Prophylactic Regenerative Peripheral Nerve Interfaces to Prevent Postamputation Pain (original) (raw)
Related papers
Plastic and reconstructive surgery. Global open, 2016
Originally designed for prosthetic control, regenerative peripheral nerve interfaces (RPNIs) prevent neuroma formation by providing free muscle grafts as physiological targets for peripheral nerve ingrowth. We report the first series of patients undergoing RPNI implantation for treatment of symptomatic postamputation neuromas. A retrospective case series of all amputees undergoing RPNI implantation for treatment of symptomatic neuromas between November 2013 and June 2015 is presented. Data were obtained via chart review and phone interviews using questions derived from the Patient Reported Outcomes Measurement Information System instruments. Statistical analyses were performed using dependent sample t tests with a significance threshold of P < 0.01. Forty-six RPNIs were implanted into 16 amputees for neuroma relief (3 upper extremities and 14 lower extremities). Mean age was 53.5 years (6 females and 10 males). All patients participated in postoperative phone interviews at 7.5 ± ...
WJBPHS, 2024
A new percutaneous Peripheral Nerve Stimulation (PNS) device is described in this paper as a potential treatment for amputation-related neuropathic pain and functional impairment in military service members and veterans. Recent advances have made it feasible to inject thin wire-coiled PNS leads percutaneously under ultrasound guidance, allowing doctors to get around the problems and invasiveness of traditional PNS systems. Avoiding the femoral and sciatic nerves may minimize the hazards associated with these leads. Phantom limb pain (PLP) is experienced by an estimated 40%-80% of amputees. This article provides a concise summary of current studies that examine the impact of PNS technological advancements on neuromodulation. This research aimed to provide healthcare providers with up-to-date, evidence-based suggestions for alleviating post-amputation discomfort.
Targeted Muscle Reinnervation Treats Neuroma and Phantom Pain in Major Limb Amputees
Annals of Surgery, 2018
Objective: To compare targeted muscle reinnervation (TMR) to ''standard treatment'' of neuroma excision and burying into muscle for postamputation pain. Summary Background Data: To date, no intervention is consistently effective for neuroma-related residual limb or phantom limb pain (PLP). TMR is a nerve transfer procedure developed for prosthesis control, incidentally found to improve postamputation pain. Methods: A prospective, randomized clinical trial was conducted. 28 amputees with chronic pain were assigned to standard treatment or TMR. Primary outcome was change between pre-and postoperative numerical rating scale (NRS, 0-10) pain scores for residual limb pain and PLP at 1 year. Secondary outcomes included NRS for all patients at final follow-up, PROMIS pain scales, neuroma size, and patient function. Results: In intention-to-treat analysis, changes in PLP scores at 1 year were 3.2 versus À0.2 (difference 3.4, adjusted confidence interval (aCI) À0.1 to 6.9, adjusted P ¼ 0.06) for TMR and standard treatment, respectively. Changes in residual limb pain scores were 2.9 versus 0.9 (difference 1.9, aCI À0.5 to 4.4, P ¼ 0.15). In longitudinal mixed model analysis, difference
Regional Anesthesia & Pain Medicine
Background and objectivesChronic neuropathic pain is a common challenging condition following amputation. Recent research demonstrated the feasibility of percutaneously implanting fine-wire coiled peripheral nerve stimulation (PNS) leads in proximity to the sciatic and femoral nerves for postamputation pain. A multicenter, double-blinded, randomized, placebo-controlled study collected data on the safety and effectiveness of percutaneous PNS for chronic neuropathic pain following amputation.MethodsTwenty-eight lower extremity amputees with postamputation pain were enrolled. Subjects underwent ultrasound-guided implantation of percutaneous PNS leads and were randomized to receive PNS or placebo for 4 weeks. The placebo group then crossed over and all subjects received PNS for four additional weeks. The primary efficacy endpoint evaluated the proportion of subjects reporting ≥50% pain reduction during weeks 1–4.ResultsA significantly greater proportion of subjects receiving PNS (n=7/12...
Postamputation pain: epidemiology, mechanisms, and treatment
Journal of Pain Research, 2013
Postamputation pain (PAP) is highly prevalent after limb amputation but remains an extremely challenging pain condition to treat. A large part of its intractability stems from the myriad pathophysiological mechanisms. A state-of-art understanding of the pathophysiologic basis underlying postamputation phenomena can be broadly categorized in terms of supraspinal, spinal, and peripheral mechanisms. Supraspinal mechanisms involve somatosensory cortical reorganization of the area representing the deafferentated limb and are predominant in phantom limb pain and phantom sensations. Spinal reorganization in the dorsal horn occurs after deafferentation from a peripheral nerve injury. Peripherally, axonal nerve damage initiates inflammation, regenerative sprouting, and increased "ectopic" afferent input which is thought by many to be the predominant mechanism involved in residual limb pain or neuroma pain, but may also contribute to phantom phenomena. To optimize treatment outcomes, therapy should be individually tailored and mechanism based. Treatment modalities include injection therapy, pharmacotherapy, complementary and alternative therapy, surgical therapy, and interventions aimed at prevention. Unfortunately, there is a lack of high quality clinical trials to support most of these treatments. Most of the randomized controlled trials in PAP have evaluated medications, with a trend for short-term efficacy noted for ketamine and opioids. Evidence for peripheral injection therapy with botulinum toxin and pulsed radiofrequency for residual limb pain is limited to very small trials and case series. Mirror therapy is a safe and cost-effective alternative treatment modality for PAP. Neuromodulation using implanted motor cortex stimulation has shown a trend toward effectiveness for refractory phantom limb pain, though the evidence is largely anecdotal. Studies that aim to prevent PAP using epidural and perineural catheters have yielded inconsistent results, though there may be some benefit for epidural prevention when the infusions are started more than 24 hours preoperatively and compared with nonoptimized alternatives. Further investigation into the mechanisms responsible for and the factors associated with the development of PAP is needed to provide an evidence-based foundation to guide current and future treatment approaches.
Journal of the American College of Surgeons
BACKGROUND: A majority of the nearly 2 million Americans living with limb loss suffer from chronic pain in the form of neuroma-related residual limb and phantom limb pain (PLP). Targeted muscle reinnervation (TMR) surgically transfers amputated nerves to nearby motor nerves for prevention of neuroma. The objective of this study was to determine whether TMR at the time of major limb amputation decreases the incidence and severity of PLP and residual limb pain. STUDY DESIGN: A multi-institutional cohort study was conducted between 2012 and 2018. Fifty-one patients undergoing major limb amputation with immediate TMR were compared with 438 unselected major limb amputees. Primary outcomes included an 11-point Numerical Rating Scale (NRS) and Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity, behavior, and interference. RESULTS: Patients who underwent TMR had less PLP and residual limb pain compared with untreated amputee controls, across all subgroups and by all measures. Median "worst pain in the past 24 hours" for the TMR cohort was 1 out of 10 compared to 5 (PLP) and 4 (residual) out of 10 in the control population (p ¼ 0.003 and p < 0.001, respectively). Median PROMIS t-scores were lower in TMR patients for both PLP (pain intensity [36.3 vs 48.3], pain behavior [50.1 vs 56.6], and pain interference [40.7 vs 55.8]) and residual limb pain (pain intensity [30.7 vs 46.8], pain behavior [36.7 vs 57.3], and pain interference [40.7 vs 57.3]). Targeted muscle reinnervation was associated with 3.03 (PLP) and 3.92 (residual) times higher odds of decreasing pain severity compared with general amputee participants. CONCLUSIONS: Preemptive surgical intervention of amputated nerves with TMR at the time of limb loss should be strongly considered to reduce pathologic phantom limb pain and symptomatic neuroma-related residual limb pain.
2022
Symptomatic neuromas are an all-too-common complication following limb amputation or extremity trauma, leading to chronic and debilitating pain for patients. Surgical resection of symptomatic neuromas has proven to be the superior method of intervention, but traditional methods of neuroma resection do not address the underlying pathophysiology leading to the formation of a future symptomatic neuroma and lead to high reoperation rates. Novel approaches employ the physiology of peripheral nerve injury to harness the regeneration of nerves to their advantage. This review explores the underlying pathophysiology of neuroma formation and centralization of pain signaling. It compares the traditional surgical approach for symptomatic neuroma resection and describes three novel surgical strategies that harness this pathophysiology of neuroma formation to their advantage. The traditional resection of symptomatic neuromas is currently the standard of care for amputation patients, but new techniques including the regenerative peripheral nerve interface, targeted muscle reinnervation, and intraosseous transposition have shown promise in improving patient pain outcomes for postamputation pain and residual limb pain. Symptomatic neuromas are a chronic and debilitating complication following amputation procedures and trauma, and the current standard of care does not address the underlying pathophysiology leading to the formation of the neuroma. New techniques are under development that may provide improved patient pain outcomes and a higher level of care for symptomatic neuroma resection.
Regional Anesthesia and Pain Medicine, 2023
Introduction We previously reported that a 6-day continuous peripheral nerve block reduces established postamputation phantom pain. To provide patients and providers with the information to best inform treatment decisions, here we reanalyze the data and present the results in a more patient-centered format. We also provide information on patient-defined clinically relevant benefits to facilitate evaluation of available studies and guide future trial design. Methods The original trial enrolled participants with a limb amputation and phantom pain who were randomized to receive a 6-day continuous peripheral nerve block(s) of either ropivacaine (n=71) or saline (n=73) in a double-masked fashion. Here we calculate the percentage of each treatment group that experienced a clinically relevant improvement as defined by previous studies as well as present what the participants of our study defined as small, medium, and large analgesic improvements using the 7-point ordinal Patient Global Impression of Change scale. Results Among patients who were given a 6-day ropivacaine infusion, 57% experienced at least a 2-point improvement on the 11-point numeric rating scale in their average and worst phantom pain 4 weeks postbaseline as compared with 26% (p<0.001) for average and 25% (p<0.001) for worst pain in patients given a placebo infusion. At 4 weeks, the percentage of participants rating their pain as improved was 53% for the active vs 30% for the placebo groups (95% CI 1.7 (1.1, 2.7), p=0.008). For all patients combined, the median (IQR) phantom pain Numeric Rating Scale improvements at 4 weeks considered small, medium, and large were 2 (0-2), 3 (2-5), and 5 (3-7), respectively. The median improvements in the Brief Pain Inventory interference subscale (0-70) associated with small, medium, and large analgesic changes were 8 (1-18), 22 (14-31), and 39 (26-47). Conclusions Among patients with postamputation phantom pain, a continuous peripheral nerve block more than doubles the chance of a clinically relevant improvement in pain intensity. Amputees with phantom and/or residual limb pain rate analgesic improvements as clinically relevant similarly to other chronic pain etiologies, although their smallest relevant improvement in the Brief Pain Inventory was significantly larger than previously published values. Trial registration number NCT01824082. HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY ⇒ Future patients and their caretakers will be able to make more-informed decisions regarding possible treatment of postamputation limb pain with continuous peripheral nerve blocks. ⇒ This information can facilitate evaluation of currently-published research, and enable future clinical researchers to improve study design and analysis.
Management of Post-Amputation Pain
2020
INTRODUCTION: The prevalence of amputation and post-amputation pain (PAP) is rising. There are two main types of PAP: residual limb pain (RLP) and phantom limb pain (PLP), with an estimated 95% of people with amputations experiencing one or both. MEDICAL MANAGEMENT: The majority of chronic PAP is due to phantom limb pain, which is neurogenic in nature. Common medications used include tricyclic antidepressants, gabapentin, and opioids. Newer studies are evaluating alternative drugs such as ketamine and local anesthetics. REHABILITATION MANAGEMENT: Mirror visual feedback and cognitive behavioral therapy are often effective adjunct therapies and have minimal adverse effects. SURGICAL MANAGEMENT: Neuromodulatory treatment and surgery for neuromas have been found to help select patients with PAP. CONCLUSION: PAP is a complex condition with mechanisms that can be located at the residual limb, spinal cord, and brain-or a combination. This complex pain can be difficult to treat. The mainstays of treatment are largely medical, but several surgical options are also being studied.
Archives of Physical Medicine and Rehabilitation, 2000
Ehde DM, Czerniecki JM, Smith DG, Campbell KM, Edwards WT, Jensen MP, Robinson LR. Chronic phantom sensations, phantom pain, residual limb pain, and other regional pain after lower limb amputation. Arch Phys Med Rehabil 2000;81:1039-44.