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The metabolic demand of walking generally increases following lower extremity amputation. This study used real-time visual feedback to modify biomechanical factors linked to an elevated metabolic demand of walking in individuals with transtibial amputation. Eight persons with unilateral, traumatic transtibial amputation and 8 uninjured controls participated. Two separate bouts of real-time visual feedback were provided during a single session of gait retraining to reduce 1) center of mass sway and 2) thigh muscle activation magnitudes and duration. Baseline and post-intervention data were collected. Metabolic rate, heart rate, frontal plane center of mass sway, quadriceps and hamstrings muscle activity, and co-contraction indices were evaluated during steady state walking at a standardized speed. Visual feedback successfully decreased center of mass sway 12% (p = 0.006) and quadriceps activity 12% (p = 0.041); however, thigh muscle co-contraction indices were unchanged. Neither condition significantly affected metabolic rate during walking and heart rate increased with center-of-mass feedback. Metabolic rate, center of mass sway, and integrated quadriceps muscle activity were all not significantly different from controls. Attempts to modify gait to decrease metabolic demand may actually adversely increase the physiological effort of walking in individuals with lower extremity amputation who are young, active and approximate metabolic rates of able-bodied adults.

Abstract Background. Postamputation pain is highly prevalent after limb amputation with neuropathic nature; calcitonin may effectively relieve many neuropathic pain states. Design. Double-blind randomized multicenter study. Setting. Our study hypothesis is to evaluate the preventive value of epidural calcitonin on postoperative pain, grade of phantom pain, and the development of allodynia and hyperalgesia in patients undergoing lower limb amputation. Patients. A cohort of 60 diabetic patients of both genders suffering from vascular insufficiency of one or both lower limbs underwent minor or major lower limb amputation. Patients were divided randomly into two equal groups: an epidural bupivacaine-calcitonin-fentanyl (BCF) group and a bupivacaine-fentanyl (BF) group. Methods. Patients were instructed about the use of a 10 cm visual analog scale (VAS). Phantom limb pain was graded using a four-grade scale. Pin-prick hyperalgesia and allodynia were evaluated at one week, one month, three months, and six months after surgery. Results. There were no significant differences between groups regarding patients' characteristics. There was no significant difference in the VAS scale between groups. There was statically significant improvement in the grade of phantom pain in the BCF group at six and 12 months after surgery (P =  0.033 and 0.001, respectively). A significantly higher number of patients developed allodynia in the BF group at six (P = 0.039) and 12 (P = 0.013) months and hyperalgesia at 12 months (P = 0.025). Conclusion. The preventive use of epidural calcitonin improved the grade of phantom pain and reduced the incidence of allodynia and hyperalgesia in patients undergoing lower limb amputation under combined spinal-epidural anesthesia during one year of follow-up.

Abstract Objective We present a technical protocol for rigorous assessment of patient-reported outcomes and psychophysical testing relevant to lumbar sympathetic blocks for the treatment of postamputation pain (PAP). This description is intended to inform future prospective investigation. Design Series of four participants from a blinded randomized sham-controlled trial. Setting Tertiary, urban, academic pain medicine center. Subjects Four participants with a single lower limb amputation and associated chronic PAP. Methods Participants were randomized to receive a lumbar sympathetic block with 0.25% bupivacaine or sham needle placement. Patient-rated outcome measures included the numerical rating scale (NRS) for pain, the McGill Pain Questionnaire–Short Form, Center for Epidemiological Studies Depression Scale, Pain and Anxiety Symptoms Scale–short version, and Pain Disability Index (PDI). Psychophysical and biometric testing was also performed, which included vibration sensation testing, pinprick sensation testing, brush sensation testing, Von Frey repeated weighted pinprick sensation, and thermal quantitative sensory testing. Results In the four described cases, treatment of PAP with a single lumbar sympathetic block but not sham intervention resulted in reduction of both residual limb pain and phantom limb pain as well as perceived disability on the PDI at three-month follow-up. Conclusions An appropriately powered randomized controlled study using this methodology may not only aid in determining the possible clinical efficacy of lumbar sympathetic block in PAP, but could also improve our understanding of underlying pathophysiologic mechanisms of PAP.

The aim of this study is to analyse the effectiveness of the Graded Motor Imagery (GraMI) protocol in phantom limb pain in amputee patients. A randomised clinical trial will be conducted, with two parallel groups and simple blinding, and a phenomenological study with semi-structured interviews. People over the age of 18, with amputation of one limb, with a minimum score of 3 on the visual analogue scale of pain, who are pharmacologically stable and have been discharged from hospital, will be recruited. An initial assessment, a post-intervention assessment (9 weeks) and a follow-up assessment (12 weeks post-intervention) will be performed, in which pain, quality of life, functionality and psychological aspects will be assessed. The aim of the qualitative study is to find out about the experience of living with phantom limb pain and to identify the satisfaction with the intervention. A descriptive, univariate and bivariate quantitative statistical analysis will be performed using the SPSS program, with a 95% confidence level and a statistical significance level of p < 0.05. The qualitative analysis will be carried out using the Atlas.ti 8.0 program, where the different interviews will be analysed, coded and categorised. The GraMI protocol allows the patient to work on motor learning through brain reorganisation, analytical movements, sensory stimulation, and functional activities. In addition, it can help to standardise the use of graded motor imagery in future studies and in clinical practice with this patient profile. NCT05083611.

High concentrations of local anesthetics may be neurotoxic for diabetic patients. Additive perineural administration of magnesium was reported to decrease the consumption of local anesthetics for nerve block. It was hypothesized that MgSO4 added to dilute ropivacaine was equianalgesic to more concentrated ropivacaine for toe amputations in diabetic patients. Seventy diabetic patients were allocated into 3 groups: 1) perineural 200 mg MgSO4 added to 0.25% ropivacaine, 2) 0.25% ropivacaine alone, and 3) 0.375% ropivacaine alone. All patients underwent popliteal sciatic nerve block that was guided by ultrasonography using the respective regimens. Time of onset, duration of motor and sensory block were recorded. Spontaneous and evoked pain score, worst pain score, additional analgesic consumption, satisfaction score and initial time of analgesic requirement of each patient were documented up to 48 hours postoperatively. In comparison with 0.25% ropivacaine alone, magnesium supplement prolonged the duration of sensory block (p = 0.001), as well as better evoked pain score at 6 hour postoperatively (p = 0.001). In comparison with evoked pain score (1.6/10) in group of 0.375% ropivacaine, magnesium plus 0.25% ropivacaine presented a little higher score (2.5/10) at 6 hour postoperatively (p = 0.001), while lower worst pain score (p = 0.001) and less postoperative total analgesic consumption (p = 0.002). The regimen of adding 200mg MgSO4 to 0.25% ropivacaine for sciatic nerve block yields equal analgesic effect in comparison with 0.375% ropivacaine. These findings have suggested that supplemental MgSO4 could not improve analgesic quality except reducing the total amount of local anesthetics requirement in diabetic toe amputations with sciatic nerve blocks.

Background Cardiovascular disease (CVD) and nontraumatic lower-limb amputation (LLA) each results in reduced life expectancy in patients with type 1 diabetes, but the differential burden between these conditions is unknown. We compared the effects of CVD and LLA on the risk of mortality in people with type 1 diabetes. Methods We used pooled data from the SURGENE, GENEDIAB, and GENESIS prospective cohorts. Data were divided into: 1/absence of CVD (myocardial infarction and/or stroke) nor LLA, 2/history of CVD alone without LLA, 3/LLA alone without CVD or 4/both conditions at baseline. Participants with baseline history of peripheral artery disease were excluded from groups 1 and 2. The study endpoint was any death occurring during follow-up, regardless of the causes. Results Among 1169 participants (male 55%, age 40 ± 13 years, diabetes duration 23 ± 11 years), CVD, LLA or both were present at baseline in 49 (4.2%), 62 (5.3%) and 20 (1.7%) subjects, respectively. All-cause death occurred in 304 (26%) participants during 17-year follow-up, corresponding to 18,426 person-years and an incidence rate of 16 (95%CI, 15–18) per 1000 person-years. The risk of death increased in individuals with baseline history of CVD (adjusted HR 2.00 [95% CI 1.34–3.01], p = 0.0008) or LLA (2.26 [1.56–3.28], p < 0.0001), versus no condition, with an additive effect in people with both conditions (5.32 [3.14–9.00], p < 0.0001). No incremental risk of death was observed in people with CVD versus LLA (0.87 [0.54–1.41]). Compared with no condition, CVD and LLA were similarly associated with reduced life expectancy during follow-up: 2.79 (95% CI 1.26–4.32) and 3.38 (1.87–4.88) years, respectively. Combined conditions expose to 7.04 (4.76–9.31) less years of life expectancy (all p < 0.0001). Conclusions CVD and LLA conferred a similar burden regarding mortality in type 1 diabetes population. Our findings encourage a careful consideration of people with type 1 diabetes and LLA as usually recommended for those with CVD, in terms of management of risk factors, treatments and prevention.

Background The present study investigated factors associated with therapeutic benefits after autologous bone marrow cell (BMC) therapy in patients with “no-option” critical limb ischemia (CLI). Methods and results Sixty-two patients with advanced CLI (Rutherford category 5 or 6) not eligible for revascularization were randomized to treatment with 40 ml of autologous BMCs (SmartPreP2) by local intramuscular ( n  = 32) or intra-arterial ( n  = 30) application. The primary endpoint was limb salvage and wound healing at 12 months. Seven patients (11 %) died during the follow-up from reasons unrelated to stem cell therapy. The BMC product of patients with limb salvage and wound healing (33/55) was characterized by a higher CD34 + cell count ( p  = 0.001), as well as a higher number of total bone marrow mononuclear cells (BM-MNCs) ( p  = 0.032), than that of nonresponders (22/55). Patients with limb salvage and wound healing were younger ( p  = 0.028), had lower C-reactive protein levels ( p  = 0.038), and had higher transcutaneous oxygen pressure (tcpO 2 ) ( p  = 0.003) before cell application than nonresponders. All patients with major tissue loss at baseline (Rutherford 6 stage of CLI, n  = 5) showed progression of limb ischemia and required major limb amputation. In the multiple binary logistic regression model, the number of applied CD34 + cells ( p  = 0.046) and baseline tcpO 2 ( p  = 0.031) were independent predictors of limb salvage and wound healing. The number of administrated BM-MNCs strongly correlated with decreased peripheral leukocyte count after 6 months in surviving patients with limb salvage ( p  = 0.0008). Conclusion Patients who benefited from autologous BMC therapy for “no-option” CLI were treated with high doses of CD34 + cells. The absolute number of applied BM-MNCs correlated with the improvement of inflammation. We hypothesize that the therapeutic benefit of cell therapy for peripheral artery disease is the result of synergistic effects mediated by a mixture of active cells with regenerative potential. Patients at the most advanced stage of CLI do not appear to be suitable candidates for cell therapy. Trial registration The study was approved and registered by the ISRCTN registry. Trial registration: ISRCTN16096154 . Registered: 26 July 2016.

Little research describes which transfemoral socket design features are important for coronal plane stability, socket comfort, and gait. Our study objectives were to (1) relate socket comfort during gait to a rank order of changes in ischial containment (IC) and tissue loading and (2) compare socket comfort during gait when tissue loading and IC were systematically manipulated. Six randomly assigned socket conditions (IC and tissue compression) were assessed: (1) IC and high, (2) IC and medium, (3) IC and low, (4) no IC and high, (5) no IC and medium, and (6) no IC and low. For the six subjects in this study, there was a strong, negative relationship between comfort and changes in IC and tissue loading (rho = -0.89). With the ischium contained, tissue loading did not influence socket comfort (p = 0.47). With no IC, the socket was equally comfortable with high tissue loading (p = 0.36) but the medium (p = 0.04) and low (p = 0.02) tissue loading conditions decreased comfort significantly. Coronal plane hip moments, lateral trunk lean, step width, and walking speed were invariant to changes in IC and/or tissue loading. Our results suggest that in an IC socket, medial tissue loading mattered little in terms of comfort. Sockets without IC required high tissue loading to be as comfortable as those with IC, while suboptimal tissue loading compromised comfort.

Abstract Objective. To define clinical phenotypes of postamputation pain and identify markers of risk for the development of chronic pain. Design. Cross-sectional study of military service members enrolled 3-18 months after traumatic amputation injury. Setting. Military Medical Center Subjects. 124 recent active duty military service members Methods. Study subjects completed multiple pain and psychometric questionnaires to assess the qualities of phantom and residual limb pain. Medical records were reviewed to determine the presence/absence of a regional catheter near the time of injury. Subtypes of residual limb pain (somatic, neuroma, and complex regional pain syndrome) were additionally analyzed and associated with clinical risk factors. Results. A majority of enrolled patients (64.5%) reported clinically significant pain (pain score ≥3 averaged over previous week). 61% experienced residual limb pain and 58% experienced phantom pain. When analysis of pain subtypes was performed in those with residual limb pain, we found evidence of a sensitized neuroma in 48.7%, somatic pain in 40.8%, and complex regional pain syndrome in 19.7% of individuals. The presence of clinically significant neuropathic residual limb pain was associated with symptoms of PTSD and depression. Neuropathic pain of any severity was associated with symptoms of all four assessed clinical risk factors: depression, PTSD, catastrophizing, and the absence of regional analgesia catheter. Conclusions. Most military service members in this cohort suffered both phantom and residual limb pain following amputation. Neuroma was a common cause of neuropathic pain in this group. Associated risk factors for significant neuropathic pain included PTSD and depression. PTSD, depression, catastrophizing, and the absence of a regional analgesia catheter were associated with neuropathic pain of any severity.

OBJECTIVE: To identify factors that influence survival after diabetes-related amputations. RESEARCH DESIGN AND METHODS: We abstracted medical records of 1,043 hospitalized subjects with diabetes and a lower-extremity amputation from 1 January to 31 December 1993 in six metropolitan statistical areas in south Texas. We identified mortality in the 10-year period after amputation from death certificate data. Diabetes was verified using World Health Organization criteria. Amputations were identified by ICD-9-CM codes 84.11-84.18 and categorized as foot, below-knee amputation, and above-knee amputation and verified by reviewing medical records. We evaluated three levels of renal function: chronic kidney disease (CKD), hemodialysis, and no renal disease. We defined CKD based on a glomerular filtration rate <60 ml/min and hemodialysis from Current Procedural Terminology (CPT) codes (90921, 90925, 90935, and 90937). We used χ² for trend and Cox regression analysis to evaluate risk factors for survival after amputation. RESULTS: Patients with CKD and dialysis had more below-knee amputations and above-knee amputations than patients with no renal disease (P < 0.01). Survival was significantly higher in patients with no renal impairment (P < 0.01). The Cox regression indicated a 290% increase in hazard for death for dialysis treatment (hazard ratio [HR] 3.9, 95% CI 3.07-5.0) and a 46% increase for CKD (HR 1.46, 95% CI 1.21-1.77). Subjects with an above-knee amputation had a 167% increase in hazard (HR 2.67, 95% CI 2.14-3.34), and below-knee amputation patients had a 67% increase in hazard for death. CONCLUSIONS: Survival after amputation is lower in diabetic patients with CKD, dialysis, and high-level amputations.