Risultati per: Low Back Pain: raccomandazioni

Objectives
Chronic musculoskeletal pain (CMP) is a prevalent and distressing condition. Cupping therapy, one of the most popular complementary and alternative medicines, has been widely used to reduce CMP. But the evidence remains controversial on the effect of cupping therapy on CMP. The objective of this review and meta-analysis is to assess the effectiveness of cupping therapy in patients with CMP.

Design
Systematic review and meta-analysis.

Data sources
PubMed, Web of Science, EBSCO, Cochrane Library and CNKI (China National Knowledge Infrastructure) were searched through 20 December 2024.

Eligibility criteria for selecting studies
We included randomised control trials that compared cupping therapy for patients with CMP on outcomes (ie, pain intensity, functional disability and mental health).

Data extraction and synthesis
Two independent reviewers used standardised methods to search, screen and code included studies. Risk of bias was assessed using the Cochrane Collaboration and Evidence Project tools. Meta-analysis was conducted using random and fixed effects models. Findings were summarised in GRADE (Grading of Recommendations Assessment, Development and Evaluation) evidence profiles.

Results
The results showed that cupping therapy (standardised mean difference (SMD)=–1.17; 95% CI=–1.93 to –0.42; p=0.002; I2=94%) had a significant reduction effect on patients with CMP’s pain intensity with moderate quality based on a random-effect model. But cupping therapy had no improvement effects on functional disability (SMD=–0.24; 95% CI=–0.93 to 0.46; p=0.51; I²=93%) and mental health (SMD=0.08; 95% CI=–0.12 to 0.27; p=0.46; I²=0%).

Conclusions
This study indicates that cupping therapy may be efficient in alleviating pain intensity in patients with CMP with immediate effects. But it cannot improve functional disability and mental health significantly.

PROSPERO registration number
CRD42023406219.

Introduction
The incidence of recurrent implantation failure (RIF) can reach up to 10% among patients undergoing in vitro fertilisation and embryo transfer worldwide. However, the clinical efficacy of low-molecular-weight heparin (LMWH) in RIF remains a subject of controversy. Currently, there is a lack of high-quality clinical research validating the effectiveness of LMWH in treating patients with RIF, particularly during frozen embryo transfer (FET) cycles. Therefore, this randomised controlled trial aimed to investigate the impact of LMWH on pregnancy outcomes in women with RIF undergoing FET.

Methods and analysis
This prospective, single-centre, double-blind randomised, placebo-controlled clinical trial will be conducted in the Second Hospital of Shandong University, China. A total of 414 women with RIF, aged ≤40 years, who are undergoing FET cycles will be recruited and randomly assigned to the study group (LMWH) or the control group (placebo). Only one blastocyst which is from day 5 or day 6 and has a Gardner morphology score ≥4 BC will be transferred. LMWH 4000–6000 IU per day or placebo will be administered by subcutaneous injection from the day of transplantation. The primary outcome is the live birth rate. The secondary outcomes include the clinical pregnancy rate, biochemical pregnancy rate, embryo implantation rate, early miscarriage rate, ongoing pregnancy rate, ectopic pregnancy rate, pregnancy-related complications, perinatal complications, fetal birth weight, congenital malformations and other adverse reactions.

Ethics and dissemination
The protocol received approval from the Ethics Committee of the Second Hospital, Cheeloo College of Medicine, Shandong University (KYLL-2023-442). The findings will be disseminated in peer-reviewed publications.

Trial registration number
Chinese Clinical Trial Registry, ChiCTR2400083577.

Introduction
Chronic non-cancer pain presents a global health problem, with a significant increase in opioid prescriptions over recent decades. However, opioid therapy poses risks of adverse events, overdose and non-medical use. As a result, many patients seek to discontinue or reduce their opioid intake. Strategies for opioid tapering often lack efficacy, prompting the investigation of novel approaches like open-label placebo (OLP), that is, the administration of a placebo with full disclosure that it is a placebo. OLP has shown efficacy in chronic non-cancer pain syndromes and has been suggested as a promising candidate for medication tapering. This study aims to assess whether OLPs can enhance the reduction of daily morphine equivalent dose (MED) in chronic non-cancer pain patients and examines its potential in mitigating opioid withdrawal symptoms.

Methods and analysis
This study is designed as a randomised, controlled, single-centre trial. Participants will be randomised into either an OLP group or a control group. The study duration will span six to nine weeks, during which all participants will aim to reduce their opioid intake. Both groups will monitor their opioid intake daily using a diary app and will receive feedback on their progress of reducing opioids. Additionally, participants in the OLP group will receive OLP tablets for the entire study period. During the first week, the OLP group will undergo a one week learning phase using a classical conditioning paradigm, where each opioid intake is paired with a placebo. In the subsequent five weeks, the OLP group will enter a dose-extension phase in which only the first opioid intake of the day is paired with a placebo, and additional placebos can be taken as desired. At the end of the study, qualitative interviews will be conducted with the first 15 participants in the OLP group. The primary outcome measure is daily opioid intake. Secondary outcomes include opioid withdrawal symptoms, pain severity, disability, anxiety, depression, opioid beliefs, intervention expectancy and qualitative data. Statistical analyses will include analysis of covariance and regression models.

Ethics and dissemination
The ethics committee of the Canton of Zurich, Switzerland, approved the study (SNCTP-nr.: SNCTP000005853/BASEC nr.: 2023–02327).
Participants will be compensated with 100 Swiss Francs for their full participation in the study. Participants who will take part in the qualitative interview will be compensated with additional 15 Swiss Francs.

Trial registration number
This study is registered at clinicaltrials.gov: NCT06350786.

Introduction
Sensorimotor training (SoMT) is a gradual balance training technique employed to treat various chronic musculoskeletal pain. Core strength training (CST) is one of the most commonly used interventions for managing low back pain (LBP). This randomied controlled trial protocol aims to determine whether the combination of SoMT and CST can significantly reduce LBP, and improve scoliosis-related outcomes and overall functional status in adult idiopathic scoliosis (AdIS) patients.

Methods and analysis
A total of 300 AdIS patients will be recruited from the outpatient clinic and randomly assigned to one of three groups: CST group, SoMT group or the combined therapy group, using stratified block randomization based on the severity of scoliosis curve. All groups will receive the intervention three times a week for 12 weeks. Sessions will be conducted in the hospital, and no home programme will be provided. Adherence and attendance will be monitored and recorded. The CST group will receive CST therapy, while the SoMT group will receive SoMT therapy, which consists of three progressive phases: static, dynamic and functional. Participants will progress to the next phase on achieving pelvic stability in the current phase. The combined therapy group will receive both CST and SoMT. Assessors and statisticians will remain blinded to participant allocation throughout the study. Assessments will be performed at baseline and at the endpoint, 12 weeks after the initiation of the intervention. The primary outcome will be the self-reported pain level, measured using the visual analogue scale. Secondary outcomes will include pain-related disability (by the Oswestry Disability Index and the Roland-Morris Disability Questionnaire), spinal morphology indicators (including Cobb angle, the angle of trunk rotation and the Sagittal Index), postural control ability (by the Tetrax IBSTM), proprioceptive sensitivity (by the repositioning error test) and health-related quality of life (by the 36-Item Short Form Health Survey). Statistical analysis will adhere to the intention-to-treat principle and will be complemented by per-protocol analysis. To compare the effects of SoMT versus CST and combined therapy versus SoMT on both primary and secondary outcomes, a linear mixed-effects model or generalised linear mixed model will be applied.

Ethics and dissemination
The current study received ethical approval from the Xinhua Hospital Ethics Committee Affiliated to Shanghai Jiao Tong University School of Medicine (XHEC-C-2024-080-3). Written informed consent will be obtained from all participants. Any interim analysis and full results will be published in an international peer-reviewed journal.

Trial registration number
This protocol was registered in the Chinese Clinical Trial Registry (ChiCTR2400085370).

Introduction
Many women need to use medications during breastfeeding. Very few medications have been adequately monitored, tested and labelled with safety information for this use. Prednisolone is one of these drugs. We aim to conduct a multicentre low-intervention clinical trial to determine the concentration of prednisolone in plasma of breastfed infants of lactating women treated with prednisolone. In addition, we will measure the concentration in maternal plasma and breast milk and calculate the daily infant dose (DID) and relative infant dose (RID). Infant cortisol levels will be analysed as a measure of clinical effects in the infants.

Methods and analysis
The study will be conducted at departments of obstetrics and gynaecology and specialist maternity and paediatric outpatient clinics in Sweden. We aim to include 30 lactating women treated with prednisolone and their breastfed infants. Breast milk and blood will be collected merely to study the secretion of prednisolone into breast milk and transfer to the infant. Participants will be treated with prednisolone according to their physician’s prescription. Study visits take place when the infant is approximately 6–8 weeks old. Milk and blood sampling of the mother will be performed at 1 hour after drug intake, in conjunction with the infant being fed. Blood sampling of the infant will be performed 2 hours after the feed. Breast milk and plasma will be biobanked for future research. Recruitment was initiated in 2024 and is ongoing. Patient representatives from the Swedish Rheumatism Association were involved in the planning of the study, and the organisation is providing information about the study on their website.

Ethics and dissemination
The clinical trial was approved by the Swedish Medical Product Agency (Dnr. 5.1.1-2023-104170). The results will be published in peer-reviewed scientific journals and disseminated at scientific meetings and through patient organisations’ websites.

Trial registration number
The clinical trial protocol is available via the Clinical Trial Information System at the European Medicines Agency (No. 2023-508913-18-00). It is also registered and publicly accessible at the EU PAS Register (EUPAS 1000000059).

Introduction
Labour pain is an unavoidable feature of childbirth and is characterised by extreme intensity. Adequate pain management is thus essential not only from the aspect of physiological pain but also due to the adverse effects of pain on the psychological well-being of parturients. Many studies have shown the benefits of acupoint hot compress. However, to date, little is known about its use for alleviating labour pain. The purpose is to evaluate the effect of acupoint hot compress on relieving pain in primiparous women during the latent phase of the first stage of labour, as well as its effects on key maternal and neonatal outcomes.

Methods and analysis
This prospective, multicentre, randomised controlled trial will be conducted across 18 institutions in China from January 2024 to August 2025. A total of 1100 primiparous women aged 20–34 years, with singleton pregnancies at 37–41 weeks of gestation, will be enrolled and randomly allocated to two groups using a central stratified block randomisation method. The controls will be treated only with obstetrical care, while those in the intervention group will receive the same obstetrical care as the control group, with the addition of acupoint hot compress therapy at 42±2°C for 4 hours, starting 1 hour after the onset of regular uterine contractions during the latent phase of labour. The primary outcome will be the pain intensity measured at 1, 3 and 5 hours after the onset of regular uterine contractions using a Visual Analog Scale.

Ethics and dissemination
The study has been approved by the ethics committee of Women’s Hospital, School of Medicine, Zhejiang University (No. IRB-20230379-R). The results of the main trial will be submitted for publication in a peer-reviewed journal.

Trial registration number
This trial is registered at Chinese Clinical Trial Registry, ChiCTR2300079244.

Introduction
Postoperative pain management is a major concern for patients undergoing distal radius open reduction internal fixation (ORIF). Inadequate pain control negatively impacts patient’s satisfaction and may increase opioid use. Topical tranexamic acid (TXA) has been demonstrated as an effective intervention that reduced acute postoperative pain in total knee arthroplasty. There is no study evaluating the effects of TXA on acute postoperative pain for distal radius ORIF. This study aims to evaluate the effect of topical TXA administration during isolated distal radius ORIF on early postoperative pain.

Methods and analysis
The effect of topical TRanexamic Acid versus placebo on acute postoperative pain following Distal Radius fracture fixation (TRADR) study is a randomised controlled double-blinded trial that will enrol 90 patients, 18 years of age or older, undergoing volar open reduction internal fixation. Patients will be randomly assigned to topical TXA versus topical saline (placebo) in a 1:1 ratio. The surgeon at the time of surgical closure after standard distal radius fixation will apply either 1 g of topical TXA (100 mg/mL; treatment group) or 10 mL of saline (control group) to the wound and let it sit for 5 min. Surgeons, patients, and outcome assessors will be blinded to the treatment group. The primary outcome is acute postsurgical pain as measured by the visual analogue scale (VAS). Pain outcomes will be between postoperative days 0 to 7, and at 2 and 6 weeks postsurgery. The secondary outcomes include opioid usage, unscheduled emergency visits, wrist swelling and adverse events.

Ethics and dissemination
This study was approved by the University Health Network Research Ethics Board (REB 23–5708). The results of this trial will be disseminated through peer-reviewed journals and presented at related conferences. The principal investigator will communicate the results with patients who have indicated an interest in knowing the results.

Trial registration number
Clinicaltrials.gov NCT06384456, April 26, 2024; Pre-enrolment.

Protocol version
Version 2.0: August 26, 2024.

Objectives
To update our previous systematic review to synthesise latest data on the prevalence of long-term pain in patients who underwent total hip replacement (THR) or total knee replacement (TKR). We aim to describe the prevalence estimates and trends in this review.

Design
Systematic review and meta-analysis.

Data sources
Update searches were conducted in MEDLINE and Embase databases from 1 January 2011 to 17 February 2024. Citation tracking was used to identify additional studies.

Eligibility criteria
We included prospective cohort studies reporting long-term pain after THR or TKR at 3, 6, 12 and 24 months postoperative.

Data extraction and synthesis
Two reviewers independently identified studies as eligible. One reviewer conducted data extraction, checked by a second reviewer. The risk of bias assessment was performed using Hoy’s checklist. Bayesian, random-effects meta-analysis was used to synthesise the results.

Results
For TKR, 68 studies with 89 time points, including 598 498 patients, were included. Multivariate meta-analysis showed a general decrease in pain proportions over time: 21.9% (95% CrI 15.6% to 29.4%) at 3 months, 14.1% (10.9% to 17.9%) at 6 months, 12.6% (9.9% to 15.9%) at 12 months and 14.6% (9.5% to 22.4%) at 24 months. Considerable heterogeneity, unrelated to examined moderators, was indicated by substantial prediction intervals in the univariate models. Substantial loss to follow-up and risk of bias led to low confidence in the results. For THR, only 11 studies were included, so it was not possible to describe the trend. Univariate meta-analysis estimated 13.8% (8.5% to 20.1%) and 13.7% (4.8% to 31.0%) of patients experiencing long-term pain 6 and 12 months after THR, respectively, though concerns in risk of bias results reduced confidence in these findings.

Conclusions
Our review suggests that approximately 22% of patients report pain 3 months post-TKR, with 12%–15% experiencing long-term pain up to 2 years. At least 14% report pain 6–12 months after THR. Given the prevalence of chronic postsurgical pain, implementing existing and developing new preventive and management strategies is crucial for optimal patient outcomes.

PROSPERO registration number
CRD42023475498.

Annals of Internal Medicine, Volume 178, Issue 5, Page 758-759, May 2025.

Annals of Internal Medicine, Volume 178, Issue 5, Page 760, May 2025.

Annals of Internal Medicine, Volume 178, Issue 5, Page 759-760, May 2025.

Annals of Internal Medicine, Volume 178, Issue 5, Page 760-761, May 2025.

Annals of Internal Medicine, Volume 178, Issue 5, Page 759, May 2025.

Introduction
There are no validated paediatric-specific diagnostic criteria for complex regional pain syndrome (CRPS). As a result, diagnostic tools developed for adults (eg, Budapest Criteria, Japanese Diagnostic Criteria, Veldman Criteria) are frequently applied in the paediatric population. However, the clinical presentations and trajectories of children can differ from adults. Given that treatment outcomes are linked to early diagnosis and intervention, the lack of paediatric-specific screening or diagnostic tools is an important knowledge gap. We aim to identify the frequency of individual criteria used in diagnosing CRPS in children and adolescents in existing literature, summarise assessment methods used to establish the diagnosis, and provide recommendations for research and clinical application.

Methods
The following databases and platforms will be searched for articles published from 2003 (year the Budapest Criteria was developed) onward: CINAHL, CENTRAL, Embase, Ovid MEDLINE, PubMed, PsycINFO and Web of Science. Our search strategy will use subject headings and text words related to the concepts of CRPS in paediatric populations, with study inclusion criteria from birth up to 18 years old, and a diagnosis of CRPS. Data will be extracted by our multidisciplinary team and findings will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.

Ethics and dissemination
This study does not involve human participants or unpublished data; therefore, approval from a human research ethics committee is not required. The findings of this scoping review will be disseminated through academic conferences and peer-reviewed publications.

Objective
Valid and reliable measurement of early childhood development (ECD) is critical for monitoring and evaluating ECD-related policies and programmes. Although ECD tools developed in high-income countries may be applicable to low- and middle-income countries (LMICs), directly applying them in LMICs can be problematic without psychometric evidence for new cultures and contexts. Our objective was to systematically appraise available evidence on the psychometric properties of tools used to measure ECD in LMIC.

Design
A systematic review following the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines.

Data sources
MEDLINE, Embase, PubMed, PsycInfo, SciELO and BVS were searched from inception to February 2025.

Eligibility criteria
We included studies that examined the reliability, validity, and measurement invariance of tools assessing ECD in children 0–6 years of age living in LMICs.

Data extraction and synthesis
Each study was independently screened by two researchers and data extracted by one randomly assigned researcher. Risk of bias was assessed using a checklist developed by the study team assessing bias due to training/administration, selective reporting and missing data. Results were synthesised narratively by country, location, age group at assessment and developmental domain.

Results
A total of 160 articles covering 117 tools met inclusion criteria. Most reported psychometric properties were internal consistency reliability (n=117, 64%), concurrent validity (n=81, 45%), convergent validity (n=74, 41%), test–retest reliability (n=73, 40%) and structural validity (n=72, 40%). Measurement invariance was least commonly reported (n=16, 9%). Most articles came from Brazil, China, India and South Africa. Most psychometric evidence was from urban (n=92, 51%) or urban–rural (n=41, 23%) contexts. Study samples focused on children aged 6–17.9 or 48–59.9 months. The most assessed developmental domains were language (n=111, 61%), motor (n=104, 57%) and cognitive (n=82, 45%). Bias due to missing data was most common.

Conclusions
Psychometric evidence is fragmented, limited and heterogeneous. More rigorous psychometric analyses, especially on measurement invariance, are needed to establish the quality and accuracy of ECD tools for use in LMICs.

PROSPERO registration number
CRD42022372305.