(Cost-)effectiveness of lower extremity nerve decompression surgery in subjects with diabetes: the DeCompression (DECO) trial-study protocol for a randomised controlled trial.

INTRODUCTION: The peripheral nerves of patients with diabetes are often pathologically swollen, which results in entrapment at places of anatomical narrowing. This results in nerve dysfunction. Surgical treatment of compression neuropathies in the lower extremities (lower extremity nerve decompression (LEND)) results in relief of symptoms and gain in peripheral nerve function, which may lead to less sensory loss (short term) and less associated detrimental effects including foot ulceration and amputations, and lower costs (long term). The aim of the DeCompression trial is to evaluate the effectiveness and (cost-)effectiveness of surgical decompression of compressed lower extremity nerves (LEND surgery) compared with patients treated with conventional (non-surgical) care. METHODS AND ANALYSIS: A stratified randomised (1 to 1) controlled trial comparing LEND surgery (intervention) with conventional non-surgical care (control strategy) in subjects with diabetes with problems of neuropathy due to compression neuropathies in the lower extremity. Randomisation is stratified for participating hospital (n=11) and gender. Patients and controls have the same follow-up at 1.5, 3, 6, 9, 12, 18, 24 and 48 months. Participants (n=344) will be recruited in 12 months and enrolled in all affiliated hospitals in which they receive both the intervention or conventional non-surgical care and follow-up. Outcome assessors are blinded to group assignment. PRIMARY OUTCOME: disease-specific quality of life (Norfolk Quality of Life Questionnaire-Diabetic Neuropathy). SECONDARY OUTCOMES: health-related quality of life (EuroQoL 5-dimension 5-level (EQ-5D5L), 36-item Short Form (SF-36)), plantar sensation (Rotterdam Diabetic Foot Test Battery), incidence of ulcerations/amputations, resource use and productivity loss (Medical Cost Questionnaire, Productivity Cost Questionnaire) during follow-up. The incremental cost-effectiveness ratio will be estimated on the basis of the collected empirical data and a cost-utility model. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Medical Research Ethics Committee of Utrecht University Medical Center (reference: NL68312.041.19v5, protocol number: 19-335/M). Dissemination of results will be via journal articles and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: NetherlandsTrial Registry NL7664.

The clinical- and cost-effectiveness of functional electrical stimulation and ankle-foot orthoses for foot drop in Multiple Sclerosis: a multicentre randomized trial.

OBJECTIVE: To compare the clinical- and cost-effectiveness of ankle-foot orthoses (AFOs) and functional electrical stimulation (FES) over 12 months in people with Multiple Sclerosis with foot drop. DESIGN: Multicentre, powered, non-blinded, randomized trial. SETTING: Seven Multiple Sclerosis outpatient centres across Scotland. SUBJECTS: Eighty-five treatment-naïve people with Multiple Sclerosis with persistent (>three months) foot drop. INTERVENTIONS: Participants randomized to receive a custom-made, AFO (n = 43) or FES device (n = 42). OUTCOME MEASURES: Assessed at 0, 3, 6 and 12 months; 5-minute self-selected walk test (primary), Timed 25 Foot Walk, oxygen cost of walking, Multiple Sclerosis Impact Scale-29, Multiple Sclerosis Walking Scale-12, Modified Fatigue Impact Scale, Euroqol five-dimension five-level questionnaire, Activities-specific Balance and Confidence Scale, Psychological Impact of Assistive Devices Score, and equipment and National Health Service staff time costs of interventions. RESULTS: Groups were similar for age (AFO, 51.4 (11.2); FES, 50.4(10.4) years) and baseline walking speed (AFO, 0.62 (0.21); FES 0.73 (0.27) m/s). In all, 38% dropped out by 12 months (AFO, n = 21; FES, n = 11). Both groups walked faster at 12 months with device (P < 0.001; AFO, 0.73 (0.24); FES, 0.79 (0.24) m/s) but no difference between groups. Significantly higher Psychological Impact of Assistive Devices Scores were found for FES for Competence (P = 0.016; AFO, 0.85(1.05); FES, 1.53(1.05)), Adaptability (P = 0.001; AFO, 0.38(0.97); FES 1.53 (0.98)) and Self-Esteem (P = 0.006; AFO, 0.45 (0.67); FES 1 (0.68)). Effects were comparable for other measures. FES may offer value for money alternative to usual care. CONCLUSION: AFOs and FES have comparable effects on walking performance and patient-reported outcomes; however, high drop-outs introduces uncertainty.

Quantitative assessment of nerve echogenicity as an additional tool for evaluation of common fibular neuropathy.

OBJECTIVE: Quantitative assessment of nerve echogenicity using the MaxEntropy, RenyiEntropy and Yen methods has shown promise in the assessment of ulnar neuropathy at the elbow. The purpose of this study was to determine the clinical usefulness of quantitative echogenicity measurement when using these three automatic thresholding methods in the evaluation of patients with common fibular (CF) neuropathy. METHODS: High-resolution ultrasonography (HRUS) images of the CF nerve from 45 patients with CF neuropathy were compared to 42 healthy controls. RESULTS: With all three methods patients with CF neuropathy had significantly higher mean hypoechoic fraction than healthy controls at the level of the fibular head (FH): MaxEntropy 87.4% versus 71.9% (p<0.001), RenyiEntropy 84.7% versus 68% (p<0.001) and Yen 87.6% versus 68.2% (p<0.001). Patients with CF neuropathy could be differentiated from healthy controls at a hypoechoic fraction cut-off point of 82% (MaxEntropy), 80% (RenyiEntropy) and 80% (Yen) with a sensitivity of 82%, 82% and 84% respectively, and a specificity of 93%, 95% and 83% respectively. Similar results were found for sonographic measurements above the FH. CONCLUSION: Quantitative assessment of nerve echogenicity using the MaxEntropy, RenyiEntropy and Yen methods can be used to distinguish between patients with CF neuropathy and healthy controls with high sensitivity and specificity. SIGNIFICANCE: These three proven automatic thresholding methods can be used to assess nerve echogenicity in future studies. Quantitative echogenicity assessment with HRUS shows promise for the future as a potential diagnostic tool in daily clinical practice.

Tendon transfers for drop foot correction: long-term results including quality of life assessment, and dynamometric and pedobarographic measurements.

BACKGROUND: Drop foot deformity is a common problem with severe restrictions in quality of life and impairment of daily activities. A technique of posterior tibial tendon transfer through the interosseus membrane and fixation to the anterior tibial and the long peroneal tendon "Bridle procedure" (stirrup-plasty) offers a physiological alternative to surgical correction. METHODS: Data of 53 consecutive patients treated by stirrup-plasty were acquired from patient's charts; 31 were interviewed with standardized questionnaires; 20 were examined physically; 19 received pedobarography, and 8 underwent dynamometric muscle function tests. Follow-up time averaged 6.5 years. RESULTS: The mean range of motion (ROM) in the ankle joint was 8° dorsiflexion and 15° plantar flexion. Most patients achieved plantigrade foot position and the majority developed gait without orthotic devices. As expected, maximum dorsiflexion torque averaged a third of the non-operated leg, according to reduced muscle diameter and strength of the transferred muscle. Pressure distribution of the sole during gait was not relevantly altered by the tendon transfer compared to the non-operated leg. Most patients were satisfied with the operative results and reported a significant increase in quality of life. CONCLUSIONS: Fusion of the transposed posterior tibial, anterior tibial and the peroneus longus tendon prevents drop foot deformity sufficiently. The stirrup mechanism, in combination with tenodesis of the toe extensors, provides a balanced foot and avoids equinovarus and cavus deformity without immobilizing the ankle joint. Improvements in quality of life parameters justify the risk of the operative procedure for the patient.

A large animal survival model (Sus scrofa) of extremity ischemia/reperfusion and neuromuscular outcomes assessment: a pilot study.

BACKGROUND: Extremity ischemia/reperfusion has been studied mostly in small-animal models with limited characterization of neuromuscular or functional outcome. The objective of this experiment was to report a large-animal survival model of extremity ischemia/reperfusion using circulating, electromyographic (EMG), gate, and histologic measures of injury and limb recovery. METHODS: Sus scrofa swine (n = 6; mean, 83 kg) were randomized to iliac artery occlusion for 0 (control), 1 (1 HR), 3 (3 HR), or 6 (6 HR) hours. Restoration of flow after a standard large-vessel reconstructive technique (thrombectomy, heparin irrigation, and patch angioplasty) was performed in each of the control, 1HR, 3HR, and 6HR animals, whereas one animal had iliac artery segment excision with no restoration (NR) of axial flow. One animal had operative exposure but no intervention on the iliac artery (sham). Animals were recovered and closely monitored for 2 weeks. Indicators of ischemia/reperfusion and functional recovery, including circulating markers, EMG measures (complex motor action potential), and Tarlov gate scoring (0-4; 0, insensate/paralyzed to 4, normal posture and no gait abnormality) were measured at 24 hours and 72 hours and 7 days and 14 days. Muscle (peroneus) and nerve (peroneal) were collected during necropsy at 14 days to assess gross and histologic changes. Duplex ultrasound was performed serially during the recovery period to confirm patency of vascular reconstruction. RESULTS: There were no deaths or failures of vascular reconstruction. Control had a Tarlov score of 4 and normal EMG measures at each point during recovery (same as sham). Tarlov scores at 1, 3, and 14 days recovery in each of the animals were as follows: 1HR: 3, 3, and 4; 3HR: 1, 2, and 4; 6HR: 1, 2, and 3; and NR: 1, 2, and 4. Complex motor action potential as a percentage of baseline at 1, 2, and 14 days recovery was as follows: 1HR: 56%, 55%, and 84%; 3HR: 9%, 8%, and 57%; 6HR: 5%, 5%, and 16%; and NR: 22%, 28%, and 33%. Muscle and nerve histology was the same in sham, control, and 1HR animals. Moderate degeneration and necrosis was observed in peroneus muscle of the 3HR animals. The peroneal nerve in 3HR demonstrated minimal Wallerian degeneration. Severe necrosis was present, as was minimal regeneration, and peroneal nerve demonstrated moderate Wallerian degeneration in 6HR. CONCLUSION: This study reports a new large-animal survival model of extremity ischemia/reperfusion using circulating, functional, and histologic markers of neuromuscular recovery. Findings provide insight into an extremity ischemic threshold after which functional neuromuscular recovery is lost. Additional study is necessary to define this threshold and factors that may move it to a more or less favorable position in the setting of extremity injury.

Multicenter study of peroneal mononeuropathy: clinical, neurophysiologic, and quality of life assessment.

This is a multicenter study on peroneal mononeuropathy (PM), in which a multidimensional protocol was performed to evaluate (1) the predisposing factors and their occurrence; (2) the relationships between the etiological, clinical, and neurophysiologic findings; and (3) disability and quality of life (QoL) in a wide sample with PM. Clinical and neurophysiologic evaluation was performed in all patients; moreover, the group adopted validated disability and QoL measurements to obtain more comprehensive and reliable data on PM. From November 2002 to January 2004, 69 patients were enrolled consecutively in 11 Italian centers. Our data showed that PM involves men more frequently than women (male : female = 4.1:1). PM was idiopathic (16%) or due to prolonged posture (23.1%), surgery (20.3%), weight loss (14.5%), trauma (11.6%), bedridden condition (7.3%), external compression from cast (5.8%), and arthrogenic cyst at the fibula (1.4%). Unexpectedly, peroneal nerve lesions were not only due to surgical operation close to the peroneal region but were also associated with thoracic-abdominal surgery. We observed conduction block in about 50-70% of postural and weight loss PM; in perioperative and idiopathic PM, conduction block or mixed damage was equally present; in PM due to trauma, we observed an exclusive axonal damage in about 60% of cases. Only in three cases (one postural PM, one idiopathic PM, and one weight loss PM), we observed a slowing of conduction velocity in the popliteal fossa-fibular head segment without conduction block. The comparison between QoL in patients with PM and in healthy subjects showed a significant involvement of physical and mental aspects. With regard to disability, 68% of patients walked with difficulty. Our data show that (1) most of the cases of PM are due to an identifiable predisposing factor; (2) there is a good correlation between predisposing factors and clinical-neurophysiologic findings; and (3) PM causes disability and deterioration of the physical and emotional aspects of QoL.