Spinal Cord Stimulation Has Comparable Efficacy in Common Pain Etiologies

Objectives. The probability of success with spinal cord stimulation (SCS) depends largely on appropriate patient selection. Here, we have assessed the predictive value of pain etiology as it relates to pain relief with SCS as part of a prospective multicenter clinical trial. Methods. Sixty‐five subjects with chronic and intractable pain tested an epidural SCS system. Subjects reported pain ratings (visual analog scale) with stimulation off and stimulation on at scheduled follow‐up visits for up to 18 months after activation of the system. Visual analog scale scores were averaged and stratified by dominant pain etiologies, comprising failed back surgery syndrome, complex regional pain syndrome, and a subgroup of subjects with miscellaneous other pain etiologies. Results. More than 70% of subjects in each subgroup had successful outcomes during the temporary trial period and similar percentages of subjects from each etiology subgroup subsequently went on to permanent implantation. After permanent implantation, all subgroups reported more than 50% pain relief, on average, at each follow‐up time point. No predictive value of pain etiology was observed. Conclusions. Spinal cord stimulation is an effective therapy for neuropathic pain arising from a variety of causes. Failed back surgery syndrome, complex regional pain syndrome, and pain of other etiologies responded equally well to SCS.     

Spinal cord stimulation for neuropathic pain

Spinal cord stimulation (SCS) is used for more than 40 years to treat localized chronic medically refractory neuropathic pain involving limb(s) and trunk. The most frequent indications remain complex regional pain syndrome (CRPS) failed back surgery syndrome (FBSS), and peripheral neuropathy. Stimulation-induced paresthesias, perceived by the patient, prevent blinded evaluation and increase the placebo effect, decreasing the credibility of the tonic SCS efficacy. Retrospective studies reported that about 50% of the patients are improved more than 50% at short-term, but long-term improvement is less. Several comparative randomized trials (RCT) are now available. In CRPS, a RCT demonstrated the superiority of SCS plus physiotherapy compared to physiotherapy alone. In FBSS, two RCTs have shown that SCS was superior to reoperation and conventional medical treatment, (CMM) respectively. New stimulation waveforms, namely burst, high frequency (10 KHz) stimulation and close-loop SCS, have been proposed recently to avoid the perception of paresthesias and/or increase the pain relief. RCTs in FBSS have suggested that these new SCS modalities were as least as efficient than conventional tonic SCS and perhaps slightly superior. Two RCTs confirmed SCS efficacy in painful diabetic neuropathy in comparison with CMM. Complications are frequent (hardware dysfunction or migration, superficial infection) but exceptionally serious. Consequently, the risk/benefit ratio is favorable to SCS, considering that chronic pain patients undergoing this procedure are usually resistant to all the other therapies.     

Results of neuromodulation for the management of chronic pain

Background and purpose : Neuromodulative treatment of chronic pain syndromes is a modern mode of treatment of neuropathic and ischaemic pain. Its effectiveness is well documented in the literature. The objective of this work is to present the results of treatment of chronic pain syndromes on the basis of eight-year experience in our department. Material and methods : Since 2002, we have conducted 9 operations of motor cortex stimulation (MCS), 2 of deep brain stimulation (DBS), 45 of spinal cord stimulation (SCS) and 5 of sacral root stimulation (SRS) in the treatment of chronic pain. Results : We obtained good long-term results of neuromodulation in the form of clinical improvement (> 50%) in 4 of 9 patients with MCS (44%), in 13 diagnosed with failed back surgery syndrome (FBSS), 8 with other neuropathic pain, and 11 with angina pectoris from a group of 45 treated with SCS. Sacral root stimulation has been successful in 3 of 5 patients with perianal pain. The best treatment results in SCS, although not statistically significant, were observed in patients treated due to FBSS (13 out of 15) and angina pectoris (11 out of 15) (p = 0.12). In patients with neuropathic pain, peripheral and central, improvement was obtained in 8 out of 15 patients. Conclusions : A good indication for spinal cord stimulation is FBSS and angina pectoris. Motor cortex stimulation is helpful in the treatment of chronic central neuropathic pain. Further observations and a larger group of patients are necessary for a reliable assessment of the effectiveness of neuromodulative treatment of chronic pain in our clinic.     

A Unique Approach to Neurostimulation in Patients With Previous Two‐Segment Spine Surgery and Obstruction of Epidural Access for Spinal Cord Stimulation: A Case Series

Introduction: Patients with extensive surgery in the lumbar and thoracic spine are often not considered for neurostimulation due to the inability to perform a conventional spinal cord stimulation (SCS) trial. We are presenting six such patients in which spinal‐peripheral neurostimulation (SPN) was used via a caudal approach. Methods: Six patients with intractable low back and leg pain following extensive lumbar and thoracic surgeries, up to at least the T10 level, underwent a stimulation trial with one caudal lead and one subcutaneous lead in order to achieve SPN. Results: In five cases, the trial was successful with coverage of the pain area and at least satisfactory pain relief. All six patients were implanted with a paddle lead(s) and a subcutaneous lead using SPN with good pain control. Conclusion: SPN with a caudal lead appears to be a viable option for SCS trial in patients with no possibilities for conventional trial lead placement.     

A Retrospective Comparison of Long-Term Treatment Results of Subcutaneous Stimulation and Spinal Cord Stimulation for Chronic Neuralgia

ObjectivesSpinal cord stimulation (SCS) is known to be an effective long-term treatment option for chronic neuropathic pain. Subcutaneous stimulation (SubQ) is increasingly used to treat chronic back and neck pain, but long-term outcomes are unclear.Materials and MethodsPatients with neurostimulation devices implanted during the past 16 years were evaluated. Their continuation or termination of the treatment was taken as a measure of long-term treatment success. Age, sex, underlying pain condition, stimulation modality (SCS, SubQ, or hybrid), occurrence, and reasons for treatment termination were documented. Patients were classified as long-term responders and long-term nonresponders and analyzed with their clinical data and stimulation modality. The sample consisted of 98 patients. Of these, 66 were treated with SCS, 21 with SubQ, and 11 with a hybrid system.ResultsApproximately 61.3% of patients receiving SubQ terminated the treatment within two years because of ineffectiveness, whereas only 28.8% of patients receiving SCS terminated their stimulation. Back and neck pain were associated with treatment termination (p = 0.011). SubQ was also significantly associated with treatment termination.ConclusionsSubQ seems not to provide substantial long-term pain relief for back and neck pain because most patients abandoned their stimulation therapy.     

Spinal Cord Stimulation: A 20‐Year Retrospective Analysis in 260 Patients

Introduction. Spinal cord stimulation (SCS) is used clinically by many pain physicians and neurosurgeons alike without regard to their own outcome data. Methods. We reviewed our 20‐year experience retrospectively of patients receiving SCS implants and analyzed our data by pain type and group. Results. We present 260 patients, 140 men and 120 women. The most frequent type of pain in our series was neuropathic pain in 44.25% and the most frequent diagnosis was peripheral vascular disease (PVD) with 98 cases. The second was failed back surgery syndrome (FBSS) with 65 cases and the third was complex regional pain syndrome type I (CRPS I), with 40 cases. In CRPS group, the mean visual analog scale (VAS) of this group was 77.89 ± 13.38. In total, 5% had no pain relief, 40% had poor pain relief, 47.5% had good pain relief, and 7.5% had excellent pain relief. In FBSS group, the mean VAS was 79.62 ± 11.69 mm. A total of 13.80% had no pain relief at all, 35.39% had poor pain relief, 50.76% had good pain relief, and there were no patients in this group who had complete pain relief. A total of 98 patients, 78 men and 20 women, were diagnosed with PVD. The mean VAS of this group was 69.75 ± 14.36 mm. A total of 11.22% had poor pain relief, 87.75% had good pain relief. One patient had complete pain relief and all patients in this group perceived at least some improvement in their symptoms. The rate of complications was close to 28% in our overall sample. Conclusions. In conclusion, we demonstrated the utility over time of this type of treatment is comparable with other series of efficacy of SCS. The analgesic efficacy was close to 65% in the overall group. The therapy was not free of complications. The preponderance of our patients was patients with the diagnosis of PVD and our results in this group of patients were excellent. These excellent results of more than 90% improvement suggest to us that SCS be considered as a first‐line approach to the clinical management of patients with pain and ulcer of PVD.     

Long-Term Outcomes of Spinal Cord Stimulation With Paddle Leads in the Treatment of Complex Regional Pain Syndrome and Failed Back Surgery Syndrome

Introduction: Spinal cord stimulation (SCS) is frequently used to treat chronic, intractable back, and leg pain. Implantation can be accomplished with percutaneous leads or paddle leads. Although there is an extensive literature on SCS, the long‐term efficacy, particularly with paddle leads, remains poorly defined. Outcome measure choice is important when defining therapeutic efficacy for chronic pain. Numerical rating scales such as the NRS‐11 remain the most common outcome measure in the literature, although they may not accurately correlate with quality of life improvements and overall satisfaction. Methods: We reviewed the medical records of patients with failed back surgery syndrome (FBSS) or complex regional pain syndrome (CRPS) implanted with SCS systems using paddle leads between 1997 and 2008 at the Cleveland Clinic with a minimum six‐month follow‐up. Patients were contacted to fill out a questionnaire evaluating outcomes with the NRS‐11 as well as overall satisfaction. Results: A total of 35 eligible patients chose to participate. More than 50% of the patients with CRPS reported greater than 50% pain relief at a mean follow‐up of 4.4 years. Approximately 30% of the FBSS patients reported a 50% or greater improvement at a mean follow‐up of 3.8 years. However, 77.8% of patients with CRPS and 70.6% of patients with FBSS indicated that they would undergo SCS surgery again for the same outcome. Conclusion: Patients with CRPS and FBSS have a high degree of satisfaction, indexed as willingness to undergo the same procedure again for the same outcome at a mean follow‐up of approximately four years. The percentage of satisfaction with the SCS system is disproportionally greater than the percentage of patients reporting 50% pain relief, particularly among patients with FBSS. This suggests that the visual analog scale may not be the optimal measure to evaluate long‐term outcomes in this patient population.     

Treatment of Multifocal Pain with Spinal Cord Stimulation

Introduction: We report a retrospective case study of combined treatment of cancer‐related pain and chronic low back and lower extremity pain related to postlaminectomy syndrome (PLS) with one spinal cord stimulation (SCS) system. Methods: The patient underwent an uneventful SCS trial with percutaneous placement of two temporary eight‐electrode leads (Medtronic Inc., Minneapolis, MN) placed at the level of T8‐T9‐T10 and T5‐T6‐T7. Results: After successful trial, he was implanted with permanent leads and generator, reporting sustained pain relief at 12‐month follow‐up visit. Discussion: SCS is a trialable, reversible, and interactive therapy permitting patients to control the level of stimulation they feel based on their degree of pain. Conclusion: SCS provides an effective, alternative treatment for select patients with cancer‐related chest wall pain and pain related to PLS who have failed conservative treatment.     

Treatment of Chronic Chest Wall Pain in a Patient With Loeys-Dietz Syndrome Using Spinal Cord Stimulation

Objective: Spinal cord stimulation (SCS) has been used with increased frequency for the treatment of intractable pain including chronic chest pain. Methods: The patient with a history of Loeys‐Dietz syndrome who underwent repair of pectus excavatum with subsequent chronic chest wall pain underwent an uneventful SCS trial with percutaneous epidural placement of two temporary eight‐electrode leads placed at the level of T3‐T4‐T5. Results: After experiencing excellent pain relief over the next two days, the patient was implanted with permanent leads and rechargeable generator four weeks later and reported sustained pain relief at 12‐month follow‐up visit. Conclusion: SCS provides an effective, alternative treatment option for select patients with Loeys‐Dietz syndrome who underwent repair of pectus excavatum with subsequent chronic chest wall pain who have failed conservative treatment. SCS may provide pain relief with advantages over conservative treatments and more invasive techniques.     

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.     

脊髓电刺激治疗复杂区域性疼痛综合征

目的探讨脊髓电刺激术（spinal cord stimulation,SCS）治疗复杂性区域性疼痛综合征（complex regional pain syndrome,CRPS）的有效性。方法回顾性分析4例CRPS病例,其均经脊髓电刺激手术治疗并随访1年以上,采用视觉模拟疼痛评分（VAS）评估疼痛转归。结果病人术后VAS评分平均降低5．4,3例病人疼痛缓解大于50％,无手术并发症。结论SCS能够安全、有效地治疗CRPS。、     

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.     

Long-Term Outcome of Spinal Cord Stimulation for Chronic Pain Management

Study Design. This is a retrospective study on 102 patients subjected to implantation of a spinal cord stimulation system for nonmalignant chronic pain management. The study was conducted through an extensive questionnaire and telephone interviews by a neutral third party. All the patients were implanted with a complete spinal cord stimulation system without a preliminary trial with a temporarily implanted electrode. Diagnostic categories were neuropathic pain, failed back syndrome, spinal cord Injury pain, and miscellaneous. Average follow-up was 3.8 years (6 months to 8 years). Patients were divided in two groups: all the implanted patients in the survey (Group A) and the implanted patients who experienced some degree of pain relief with the stimulation (Group B). Group B (80 patients) closely matches previously published series where an initial temporary screening was performed. Results. Twenty-one percent of the patients never experienced any pain relief. Of the remaining 80, 75% were still using the stimulator. Fifty-one percent of the 80 patients were experiencing good to excellent results and 20% moderate results. There was no reduction over time in the amount of pain relief in patients who initially had at least 75% pain relief. Patients with initial pain relief between 50% and 74% observed a moderate reduction in their pain relief after two years. Patients who initially experienced less than 50% pain relief observed a dramatic reduction in their results in the long term follow-up. Psychological screening contributed to the success of the procedure. Conclusions. With proper medical and psychological screening and with demonstrated initial pain relief, spinal cord stimulation remains an effective modality in the long-term management of severe chronic pain.     

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.     

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.     

Invasive brain stimulation for the treatment of neuropathic pain

Neurostimulation therapy is indicated for neuropathic pain that is refractory to medical treatment, and includes stimulation of the dorsal spinal cord, deep brain structures, and the precentral motor cortex. Spinal cord stimulation is validated in the treatment of selected types of chronic pain syndromes, such as failed back surgery syndrome. Deep brain stimulation (DBS) has shown promise as a treatment for peripheral neuropathic pain and phantom limb pain. Compared with DBS, motor cortex stimulation (MCS) is currently more frequently used, mainly because it is more easily performed, and has a wider range of indications (including central poststroke pain). Controlled trials have demonstrated the efficacy of MCS in the treatment of various types of neuropathic pain, although these trials included a limited number of patients and need to be confirmed by large, controlled, multicenter studies. Despite technical progress in neurosurgical navigation, results from studies of MCS are variable, and validated criteria for selecting good candidates for implantation are lacking. However, the evidence in favor of MCS is sufficient to include it in the range of therapeutic options for refractory neuropathic pain. In this Review, the respective efficacies and mechanisms of action of DBS and MCS are discussed.     

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.     

Direct Sciatic Nerve Electrical Stimulation for Complex Regional Pain Syndrome Type 1

ObjectiveFoot and leg pain in complex regional pain syndrome (CRPS) presents a challenge even with neuromodulation techniques such as spinal cord stimulation (SCS). We report our experience with a novo technique of direct sciatic nerve electrical stimulation (DISNES) for intractable foot and leg pain in CRPS I.Materials and MethodsFollowing Research Ethics Board (REB) approval, data were gathered for 16 patients (10 women and 6 men, age 26–61 years) who had been subjected to ipsilateral DISNES. All 16 patients had failed conventional medical management. As well, seven subjects were previously treated with SCS for CRPS I pain. These subjects reported pain relief in the thigh and leg, however the SCS was unable to alleviate the disabling foot pain despite varied and multiple programming techniques. The remaining nine subjects were treated primarily with DISNES. Evaluation was done using visual analog scale (VAS), Oswestry Disability Index version 2 (ODI), and quality of life (EQ-5D and SF-36) scores done both pre-DISNES and at two follow-ups.ResultsVAS scores decreased by 59% at follow-up (F/U) 1 (P = 0.00001) and 46% F/U 2. ODI improving by 40% F/U 1 (P = 0.0038) and 37% F/U 2. SF-36 scores improved by 69% F/U 1 (P = 0.015) and 80% F/U 2. EQ-5D scores improved significantly by F/U 1 (P = 0.00030) but insignificantly at F/U 2 (P = 0.81). There was also a rapid resolution of autonomic features such as edema, hyperemia, and allodynia (within 7–10 days). Three subjects returned to work post-DISNES.ConclusionOur study shows that DISNES helps to control the disabling foot pain in CRPS I, thus improving the quality of life, improving ambulation and decreasing disability. DISNES also alleviates autonomic features and dystonia in CRPS I. Further studies are needed to determine long-term efficacy as this study pool is limited in size and follow-up period.     

Spinal Cord Stimulation in Complex Regional Pain Syndrome Type I of Less Than 12‐Month Duration

Introduction: Complex regional pain syndrome type 1 (CRPS‐1) has a 31% probability of becoming chronic. The early use of spinal cord stimulation (SCS) has been recommended as a strategy to prevent chronicity and functional impairment. Methods: In a prospective study, we treated 74 CRPS‐1 patients with a mean disease duration of 17 weeks with standard therapy consisting of physical therapy, topical dimethyl sulfoxide, analgesics, transcutaneous stimulation, and sympathetic blockade. Patients who did not respond to standard therapy were offered a treatment with SCS. In these patients, we investigated the impact on pain, quality of life, and function. Results: Out of these 74 patients treated with standard therapy, six patients were included for early SCS treatment. The overall mean pain relief after one year was 35%. The mental component of the Short Form 36 improved; however, there was no effect on the physical component. None of the SCS treated patients showed a clear improvement in functional outcome. Discussion: We conclude that the feasibility of performing a randomized controlled trial on early SCS therapy in CRPS‐1 is low because of the good disease improvement with standard therapy in the first year after onset. This study raises questions about the need to use SCS early in the course of CRPS‐1 because of the probable lack of additional benefit compared with SCS in chronic CRPS‐1.