromodulatory hardware and leads result in increasingly safe, stable and efficacious treatment of pain in the extremities. Peripheral nerve stimulation has shown to be an increasingly viable option for many painful conditions with neuropathic and possibly nociceptive origins. This chapter focuses on the historical use of neuromodulation in the extremities, technical tasks associated with implant, selection of candidates, and potential pitfalls of and solutions for implanting devices around the peripheral nervous system for extremity pain.

Neuromodulation practitioners increasingly recognize the potential for peripheral nerve field stimulation (PNfS) to treat pain originating from the trunk. Conditions resulting in truncal pain that may respond to PNfS include cervical and lumbar postlaminectomy syndrome, inguinal neurapraxia, post-herpetic neuralgia, and post-thoracotomy pain. The focus of this chapter is to review the mechanism of action in PNfS, patient selection factors, programming strategies, and technical considerations.

Peripheral nerve stimulation and, recently, peripheral nerve field stimulation are excellent options for the control of extremity pain in instances where conventional methods have failed and surgical treatment is ruled inappropriate. New techniques, ultrasound guidance, smaller generators, and task-specific neuromodulatory hardware and leads result in increasingly safe, stable and efficacious treatment of pain in the extremities. Peripheral nerve stimulation has shown to be an increasingly viable option for many painful conditions with neuropathic and possibly nociceptive origins. This chapter focuses on the historical use of neuromodulation in the extremities, technical tasks associated with implant, selection of candidates, and potential pitfalls of and solutions for implanting devices around the peripheral nervous system for extremity pain.

Neuromodulation practitioners increasingly recognize the potential for peripheral nerve field stimulation (PNfS) to treat pain originating from the trunk. Conditions resulting in truncal pain that may respond to PNfS include cervical and lumbar postlaminectomy syndrome, inguinal neurapraxia, post-therpetic neuralgia, and post-thoracotomy pain. The focus of this chapter is to review the mechanism of action in PNfS, patient selection factors, programming strategies, and technical considerations.

Spasticity in stroke patients interferes with coordinated muscle firing patterns of the lower extremity leading to gait abnormalities. The goal of this study was to improve ankle function during walking by augmenting treadmill gait retraining with a visual EMG biofeedback technique. Eight stroke patients who could ambulate between 0.5 and 0.9 m/s participated in the study. The training consisted of 12 sessions of treadmill walking during which the activity of the tibialis anterior and gastrocnemius lateralis muscles of the affected side was displayed on a computer screen. Targets were shown to indicate to the subject when to activate the monitored muscles. Gait evaluations were performed before and after the training period to test the hypothesis that ankle mechanics improved following the intervention. Improvements in gait function were characterized by changes in temporal gait parameters and lower extremity kinematics and kinetics. Subjects showed an increase in gait speed, time of single leg support on the affected side, ankle power generation at push-off and a reduction in knee extensor moment. These results indicate that treadmill gait retraining augmented via visual EMG-biofeedback facilitates improvements in hemiparetic gait.

Objective Cervical nerve root stimulation (CRS) is a technique of assessing the proximal segments of motor axons destined to upper extremity muscles. Few studies report normal values. The objective was to determine CMAP onset-latencies and CMAP amplitude, area, and duration changes in healthy controls for the abductor pollicis brevis (APB), abductor digiti minimi (ADM), biceps, and riceps muscles. In addition, to determine the tolerability of CRS, as measured by the visual analog scale (VAS). Methods We studied 21 healthy volunteers prospectively with CRS using four target muscles (APB, ADM, biceps, and triceps) bilaterally. Collision studies were used in all APB recordings. VAS was obtained in all subjects. Results Mean CMAP onset-latencies were: APB 14±1.5 ms; ADM 14.2±1.5 ms; biceps 5.4±0.6 ms; triceps 5.4±1.0 ms. Onset-latency significantly correlated with height for all nerves. The mean change in CMAP amplitude and area (%) between most distal stimulation and CRS was: APB reduction of 15.1±11.6 and 4.9±3.6%; ADM reduction of 21.1±10.7 and 17.2±8.8; biceps reduction of 10±11.5 and reduction of 8.7±6.8; triceps increase of 3.3±5.2 and 11.0±9.9% respectively. Mean CMAP duration change between most distal stimulation and CRS was: APB, increase of 20.4±7.4%; ADM, increase of 14.4±8.5%; biceps, increase of 13.9±10.8%; triceps, increase of 7.7±6.7%. The mean VAS score was 3.8±1.2, and all subjects completed the study. Conclusions The present study establishes normative data and indicates that CRS is a well-tolerated technique. Significance The normal values may be used as reference data for the needle CRS technique in the assessment of proximal conduction abnormalities.

Objective To study the electromyographic profile--including ON, OFF, and peak timing locations--of the lateral gastrocnemius muscle over a wide range of walking speeds (0.5-2.1 m/sec) in healthy young adults. Design We studied gastrocnemius muscle-firing patterns using an electromyographic surface electrode in 15 healthy subjects ambulating on a treadmill at their normal walking speed and at three paced walking speeds (0.5, 1.8, and 2.1 m/sec). Initial heel contact was determined from a force-sensitive switch secured to the skin over the calcaneous. Results For all speeds, the gastrocnemius firing pattern was characterized by a main peak, occurring 40-45% into the gait cycle, that increased in amplitude with walking speed. Speeds of > or =1.3 m/sec produced a common electromyographic timing profile, when the profile is expressed relative to the stride duration. However, at 0.5 m/sec (a speed typical of individuals with upper-motor neuron lesions), the onset of gastrocnemius firing was significantly delayed by 3-6% of the gait cycle and was prolonged by 8-11% of the gait cycle. Conclusion Many patients with upper motor neuron lesions (e.g., stroke and traumatic brain injury) walk at speeds much slower than those commonly described in the literature for normal gait. At the slow walking speed of 0.5 m/sec, we have measured noticeable changes in the electromyographic timing profile of the gastrocnemius muscle. Given the importance of appropriate plantar flexor firing patterns to maximize walking efficiency, understanding the speed-related changes in gastrocnemius firing patterns may be essential to gait restoration.

An educational program was developed incorporating people with disabilities (PWDs) as "consumer-trainers" who educate physical medicine and rehabilitation residents about challenges in everyday living and their solutions to these. During the residency postgraduate years 2 and 4, pairs of residents visited trainers in their homes and at their jobs to learn about their lifestyles and adaptations. Residents' described the experience as "excellent, outstanding, invaluable" in more than half of the evaluations. PWDs can educate physical medicine and rehabilitation residents about living with disabilities. This new residency educational strategy encourages residents to value the perspective of PWDs.