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INTRODUCTION: The long-term effects of a capitate fracture are unknown. The aim of this study was to assess both clinical and radiological long-term outcomes after a capitate fracture. MATERIALS AND METHODS: From a cohort of 526 consecutive patients with post traumatic radial sided wrist pain, 23 were identified diagnosed with a capitate fracture. 16 of these (11 males and 5 females) with a median age at injury of 17.5 years (range 11-27 years) were eligible for a follow-up after a median of 16 years (range 8 to 17 years). In this study patients were examined using conventional radiographs, computed tomography (CT) and magnetic resonance imaging (MRI) at the time of injury and with CT at the follow-up. At follow-up radiological signs of osteoarthritis were graded in four stages and clinical outcome was evaluated by measuring range of wrist motion and grip and pinch strength. The subjective outcome was assessed using DASH and PRWE questionnaires. RESULTS: Five patients had isolated capitate fractures and 11 had concomitant fractures, 10 of which had a simultaneous scaphoid fracture. 14 patients had been treated non-surgically in a cast and two patients were treated surgically. None of the fractures were visible on conventional radiographs at the time of injury. At follow-up all fractures had healed without signs of avascular necrosis. In one patient, CT examination revealed osteoarthritis between the capitate and lunate. This did not cause clinical symptoms. Functional impairments and pain scores were low: median DASH score 0, median PRWE 3 and median VAS pain score 0. We found no impairment in range of motion or grip and pinch strength. CONCLUSIONS: At a median of 16-year follow-up, patients with a capitate fracture report normal self-assessed hand function as well as good wrist motion and strength. The risk of development of posttraumatic arthritis in the joints around the capitate is low.
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Antimaláricos , Artemisininas , Resistencia a Medicamentos , Quimioterapia Combinada , Malaria Falciparum , Plasmodium falciparum , Humanos , Artemisininas/uso terapéutico , Antimaláricos/uso terapéutico , Plasmodium falciparum/efectos de los fármacos , Malaria Falciparum/tratamiento farmacológico , África/epidemiologíaRESUMEN
Background: The Zanzibar archipelago of Tanzania has become a low-transmission area for Plasmodium falciparum. Despite being considered an area of pre-elimination for years, achieving elimination has been difficult, likely due to a combination of imported infections from mainland Tanzania and continued local transmission. Methods: To shed light on these sources of transmission, we applied highly multiplexed genotyping utilizing molecular inversion probes to characterize the genetic relatedness of 282 P. falciparum isolates collected across Zanzibar and in Bagamoyo district on the coastal mainland from 2016 to 2018. Results: Overall, parasite populations on the coastal mainland and Zanzibar archipelago remain highly related. However, parasite isolates from Zanzibar exhibit population microstructure due to the rapid decay of parasite relatedness over very short distances. This, along with highly related pairs within shehias, suggests ongoing low-level local transmission. We also identified highly related parasites across shehias that reflect human mobility on the main island of Unguja and identified a cluster of highly related parasites, suggestive of an outbreak, in the Micheweni district on Pemba island. Parasites in asymptomatic infections demonstrated higher complexity of infection than those in symptomatic infections, but have similar core genomes. Conclusions: Our data support importation as a main source of genetic diversity and contribution to the parasite population in Zanzibar, but they also show local outbreak clusters where targeted interventions are essential to block local transmission. These results highlight the need for preventive measures against imported malaria and enhanced control measures in areas that remain receptive to malaria reemergence due to susceptible hosts and competent vectors. Funding: This research was funded by the National Institutes of Health, grants R01AI121558, R01AI137395, R01AI155730, F30AI143172, and K24AI134990. Funding was also contributed from the Swedish Research Council, Erling-Persson Family Foundation, and the Yang Fund. RV acknowledges funding from the MRC Centre for Global Infectious Disease Analysis (reference MR/R015600/1), jointly funded by the UK Medical Research Council (MRC) and the UK Foreign, Commonwealth & Development Office (FCDO), under the MRC/FCDO Concordat agreement and is also part of the EDCTP2 program supported by the European Union. RV also acknowledges funding by Community Jameel.
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Malaria Falciparum , Plasmodium falciparum , Tanzanía/epidemiología , Plasmodium falciparum/genética , Plasmodium falciparum/aislamiento & purificación , Malaria Falciparum/transmisión , Malaria Falciparum/parasitología , Malaria Falciparum/epidemiología , Humanos , GenotipoRESUMEN
Standard volar plates often do not fit the surface of the malunited distal radius after osteotomy, necessitating an offset angle for accurate volar tilt correction. The correction can be achieved if the plate is held at the correct angle when the distal screws are locked. With the advantage of 3D surgical planning and patient-specific instruments, we developed a shim instrument to assist the surgeon in securing the plate at the intended angle when locking the distal screws, and evaluated radiological results. Five female patients aged 63-74 with dorsally angulated extra-articular malunions underwent surgery using 3D-printed guides and the shim instrument. The plate position, drilling guide alignment, screw placements, and distal radius correction on postoperative CTs were compared with the surgical plans. Errors were measured using an anatomical coordinate system, and standard 2D radiographic measures were extracted. Preoperative dorsal tilt ranged from 16° to 35°, and postoperative volar tilt from 1° to 11°. 3D analysis revealed mean absolute correction errors of 6.1° in volar tilt, 1.6° in radial inclination, and 0.6 mm in ulnar variance. The volar tilt error due to the shim instrument, indicated by the mean angle error of the distal screws to the plate, was 2.1° but varied across the five patients. Settling of the distal radius, due to tension during and after reduction, further contributed to a mean loss of 3.5° in volar tilt. The shim instrument helped with securing plates at the intended angle; however, further correction improvements should consider the tension between the fragments of osteoporotic bone.
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Placas Óseas , Fijación Interna de Fracturas , Fracturas Mal Unidas , Osteotomía , Fracturas del Radio , Humanos , Femenino , Osteotomía/métodos , Osteotomía/instrumentación , Persona de Mediana Edad , Fracturas del Radio/cirugía , Fracturas del Radio/diagnóstico por imagen , Anciano , Fracturas Mal Unidas/cirugía , Fracturas Mal Unidas/diagnóstico por imagen , Fijación Interna de Fracturas/instrumentación , Fijación Interna de Fracturas/métodos , Impresión Tridimensional , Cirugía Asistida por Computador , Imagenología Tridimensional , Tornillos Óseos , Tomografía Computarizada por Rayos XRESUMEN
AIM: The purpose of this study was to evaluate clinical, patient rated and radiological outcome of the scaphoid trapezium pyrocarbon implant (STPI) at a minimum of three years follow-up. METHODS: Consecutive patients operated with the STPI due to scaphotrapeziotrapezoidal (STT) arthritis between 2012 and 2019 were included. Patients were evaluated preoperatively and annually after surgery for range of motion, grip strength, key pinch, quick-DASH, pain, and satisfaction. Radiographs were evaluated for implant position, signs of dorsal intercalated segment instability (DISI), capitolunate (CL) angle, scapholunate (SL) distance, and presence of osteophytes. RESULTS: Twenty-six patients (29 implants) were included. Seven implants were revised during the follow up, mainly due to pain: three implants were removed, four patients received a new STPI of a different size, leaving 22 implants in 20 patients available for follow up, 9 males and 11 females. Median age was 61.7 years (51-78 years). Median follow-up time was 68 months (37-105 months). Comparing preoperative status to the last follow-up, wrist extension and deviation, thumb abduction, and grip strength did not change. Key Pinch, quick DASH, pain, and patient satisfaction improved significantly at last follow-up. Radiographic signs of DISI were seen in six cases preoperatively and in 12 cases at last follow-up. CONLUSION: At a minimum of three years follow-up, the STPI used for STT-arthritis improve pain, quick-DASH result, and patient satisfaction significantly. ROM and grip strength did not change compared to preoperative values. Radiographic signs of carpal instability were common at the follow-up and the revision rate was high.
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Artritis , Carbono , Hueso Escafoides , Masculino , Femenino , Humanos , Persona de Mediana Edad , Estudios de Seguimiento , Estudios Retrospectivos , Hueso Escafoides/diagnóstico por imagen , Hueso Escafoides/cirugía , Dolor , Rango del Movimiento Articular , Fuerza de la ManoRESUMEN
BACKGROUND: Intra-individual variability (IIV), a measure of variance within an individual's performance, has been demonstrated as metrics of brain responses for neural functionality. However, how mental fatigue modulates IIV remains unclear. Consequently, the development of robust mental fatigue detection methods at the single-trial level is challenging. NEW METHODS: Based on a long-duration flanker task EEG dataset, the modulations of mental fatigue on IIV were explored in terms of response time (RT) and trial-to-trial latency variations of event-related potentials (ERPs). Specifically, latency variations were quantified using residue iteration decomposition (RIDE) to reconstruct latency-corrected ERPs. We compared reconstructed ERPs with raw ERPs by means of temporal principal component analysis (PCA). Furthermore, a single-trial classification pipeline was developed to detect the changes of mental fatigue levels. RESULTS: We found an increased IIV in the RT metric in the fatigue state compared to the alert state. The same sequence of ERPs (N1, P2, N2, P3a, P3b, and slow wave, or SW) was separated from both raw and reconstructed ERPs using PCA, whereas differences between raw and reconstructed ERPs in explained variances for separated ERPs were found owing to IIV. Particularly, a stronger N2 was detected in the fatigue than alert state after RIDE. The single-trial fatigue detection pipeline yielded an acceptable accuracy of 73.3%. COMPARISON WITH EXISTING METHODS: The IIV has been linked to aging and brain disorders, and as an extension, our finding demonstrates IIV as an efficient indicator of mental fatigue. CONCLUSIONS: This study reveals significant modulations of mental fatigue on IIV at the behavioral and neural levels and establishes a robust mental fatigue detection pipeline.
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Electroencefalografía , Potenciales Evocados , Fatiga Mental , Tiempo de Reacción , Humanos , Fatiga Mental/fisiopatología , Electroencefalografía/métodos , Potenciales Evocados/fisiología , Masculino , Adulto , Adulto Joven , Femenino , Tiempo de Reacción/fisiología , Análisis de Componente Principal , Encéfalo/fisiología , Encéfalo/fisiopatología , Desempeño Psicomotor/fisiología , Individualidad , Procesamiento de Señales Asistido por ComputadorRESUMEN
The spatial distribution of muscle fibre activity is of interest in guiding therapy and assessing recovery of motor function following injuries of the peripheral or central nervous system. This paper presents a new method for stable estimation of motor unit territory centres from high-density surface electromyography (HDsEMG). This completely automatic process applies principal component compression and a rotatable Gaussian surface fit to motor unit action potential (MUAP) distributions to map the spatial distribution of motor unit activity. Each estimated position corresponds to the signal centre of the motor unit territory. Two subjects were used to test the method on forearm muscles, using two different approaches. With the first dataset, motor units were identified by decomposition of intramuscular EMG and the centre position of each motor unit territory was estimated from synchronized HDsEMG data. These positions were compared to the positions of the intramuscular fine wire electrodes with depth measured using ultrasound. With the second dataset, decomposition and motor unit localization was done directly on HDsEMG data, during specific muscle contractions. From the first dataset, the mean estimated depth of the motor unit centres were 8.7, 11.6, and 9.1 mm, with standard deviations 0.5, 0.1, and 1.3 mm, and the respective depths of the fine wire electrodes were 8.4, 15.8, and 9.1 mm. The second dataset generated distinct spatial distributions of motor unit activity which were used to identify the regions of different muscles of the forearm, in a 3-dimensional and projected 2-dimensional view. In conclusion, a method is presented which estimates motor unit centre positions from HDsEMG. The study demonstrates the shifting spatial distribution of muscle fibre activity between different efforts, which could be used to assess individual muscles on a motor unit level.
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Contracción Muscular , Músculo Esquelético , Humanos , Electromiografía/métodos , Músculo Esquelético/fisiología , Contracción Muscular/fisiología , Electrodos , Fibras Musculares Esqueléticas , Potenciales de AcciónRESUMEN
BACKGROUND: Individuals with wrist osteoarthritis (OA) can suffer from pain, muscular weakness, and impaired motion of the wrist, which can reduce the quality of life. While there is strong evidence that all patients with OA should receive first-line treatment with education and exercises, this approach has not yet been proposed for individuals with wrist OA. Therefore, this trial aimed to evaluate the effectiveness of a first line neuromuscular joint-protective exercise therapy program compared to a training program with range of motion (ROM) exercises in patients with wrist OA. METHODS: In this randomized controlled trial (RCT), 48 patients with symptomatic and radiographically confirmed wrist OA were randomly allocated to a 12-week self-management program with either a neuromuscular joint-protective exercise therapy program (intervention group) or a training program with ROM exercises only (control group). Our primary outcome measure was the Patient-Rated Wrist Evaluation (PRWE) with secondary outcome measures of grip strength, range of wrist motion, the Numerical Pain Rating, Scale (NPRS), the Disabilities of the Arm, Shoulder, and Hand (DASH) and the Generalized Self-Efficacy Scale (GSES). The outcome measures were evaluated by a blinded assessor at baseline and 12 weeks. Between-groups differences were analyzed using the Mann-Whitney U test and within-group differences were analyzed with the Wilcoxon signed-rank test. RESULTS: A total of 41 participants were analyzed at 12 weeks. There were no significant differences in PRWE between the groups at 12 weeks (p = 0.27). However, DASH improved significantly in the intervention group compared to the control group (p = 0.02) and NPRS on load within the intervention group (p = 0.006). The difference in DASH should be interpreted with caution since it could be due to a non-significant increase (worsening) from baseline in the control group in combination with a non-significant decrease (improvement) in the intervention group. CONCLUSIONS: This RCT showed that the novel neuromuscular joint-protective exercise therapy program was not superior in reducing pain and improving function compared to a training program with ROM exercises at 12 weeks. Future research is warranted to evaluate the effectiveness of forthcoming exercise therapy treatment programs for patients with wrist OA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05367817. Retrospectively registered on 10/05/2022. https://clinicaltrials.gov .
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Terapia por Ejercicio , Muñeca , Humanos , Ejercicio Físico , Extremidad Superior , DolorRESUMEN
Objective: Evaluation of the hand function affected when replacing a malfunctioning hand by a bionic hand. Design: Case report. Subjects: One individual that wished for a better quality of life after unsatisfying hand function following a replantation. Methods: A quantitative and qualitative evaluation of body functions as well as activity performance and participation before and after a planned amputation and prosthetic fitting is presented. Results: Improvements were seen in the patient-reported outcome measures (PROMs) that were used regarding activity (Disability of the Arm, Shoulder and Hand [DASH] and Canadian Occupational Performance Measure [COPM]), pain (Neuropathic Pain Symptom Inventory [NPSI], Brief Pain Inventory [BPI], Visual Analogue Scale [VAS]), cold intolerance (CISS) and health related quality of life (SF-36), as well as in the standardised grip function test, Southampton Hand Assessment Procedure (SHAP). No referred sensations were seen but the discriminative touch on the forearm was improved. In the qualitative interview, a relief of pain, a lack of cold intolerance, improved appearance, better grip function and overall emotional wellbeing were expressed. Conclusions: The planned amputation and subsequent fitting and usage of a hand prosthesis were satisfying for the individual with positive effects on activity and participation. Clinical relevance: When the hand function after a hand replantation does not reach satisfactory levels, a planned amputation and a prosthetic hand can be the right solution.
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The Zanzibar archipelago of Tanzania has become a low-transmission area for Plasmodium falciparum. Despite being considered an area of pre-elimination for years, achieving elimination has been difficult, likely due to a combination of imported infections from mainland Tanzania, and continued local transmission. To shed light on these sources of transmission, we applied highly multiplexed genotyping utilizing molecular inversion probes to characterize the genetic relatedness of 282 P. falciparum isolates collected across Zanzibar and in Bagamoyo District on the coastal mainland from 2016-2018. Overall, parasite populations on the coastal mainland and Zanzibar archipelago remain highly related. However, parasite isolates from Zanzibar exhibit population microstructure due to rapid decay of parasite relatedness over very short distances. This, along with highly related pairs within shehias, suggests ongoing low level local transmission. We also identified highly related parasites across shehias that reflect human mobility on the main island of Unguja and identified a cluster of highly related parasites, suggestive of an outbreak, in the Micheweni district on Pemba island. Parasites in asymptomatic infections demonstrated higher complexity of infection than those in symptomatic infections, but have similar core genomes. Our data support importation as a main source of genetic diversity and contribution to the parasite population on Zanzibar, but they also show local outbreak clusters where targeted interventions are essential to block local transmission. These results highlight the need for preventive measures against imported malaria and enhanced control measures in areas that remain receptive for malaria reemergence due to susceptible hosts and competent vectors.
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This study describes the age and sex distribution, trauma mechanism, treatment and influence of patient-reported outcomes of 6542 carpal fractures from the Swedish Fracture Registry (SFR). The most commonly fractured carpal bone was the scaphoid (60%), followed by the triquetrum (25%), hamate (5%) and trapezium (4%). The mean age at injury was 41 years, and 69% of patients were male. The age and sex distribution of carpal fractures differed substantially between the different carpal bones. Men were more likely to sustain a carpal fracture after high-energy trauma and were more likely to be treated surgically. Carpal fractures had a small negative effect on the Short Musculoskeletal Function Assessment Hand/Arm Index and EQ-5D scores 1 year after the injury.Level of evidence: IV.
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Huesos del Carpo , Fracturas Óseas , Traumatismos de la Mano , Hueso Escafoides , Hueso Trapecio , Traumatismos de la Muñeca , Humanos , Masculino , Femenino , Suecia , Fracturas Óseas/terapia , Huesos del Carpo/lesiones , Traumatismos de la Muñeca/epidemiología , Hueso Escafoides/lesionesRESUMEN
Objective.Nerve rehabilitation following nerve injury or surgery at the wrist level is a lengthy process during which not only peripheral nerves regrow towards receptors and muscles, but also the brain undergoes plastic changes. As a result, at the time when nerves reach their targets, the brain might have already allocated some of the areas within the somatosensory cortex that originally processed hand signals to some other regions of the body. The aim of this study is to show that it is possible to evoke a variety of somatotopic sensations related to the hand while stimulating proximally to the injury, therefore, providing the brain with the relevant inputs from the hand regions affected by the nerve damage.Approach.This study included electrical stimulation of 28 able-bodied participants where an electrode that acted as a cathode was placed above the Median nerve at the wrist level. The parameters of electrical stimulation, amplitude, frequency, and pulse shape, were modulated within predefined ranges to evaluate their influence on the evoked sensations.Main results.Using this methodology, the participants reported a wide variety of somatotopic sensations from the hand regions distal to the stimulation electrode.Significance.Furthermore, to propose an accelerated stimulation tuning procedure that could be implemented in a clinical protocol and/or standalone device for providing meaningful sensations to the somatosensory cortex during nerve regeneration, we trained machine-learning techniques using the gathered data to predict the location/area, naturalness, and sensation type of the evoked sensations following different stimulation patterns.
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Nervio Mediano , Muñeca , Humanos , Estimulación Eléctrica , Sensación , Nervios Periféricos/fisiologíaRESUMEN
Tactile feedback plays a vital role in inducing ownership and improving motor control of prosthetic hands. However, commercially available prosthetic hands typically do not provide tactile feedback and because of that the prosthetic user must rely on visual input to adjust the grip. The classical rubber hand illusion (RHI) where a brush is stroking the rubber hand, and the user's hidden hand synchronously can induce ownership of a rubber hand. In the classic RHI the stimulation is modality-matched, meaning that the stimulus on the real hand matches the stimulus on the rubber hand. The RHI has also been used in previous studies with a prosthetic hand as the "rubber hand," suggesting that a hand prosthesis can be incorporated within the amputee's body scheme. Interestingly, previous studies have shown that stimulation with a mismatched modality, where the rubber hand was brushed, and vibrations were felt on the hidden hand also induced the RHI. The aim of this study was to compare how well mechanotactile, vibrotactile, and electrotactile feedback induced the RHI in able-bodied participants and forearm amputees. 27 participants with intact hands and three transradial amputees took part in a modified RHI experiment. The rubber hand was stroked with a brush, and the participant's hidden hand/residual limb received stimulation with either brush stroking, electricity, pressure, or vibration. The three latter stimulations were modality mismatched with regard to the brushstroke. Participants were tested for ten different combinations (stimulation blocks) where the stimulations were applied on the volar (glabrous skin), and dorsal (hairy skin) sides of the hand. Outcome was assessed using two standard tests (questionnaire and proprioceptive drift). All types of stimulation induced RHI but electrical and vibration stimulation induced a stronger RHI than pressure. After completing more stimulation blocks, the proprioceptive drift test showed that the difference between pre- and post-test was reduced. This indicates that the illusion was drifting toward the rubber hand further into the session.
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BACKGROUND: Post-traumatic wrist osteoarthritis (OA) can eventually lead to pain, muscular weakness, and stiffness of the wrist, which can affect the function of the entire upper limb and reduce the quality of life. Although there is strong evidence that all patients with OA should be offered adequate education and exercises as a first-line treatment, an effective self-management program, including structured education and therapeutic exercises, has not yet been introduced for individuals with wrist OA. This trial aims to evaluate the effectiveness of an exercise therapy program with joint protective strategies to improve neuromuscular control (intervention group) compared to a training program with range of motion exercises (control group). METHODS: This is a single-blinded randomized controlled trial (RCT) with two treatment arms in patients with symptomatic and radiographically confirmed wrist OA. The trial will be conducted at a hand surgery department. The participants will be randomly assigned either to a neuromuscular exercise therapy program or to a training program with range of motion exercises only. Participants in both groups will receive a wrist orthosis and structured education on wrist anatomy, pathophysiology, and joint protective self-management strategies. The programs consist of home exercises that will be performed twice a day for 12 weeks. The Patient-Rated Wrist Evaluation (PRWE) is the primary outcome measure of pain and function. Wrist range of motion (ROM), grip strength, the Numeric Pain Rating scale (NPRS), Disabilities of the Arm, Shoulder, and Hand (DASH), the General Self-Efficacy Scale (GSES), Global Rating of Change (GROC), and conversion to surgery are the secondary measures of outcome. Assessments will be performed at baseline and at 3, 6, and 12 months after baseline by a blinded assessor. DISCUSSION: The upcoming results from this trial may add new knowledge about the effectiveness of a self-managed exercise therapy program on pain and function for individuals with wrist OA. If the present self-management program proves to be effective, it can redefine current treatment strategies and may be implemented in wrist OA treatment protocols. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05367817. Retrospectively registered on 27 April 2022. https://clinicaltrials.gov .
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Osteoartritis de la Rodilla , Automanejo , Humanos , Osteoartritis de la Rodilla/terapia , Resultado del Tratamiento , Muñeca , Terapia por Ejercicio/efectos adversos , Terapia por Ejercicio/métodos , Dolor , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
During the COVID-19 pandemic, Sweden was among the few countries that did not enforce strict lockdown measures but instead relied more on voluntary and sustainable mitigation recommendations. While supported by the majority of Swedes, this approach faced rapid and continuous criticism. Unfortunately, the respectful debate centered around scientific evidence often gave way to mudslinging. However, the available data on excess all-cause mortality rates indicate that Sweden experienced fewer deaths per population unit during the pandemic (2020-2022) than most high-income countries and was comparable to neighboring Nordic countries through the pandemic. An open, objective scientific dialogue is essential for learning and preparing for future outbreaks.
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COVID-19 , Humanos , COVID-19/epidemiología , COVID-19/prevención & control , Suecia/epidemiología , SARS-CoV-2 , Pandemias/prevención & control , Control de Enfermedades Transmisibles , PolíticasRESUMEN
Background Treatment algorithm for disruption of the triangular fibrocartilage complex (TFCC) from the ulnar fovea includes direct TFCC repair, tendon reconstruction of the radioulnar ligaments, or a salvage procedure in cases with painful distal radioulnar joint (DRUJ) degeneration. Case Description We describe our surgical technique for reconstruction of the distal oblique bundle (DOB), to attain DRUJ stability in a young man, after failed attempts of direct TFCC reinsertion and radioulnar ligament reconstruction with the Adams procedure. Literature Review Reconstruction of the central band of the interosseous membrane is well recognized for Essex-Lopresti injuries that demonstrate longitudinal forearm instability. The role for reconstruction/reinforcement of the DOB to restore DRUJ stability after TFCC injury has not gained the same recognition and needs further clarification. Clinical Relevance DOB reconstruction technique described is extra-articular and technically straightforward. We believe that the procedure could be considered for patients with an irreparable TFCC injury as a part of the treatment algorithm for younger patients, who otherwise would face a more extensive salvage procedure.
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BACKGROUND: Painful conditions such as residual limb pain (RLP) and phantom limb pain (PLP) can manifest after amputation. The mechanisms underlying such postamputation pains are diverse and should be addressed accordingly. Different surgical treatment methods have shown potential for alleviating RLP due to neuroma formation - commonly known as neuroma pain - and to a lesser degree PLP. Two reconstructive surgical interventions, namely targeted muscle reinnervation (TMR) and regenerative peripheral nerve interface (RPNI), are gaining popularity in postamputation pain treatment with promising results. However, these two methods have not been directly compared in a randomised controlled trial (RCT). Here, we present a study protocol for an international, double-blind, RCT to assess the effectiveness of TMR, RPNI, and a non-reconstructive procedure called neuroma transposition (active control) in alleviating RLP, neuroma pain, and PLP. METHODS: One hundred ten upper and lower limb amputees suffering from RLP will be recruited and assigned randomly to one of the surgical interventions (TMR, RPNI, or neuroma transposition) in an equal allocation ratio. Complete evaluations will be performed during a baseline period prior to the surgical intervention, and follow-ups will be conducted in short term (1, 3, 6, and 12 months post-surgery) and in long term (2 and 4 years post-surgery). After the 12-month follow-up, the study will be unblinded for the evaluator and the participants. If the participant is unsatisfied with the outcome of the treatment at that time, further treatment including one of the other procedures will be discussed in consultation with the clinical investigator at that site. DISCUSSION: A double-blind RCT is necessary for the establishment of evidence-based procedures, hence the motivation for this work. In addition, studies on pain are challenging due to the subjectivity of the experience and the lack of objective evaluation methods. Here, we mitigate this problem by including different pain evaluation methods known to have clinical relevance. We plan to analyse the primary variable, mean change in NRS (0-10) between baseline and the 12-month follow-up, using the intention-to-treat (ITT) approach to minimise bias and keep the advantage of randomisation. The secondary outcomes will be analysed on both ITT and per-protocol (PP). An adherence protocol (PP population) analysis will be used for estimating a more realistic effect of treatment. TRIAL REGISTRATION: ClincialTrials.gov NCT05009394.
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Amputados , Neuroma , Miembro Fantasma , Humanos , Miembro Fantasma/diagnóstico , Miembro Fantasma/etiología , Miembro Fantasma/cirugía , Amputación Quirúrgica/efectos adversos , Neuroma/cirugía , Extremidad Inferior , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
The current framework for testing and regulating vaccines was established before the realization that vaccines, in addition to their effect against the vaccine-specific disease, may also have "non-specific effects" affecting the risk of unrelated diseases. Accumulating evidence from epidemiological studies shows that vaccines in some situations can affect all-cause mortality and morbidity in ways that are not explained by the prevention of the vaccine-targeted disease. Live attenuated vaccines have sometimes been associated with decreases in mortality and morbidity that are greater than anticipated. In contrast, some non-live vaccines have in certain contexts been associated with increases in all-cause mortality and morbidity. The non-specific effects are often greater for female than male individuals. Immunological studies have provided several mechanisms that explain how vaccines might modulate the immune response to unrelated pathogens, such as through trained innate immunity, emergency granulopoiesis, and heterologous T-cell immunity. These insights suggest that the framework for the testing, approving, and regulating vaccines needs to be updated to accommodate non-specific effects. Currently, non-specific effects are not routinely captured in phase I-III clinical trials or in the post-licensure safety surveillance. For instance, an infection with Streptococcus pneumoniae occurring months after a diphtheria-tetanus-pertussis vaccination would not be considered an effect of the vaccination, although evidence indicates it might well be for female individuals. Here, as a starting point for discussion, we propose a new framework that considers the non-specific effects of vaccines in both phase III trials and post-licensure.
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Vacuna contra Difteria, Tétanos y Tos Ferina , Vacunación , Humanos , Masculino , Femenino , Vacunación/efectos adversos , Vacunas AtenuadasRESUMEN
In October, 2021, WHO recommended that the RTS,S malaria vaccine, with its strong safety profile and high impact, be provided to children from age 5 months in regions with moderate to high Plasmodium falciparum malaria transmission. The evidence base included phase 3 trials in seven African countries and an ongoing malaria vaccine implementation programme (MVIP) in three African countries. We highlight problems with the MVIP mortality data, including potential confounding, inappropriate use of severe malaria as a surrogate marker, a statistically non-significant effect, and assessment after 2 years instead of the stipulated 4 years, which could have inflated the benefits and deflated the risks associated with the vaccine. We conclude that the claimed impact of the MVIP on mortality is not based on enough scientific evidence and that the MVIP findings do not rule out the possibility of increased mortality among vaccinated girls compared with vaccinated boys, as observed in the phase 3 studies. The MVIP should adhere fully to the planned analyses and the data should be made available for independent assessment. Roll-out of the vaccine elsewhere should include rigorous evaluation, especially of its safety.