Spinal Cord Stimulation in Conjunction With Peripheral Nerve Field Stimulation for the Treatment of Low Back and Leg Pain: A Case Series

Background. The treatment of chronic low back and leg pain remains a difficult medical challenge, particularly for patients with postlaminectomy syndrome. While spinal cord stimulation (SCS) has been a significant addition to the available options, it is often inadequate in relieving both the back and leg pain components. We hypothesized that for some patients the combination of SCS with peripheral nerve field stimulation (PNFS) would be a safe, effective alternative that would be more effective than either modality alone. Objective. Our objective was to demonstrate the efficacy of PNFS used in combination with SCS for the treatment of chronic pain syndromes involving the lower back and legs. Study Design. Case series. Methods. A total of 20 patients with chronic low back and leg pain syndromes who had failed conventional therapies underwent implantation of a combination of traditional SCS and PNFS. Leads were placed in the epidural space, as well as superficially in the subcutaneous tissues of the lower back, directly in the region of maximum pain. Patients initially underwent a trial of stimulation to assess response, and a permanent system was implanted if patients reported greater than 50% pain relief during the trial. For some patients, a combination was used at the time of the initial trial. In other cases, the decision to proceed with the combination was made later, either at the time of permanent implant, or later on, after SCS alone failed to adequately control pain. Results. In each case, PNFS was used in combination with traditional SCS for patients with chronic lower back and lower extremity pain. While not all of these patients ultimately proceeded with the combination of SCS and PNFS to control their pain, the majority of patients found the combination better in controlling their overall pain than either modality alone. In addition, using a combined approach at the time of trial provided a noninvasive and effective method of comparing the efficacy of each method, allowing patients to identify the best form of neuromodulation for their particular pain. Conclusions. Due to the availability of 16 contact capacity generators, neurostimulation with multiple leads in various combinations—including both epidural and peripheral nerve field stimulation simultaneously—can be applied safely and effectively. The availability of this combined approach for a trial of stimulation prior to implant allows patients to compare SCS to PNFS and to indicate a preference for one over the other or for the combination. We conclude that PNFS may be used in combination with SCS as a safe and effective alternative treatment for patients with chronic low back and leg pain, and further suggest that the combined approach should be considered as a treatment option for this population.     

Subcutaneous Peripheral Nerve Stimulation with Inter‐lead Stimulation for Axial Neck and Low Back Pain: Case Series and Review of the Literature

Objectives: While pain in the extremities often responds to treatment using spinal cord stimulation (SCS), axial pain is notoriously refractory to SCS. Interest in subcutaneous peripheral nerve stimulation (SQ PNS) as an alternative to SCS has emerged, but the most appropriate electrode locations and neurostimulator programming techniques are not yet clear. Methods: A retrospective review was conducted of consecutive patients evaluated from August 2009 to December 2010 who had undergone trial of SQ PNS with inter‐lead stimulation for axial spine pain. Patients proceeding to implant were followed postoperatively with routine clinical visits and a survey form at last follow‐up. Ultrasound was used intraoperatively to ensure placement of electrodes at the appropriate depth in patients with larger body mass index. Primary outcome was patient‐reported pain relief at last follow‐up. Literature review was conducted by searching MEDLINE (1948–present) and through an unstructured review by the authors. Results: Ten patients underwent trial of SQ PNS and six proceeded to permanent implantation. Fifty percent (3/6) of implanted patients preferred neurostimulation programming that included inter‐lead stimulation (“cross‐talk”). Average duration of postoperative follow‐up was 4.5 months (range 2–9 months). Average patient‐reported pain relief at last follow‐up was 45% (range 20–80%). One patient required re‐operation for migration. Patients not proceeding to implant had paresthesia coverage but no analgesia. Conclusion: SQ PNS is a promising therapy for axial neck and back pain based on a small cohort of patients. Ultrasound was useful to assist with electrode placement at the most appropriate depth beneath the skin. While inter‐lead stimulation has been preferred by patients in published reports, we did not find it clearly influenced pain relief. Future investigations should include a randomized, controlled study design, as well as defined implantation technique and neurostimulator programming algorithms.     

Subcutaneous Stimulation as an Additional Therapy to Spinal Cord Stimulation for the Treatment of Lower Limb Pain and/or Back Pain: A Feasibility Study

Objective: The objective of this study was to demonstrate the efficacy of subcutaneous stimulation (SubQ) as an additional therapy in patients with failed back surgery syndrome (FBSS) with chronic refractory pain, for whom spinal cord stimulation (SCS) was unsuccessful in treating low back pain. Study Design: Case series. Materials and Methods: FBSS patients with chronic limb and/or low back pain whose conventional therapies had failed received a combination of SCS (8‐contact Octad lead) and/or SubQ (4‐contact Quad Plus lead(s)). Initially leads were placed in the epidural space for SCS for a trial stimulation to assess response to suppression of limb and low back pain. Where SCS alone was insufficient in treating lower back pain, leads were placed superficially in the subcutaneous tissue of the lower back, directly in the middle of the pain area. A pulse generator was implanted if patients reported more than 50% pain relief during the trial period. Pain intensity for limb and lower back pain was scored separately, using visual analog scale (VAS). Pain and Quebec Back Pain Disability Scale (QBPDS) after 12‐month treatment were compared with pain and QBPDS at baseline. Results: Eleven FBSS patients, five male and six female (age: 51 ± 8 years; mean ± SD), in whom SCS alone was insufficient in treating lower back pain, were included. In nine cases, SubQ was used in combination with SCS to treat chronic lower back and lower extremity pain. In two cases only SubQ was used to treat lower back pain. SCS significantly reduced limb pain after 12 months (VAS_bl: 62 ± 14 vs. VAS_12m: 20 ± 11; p= 0.001, N= 8). SubQ stimulation significantly reduced low back pain after 12 months (VAS_bl: 62 ± 13.0 vs. VAS_12m: 32 ± 16; p= 0.0002, N= 10). Overall pain medication was reduced by more than 70%. QBPDS improved from 61 ± 15 to 49 ± 12 (p= 0.046, N= 10). Furthermore, we observed that two patients returned to work. Conclusion: SubQ may be an effective additional treatment for chronic low back pain in patients with FBSS for whom SCS alone is insufficient in alleviating their pain symptoms.     

Peripheral Nerve Field Stimulation in the Treatment of Postlaminectomy Syndrome after Multilevel Spinal Surgeries

Introduction: Chronic low back pain in patients with postlaminectomy syndrome (PLS) is challenging to treat, especially for patients who have undergone multilevel surgical procedures. Despite conservative therapy and available interventional pain procedures including spinal cord stimulation (SCS) and intrathecal therapies, patients may continue with intractable low back pain. Peripheral nerve field stimulation (PNFS) may represent an effective alternative treatment option for these patients when conventional treatments do not provide adequate relief of intractable low back pain. Methods: Eighteen patients underwent an uneventful PNFS trial with percutaneous placement of four temporary quadripolar leads (Medtronic, Inc., Minneapolis, MN, USA) placed subcutaneously over the lumbar or thoraco‐lumbar area. Results: After experiencing excellent pain relief over the next two days, temporary leads were removed. The patients were implanted with permanent leads and rechargeable or non‐rechargeable generator two to four weeks after temporary lead removal. All patients reported sustained pain relief 12 months after implantation. Discussion: PNFS with use of four vertically orientated leads provides an effective treatment option for patients with PLS after multilevel surgical procedures with intractable low back pain who have failed conservative treatment. PNFS may provide pain relief with advantages over conservative treatments and interventional treatments including SCS and intrathecal therapy. Conclusion: PNFS may be more effective in treating intractable low back pain than SCS in patients with PLS after multilevel spinal surgeries.     

Spontaneous Resolution of Nausea Induced by Spinal Cord Stimulation for Failed Back Surgery Syndrome

Introduction: Spinal cord stimulation (SCS) is used for treatment of pain arising from a variety of pathologies. Reported side‐effects related to SCS are most commonly technical complications including malfunction, lead migration, or severance. Up to date, only a few cases of gastrointestinal side‐effects have been reported. Materials and Methods: A 54‐year‐old man with a 20‐year history of low back pain developed persistent and refractory nausea following spinal cord stimulator implantation. Results: The nausea resolved spontaneously within eight weeks allowing continued use of the spinal cord stimulator. Conclusions: In this case report, we described the uncommon side‐effect of nausea because of SCS that resolved over time allowing continued neurostimulation therapy in a patient with arachnoiditis and failed lumbar back surgery syndrome. We encourage other providers to report similar cases to help elucidate the mechanism of these seemingly underreported side‐effects to allow continuation of the therapeutic effects of SCS.     

Prospective,Two-part Study of the Interaction Between Spinal Cord Stimulation and Peripheral Nerve Field Stimulation in Patients with Low Back Pain: Development of a New Spinal-Peripheral Neurostimulation Method

Objective: The goal of the study was to assess the efficacy of interaction between spinal cord stimulation (SCS) and peripheral nerve field stimulation (PNFS) and to evaluate a new spinal‐peripheral neuromodulation method for low back pain. Materials and Methods: The prospective two‐part study included patients with low back pain due to failed back surgery syndrome and/or spinal stenosis. In the first part 20 patients were implanted with SCS and PNFS. They selected the best program out of three: SCS alone, PNFS alone, or both together. In the second part another 20 patients with the same implanted leads were selecting between three programs: SCS and PNFS separately, SCS as anode and PNFS as cathode, or in reverse. Results: In the first part 79% of the patients selected simultaneous use of SCS and PNFS. The overall success of the trials was 85%. In the second part communication between SCS and PNFS provided wider coverage of axial pain. The overall success of the trials was 90%. Conclusion: Simultaneous use of SCS and PNFS increase efficacy of both methods for axial back pain. The new SPN method showed great potential in providing coverage for back pain.     

Spinal Cord Stimulation With Hybrid Lead Relieves Pain in Low Back and Legs

Objective: The failed back surgery syndrome (FBSS) is the most common chronic pain syndrome. Whereas it is relatively easy to achieve pain relief in the lower limbs of FBSS patients with spinal cord stimulation (SCS), it is difficult to manage low back pain with SCS. The performance of a paddle‐shaped SCS lead that can be inserted surgically as well as percutaneously (a hybrid lead) was evaluated in a prospective study on the relief of low back pain and leg pain in patients with FBSS. Materials and Methods: Patients with FBSS being eligible for SCS were enrolled in the study, and a hybrid lead was placed surgically. Outcome measures included pain scores for low back and leg pain assessed by visual analog scale (VAS), pain medication, and patient satisfaction. These scores were assessed before and at regular intervals after implantation. Results: It was shown that a single hybrid lead, generally positioned over the physiological midline of the spinal cord, is capable of alleviating both low back and leg pain in patients with FBSS. Forty‐five subjects were eligible for SCS and received trial stimulation. Forty‐two of them had a successful trial period and were converted to a permanent system. Their average VAS score at baseline was 8.0 for lower limb pain and 7.5 for low back pain. After six months of SCS, these average VAS scores were reduced to 3.2 and 3.5, respectively, and also pain medication was reduced significantly. Conclusion: SCS with a hybrid lead in subjects with FBSS is safe, and causes significant pain relief in both the low back and the lower limbs.     

Spinal Cord Stimulation for Failed Back Surgery Syndrome

Objective. The purpose of this study is to evaluate the effectiveness of modern spinal cord stimulation (SCS) for the treatment of failed back surgery syndrome (FBSS). Materials and Methods. Thirty patients were treated with SCS between December 1992 and January 1998 for low back and radicular pain after multiple failed back surgeries. Permanent systems were implanted if trial stimulation led to > 50% pain reduction. Median long‐term follow‐up was 34 months (range, 6–66 months). Severity of pain was determined postoperatively by a disinterested third party. Results. Overall, 12 of the 16 patients (75%) who received permanent implants continued to report at least 50% relief of pain at follow‐up. All six patients who underwent placement of laminectomy‐styled electrode for SCS in the thoracic region had > 50% pain relief at long‐term follow‐up. Visual analog scores decreased an average of 3.2 (from 8.6 preoperatively to 5.4 postoperatively). Patients undergoing SCS placement via laminectomy in the thoracic region experienced an average decrease of 4.9 in VAS, whereas those who underwent percutaneous placement of thoracic leads had an average decrease of 2.5. Conclusions. SCS is an effective treatment for chronic low back and lower extremity pain which is refractory to conservative therapy and which is not amenable to corrective anatomic surgery. Though our patient population is small, our results imply that the laminectomy‐style electrodes in the thoracic region achieve better long‐term effectiveness than percutaneous leads.     

Ultrasound-Guided Peripheral Nerve Stimulation of Cervical,Thoracic, and Lumbar Spinal Nerves for Dermatomal Pain: A Case Series

ObjectivesWith the development of percutaneously inserted devices, peripheral nerve stimulation (PNS) has been gaining attention within chronic pain literature as a less invasive neurostimulation alternative to spinal column and dorsal root ganglion stimulation. A majority of current PNS literature focuses on targeting individual distal nerves to treat individual peripheral mononeuropathies, limiting its applications. This article discusses our experience treating dermatomal pain with neurostimulation without needing to access the epidural space by targeting the proximal spinal nerve with peripheral nerve stimulation under ultrasound-guidance.Materials and MethodsA temporary, percutaneous PNS was used to target the proximal spinal nerve in 11 patients to treat various dermatomal pain syndromes in patients seen in an outpatient chronic pain clinic. Four patients received stimulation targeting the lumbar spinal nerves and seven patient received stimulation targeting the cervical or thoracic spinal nerves.ResultsThe case series presents 11 cases of PNS of the proximal spinal nerve. Seven patients, including a majority of the patients with lumbar radiculopathy, had analgesia during PNS. Four patients, all of whom targeted the cervical or thoracic spinal nerves, did not receive analgesia from PNS.ConclusionPNS of the proximal spinal nerve may be an effective modality to treat dermatomal pain in patients who are not candidates for other therapies that require access to the epidural space. This technique was used to successfully treat lumbar radiculopathy, post-herpetic neuralgia, and complex regional pain syndrome.     

Lumbar and Sacral Nerve Root Stimulation (NRS) in the Treatment of Chronic Pain: A Novel Anatomic Approach and Neuro Stimulation Technique

Objective. The conventional technique used to stimulate the lumbar dermatomes is by stimulation of the dorsal columns of the spinal cord. Until recently, stimulation of nerve roots had not been successfully accomplished. We had performed selective nerve root cannulations for the placement of temporary catheters at cervical, thoracic, lumbar, and sacral levels in chronic pain patients using a caudad rather than craniad approach. We hypothesized that by stimulating the nerve roots we could improve paresthesia coverage in areas which cannot be covered effectively by spinal cord stimulation (SCS). To test this hypothesis, we have performed trials of nerve root stimulation (NRS) in patients who had failed SCS, or who were not candidates for SCS because their pain was otherwise inaccessible to stimulation. Methods. Five patients who had been unresponsive to conservative treatment, surgery, or SCS underwent 7-day trials with NRS. The diagnoses included: ilioinguinal neuralgia, discogenic low back pain, failed back syndrome, vulvodynia, and interstitial cystitis. We collected paresthesia maps, pain maps, pain visual analog scale (VAS) scores, and patient satisfaction ratings. Results. Paresthesia coverage was above 75% in all patients. VAS scores declined from a mean of 9 ± 1.0 to 2.4 ± 2.1 (p < 0.05, n= 5), all 5 patients requested permanent implantation, and 4 have been implanted so far. Conclusions. Lumbar and sacral NRS trials resulted in adequate paresthesia coverage and effective pain relief in all 5 patients. Further clinical trials to evaluate long-term success rates and safety are indicated. Detailed mapping studies are needed to evaluate the relationship between electrode placement and paresthesia patterns as well as the optimal stimulation parameters.     

Spinal‐Peripheral Neurostimulation (SPN) for Bilateral Postherniorrhaphy Pain: A Case Report

Objective: Postherniorrhaphy pain is a not uncommon, and difficult to treat, pain condition. Success with different methods of neurostimulation has been reported in the literature in the last decade. We assess the use of a new modality of neuromodulation—spinal‐peripheral neurostimulation (SPN). Materials and Methods: We report the results of treatment of a patient with bilateral, intractable postherniorrhaphy pain with SPN. Results: Significant reduction in pain and decrease in opioid consumption have been achieved. Conclusion: SPN can be an effective treatment for postherniorrhaphy pain resistant to conservative management.     

New Therapy for Refractory Chronic Mechanical Low Back Pain—Restorative Neurostimulation to Activate the Lumbar Multifidus: One Year Results of a Prospective Multicenter Clinical Trial

Objectives

The purpose of the international multicenter prospective single arm clinical trial was to evaluate restorative neurostimulation eliciting episodic contraction of the lumbar multifidus for treatment of chronic mechanical low back pain (CMLBP) in patients who have failed conventional therapy and are not candidates for surgery or spinal cord stimulation (SCS).

Materials and Methods

Fifty‐three subjects were implanted with a neurostimulator (ReActiv8, Mainstay Medical Limited, Dublin, Ireland). Leads were positioned bilaterally with electrodes close to the medial branch of the L2 dorsal ramus nerve. The primary outcome measure was low back pain evaluated on a 10‐Point Numerical Rating Scale (NRS). Responders were defined as subjects with an improvement of at least the Minimal Clinically Important Difference (MCID) of ≥2‐point in low back pain NRS without a clinically meaningful increase in LBP medications at 90 days. Secondary outcome measures included Oswestry Disability Index (ODI) and Quality of Life (QoL; EQ‐5D).

Results

For 53 subjects with an average duration of CLBP of 14 years and average NRS of 7 and for whom no other therapies had provided satisfactory pain relief, the responder rate was 58%. The percentage of subjects at 90 days, six months, and one year with ≥MCID improvement in single day NRS was 63%, 61%, and 57%, respectively. Percentage of subjects with ≥MCID improvement in ODI was 52%, 57%, and 60% while those with ≥MCID improvement in EQ‐5D was 88%, 82%, and 81%. There were no unanticipated adverse events (AEs) or serious AEs related to the device, procedure, or therapy. The initial surgical approach led to a risk of lead fracture, which was mitigated by a modification to the surgical approach.

Conclusions

Electrical stimulation to elicit episodic lumbar multifidus contraction is a new treatment option for CMLBP. Results demonstrate clinically important, statistically significant, and lasting improvement in pain, disability, and QoL.     

A Prospective,Randomized Single-Blind Crossover Study Comparing High-Frequency 10,000 Hz and Burst Spinal Cord Stimulation

ObjectivesAlthough both high-frequency and burst spinal cord stimulation (SCS) have shown improved efficacy and patient satisfaction compared with conventional tonic stimulation, there are limited data directly comparing the two. This study aimed to compare both high-frequency 10,000 Hz and burst SCS in the same patients in terms of pain relief and satisfaction in those with axial back pain with or without leg pain.Materials and MethodsThis prospective, single-blind, randomized controlled trial was conducted at an outpatient pain clinic within an academic medical center. Participants were randomly allocated to one of two groups in which they trialed either burst or high-frequency 10,000 Hz SCS over five days, followed by a 24- to 48-hour washout period with no stimulation, and the alternative therapy over the remaining four days. Visual analog scale (VAS) scores were collected immediately before and after both therapy trials. Secondary end points included percentage change in VAS score and patient preference.ResultsOf 25 participants, those receiving burst followed by high-frequency SCS (n = 11) had a mean VAS difference of 4.73 after the first trial period and 2.86 after the second. Of those receiving high-frequency followed by burst SCS (n = 14), mean VAS difference after the first trial period was 4.00 and 1.93 after the second trial period. Four participants were withdrawn owing to lead migration. Both therapies showed statistically significant differences in pre- minus post-VAS scores and percent relief. There were no significant differences in carryover or treatment effects between the two groups. There was a statistically significant association between trial sequence and stimulator type implanted because the first stimulator trialed was more likely to be chosen.ConclusionsThere were no observed differences in VAS pain score decrease when comparing burst and high-frequency 10,000 Hz SCS programming therapies. Patient preference followed an order effect, favoring the first programming therapy in the trial sequence.     

Triangular Stimulation Method Utilizing Combination Spinal Cord Stimulation With Peripheral Subcutaneous Field Stimulation for Chronic Pain Patients: A Retrospective Study

Objectives: This retrospective data collection study aims to evaluate the responses of patients who have been implanted with a neuromodulation system using a combination of spinal cord stimulation (SCS) and peripheral subcutaneous field stimulation (PSFS) leads for chronic intractable pain. Materials and Methods: Forty patients with chronic, intractable pain implanted with both SCS and PSFS leads were enrolled in a retrospective data collection study. Pre‐implant data (demographics, pain levels, pain location, and medication use) and post‐implant data (pain levels, medication use, and device programming reports) were compared to measure short‐ and long‐term improvements in pain for a period of approximately six months. Device system use and parameter data were collected. Results: The majority of patients experienced immediate and short‐term pain relief and reduction in oral pain medications as a result of combination SCS/PSFS therapy. The improvements were maintained for some, but not all patients by six months. Patients cycled through multiple programs over follow‐up; the use of triangular stimulation was consistent over time, and by six months, patients preferred this program over others. Limitations of the retrospective chart review included missing data and variable follow‐up times, and may have made determinations of long‐term efficacy difficult. Conclusions: This study demonstrates that combination SCS and PSFS therapy is potentially a beneficial treatment option for reducing pain levels and oral pain medication compared with baseline in previously resistive chronic pain patients. There is a need for further study of this therapy in a greater number of subjects and in a prospective, controlled setting. In the author's general experience, triangular stimulation is very effective for treating isolated low back pain, because it covers larger topographic areas of the lower back than flow or field stimulation. An investigational device exemption study will be necessary for subcutaneous field stimulation indicated for focal isolated pain to be adequately investigated and utilized by physicians in the future.     

Spinal Cord Stimulation vs. Conventional Medical Management: A Prospective,Randomized, Controlled,Multicenter Study of Patients with Failed Back Surgery Syndrome (PROCESS Study)

Introduction. Since its first application in 1967, numerous case series indicate that spinal cord stimulation (SCS) is an effective treatment for the management of failed back surgery syndrome (FBSS). However, only one randomized controlled trial has demonstrated that SCS provides more effective pain relief than re‐operation and conventional medical management. The PROCESS randomized, controlled, multicenter trial aims to assess the clinical effectiveness and cost‐effectiveness of SCS when added to conventional medical management compared to conventional medical management alone in patients with FBSS. Methods/Design. A total of 100 FBSS patients with predominantly neuropathic leg pain will be recruited from 12 centers and randomized to receive either conventional medical management alone or in combination with SCS for a period of 24 months. Patients will be evaluated at 1, 3, 6, 9, 12, 18, and 24 months. At the 6‐month visit, patients will be classified as successful (≥  50% pain relief in the legs) or unsuccessful (< 50% pain relief in the legs). If the results of the randomized treatment are unsuccessful, patients can cross over to the alternative treatment arm. Discussion. This paper highlights the rationale, design, methods, and challenges of an ongoing prospective, randomized, controlled, multicenter clinical trial that has been undertaken to obtain conclusive evidence of the clinical efficacy and cost‐effectiveness of an SCS system in patients with FBSS.     

Combined Spinal Cord and Peripheral Nerve Field Stimulation for Persistent Post‐Herniorrhaphy Pain

Objectives: Chronic post‐hernia pain is a common complication after inguinal herniorrhaphies. Peripheral nerve field stimulation (PNFS) and spinal cord stimulation (SCS) are two new promising treatment modalities. Four patients with persistent neuropathic post‐hernia pain were recruited for this prospective study. Materials and Methods: Electrodes were inserted into the epidural space of the spinal canal and into the subcutaneous tissue in the inguinal region during a single surgical procedure. During a 14‐day trial, double‐blind stimulation was performed via an external stimulator: three days using the spinal electrode (SCS), three days using the inguinal electrode (PNFS), three days using both (SCS + PNFS), and five days off, with an alternating order from patient to patient. During the trial, pain intensity was assessed thrice daily by the visual analog scale. Additionally, pain intensity and quality of life (QOL) were assessed before and after surgical intervention by the Brief Pain Inventory, SF36 scale, and Pain Disability Index. Results: All patients had a marked pain reduction during the trial phase, and this reduction was more prominent when both electrodes were activated simultaneously (p < 0.001). At the late follow‐up, a significant pain reduction and improvement of QOL was observed in three patients. Conclusions: Both SCS and PNFS are effective in treating post‐hernia pain, but the magnitude of pain reduction was more prominent with concomitant stimulation. Combined PNFS and SCS should be considered for patients with a less than optimal response to either SCS or PNFS. More studies are necessary to address the cost‐effect issues of this new approach to treatment.     

Spinal Cord Stimulation (SCS) in Conjunction With Peripheral Nerve Field Stimulation (PNfS) for the Treatment of Complex Pain in Failed Back Surgery Syndrome (FBSS)

Background: Failed back surgery syndrome (FBSS) is a well‐defined pathologic condition observed over many years. Design: We have investigated the effect of spinal cord stimulation (SCS) with peripheral nerve field stimulation (PNfS) in eight patients with FBSS Outcome Measure: The following parameters were collected and analyzed: The pain intensity score on a 0–10 numbering rating scale (NRS), the psychologic profile with Beck Depression Inventory (BDI), the pain quality with McGill Pain Questionnaire—short form (MGPQ‐sf), the back pain with Oswestry scale score (OS), and the health general quality pattern with QualityMetric's SF‐36v2^® Health Survey. Patients: Eight patients with low back and radicular pain in FBSS are reported. The mean duration of pain was 6.7 months, and the mean NRS score was 9.5, BDI 28.8, MGPQ‐sf 16.8, OS 44.5, and SF‐36 score was 72.8. The average drug intake of opioids was 250 mg/day. Intervention: In six patients, two octopolar leads were placed in epidural space at D7‐D8 and D8‐D9, in conjunction with two octopolar leads placed in lumbar‐sacral subcutaneous space (Precision System, Boston Scientific, Valencia, CA, USA), and in two patients, a two tetrapolar leads was placed in epidural space at D8‐D9 with two tetrapolar leads (Pisces Quad, Plus, Medtronic Inc., Minneapolis, MN, USA) placed in lumbar‐sacral subcutaneous space (Restore Ultra, Medtronic Inc., Minneapolis, MN, USA). Results: After one year mean of follow‐up, the mean NRS score was 4, BDI 8, MGPQ‐sf 5, OS 21, and the SF‐36 score was increased at 108.5. The mean drug intake of opioids was decreased at 20 mg/day. Conclusion: The combination of SCS and PNfS, using the latest rechargeable systems, may be a valid therapeutic strategy in FBSS.     

An Analysis of the Components of Pain,Function, and Health‐Related Quality of Life in Patients with Failed Back Surgery Syndrome Treated with Spinal Cord Stimulation or Conventional Medical Management

Objectives: Failed back surgery syndrome (FBSS) patients experience pain, functional disability, and reduced health‐related quality of life (HRQoL) despite anatomically successful surgery. Examining sub‐dimensions of health outcomes measures provides insight into patient well‐being. Materials and Methods: The international multicenter PROCESS trial collected detailed HRQoL (EuroQol‐5D; Short‐Form 36) and function (Oswestry Disability Index) information on 100 FBSS patients. Results: At baseline, patients reported moderate‐to‐severe leg and back pain adversely affecting all dimensions of function and HRQoL. Compared with conventional medical management alone, patients also receiving spinal cord stimulation (SCS) reported superior pain relief, function, and HRQoL at six months on overall and most sub‐component scores. The majority of these improvements with SCS were sustained at 24 months. Nonetheless, 36–40% of patients experienced ongoing marked disability (standing, lifting) and HRQoL problems (pain/discomfort). Conclusions: Longer‐term patient management and research must focus on these refractory FBSS patients with persisting poor function and HRQoL outcomes.     

Spinal Cord Stimulation as Alternative Treatment for Chronic Post‐Herniorrhaphy Pain

Objective: Our goal was to determine the efficacy of spinal cord stimulation for patients with intractable post‐herniorrhaphy pain which conventional treatment failed to ameliorate. Procedure: The patients underwent an uneventful spinal cord stimulator (SCS) trial with percutaneous placement of two eight‐electrode epidural leads (Medtronic Inc, Minneapolis, MN, USA) to level T7‐T8‐T9. Results: Upon experiencing excellent pain relief over the next two days during the trial, the patients were implanted with permanent leads and rechargeable or non‐rechargeable generators two to four weeks later and reported sustained pain relief during following 12 months after implantation. Conclusion: We conclude that SCS offers an alternative treatment option for intractable post‐herniorrhaphy pain. This type of treatment should be considered for use in a select group of patients when all conventional treatments failed.     

Peripheral Nerve Field Stimulation for the Treatment of Chronic Low Back Pain: Preliminary Results of Long‐Term Follow‐up: A Case Series

Objective. Our objective was to determine the efficacy of peripheral nerve field stimulation (PNFS) for the treatment of chronic lower back pain. PNFS is becoming increasingly recognized as a safe, minimally invasive, and easily reversible treatment for a variety of chronic pain conditions. Chronic low back pain is a common cause of disability and one that is difficult to treat effectively. We hypothesized that PNFS would be a safe, effective alternative for patients with chronic low back pain, which has not been previously reported. Materials and Methods. Six patients with chronic low back pain who had failed conventional therapies were implanted in the subcutaneous tissues of the low back region with neurostimulation leads. Leads were placed superficially in the region of maximum pain, as identified by each individual patient. Patients initially underwent a trial of stimulation to assess response, and a permanent system was subsequently implanted if patients reported greater than 50% pain relief in the low back during the trial. Results. In each case presented here, PNFS enabled patients to decrease their pain medication and increase their level of activity. The patients all reported reduction in pain as measured by visual analog scale scores and an improved quality of life. Conclusion. We conclude that PNFS is a safe and effective alternative treatment for patients with chronic low back pain, and should be considered in this population.