Multimodal therapeutic intervention program associated with photobiomodulation therapy for individuals with chronic nonspecific neck pain: protocol for a clinical trial.

BACKGROUND: Neck pain is a prevalent global musculoskeletal issue, significantly contributing to the loss of years of healthy life due to disability. Chronic nonspecific neck pain (CNNP) involves diverse symptoms impacting mobility and quality of life. While therapeutic exercises demonstrate efficacy, the role of photobiomodulation therapy (PBMT) remains uncertain. This study aims to assess the additional effects of PBMT within a multimodal therapeutic intervention for CNNP. METHODS: A randomized, two-arm, controlled, blind clinical trial follows CONSORT and SPIRIT guidelines. Participants diagnosed with CNNP will receive a stand-alone multimodal therapeutic intervention or the same program with additional PBMT. The primary outcomes will be assessed by the functional disability identified through applying the NDI (Neck Disability Index). Secondary outcomes will be pain intensity during rest and active neck movement, catastrophizing and kinesiophobia, functionality, and disability assessed at baseline, after 8 weeks, and at a 4-week follow-up. Both groups receive pain education before personalized interventions, including resistance exercises, neuromuscular activities, mobility, and body balance. The PBMT group undergoes low-level light therapy. Intention-to-treat analysis, using linear mixed models, employs data presented as mean, standard deviation, and differences with a 95% confidence interval. Non-normally distributed variables transform. Statistical significance is set at 5%. DISCUSSION: This study addresses a critical gap in understanding the combined effects of PBMT and therapeutic exercises for CNNP. The findings aim to guide clinicians, researchers, and CNNP sufferers through rigorous methodology and diverse outcome assessments, offering valuable insights into evidence-based practices for CNNP management. Data confidentiality is maintained throughout, ensuring participant privacy during statistical analysis. TRIAL REGISTRATION: Effects of adding photobiomodulation to a specific therapeutic exercise program for the treatment of individuals with chronic nonspecific neck pain, registration number: NCT05400473, on 2022-05-27.

What are the costs of managing neck and low back pain in Brazil? Investigation of a ten-year period from the perspective of the Brazilian public health system.

INTRODUCTION: Considering the prospects of increased prevalence and disability due to neck and low back pain, it is relevant to investigate the care processes adopted, to assist future public policies and decision-making for a better allocation of resources. Objective: the aim of this study was to estimate the costs arising from inpatient and outpatient care of individuals with Neck Pain (NP) and Low Back Pain (LBP) in Brazil, between 2010 and 2019. METHODS: This is a cost-of-illness study from the perspective of the Brazilian public health system, based on health conditions with high prevalence (neck and low back pain). Data were presented descriptively using absolute and relative values. RESULTS: Between 2010 and 2019, the health system spent more than $600 million (R$ 2.3 billion) to treat NP and LBP in adults, and LBP accounted for most of the expenses. Female had higher absolute expenses in inpatient care and in the outpatient system. CONCLUSION: Our study showed that the costs with NP and LBP in Brazil were considerable. Female patients had higher outpatient costs and male patients had higher hospitalization costs. Healthcare expenses were concentrated for individuals between 34 and 63 years of age.

This study focused on understanding how much it cost to treat neck pain (NP) and low back pain (LBP) in Brazil between 2010 and 2019, from the point of view of the public health system (i.e. Unified Health System ­ SUS). The idea was to find out how much money was spent and where. It turned out that the SUS spent, in total, more than US$600 million (R$2.3 billion) with LBP responsible for most of these expenses. Furthermore, we noted that women had higher outpatient care costs, while men had higher hospitalization costs. Those costs were more concentrated in people aged between 34 and 63 years.

A systematic review and meta-analysis of randomized controlled trials on the effectiveness of high-intensity laser therapy in the management of neck pain.

The purpose of this systematic review was to evaluate the effects of high-intensity laser therapy (HILT) on pain, disability, and range of movement in patients with neck pain. Randomized controlled trials (RCTs) of HILT for neck pain disorders were searched across databases such as PubMed, Web of Science, Scopus, CINAHL, Science Direct, Cochrane Library, the PEDro database, and Google Scholar (updated January 7, 2024). The main outcome was pain intensity, with neck disability and cervical range of motion as secondary outcomes. Researchers reviewed article titles and abstracts from different databases using the Rayyan web app. Study quality was assessed using the Cochrane risk of bias tool, and evidence-based recommendations were developed using the GRADE approach. A meta-analysis was conducted to calculate the pooled effect in terms of mean differences (MD) for the outcomes of interest, along with a 95% confidence interval (95% CI). Twenty studies met the selection criteria and were potentially eligible for inclusion in the meta-analysis. At the end of the treatment, there was a statistically significant (p < 0.01) pooled MD of -14.1 mm for pain intensity (17 RCTs) with the VAS (95% CI:-18.4,-9.7), 3.9° (95% CI:1.9,6.7) for cervical extension (9 RCTs), and -8.3% (95% CI:-14.1,-4.1) for disability diminish (12 RCTs) with the neck disability index in favor of HILT. Only the results for pain intensity are in line with the minimal clinically important differences (MCID) reported in the literature. Overall, the evidence was deemed significant but with low certainty, attributed to observed heterogeneity and some risk of bias among the RCTs. HILT demonstrates effectiveness in reducing neck pain and disability while enhancing cervical extension when added to other physical therapy interventions, especially therapeutic exercise, based on a moderate level of evidence. This review highlights that the most favorable results are obtained when HILT is employed to address myofascial pain, cervical radiculopathy and chronic neck pain.PROSPERO registration number: CRD42023387394 (Registration date, 14/01/2023).

Contextual Factors-Enriched Standard Care on mechanical neck pain (ContextualizAR trial): Protocol for a randomised controlled trial.

BACKGROUND: Understanding the influence of contextual factors (CFs) on interventions for mechanical neck pain (MNP) is essential for evidence-based practice in physical therapy. However, the specific effects and synergies of combining different CFs remain unclear. OBJECTIVE: The primary purpose of this study will be to determine if a CFs-Enriched Standard Care (SC) approach is an effective treatment for MNP in terms of reducing pain and improving function. METHODS: This will be an assessor-blinded, 2-group (1:1) randomised clinical trial (RCT) aiming to enrol 94 participants with neck pain persisting for more than 4 weeks. Both groups will undergo 4 weeks of SC twice weekly, following established clinical practice guidelines. In the intervention group, CFs will be enhanced, encompassing the physical, psychological, and social elements inherent in the clinical encounter, based on existing evidence. The primary outcomes will encompass changes in pain and disability after 4 weeks of treatment, with a follow-up reassessment at week 12 post-treatment. Secondary outcomes will include changes in Active Range of Motion, Global Rating of Change, and Satisfaction with treatment. The change between groups after treatment and at the 12-week follow-up will be reported for all outcomes, considering the difference from scores recorded at baseline. RESULTS: We hypothesise that a 4-week CFs-Enriched SC approach will be superior to SC alone in terms of patient-reported disability and pain, with measurements conducted using the Northwick Park Neck Pain Questionnaire and the Numeric Pain Rating Scale, respectively. CONCLUSION: This RCT rigorously assesses the effect of purposeful manipulation of CFs during MNP treatment. By elucidating the role of these factors, our findings have the potential to significantly refine clinical practice in managing MNP, thereby enhancing patient care, and advancing the fields of physical therapy and rehabilitation.

Chronic Neck Pain Prevalence Before and After COVID-19 Restrictions and Its Relationship With Digital Device Screen Viewing: A Population Study.

OBJECTIVE: To estimate the prevalence of chronic neck pain (CNP) among the adult population in Peru during the post-coronavirus disease 2019 (COVID-19) restriction period compared with that during the pre-pandemic period and evaluate its association with prolonged digital devices connected to the internet (DDCI) screen viewing. METHODS: We conducted a cross-sectional study using a representative sample of adults living in Peru in November 2022. A structured survey was employed to identify CNP, and the exposure variable was set as the duration of DDCI screen viewing. The McNemar test was used to compare CNP prevalence pre- and post-COVID-19 restrictions, and ordinal logistic regression was used to evaluate its association with prolonged screen viewing. RESULTS: A total of 1,202 individuals participated, with 52.8% females and 79.9% residing in urban areas. Following the restrictions, the prevalence of CNP occurring daily or almost daily and at least once a week was 14.8% and 27.8%, respectively (95% confidence Interval [95% CI], 12.6-17.3 and 24.9-30.9), representing a significant increase (p<0.001) compared with pre-pandemic estimates. Notably, among those viewing DDCI screens for ≥8 hours, the odds ratio for CNP frequency escalation compared with those who did not or rarely view screens was 1.61 (95% CI, 1.04-2.50; p=0.033). CONCLUSION: Approximately 4 of 10 adults in Peru experienced CNP following the lifting of COVID-19 social restrictions, more than double the pre-pandemic prevalence. Furthermore, prolonged viewing of DDCI screens increased the risk of having this condition.

Craniocervical Pain, Sleep Quality, Depressive Symptoms, and Physical Activity in Healthcare Workers During COVID-19 Pandemic.

BACKGROUND: An increase in the workload and use of personal protective equipment by healthcare workers was observed during the COVID-19 pandemic. Due to the connections between craniocervical structures, symptoms such as neck pain and temporomandibular symptoms could be influenced by the use of PPE. AIMS: To assess the prevalence of craniocervical pain, sleep quality, physical activity, and depressive symptoms and relationship among craniocervical symptoms in healthcare workers before and during the COVID-19 pandemic in Brazil. DESIGN: Cross-sectional study. PARTICIPANTS: Healthcare workers. SETTINGS: An online questionnaire included a self-report of craniocervical pain intensity [orofacial pain, neck pain, and headache (Numerical Rating Scale)], sleep quality (Pittsburgh Sleep Quality Index), depressive symptoms (Patient Health Questionnaire two items) and physical activity (self-report). METHODS: The sample analysis was performed by descriptive statistics, the paired t-test was used to compare symptoms intensity before and during the pandemic. The relationship between dependent and independent samples was assessed through McNemar test, Pearson's chi-squared test, and Student's independent t-test. A value of p < .05 was adopted as statistical significance. RESULTS: Overall, 147 participants replied the questionnaires. Headache, neck pain, and orofacial pain complaints increased during the pandemic in healthcare workers (p < 0.001). Craniocervical pain was correlated with poor sleep quality, probable depression, and physical activity during the pandemic (p < 0.05). CONCLUSION: Healthcare workers self-reported more craniocervical pain during the COVID-19 pandemic compared to before the pandemic. In addition, poor sleep quality, depressive symptoms, and physical inactivity were associated with craniocervical symptoms during this period.

Exercise-induced hypoalgesia in chronic neck pain: A narrative review.

Chronic neck pain (CNP) is a worldwide health problem with several risk factors. One of the most widely used treatments for managing this condition is therapeutic exercise, which could generate a response called exercise-induced hypoalgesia (EIH). There is no consensus on the best exercise modality to induce hypoalgesia. Therefore, this review aims to analyze and synthesize the state-of-the-art about the hypoalgesic effect of exercise in subjects with CNP. We included articles on EIH and CNP in patients older than 18 years, with pain for more than three months, where the EIH response was measured. Articles that studied CNP associated with comorbidities or measured the response to treatments other than exercise were excluded. The studies reviewed reported variable results. Exercise in healthy subjects has been shown to reduce indicators of pain sensitivity; however, in people with chronic pain, the response is variable. Some investigations reported adverse effects with increased pain intensity and decreased pain sensitivity, others found no clinical response, and some even reported EIH with decreased pain and increased sensitivity. EIH is an identifiable, stimulable, and helpful therapeutic response in people with pain. More research is still needed on subjects with CNP to clarify the protocols and therapeutic variables that facilitate the EIH phenomenon. In addition, it is necessary to deepen the knowledge of the intrinsic and extrinsic factors that influence EIH in people with CNP.

Mapping of Neck Disability Index domains linked to the international classification of functioning and disability / Mapeamento dos domínios do neck disability index vinculados à classificação internacional de funcionalidade e incapacidade

Objective: This study aims to link NDI items to CIF using specific and up-to-date linking rules. Methods: It is a measurement properties analysis study in which two evaluators performed the link between NDI and CIF, both with experience in CIF taxonomy and NDI application. Thus, ten binding rules developed and updated specifically for binding the ICF to other instruments were applied. Results: The Kappa coefficient determined the level of agreement between the evaluators with a confidence interval of 95%. All NDI items were linked to ICF codes; there was no need to use the term "non-definable." The degree of agreement between the evaluators about the domains and the categories of the ICF's first, second, and third levels was almost perfect. Conclusion: Therefore, the NDI is well linked to the codes related to the ICF domains' Activity, Participation, Functions, and Structure. However, no concepts related to contextual factors were identified.

Objetivo: Este estudo visa vincular itens da NDI ao CIF usando regras de vinculação específicas e atualizadas. Métodos: É um estudo de análise de propriedades de medição no qual dois avaliadores realizaram a ligação entre NDI e CIF, ambos com experiência em taxonomia CIF e aplicação de NDI. Assim, foram aplicadas dez regras de vinculação desenvolvidas e atualizadas especificamente para vincular a ICF a outros instrumentos. Resultados: O coeficiente Kappa determinou o nível de concordância entre os avaliadores com um intervalo de confiança de 95%. Todos os itens do NDI estavam vinculados a códigos ICF; não havia necessidade de utilizar o termo "não definível". O grau de concordância entre os avaliadores em relação aos domínios e às categorias do primeiro, segundo e terceiro níveis da ICF foi caracterizado como quase perfeito. Conclusão: Portanto, o NDI está bem ligado aos códigos relacionados à Atividade, Participação, Funções e Estrutura dos domínios da ICF. Entretanto, não foram identificados conceitos relacionados a fatores contextuais.

Comparison of the clinical effectiveness of Class IV Laser therapy and therapeutic ultrasound in patients with chronic neck pain: a randomized controlled trial / Comparação da eficácia clínica da terapia a laser Classe IV e do ultrassom terapêutico em pacientes com dor cervical crônica: um estudo controlado e randomizado

INTRODUCTION: Chronic neck pain (CNP) is a common musculoskeletal problem that affects a large proportion of the population and lasts longer than three months. It has a high cost in terms of life, disability, and healthcare. Several modalities have effectively provided immediate and long-term relief for CNP; however, the comparative clinical effectiveness of these modalities is limited. OBJECTIVES: The study aimed to determine the clinical effectiveness of Class IV Laser therapy and Therapeutic Ultrasound (TUS) in patients with CNP. METHODS AND MATERIALS: Forty-four patients with CNP of both genders were recruited from an age range of 20­45 years from the Department of Musculoskeletal Physiotherapy of Maharishi Markandeshwar Institute of Physiotherapy, MM(DU), Ambala, India. They were divided into two groups at random: the LASER group A (n = 22) and the TUS group B (n = 22). The intervention duration was 2 weeks with 6 treatment sessions. Pre- and post-treatment outcome measures were assessed with the Visual Analog Scale (VAS), Algometer, Goniometer, and Neck Disability Index (NDI) questionnaires at baseline and after 2 weeks of intervention. The LASER group received a target dose of 10 joules per cm2 at a power of 10 watts, with a continuous dosage frequency. The TUS group underwent a continuous mode ultrasound (3 MHz, 1 W/cm2) for 6 minutes. The Shapiro-Wilk test was used to assess the normality of the data. For parametric and non-parametric data analysis within the group, the paired t-test and Wilcoxon signed rank were used. The independente t-test and Mann-U Whitney test were used for the group comparison of parametric and non-parametric data, respectively. RESULTS: In both groups, there was a significant improvement in all the outcome measures (p<0.001). There was a statistically significant difference between the two interventions in VAS, Pain Pressure Threshold (PPT), and NDI (p<0.05). CONCLUSION: Class IV Laser therapy is clinically more effective than therapeutic ultrasound in treating patients with chronic neck pain.

INTRODUÇÃO: A dor cervical crônica (DCC) é um problema musculoesquelético comum que afeta uma grande proporção da população e dura mais de três meses. Ela tem um alto custo em termos de vida, incapacidade e assistência médica. Várias modalidades têm proporcionado alívio imediato e de longo prazo para a dor cervical crônica; entretanto, a eficácia clínica comparativa dessas modalidades é limitada. OBJETIVOS: O objetivo do estudo foi determinar a eficácia clínica da terapia a laser de classe IV e do ultrassom terapêutico (UST) em pacientes com DCC. MÉTODOS E MATERIAIS: Quarenta e quatro pacientes com DCC de ambos os sexos, em uma faixa etária de 20 a 45 anos, foram recrutados do Departamento de fisioterapia musculoesquelética do Instituto de Fisioterapia Maharishi Markandeshwar, MM (DU), Ambala, Índia. Eles foram divididos em dois grupos de forma aleatória: o grupo LASER A (n = 22) e o grupo UST B (n = 22). A duração da intervenção foi de 2 semanas com 6 sessões de tratamento. As medidas de resultado pré e pós-tratamento foram avaliadas com os questionários Escala Visual Analógica (EVA), Algometer, Goniometer e Índice de Incapacidade do Pescoço (IIP) na linha de base e após 2 semanas de intervenção. O grupo LASER recebeu dose alvo de 10 joules por cm2 na potência de 10 watts, com frequência de dosagem contínua. O grupo UST foi submetido a ultrassom em modo contínuo (3 MHz, 1 W/cm2) por 6 minutos. O teste de Shapiro-Wilk foi utilizado para avaliar a normalidade dos dados. Para análise dos dados paramétricos e não paramétricos dentro do grupo, foram utilizados o teste t pareado e o posto sinalizado de Wilcoxon. O teste t independente e o teste Mann-U Whitney foram utilizados para comparação de grupos para dados paramétricos e não paramétricos, respectivamente. RESULTADOS: Em ambos os grupos, houve uma melhora significativa em todas as medidas de resultado (p<0,001). Houve uma diferença estatisticamente significativa entre as duas intervenções na EVA, Limiar de pressão de dor (PPT) e IIP (p<0,05). CONCLUSÕES: A terapia a laser de classe IV é clinicamente mais eficaz do que o ultrassom terapêutico no tratamento de pacientes com dor cervical crônica.

Tampa Scale for Kinesiophobia in chronic neck pain patients (TSK-neck): structural and construct validity and reliability in a Brazilian population.

BACKGROUND: To date, there are no studies in the literature that define the internal structure of the Tampa Scale for Kinesiophobia (TSK) in patients with chronic neck pain based on factorial analysis. As such, we aimed to verify and identify the best structure of the Brazilian version of the TSK in patients with chronic neck pain. METHODS: We included Brazilian participants aged ≥18 years, both sexes, with self-reported neck pain for more than 3 months and pain intensity ≥3 on the Numerical Pain Rating Scale (NPRS). Dimensionality and number of TSK items were assessed using confirmatory factor analysis (CFA). We tested the following internal structures: structure 1 (1 domain and 17 items), structure 2 (1 domain and 11 items), structure 3 (2 domains and 11 items), and structure 4 (2 domains and 9 items). We used the Pain-Related Catastrophizing Thoughts Scale (PCTS) and the NPRS for construct validity. In addition, we assessed test-retest reliability for the seven-day interval using intraclass correlation coefficient (ICC2,1), Cronbach's alpha to assess internal consistency, and ceiling and floor effects. RESULTS: The study sample included of 335 patients. Most were women (77.6%), young adults (~ 34 years), single (48.4%), with complete primary education (57.3%), physically inactive (66.6%), with a mean pain duration of 46 months and a mean pain intensity of ~ 5 points on the NPRS. Redundancy was found in the following items: item 1 with item 2 (modification indices = 21.419) and item 13 with item 15 (modification indices = 13.641). Subsequently, based on these paired analyses, the items with the lowest factor loadings (items 2 and 15) were excluded. As such, TSK structure 4 was composed of two domains ("somatic focus" and "activity avoidance") and 9 items, which showed adequate fit indices and lower AIC and SABIC values. We observed significant values (p < 0.05) with a correlation magnitude greater than 0.142 to 0.657 between the two domains of the TSK-neck and the other instruments (PCTS and NPRS). We found excellent reliability (ICC2,1 ≥ 0.96) and adequate internal consistency (Cronbach's alpha ≥0.98) of the TSK-neck. Finally, ceiling and floor effects were not observed. CONCLUSION: The TSK-neck structure with two domains (somatic focus and activity avoidance) and nine items is the most appropriate for patients with chronic neck pain.

Smartphone addiction, musculoskeletal pain and functionality in university students - a observational study.

Smartphone addiction and its excessive use could cause musculoskeletal symptoms such neck and upper limb pain. The purpose of this study was to investigate the association between smartphone use and musculoskeletal pain in the upper limbs and neck, as well as to observe the relationship in between smartphone addiction and musculoskeletal pain and upper limb function in university students. It is a cross-sectional, analytical study. A total of 165 university students participated in the research. Each student had their own smartphone. The students answered a structured questionnaire about pain in the upper limbs and neck; the Smartphone Addiction Inventory (SPAI) and the Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH). Prevalence of neck and upper limb pain was 34.0%. Smartphone addiction and its use to play games and listen to music were risk factors to upper limb pain. Moreover, the smartphone addiction and age proved to be risk factors to neck pain. There was correlation between DASH and SPAI scores, and there was association between DASH score and neck and upper limb pain. Being of the female sex and smartphone addiction predicted the risk of incapacity development. We found association between neck and upper limb pain with smartphone addiction. Functional incapacity was associated to neck and upper limb pain. It was predicted by smartphone addiction and being of the female sex.

Multimodal analgesia versus patient-controlled analgesia in the management of acute postoperative spinal pain: systematic review and meta-analysis / Analgesia multimodal versus analgesia controlada pelo paciente no tratamento da dor aguda pós-operatória da coluna: revisão sistemática e meta-análise

ABSTRACT BACKGROUND AND OBJECTIVES: Spine diseases have a high annual prevalence and are the main causes of years lived with disability and chronic pain. Among the postoperative analgesic control options, patient-controlled analgesia (PCA) and multimodal analgesia (MMA) have shown good clinical results. This meta-analysis seeks new evidence to help in the treatment of acute postoperative pain in patients undergoing spinal surgery. CONTENTS: The following databases were used: Cochrane Central Register of Controlled Trials, Medline and Embase. Studies that compared two post-surgical analgesic interventions were included; MMA and PCA. The parameters evaluated were: analgesic effect; opioid consumption; length of hospital stay; and adverse effects. Registration of the systematic review protocol: (PROSPERO CRD42023446627). There was no statistical difference when assessing analgesic improvement comparing MMA to PCA (MD -0.12 [-0.41, 0.17] 95%CI with p=0.69). There was a statistical difference, with lower opioid consumption in MMA compared to PCA (MD -3.04 [-3.69, -2.39] 95%CI with p=0.0002). Statistically significant difference regarding length of hospital stay in favor of MMA (MD -13.17 [-16.98, -9.36] 95%CI with p=0.00001), and significantly lower incidence of nausea and vomiting in patients undergoing MMA in compared to PCA (OR 0.26 [0.11, -0.64] 95%CI with p=0.003). CONCLUSION: MMA was equivalent to PCA in the treatment of acute postoperative spinal pain, with the significant clinical advantage and safety of lower amounts of infused opioids, shorter hospital stay and lower incidence of adverse effects.

RESUMO JUSTIFICATIVA E OBJETIVOS: As doenças da coluna apresentam alta prevalência anual e são as principais causas de anos vividos com incapacidade e de cronificação da dor. Dentre as opções de controle analgésico pós-operatória, a analgesia controlada pelo paciente (ACP) e a analgesia multimodal (AMM) apresentam bons resultados clínicos. O objetivo deste estudo foi buscar novas evidências que auxiliem no tratamento da dor aguda no pós-operatório do paciente submetido à cirurgia da coluna. CONTEÚDO: As bases de dados utilizadas: Cochrane Central Register of Controlled Trials, Medline e Embase. Foram incluídos estudos que compararam duas intervenções analgésicas pós-cirúrgicas; AMM e ACP. Os parâmetros avaliados foram: efeito analgésico; consumo de opioide; tempo de internação hospitalar e efeitos adversos. Registro do protocolo de revisão sistemática: (PROSPERO CRD42023446627). Não houve diferença estatística quando avaliadas a melhora analgésica comparando a AMM à ACP (MD -0,12 [-0,41, 0,17] 95%CI com p=0,69). Houve diferença estatística, com menor consumo de opioide na AMM em comparação à ACP (MD -3,04 [-3,69, -2,39] 95%IC com p=0,0002). Diferença estatística significativa com relação ao tempo de permanência hospitalar a favor da AMM (MD -13,17 [-16,98, -9,36] 95%IC com p=0,00001), e incidência significativamente menor de náuseas e vômitos nos pacientes submetidos a AMM em comparação a ACP (OR 0,26 [0,11, -0,64] 95%IC com p=0,003). CONCLUSÃO: A AMM foi equivalente à ACP no tratamento da dor aguda pós-operatória da coluna, com a significativa vantagem clínica e a segurança de menores quantidades de opioides infundidos, menor tempo de internação hospitalar e menor incidência de efeitos adversos.

Central sensitization in adults with chronic neck pain: cross-cross study exploring differences by gender / Sensibilização central em adultos com dor cervical crônica: estudo transversal explorando as diferenças por sexo

ABSTRACT BACKGROUND AND OBJECTIVES: The presence of central sensitization (CS) in people with chronic neck pain requires clarification, as does the possible disparities between genders. Therefore, this study aimed to evaluate the presence of CS in chronic neck pain according to gender. METHODS: Cross-sectional study with the participation of 260 adults (18-59 years old) with chronic neck pain, carried out between September 2022 and September 2023. Instruments were applied to collect sociodemographic profile, pain characteristics, cervical functional disability and presence of SC. The software SPSS 23.0 was used for comparative analyzes. RESULTS: Regarding disparities between genders, there were no differences in the intensity of pain and cervical functional disability (p=0.134 and p=0.277, respectively). However, SC was higher in women (43.5 ± 14.0; p=0.003). In females, CS was related to "pain interference" in the aspects of walking (r=0.311; p=0.001), relationships with people (r=0.309; p=0.001), appreciation of life (r=0.321; p= 0.001) and with cervical functional disability (r=0.570; p=0.001). In males, CS was related to "pain interference" in aspects such as general activity (r=0.311; p=0.008), mood (r=0.376; p=0.001), walking (r=0.313; p= 0.007), relationships with people (r=0.477; p=0.001), sleep (r=0.321; p=0.006), appreciation of life (r=0.427 p=0.001) and functional disability (r=0.667; p<0.001). CONCLUSION: Women with chronic neck pain showed a greater presence of CS, while CS in men was related to a variety of aspects that negatively affect life. Given this, differences between genders could be considered in the management of patients with chronic neck pain.

RESUMO JUSTIFICATIVA E OBJETIVOS: A presença de sensibilização central (SC) em pessoas com dor cervical crônica carece de esclarecimentos, bem como as possíveis disparidades entre os sexos. Portanto, objetivou-se avaliar a presença de SC na dor cervical crônica de acordo com o sexo. MÉTODOS: Estudo transversal com a participação de 260 adultos (18-59 anos) com dor cervical crônica, realizado entre setembro de 2022 e setembro de 2023. Foram aplicados instrumentos para coletar perfil sociodemográfico, características da dor, incapacidade funcional da cervical e presença de SC. Para análises comparativas foi utilizado o SPSS 23.0. RESULTADOS: Nas disparidades entre os sexos, não houve diferenças na intensidade da dor e incapacidade funcional cervical (p=0,134 e p=0,277, respectivamente). No entanto, a SC foi mais elevada nas mulheres (43,5 ± 14,0; p=0,003). No sexo feminino, a SC apresentou relação com a "interferência da dor" nos aspectos: caminhar (r=0,311; p=0,001), relacionamento interpessoal (r=0,309; p=0,001), apreciação da vida (r=0,321; p=0,001) e com incapacidade funcional da cervical (r=0,570; p=0,001). Já no sexo masculino, a SC teve relação com a "interferência da dor" em aspectos como atividade geral (r=0,311; p=0,008), humor (r=0,376; p=0,001), caminhar (r=0,313; p=0,007), relacionamento interpessoal (r=0,477; p=0,001), sono (r=0,321; p=0,006), apreciação da vida (r=0,427 p=0,001) e incapacidade funcional (r=0,667; p<0,001). CONCLUSÃO: Mulheres com dor cervical crônica mostraram maior presença da SC, enquanto nos homens a SC esteve relacionada a uma variedade de aspectos que afetam negativamente a vida. Diante disso, as diferenças entre os sexos poderiam ser consideradas no gerenciamento de pacientes com dor cervical crônica.

Prevalence of cervical pain in adults in the city of aracaju, sergipe, brazil / Prevalência de dor cervical em adultos da cidade de aracaju, sergipe, brasil / Prevalencia de dolor cervical en adultos de la ciudad de aracaju, sergipe, brasil

ABSTRACT: Objective: To estimate the current and last 12-month prevalence of cervical pain (CP) in adults in Aracaju, Sergipe, Brazil. Method: Cross-sectional study with 242 adults aged between 18 and 59 living in urban areas. Sociodemographic data, one-time and 12-month CD prevalence, pain intensity assessed using the Numerical Pain Scale, and functional limitation using the Neck Disability Index were evaluated. Results: The prevalence of punctual CD at the interview was 27.7%, while 66.1% had felt pain in the last 12 months. Of the people who felt punctual CP at the time of the interview, the mean pain intensity was 6±4.76, and 82% had a functional disability (mild, moderate, or severe). Conclusion: The prevalence of punctual CD in the last 12 months was high among adults, pain intensity was moderate, and functional disability was mild. Our results demonstrate that the prevalence of cervical pain in adults is high and can influence several aspects of a person's life. Level of Evidence IV; Observational, Randomized and Cross-Sectional Study.

RESUMO: Objetivo: Estimar a prevalência da dor cervical (DC) atual e nos últimos 12 meses em adultos, na cidade de Aracaju, Sergipe, Brasil. Método: Estudo transversal com 242 adultos entre 18 e 59 anos residentes na área urbana. Foram avaliados os dados sociodemográficos, prevalência da DC pontual e em 12 meses, intensidade da dor avaliada por meio da Escala Numérica da Dor e a limitação funcional pelo Neck Disability Index. Resultados: A prevalência de DC pontual no momento da entrevista foi de 27,7%, enquanto 66,1% sentiram dor nos últimos 12 meses. Das pessoas que sentiam DC pontual no momento da entrevista, a média de intensidade da dor foi 6±4,76 e 82% apresentavam incapacidade funcional (leve, moderada ou forte). Conclusão: A prevalência de DC pontual e nos últimos 12 meses foi alta entre os adultos, a intensidade de dor foi moderada e incapacidade funcional leve. Nossos resultados demonstram que a prevalência de dor cervical em adultos é alta e pode influenciar diversos aspectos na vida da pessoa. Nível de Evidência IV; Estudo Observacional, Aleatório e Transversal. A prevalência de DC pontual e nos últimos 12 meses foi alta entre os adultos, a intensidade de dor foi moderada e incapacidade funcional leve. Nossos resultados demonstram que a prevalência de dor cervical em adultos é alta e pode influenciar diversos aspectos na vida da pessoa. Nível de Evidência IV; Estudo Observacional, Aleatório e Transversal.

RESUMEN: Objetivo: Estimar la prevalencia del dolor cervical (DC) actual y en los últimos 12 meses en adultos, en la ciudad de Aracaju, Sergipe, Brasil. Método: Estudio transversal con 242 adultos entre 18 y 59 años residentes en zona urbana. Se evaluaron datos sociodemográficos, prevalencia puntual y de 12 meses de DC, intensidad del dolor evaluada mediante la Escala Numérica de Dolor y limitación funcional mediante el "Neck Disability Index". Resultados: La prevalencia de DC puntual al momento de la entrevista fue del 27,7%, mientras que el 66,1% había sentido dolor en los últimos 12 meses. De las personas que sintieron parálisis cerebral ocasional en el momento de la entrevista, la intensidad media del dolor fue de 6±4,76 y el 82% tenía discapacidad funcional (leve, moderada o grave). Conclusión: La prevalencia de DC específica y en los últimos 12 meses fue alta entre los adultos, la intensidad del dolor fue moderada y la discapacidad funcional fue leve. Nuestros resultados demuestran que la prevalencia del dolor cervical en adultos es alta y puede influir en varios aspectos de la vida de una persona. Nivel de Evidencia IV; Estudio Observacional, Aleatorizado y Transversal.

Cost-effectiveness of a second opinion program on spine surgeries: an economic analysis.

BACKGROUND: In this study we proposed a new strategy to measure cost-effectiveness of second opinion program on spine surgery, using as measure of effectiveness the minimal important change (MIC) in the quality of life reported by patients, including the satisfaction questionnaire regarding the treatment and direct medical costs. METHODS: Retrospective analysis of patients with prior indication for spine surgery included in a second opinion program during May 2011 to May 2019. Treatment costs and outcomes were compared considering each patients' recommended treatment before and after the second opinion. Costs were measured under the perspective of the hospital, including hospital stay, surgical room, physician and staff fees and other costs related to hospitalization when surgery was performed and physiotherapy or injection costs when a conservative treatment was recommended. Reoperation costs were also included. For comparison analysis, we used data based on our clinical practice, using data from patients who underwent the same type of surgical procedure as recommended by the first referral. The measure of effectiveness was the percentage of patients who achieved the MIC in quality of life measured by the EQ-5D-3 L 2 years after starting treatment. An incremental cost-effectiveness ratio (ICER) was calculated. RESULTS: Based upon the assessment of 1,088 patients that completed the entire second opinion process, conservative management was recommended for 662 (60.8%) patients; 49 (4.5%) were recommended to injection and 377 (34.7%) to surgery. Complex spine surgery, as arthrodesis, was recommended by second opinion in only 3.7% of cases. The program resulted in financial savings of -$6,705 per patient associated with appropriate treatment indication, with an incremental effectiveness of 0.077 patients achieving MIC when compared to the first referral, resulting in an ICER of $-87,066 per additional patient achieving the MIC, ranging between $-273,016 and $-41,832. CONCLUSION: After 2 years of treatment, the second opinion program demonstrated the potential for cost-offsets associated with improved quality of life.

Autocuidado digital en el manejo de los trastornos musculoesqueléticos de columna: revisión sistemática y metanálisis / Digital self-care in the management of spine musculoskeletal disorders: A systematic review and meta-analysis / Autocuidado digital no manejo de distúrbios musculoesqueléticos de coluna: revisão sistemática e metanálise

Objetivo: analizar la efectividad del autocuidado digital en el manejo del dolor y la discapacidad funcional en personas con trastornos musculoesqueléticos espinales. Método: revisión sistemática de la literatura, desarrollada con la checklist PRISMA, de ensayos clínicos aleatorizados sobre personas con trastornos musculoesqueléticos de columna e intervenciones digitales a las que se accede por computadora, smartphones u otro dispositivo portátil. Bases de datos consultadas: National Library of Medicine, Excerpta Médica dataBASE, SciVerse Scopus, Literatura Latinoamericana y del Caribe en Ciencias de la Salud, Science Citation Indexes, Cummulative Index to Nursing and Allied Health Literature y Physiotherapy Evidence Database. Síntesis de resultados descriptiva y por metanálisis (modelo de efectos fijos) realizada con el software Review Manager. Calidad metodológica evaluada mediante la escala Physiotherapy Evidence Database. Resultados: se seleccionaron 25 ensayos (5142 participantes) que mostraron mejoras estadísticamente significativas (p<0,05) del 54% (12/22) en los niveles de dolor y del 47% (10/21) en la discapacidad funcional en el grupo intervención. Los metanálisis mostraron efectos moderados sobre la intensidad del dolor y efectos pequeños sobre la discapacidad funcional. Predominaron los estudios de calidad media. Conclusión: las intervenciones de atención digital demostraron resultados beneficiosos para la intensidad del dolor y la discapacidad funcional, principalmente para el dolor lumbar crónico. Se ha demostrado que la atención digital es promisoria para favorecer el automanejo de las afecciones musculoesqueléticas de columna. Registro PROSPERO CRD42021282102.

Objective: to analyze the effectiveness of digital self-care in the management of pain and functional disability among people with spine musculoskeletal disorders. Method: a systematic literature review, developed with the PRISMA checklist, of randomized clinical trials of people with spine musculoskeletal disorders and digital interventions accessed by means of computers, smartphones or other portable devices. Databases researched: National Library of Medicine, Excerpta Médica dataBASE, SciVerse Scopus, Literatura Latino-Americana e do Caribe em Ciências da Saúde, Science Citation Indexes, Cumulative Index to Nursing and Allied Health Literature and Physiotherapy Evidence Database. The descriptive synthesis of the results and by means of meta-analyses (fixed-effects model) was performed with the Review Manager software. The methodological quality was evaluated with the Physiotherapy Evidence Database scale. Results: a total of 25 trials were selected (5,142 participants), which showed statistically significant improvements (p <0.05) in 54% (12/22) in the pain levels and 47% (10/21) in functional disability in the Intervention Group. The meta-analyses showed moderate effects on pain intensity and small effects on functional disability. There was a predominance of medium quality studies. Conclusion: the digital care interventions showed a beneficial result in pain intensity and in functional disability, mainly for chronic low back pain. Digital care emerges as promising to support self-management of the spine musculoskeletal conditions. PROSPERO registry number CRD42021282102.

Objetivo: analisar a efetividade do autocuidado digital no manejo da dor e incapacidade funcional em pessoas com distúrbios musculoesqueléticos de coluna. Método: revisão sistemática da literatura, desenvolvida com o checklist PRISMA, de ensaios clínicos randomizados de pessoas com distúrbios musculoesqueléticos de coluna e intervenções digitais acessadas por computador, smartphones ou outro dispositivo portátil. Bases pesquisadas: National Library of Medicine, Excerpta Médica dataBASE, SciVerse Scopus, Literatura Latino-Americana e do Caribe em Ciências da Saúde, Science Citation Indexes, Cummulative Index to Nursing and Allied Health Literature e Physiotherapy Evidence Database. Síntese dos resultados descritiva e por metanálises (modelo de efeitos fixos) com o software Review Manager. Qualidade metodológica avaliada pela escala Physiotherapy Evidence Database. Resultados: selecionaram-se 25 ensaios (5142 participantes) que revelaram melhoras estatisticamente significativas (p<0,05) em 54% (12/22) nos níveis de dor e 47% (10/21) na incapacidade funcional no grupo intervenção. As metanálises mostraram efeitos moderados na intensidade da dor e pequenos na incapacidade funcional. Houve predominância de estudos de média qualidade. Conclusão: intervenções de cuidados digitais mostraram resultado benéfico na intensidade da dor e na incapacidade funcional principalmente para dor lombar crônica. Evidenciam-se os cuidados digitais como promissores para apoiar o autogerenciamento das condições musculoesqueléticas de coluna. Registro PROSPERO CRD42021282102.

Uso de dispositivos móviles y alteraciones cervicales en estudiantes universitarios / Use of mobile devices and cervical disorders in university students / Uso de dispositivos móveis e distúrbios cervicais em estudantes universitários

Las alteraciones cervicales son un problema multifactorial que afecta a la sociedad moderna. Posturas viciosas, traumatismos y defectos congénitos relacionados con la columna cervical pueden desarrollar inestabilidad, pinzamiento radicular, cervicoartrosis y cervicalgias. Objetivo. Relacionar el uso de dispositivos móviles con las alteraciones cervicales en estudiantes universitarios. Materiales y métodos. Estudio descriptivo, observacional, que se realizó entre los meses de mayo y julio del 2023, cuya muestra fue de 172 estudiantes universitarios que se obtuvo aplicando la fórmula para el cálculo muestral de poblaciones conocidas, mediante un muestreo no probabilístico. Se utilizó el test goniométrico para medir el rango articular, el test postural para identificar las alteraciones posturales, la técnica de palpación para identificar dolor inespecífico, prueba de resistencia para los músculos flexores (NFMET) y extensores (NEET), por último, se realizó la prueba de Spurling para identificar casos de radiculopatías. Resultados. Aunque las relaciones estadísticas no fueron consistentes, se observó que quienes utilizaron más tiempo los teléfonos celulares (87,0%) mostraron más limitaciones cervicales que los usuarios menos frecuentes (73,5%). La movilidad articular fue limitada en el 84,3% de la población, especialmente en varones (93,5%); la resistencia muscular normal en extensión fue más prevalente en el caso de los hombres (84,9%), mientras que la resistencia alterada en flexión fue más prevalente en mujeres (94,9%). Conclusiones. Según los resultados obtenidos en esta investigación, no se encontró suficiente evidencia para determinar una relación estadísticamente significativa (P˃0,05) entre las alteraciones cervicales y el uso de teléfonos celulares, aunque se observó una mayor limitación en el caso de quienes más tiempo utilizaban el dispositivo móvil.

Cervical disorders are a multifactorial problem affecting modern society. Vicious postures, trauma and congenital defects related to the cervical spine can develop instability, radicular impingement, cervicoarthrosis and cervicalgia. Objective. To relate the use of mobile devices with cervical disorders in university students. Materials and methods. Descriptive, observational study carried out between May and July 2023, with a sample of 172 university students obtained by applying the formula for the sample calculation of known populations, by means of non-probabilistic sampling. The goniometric test was used to measure joint range, the postural test to identify postural alterations, the palpation technique to identify non-specific pain, resistance test for flexor (NFMET) and extensor (NEET) muscles, and finally, the Spurling test was performed to identify cases of radiculopathy. Results. Although the statistical relationships were not consistent, it was observed that those who used cell phones longer (87.0%) showed more cervical limitations than less frequent users (73.5%). Joint mobility was limited in 84.3% of the population, especially in men (93.5%); normal muscular endurance in extension was more prevalent in men (84.9%), while impaired endurance in flexion was more prevalent in women (94.9%). Conclusions. According to the results obtained in this investigation, there was not enough evidence to determine a statistically significant relationship (P˃0.05) between cervical alterations and cell phone use, although a greater limitation was observed in the case of those who used the mobile device the longest.

Os distúrbios cervicais são um problema multifatorial que afeta a sociedade moderna. Posturas viciosas, traumas e defeitos congênitos relacionados à coluna cervical podem levar a instabilidade, impacto radicular, cervicoartrose e cervicalgia. Objetivo. Relacionar o uso de dispositivos móveis com distúrbios cervicais em estudantes universitários. Materiais e métodos. Estudo descritivo, observacional, realizado entre maio e julho de 2023, com uma amostra de 172 estudantes universitários obtida pela aplicação da fórmula para o cálculo de amostras de populações conhecidas, por meio de amostragem não probabilística. Foram utilizados o teste goniométrico para medir a amplitude articular, o teste postural para identificar alterações posturais, a técnica de palpação para identificar dores inespecíficas, o teste de resistência para músculos flexores (NFMET) e extensores (NEET) e o teste de Spurling para identificar casos de radiculopatia. Resultados. Embora as relações estatísticas não tenham sido consistentes, observou-se que aqueles que usavam telefones celulares por mais tempo (87,0%) apresentavam mais limitações cervicais do que os usuários menos frequentes (73,5%). A mobilidade articular foi limitada em 84,3% da população, especialmente no sexo masculino (93,5%); a resistência muscular normal em extensão foi mais prevalente no sexo masculino (84,9%), enquanto a resistência prejudicada em flexão foi mais prevalente no sexo feminino (94,9%). Conclusões. De acordo com os resultados obtidos nesta pesquisa, não houve evidências suficientes para determinar uma relação estatisticamente significativa (P˃0,05) entre os distúrbios cervicais e o uso de telefones celulares, embora tenha sido observada uma limitação maior no caso daqueles que usaram o dispositivo móvel por períodos mais longos.

Análisis de la discapacidad por trastornos musculoesqueléticos en México de 1990 a 2021 / Analysis of musculoskeletal disorders-associated disability in Mexico from 1990 to 2021

Resumen Antecedentes: Los trastornos musculoesqueléticos (TME) afectan a 1710 millones de personas en todo el mundo y es la principal causa de discapacidad. Objetivo: Analizar los años vividos con discapacidad (AVD) por TME en México entre 1990 y 2021. Material y métodos: Con las estimaciones del estudio de la Carga Global de la Enfermedad 2021 se analizaron los AVD por TME y sus seis categorías: osteoartritis, artritis reumatoide, gota, dolor cervical, lumbalgia y otros TME. Se evaluaron patrones y tendencias del número, tasa cruda y tasa estandarizada por edad de los AVD a nivel nacional, estatal, por grupos de edad y sexo. Resultados: Los TME constituyeron la principal causa de AVD en México entre 1990 y 2021, con un incremento de 57.3 %; pasaron de 1458.4 a 2293.7 por 100 000 habitantes. La lumbalgia (840.6 AVD) destacó con la mayor tasa en 2021 y la osteoartritis, con el mayor incremento. Los TME se incrementaron con la edad y, con excepción de la gota, afectaron más a las mujeres. Conclusiones: De 1990 a 2021, los TME constituyeron la principal causa de AVD en México, con mayor impacto en adultos y mujeres. Los TME se evidencian desde edades tempranas, de ahí la necesidad de intervenciones continuas para preservar la calidad de vida.

Abstract Background: Musculoskeletal disorders (MSD) affect 1.71 billion people worldwide and are the leading cause of disability. Objective: To analyze the years lived with disability (YLD) attributed to MSD in Mexico between 1990 and 2021. Material and methods: With estimates from the Global Burden of Disease 2021 study, the YLDs due to MSD and their six categories were analyzed, including osteoarthritis, rheumatoid arthritis, gout, neck pain, low back pain, as well as other MSDs. Patterns and trends in the number, crude rate, and YLD age-standardized rate were evaluated at the national and state levels, as well as by age group and gender. Results: MSDs were the main cause of YLDs in Mexico between 1990 and 2021, with an increase of 57.3%, going from 1,458.4 to 2,293.7 per 100,000 population. Low back pain (840.6 YLD) showed the highest rate in 2021, while osteoarthritis had the largest increase. MSDs increased with age and, and except for gout, affected women more often. Conclusions: From 1990 to 2021, MSDs were the main cause of YLDs in Mexico, with a higher impact on adults and women. MSDs can appear early in life, hence the need for continuous interventions in order to preserve quality of life.

Efficacy of telerehabilitation exercise in patients with chronic neck pain: a protocol for a non-inferiority randomized controlled trial.

The aim of this study is to investigate if telerehabilitation is just as effective as the same face-to-face exercise program in patients with chronic neck pain (NP). 140 participants will participate in this non-inferiority randomized controlled trial. Primary outcomes will be pain intensity and disability, and secondary outcomes will be kinesiophobia, catastrophizing, fear avoidance beliefs, anxiety and depression symptoms, self-efficacy for pain and global perceived effect. It will be collected at baseline, 6 weeks and 6 months after intervention. The analysis of non-inferiority will be calculated by mixed linear models considering the non-inferiority margin. The results of this clinical trial will be able to overcome the barriers that physiotherapists face for the success of their therapies. In addition, it may reduce the high demands and public health costs with NP. Brazilian Clinical Trials Registry (RBR-6VBSMB). Clinical Trial Registration: REBEC (Brazilian Registry of Clinical Trials) RBR-6VBSMB (ClinicalTrials.gov).

What is this article about? This study aims to compare the effect of face-to-face and telerehabilitation treatment for chronic neck pain, since it is the third condition that causes most disability in the world among musculoskeletal conditions. In addition, because its prevalence occurs at an economically active age, it generates a drop in productivity and absenteeism at work. Due to the high public health expenses with chronic neck pain, telerehabilitation is a tool with great potential for reducing waiting lists and barriers to therapy success (transport, time, money). What do the results of the study mean? This is the first clinical trial to investigate the efficacy of telerehabilitation exercise in patients with chronic neck pain and the results will be able to overcome the barriers that physiotherapists face for the success of their therapies. In addition, it may reduce the high demands and public health costs with neck pain and may help patients experience less pain and disability and become more self-sufficient in managing their chronic condition.

Effect of a telerehabilitation exercise program versus a digital booklet with self-care for patients with chronic non-specific neck pain: a protocol of a randomized controlled trial assessor-blinded, 3 months follow-up.

BACKGROUND: Neck pain is the fourth worldwide leading cause of disability and represents 22% of musculoskeletal disorders. Conservative intervention has been strongly recommended to treat chronic neck pain and Telerehabilitation is the alternative for the treatment of musculoskeletal conditions. There is a lack of high-quality research on the effects of telerehabilitation in patients with neck pain and functional disability. Therefore, this study aims to evaluate the effect of a telerehabilitation exercise program versus a digital booklet only with self-care information in individuals with non-specific chronic neck pain. METHODS: This is a prospectively registered, assessor-blinded, two-arm randomized controlled trial comparing a telerehabilitation exercise program versus a digital booklet with self-care information. Seventy patients will be recruited with non-specific chronic neck pain. Follow-ups will be conducted post-treatment, 6 weeks, and 3 months after randomization. The primary outcome will be disability at post-treatment (6 weeks) measured using neck pain disability. Secondary outcomes will be pain intensity levels, global perceived effect, self-efficacy, quality of life, kinesiophobia, and adherence to treatment. In our hypothesis, patients allocated to the intervention group experience outcomes that are similar to those of those assigned to the self-care digital booklet. Our hypothesis can then be approved or disapproved based on the results of the study. DISCUSSION: This randomized clinical trial will provide reliable information on the use of telerehabilitation to treat patients with chronic non-specific neck pain. TRIAL REGISTRATION: The study was prospectively registered at the Brazilian Registry of Clinical Trials (number: RBR-10h7khvk). Registered on 16 September 2022.