A review of prospective studies regarding percutaneous peripheral nerve stimulation treatment in the management of chronic pain.
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ABSTRACT:
SUBMITTER: Pritzlaff SG
PROVIDER: S-EPMC11234914 | biostudies-literature | 2024
REPOSITORIES: biostudies-literature
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A review of prospective studies regarding percutaneous peripheral nerve stimulation treatment in the management of chronic pain.
Pritzlaff Scott G SG Latif Usman U Rosenow Joshua M JM Chae John J Wilson Richard D RD Huffman William J WJ Crosby Nathan D ND Boggs Joseph W JW
Pain management 20240610 4
Conventionally, peripheral nerve stimulation (PNS) for treatment of chronic pain has involved a two-stage process: a short-term (e.g., 7 days) trial and, if significant pain relief is achieved, a permanent PNS system is implanted. A percutaneous PNS treatment is now available where a coiled lead may be implanted for up to 60 days with the goal of producing sustained relief. In the present review, published prospective trials using percutaneous PNS treatment were identified and synthesized. The c ...[more]
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Project description:INTRODUCTION:Chronic pain and reduced function are significant problems for Military Service members and Veterans following amputation. Peripheral nerve stimulation (PNS) is a promising therapy, but PNS systems have traditionally been limited by invasiveness and complications. Recently, a novel percutaneous PNS system was developed to reduce the risk of complications and enable delivery of stimulation without surgery. MATERIALS AND METHODS:Percutaneous PNS was evaluated to determine if stimulation provides relief from residual and phantom limb pain following lower-extremity amputation. PNS leads were implanted percutaneously to deliver stimulation to the femoral and/or sciatic nerves. Patients received stimulation for up to 60 days followed by withdrawal of the leads. RESULTS:A review of recent studies and clinical reports found that a majority of patients (18/24, 75%) reported substantial (≥50%) clinically relevant relief of chronic post-amputation pain following up to 60 days of percutaneous PNS. Reductions in pain were frequently associated with reductions in disability and pain interference. CONCLUSIONS:Percutaneous PNS can durably reduce pain, thereby enabling improvements in quality of life, function, and rehabilitation in individuals with residual or phantom limb pain following amputation. Percutaneous PNS may have additional benefit for Military Service members and Veterans with post-surgical or post-traumatic pain.
| S-EPMC6614808 | biostudies-literature
Project description:Peripheral nerve stimulation (PNS) has been utilized for over 50 years with accumulating evidence of efficacy in a variety of chronic pain conditions. The level and strength of evidence supporting the use of PNS for peripheral neuropathic pain remains unclear. The purpose of this review is to synthesize data from prospective studies on the efficacy of PNS for neuropathic pain as it pertains to pain intensity, neurological deficits/neuropathy (e.g., weakness, sensory deficits, gait/balance), and other secondary outcomes (quality of life, satisfaction, emotional functioning, and adverse events). In compliance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, this review identified articles from MEDLINE(R), EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus. Overall, per the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria, pooled results demonstrate very low quality or low quality of evidence supporting modest to substantial improvement in pain and neurological function after PNS implantation for treatment of peripheral neuropathic pain. PNS for phantom limb pain was the only indication that had moderate level evidence. Future prospective and well-powered studies are warranted to assess the efficacy of PNS for peripheral neuropathic pain.
| S-EPMC9599770 | biostudies-literature
Project description:BackgroundPeripheral nerve stimulation (PNS) has been increasingly used to manage acute and chronic pain. However, the level of clinical evidence to support its use is not clear.ObjectivesTo assess the clinical evidence of PNS in the treatment of acute or chronic pain.Study designA systematic review of the efficacy and safety of PNS in managing acute or chronic pain.MethodsData sources were PubMed, Cochrane Library, Scopus, CINAHL Plus, Google Scholar, and reference lists. The literature search was performed up to December 2019. Study selection included randomized trials, observational studies, and case reports of PNS in acute or chronic pain. Data extraction and methodological quality assessment were performed utilizing Cochrane review methodologic quality assessment and Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB) and Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR). The evidence was summarized utilizing principles of best evidence synthesis on a scale of 1 to 5. Data syntheses: 227 studies met inclusion criteria and were included in qualitative synthesis.ResultsEvidence synthesis based on randomized controlled trials (RCTs) and observational studies showed Level I and II evidence of PNS in chronic migraine headache; Level II evidence in cluster headache, postamputation pain, chronic pelvic pain, chronic low back and lower extremity pain; and Level IV evidence in peripheral neuropathic pain, and postsurgical pain. Peripheral field stimulation has Level II evidence in chronic low back pain, and Level IV evidence in cranial pain.LimitationsLack of high-quality RCTs. Meta-analysis was not possible due to wide variations in experimental design, research protocol, and heterogeneity of study population.ConclusionsThe findings of this systematic review suggest that PNS may be effective in managing chronic headaches, postamputation pain, chronic pelvic pain, and chronic low back and lower extremity pain, with variable levels of evidence in favor of this technique.
| S-EPMC8897810 | biostudies-literature
Project description:BackgroundPercutaneous peripheral nerve stimulation is an analgesic technique involving the percutaneous implantation of a lead followed by the delivery of electric current using an external pulse generator. Percutaneous peripheral nerve stimulation has been used extensively for chronic pain, but only uncontrolled series have been published for acute postoperative pain. The current multicenter study was undertaken to (1) determine the feasibility and optimize the protocol for a subsequent clinical trial and (2) estimate the treatment effect of percutaneous peripheral nerve stimulation on postoperative pain and opioid consumption.MethodsPreoperatively, an electrical lead was percutaneously implanted to target the sciatic nerve for major foot/ankle surgery (e.g., hallux valgus correction), the femoral nerve for anterior cruciate ligament reconstruction, or the brachial plexus for rotator cuff repair, followed by a single injection of long-acting local anesthetic along the same nerve/plexus. Postoperatively, participants were randomized to 14 days of either electrical stimulation (n = 32) or sham stimulation (n = 34) using an external pulse generator in a double-masked fashion. The dual primary treatment effect outcome measures were (1) cumulative opioid consumption (in oral morphine equivalents) and (2) mean values of the "average" daily pain scores measured on the 0 to 10 Numeric Rating Scale within the first 7 postoperative days.ResultsDuring the first 7 postoperative days, opioid consumption in participants given active stimulation was a median (interquartile range) of 5 mg (0 to 30) versus 48 mg (25 to 90) in patients given sham treatment (ratio of geometric means, 0.20 [97.5% CI, 0.07 to 0.57]; P < 0.001). During this same period, the average pain intensity in patients given active stimulation was a mean ± SD of 1.1 ± 1.1 versus 3.1 ± 1.7 in those given sham (difference, -1.8 [97.5% CI, -2.6 to -0.9]; P < 0.001).ConclusionsPercutaneous peripheral nerve stimulation reduced pain scores and opioid requirements free of systemic side effects during at least the initial week after ambulatory orthopedic surgery.Editor’s perspective
| S-EPMC8249357 | biostudies-literature
Project description:Peripheral nerve stimulation (PNS) was the first application of neuromodulation. Widespread application of PNS was limited by technical concerns. Recent advances now allow the percutaneous placement of leads with ultrasound or fluoroscopic guidance, while the transcutaneous powering of these leads removes the need for leads to cross major joints. This systematic review was written to assess the current status of high-quality evidence supporting the use of PNS for pain conditions treated by interventional pain physicians. The available literature on PNS, limited to conditions treated by interventional pain physicians, was reviewed and the quality assessed. Literature from 1966 to June 2021 was reviewed. The outcome measures were pain relief and functional improvement. One hundred and two studies were identified. Five randomized controlled trials (RCT) and four observational studies, all case series, met the inclusion criteria. One RCT was of high quality and four were of moderate quality; all four case series were of moderate quality. Three of the RCTs and all four case series evaluated peripheral nerve neuropathic pain. Based upon these studies, there is level II evidence supporting the use of PNS to treat refractory peripheral nerve injury. One moderate-quality RCT evaluated tibial nerve stimulation for pelvic pain, providing level III evidence for this indication. One moderate-quality RCT evaluated surgically placed cylindrical leads for cluster headaches, providing level III evidence for this indication. The evidence suggests that approximately two-thirds of patients with peripheral neuropathic pain will have at least 50% sustained pain relief. Adverse events from PNS are generally minor. A major advantage of PNS over spinal cord stimulation is the absence of any risk of central cord injury. The study was limited by the paucity of literature for some indications. No studies dealt with joint-related osteoarthritic pain.
| S-EPMC8586061 | biostudies-literature
Project description:Peripheral neuropathic pain (PNP) and complex regional pain syndrome (CRPS) can be effectively treated with peripheral nerve stimulation. In this clinical trial report, effectiveness of novel, miniature, wirelessly controlled microstimulator of tibial nerve in PNP and CRPS was evaluated. In this pilot study the average preoperative visual analog scale (VAS) score in six patients was 7.5, with 1, 3 and 6 months: 2.6 (p=0.03), 1.6 (p=0.03), and 1.3 (p=0.02), respectively. The mean average score in the six patients a week preceding the baseline visit was 7.96, preceding the 1, 3 and 6 month visits: 3.32 (p=0.043), 3.65 (p=0.045), and 2.49 (p=0.002), respectively. The average short-form McGill pain score before surgery was 23.8, and after 1, 3 and 6 months it was 11.0 (p=0.45), 6.3 (p=0.043), and 4.5 (p=0.01), respectively. Applied therapy caused a reduction of pain immediately after its application and clinical improvement was sustained on a similar level in all patients for six months. No complications of the treatment were observed. Intermittent tibial nerve stimulation by using a novel, miniature, wirelessly controlled device can be effective and feasible in PNP and CRPS. It is a safe, minimally invasive, and convenient neuromodulative method.
| S-EPMC5359134 | biostudies-literature
Project description:IntroductionThe objective of the present feasibility study was to investigate the use of a new treatment modality-percutaneous peripheral nerve stimulation (PNS)-in controlling the often severe and long-lasting pain following total knee arthroplasty (TKA).MethodsFor patients undergoing a primary, unilateral TKA, both femoral and sciatic open-coil percutaneous leads (SPR Therapeutics, Cleveland, OH) were placed up to seven days prior to surgery using ultrasound guidance. The leads were connected to external stimulators and used both at home and in the hospital for up to six weeks total.ResultsIn six of seven subjects (86%), the average of daily pain scores across the first two weeks was <4 on the 0-10 Numeric Rating Scale for pain. A majority of subjects (four out of seven; 57%) had ceased opioid use within the first week (median time to opioid cessation for all subjects was six days). Gross sensory/motor function was maintained during stimulation, enabling stimulation during physical therapy and activities of daily living. At 12 weeks following surgery, six of seven subjects had improved by >10% on the Six-Minute Walk Test compared to preoperative levels, and WOMAC scores improved by an average of 85% compared to before surgery. No falls, motor block, or lead infections were reported.ConclusionsThis feasibility study suggests that for TKA, ultrasound-guided percutaneous PNS is feasible in the immediate perioperative period and may provide analgesia without the undesirable systemic effects of opioids or quadriceps weakness induced by local anesthetics-based peripheral nerve blocks.
| S-EPMC6339601 | biostudies-literature
Project description:IntroductionChronic axial low back pain (CLBP) that is not responsive to medication management or physical therapy often requires significant clinical intervention. Several interventional pain management options exist, including a 60-day peripheral nerve stimulation (PNS) treatment. This economic evaluation investigated the potential for projected cost savings associated with prioritizing 60-day PNS treatment relative to a 'standard of care' (SOC) approach (where patients do not have access to 60-day PNS).MethodsA decision tree (supervised machine learning) model tracked treatment progression across two hypothetical cohorts of US patients with CLBP in whom non-interventional options were ineffective (Cohort A: treatment starting with 60-day PNS followed by any additional interventional and surgical treatments versus Cohort B: standard of care interventional and surgical treatments without access to 60-day PNS). Treatment efficacy estimates were based on published success rates. Conditional on treatment failure, up to two additional interventions were considered within the 12-month time frame in both cohorts. SOC treatment options included epidural injection, radiofrequency ablation (RFA), basivertebral nerve ablation (BVNA), PNS permanent implant (PNS-PI), spinal cord stimulator (SCS) trial/implant, and spinal fusion surgery. Treatment choice probabilities in both cohort algorithms were based on clinician interviews. Costs were based on national Medicare reimbursement levels in the ambulatory surgery center (ASC) setting. Savings reflected the difference in projected costs between cohorts. A Monte Carlo simulation and sensitivity analyses were conducted to generate confidence intervals and identify important inputs.ResultsThe treatment algorithm which prioritized initial 60-day PNS treatment was projected to save $8056 (95% CI $6112-$9981) per patient during the first year of interventional treatment relative to the SOC approach.ConclusionsUse of the 60-day PNS treatment as an initial interventional treatment in patients with CLBP may result in significant savings for Medicare. Projected savings may be even larger for commercial payers covering non-Medicare patients.
| S-EPMC11393265 | biostudies-literature
Project description:BackgroundPercutaneous peripheral nerve stimulation (PNS) is an analgesic modality involving the insertion of a lead through an introducer needle followed by the delivery of electric current after needle withdrawal. This modality has been used extensively to treat chronic pain, but only small series have been published involving postoperative pain. The ultimate objective of this study is to determine the postoperative effects of percutaneous PNS following moderately to severely painful ambulatory surgery within a real-world clinical practice setting. The primary hypothesis is that surgical pain and opioid consumption during the initial 7 days after surgery will be reduced by percutaneous PNS compared with usual and customary analgesia (dual primary outcome measures).DesignA multicenter pragmatic effectiveness trial. We are randomizing participants having painful orthopedic surgical procedures of the upper and lower extremity to receive 14 days of either 1) electrical stimulation or 2) sham in a double-masked fashion. End points are being assessed at various time points over 12 postoperative months.SummaryThe postoperative experience will be much improved if percutaneous PNS provides potent analgesia while concurrently decreasing opioid requirements following painful surgery. Because this modality can be administered for up to 60 days at home, it may provide postoperative analgesia that outlasts surgical pain yet has relatively few risks and, unlike opioids, has no systemic side effects or potential for abuse, addiction, and overdose. Percutaneous PNS has the potential to revolutionize postoperative analgesia as it has been practiced for the past century. This study will inform key stakeholders regarding an evidence-based nonpharmacologic approach to the management of postoperative pain.
| S-EPMC7824994 | biostudies-literature
Project description:IntroductionThis study evaluates the financial impact on healthcare payers when chronic pain patients initiate peripheral nerve stimulation (PNS) with a 60-day percutaneous PNS (60-Day PNS) treatment versus a conventional brief PNS trial (PNS-BT) with possible follow-on of a permanently implanted PNS system (PNS-PI).MethodsCenters for Medicare & Medicaid Services (CMS) fee-for-service (FFS) data were analyzed to identify patients with at least 12 months of follow-up (median 26.4 months) who initiated PNS treatment with: (1) 60-Day PNS or (2) PNS-BT. An economic decision tree model assessed the cost to payers in each cohort. Clinical response to 60-Day PNS was estimated by retrospectively reviewing anonymized outcomes from a national real-world database, focusing on patients ≥ 65 years of age who were implanted with a 60-day percutaneous PNS system. For the economic model, a Monte Carlo simulation with 10,000 iterations was used to generate 95% confidence intervals, considering variability in treatment outcome probability and costs.ResultsBased on CMS data, among 60-Day PNS patients, 18% (229/1265) proceeded to a permanently implanted PNS system with a 4% explant rate (10/229). Among PNS-BT patients, 41% (1140/2811) received a permanent implant with a 7% rate of explant (77/1140). Estimated PNS-related weighted average costs for the 60-Day PNS cohort [US$17,344; 95% confidence interval (CI): $16,168-$18,527] were lower than the PNS-BT cohort ($24,392; 95% CI $22,865-$25,941) when considering the percent of patients who advanced to a permanently implanted PNS system. The total cost per successful outcome also favored 60-Day PNS ($25,228 per success for the 60-Day PNS cohort vs. $64,502 per success for the PNS-BT cohort) as a first-line approach in PNS treatment.ConclusionsThe findings suggest that, when PNS for chronic pain is warranted, initiating PNS with a 60-day treatment is more cost-effective than utilizing a brief conventional trial.
| S-EPMC11751244 | biostudies-literature