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2.
J Physiother ; 70(1): 51-64, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38072712

ABSTRACT

QUESTIONS: How do authors of randomised controlled trials (RCTs) interpret the clinical relevance of the effects of physiotherapy interventions compared with no intervention on pain intensity, physical function and time to recovery in people with chronic low back pain (CLBP)? How can the clinical relevance be re-interpreted based on the available smallest worthwhile effect (SWE) threshold for this comparison? Are the studies in this field adequately powered? DESIGN: Cross-sectional meta-research study. PARTICIPANTS: People with CLBP. OUTCOME MEASURES: Pain intensity, physical function and time to recovery. RESULTS: This review included 23 RCTs with 1,645 participants. Twenty-two and 18 studies were included in the analysis of pain intensity and physical function, respectively. No studies investigated time to recovery. Sixteen studies reported varying thresholds to interpret clinical relevance for physical function and pain intensity. Discrepancies between interpretation using the minimal important difference and SWE values were observed in five studies. Study power ranged from 9% to 98%, with only four studies having a power > 80%. CONCLUSION: Little attention is given to the interpretation of clinical relevance in RCTs comparing physiotherapy with no intervention in CLBP, with great heterogeneity in the frameworks and thresholds used. Future trials should inform patients and clinicians on whether the effect of an intervention is large enough to be worthwhile, using a reliable and comprehensive approach like available SWE estimates. REGISTRATION: medRxiv https://doi.org/10.1101/2022.12.14.22283454.


Subject(s)
Chronic Pain , Low Back Pain , Humans , Low Back Pain/therapy , Clinical Relevance , Physical Therapy Modalities , Pain Measurement , Chronic Pain/therapy
3.
J Pain ; 25(1): 31-38, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37604361

ABSTRACT

We conducted a meta-epidemiological study on all non-specific low back pain (NSLBP) trial registrations on the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov. We aimed to 1) assess the uptake of the core outcome set (COS) for NSLBP in clinical trials; 2) assess the uptake of the core outcome measurement set for NSLBP in clinical trials; and 3) determine whether specific study characteristics are associated with the COS uptake. After applying the relevant filters for the condition, study type, and phase of the trial, 240 registry entries were included in this study. Only 50 (20.8%) entries showed a full COS uptake, and this rate did not increase over time. Most registry entries that planned to measure physical functioning (n = 152) used the Roland-Morris Disability Questionnaire (n = 74; 48.7%); a small percentage used the numeric rating scale (n = 60; 27.3%) or Short Form-12 (n = 5; 8.3%) if they planned to measure pain intensity (n = 220) or health-related quality of life (n = 60), respectively. Only the planned sample size (OR = 1.02; 95% CI = 1.01, 1.03) showed a significant but small association with COS uptake. The uptake of the COS for NSLBP is poor. Only 21% of the randomized controlled trials aimed to measure all COS domains in their study registration and COS uptake is not increased over time. Great heterogeneity in measurement instruments was also observed, revealing poor core outcome measurement set uptake. PERSPECTIVE: The Core Outcome Set (COS) for non-specific low back pain was published more than 20 years ago. We evaluated whether trial registrations are using this set of outcomes when testing interventions for low back pain. Full uptake was found only in 21% of the sample, and this is not increasing over time. Researchers should use the COS to ensure that trials measure relevant outcomes consistently.


Subject(s)
Low Back Pain , Humans , Low Back Pain/epidemiology , Low Back Pain/therapy , Quality of Life , Epidemiologic Studies , Research Design , Outcome Assessment, Health Care
5.
J Clin Epidemiol ; 162: 145-155, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37704114

ABSTRACT

OBJECTIVES: To explore the relationships between the risk of bias and treatment effect estimates for exercise therapy interventions on pain intensity and physical functioning outcomes in randomized controlled trials (RCTs) involving patients with chronic low back pain. STUDY DESIGN AND SETTING: A cross-sectional meta-epidemiological study of the 230 RCTs (31,674 participants) in the 2021 'Exercise therapy for chronic low back pain' Cochrane Review were included. Study design characteristics, sample size, prospective trial registration, flowchart information, interventions, and comparisons were extracted. Independent pairs of reviewers assessed the risk of bias using the Cochrane Risk of Bias 2 tool. RESULTS: The metaregression included 220 (pain intensity) and 203 (physical functioning) effect sizes. Unadjusted and adjusted metaregression models showed no significant associations between the bias domains and pain intensity effect sizes. Only domain 'bias in the measurement of the outcome' was significantly associated with physical functioning (standardized mean difference: -0.40, 95% confidence interval: -0.77 to -0.02) when adjusted for flowchart reported (yes/no), prospective trial registration, sample size, and comparator type. CONCLUSION: The risk of bias in the measurement of the outcome could lead to slight overestimates of the effect size for physical functioning. Clinicians should consider this when they read and assess RCT results in this field. We encourage metaresearchers to replicate our findings using a consistent approach for evaluating the risk of bias (i.e., the RoB 2 tool) in other musculoskeletal conditions and interventions to investigate their generalizability.


Subject(s)
Chronic Pain , Low Back Pain , Humans , Low Back Pain/epidemiology , Low Back Pain/therapy , Chronic Pain/epidemiology , Chronic Pain/therapy , Randomized Controlled Trials as Topic , Exercise Therapy/methods , Epidemiologic Studies
6.
J Orthop Sports Phys Ther ; 53(9): 510-528, 2023 09.
Article in English | MEDLINE | ID: mdl-37561605

ABSTRACT

OBJECTIVE: We aimed to estimate the benefits and harms of cervical spinal manipulative therapy (SMT) for treating neck pain. DESIGN: Intervention systematic review with meta-analysis of randomized controlled trials (RCTs). LITERATURE SEARCH: We searched the MEDLINE, Cochrane CENTRAL, Embase, CINAHL, PEDro, Chiropractic Literature Index bibliographic databases, and grey literature sources, up to June 6, 2022. STUDY SELECTION CRITERIA: RCTs evaluating SMT compared to guideline-recommended and nonrecommended interventions, sham SMT, and no intervention for adults with neck pain were eligible for our systematic review. Prespecified outcomes included pain, range of motion, disability, health-related quality of life. DATA SYNTHESIS: Random-effects meta-analysis for clinically homogenous RCTs at short-term and long-term outcomes. Risk of bias was assessed using the Cochrane Risk of Bias 2.0 Tool. We used the Grading of Recommendations, Assessment, Development, and Evaluations approach to judge the certainty of evidence. RESULTS: We included 28 RCTs. There was very low to low certainty evidence that SMT was more effective than recommended interventions for improving pain at short term (standardized mean difference [SMD], 0.66; 95% confidence interval [CI]: 0.35, 0.97) and long term (SMD, 0.73; 95% CI: 0.31, 1.16), and for reducing disability at short-term (SMD, 0.95; 95% CI: 0.48, 1.42) and long term (SMD, 0.65; 95% CI: 0.23, 1.06). Transient side effects only were found (eg, muscle soreness). CONCLUSION: There was very low certainty evidence supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain. J Orthop Sports Phys Ther 2023;53(9):510-528. Epub: 10 August 2023. doi:10.2519/jospt.2023.11708.


Subject(s)
Manipulation, Spinal , Neck Pain , Adult , Humans , Neck Pain/therapy , Neck Pain/etiology , Manipulation, Spinal/adverse effects , Bias
7.
MethodsX ; 10: 102239, 2023.
Article in English | MEDLINE | ID: mdl-37305803

ABSTRACT

Chronic low back pain (cLBP) is one of the leading worldwide causes of disability. The smallest worthwhile effect (SWE) parameter has been proposed to find a threshold of clinical relevance. Specific values of the SWE have been calculated in patients with cLBP for pain intensity, physical functioning and time to recovery for physiotherapy compared with no intervention. Our objectives are 1) To evaluate how authors have interpreted the clinical relevance of the effect of physiotherapy compared to no-intervention on pain, physical functioning and time to recovery; 2) To reinterpret the clinical relevance of these between-group differences based on the available SWE estimates; 3) To evaluate, for descriptive purposes, whether the studies are adequately powered or underpowered considering the published SWE values and a power threshold of 80%. A systematic search in Medline, PEDro, Embase and Cochrane CENTRAL will be conducted. We will search for RCT investigating the effectiveness of physiotherapy as compared to no interventions in people with cLBP. We will compare the authors' interpretation of results for clinical relevance with their results to determine if they meet their a-priori definitions. Then, we will perform a re-interpretation of the between-group differences based on SWE values published for cLBP.

9.
Br J Sports Med ; 57(14): 899-905, 2023 Jul.
Article in English | MEDLINE | ID: mdl-36517214

ABSTRACT

To develop a screening tool for pelvic floor dysfunction (PFD) in female athletes for use by sports medicine clinicians (eg, musculoskeletal/sports physiotherapists, sports and exercise medicine physicians), which guides referral to a PFD specialist (eg, pelvic floor/women's health physiotherapist, gynaecologist, urogynaecologist, urologist).Between February and April 2022, an international two-round modified Delphi study was conducted to assess expert opinion on which symptoms, risk factors and clinical and sports-related characteristics (items) should be included in a screening tool. We defined consensus a priori as >67% response agreement to pass each round.41 and 34 experts participated in rounds 1 and 2, respectively. Overall, seven general statements were endorsed as relevant by most participants highlighting the importance of screening for PFD in female athletes. Through consensus, the panel developed the Pelvic Floor Dysfunction-ScrEeNing Tool IN fEmale athLetes (PFD-SENTINEL) and agreed to a cluster of PFD symptoms (n=5) and items (risk factors, clinical and sports-related characteristics; n=28) that should prompt specialist care. A clinical algorithm was also created: a direct referral is recommended when at least one symptom or 14 items are reported. If these thresholds are not reached, continuous monitoring of the athlete's health is indicated.Despite increasing awareness and clinical relevance, barriers to identify PFD in female athletes are still present. The PFD-SENTINEL is a new resource for sports medicine clinicians who regularly assess female athletes and represents the first step towards early PFD identification and management. Further studies to validate the tool are needed.


Subject(s)
Pelvic Floor Disorders , Humans , Female , Pelvic Floor Disorders/diagnosis , Pelvic Floor Disorders/etiology , Delphi Technique , Pelvic Floor , Consensus , Athletes
10.
Braz J Phys Ther ; 26(5): 100450, 2022.
Article in English | MEDLINE | ID: mdl-36270163

ABSTRACT

BACKGROUND: Systematic reviews (SRs) and meta-analyses are essential resources for the clinicians. They allow to evaluate the strengths and the weaknesses of the evidence to support clinical decision-making if they are adequately reported. Little is known in the rehabilitation field about the completeness of reporting of SRs and its relationship with the risk of bias (ROB). OBJECTIVES: Primary: 1) To evaluate the completeness of reporting of systematic reviews (SRs) published in rehabilitation journals by evaluating their adherence to the PRISMA 2009 checklist, 2) To investigate the relationship between ROB and completeness of reporting. Secondary: To study the association between completeness of reporting and journals and study characteristics. METHODS: A random sample of 200 SRs published between 2011 and 2020 in 68 rehabilitation journals was indexed under the "rehabilitation" category in the InCites database. Two independent reviewers evaluated adherence to the PRISMA checklist and assessed ROB using the ROBIS tool. Overall adherence and adherence to each PRISMA item and section were calculated. Regression analyses investigated the association between completeness of reporting, ROB, and other characteristics (impact factor, publication options, publication year, and study protocol registration). RESULTS: The mean overall PRISMA adherence across the 200 studies considered was 61.4%. Regression analyses show that having a high overall ROB is a significant predictor of lower adherence (B=-7.1%; 95%CI -12.1, -2.0). Studies published in fourth quartile journals displayed a lower overall adherence (B= -7.2%; 95%CI -13.2, -1.3) than those published in first quartile journals; the overall adherence increased (B= 11.9%; 95%CI 5.9, 18.0) if the SR protocol was registered. No association between adherence, publication options, and publication year was found. CONCLUSION: Reporting completeness in rehabilitation SRs is suboptimal and is associated with ROB, impact factor, and study registration. Authors of SRs should improve adherence to the PRISMA guideline, and journal editors should implement strategies to optimize the completeness of reporting.


Subject(s)
Periodicals as Topic , Humans , Checklist , Research Design
11.
J Physiother ; 68(4): 244-254, 2022 10.
Article in English | MEDLINE | ID: mdl-36266185

ABSTRACT

QUESTION: Which is the most effective conservative intervention for patients with non-specific chronic neck pain (CNSNP)? DESIGN: A systematic review and network meta-analysis of randomised clinical trials. PARTICIPANTS: Adults with CNSNP of at least 3 months duration. INTERVENTIONS: All available pharmacological and non-pharmacological interventions. OUTCOME MEASURES: The primary outcomes were pain intensity and disability. The secondary outcome was adverse events. RESULTS: Overall, 119 RCTs (12,496 patients; 32 interventions) were included. Risk of bias was low in 50.4% of trials, unclear in 22.7% and high in 26.9%. Compared with inert treatment, a combination of active and/or passive multimodal non-pharmacological inventions (eg, exercise and manual therapy) were effective for pain on a 0-to-10 scale at 1 month (MD range 0.84 to 3.74) and at 3 to 6 months (MD range 1.06 to 1.49), and effective on disability on a 0-to-100 scale at 1 month (MD range 10.26 to 14.09) and 3 to 6 months (MD range 5.60 to 16.46). These effects ranged from possible to definite clinical relevance. Compared with inert treatment, anti-inflammatory drugs alone or in combination with another non-pharmacological treatment did not reduce pain at 1 month or 3 to 6 months. At 12 months, no superiority was found over inert treatment on both outcomes. Most mild adverse events were experienced following acupuncture/dry needling intervention. On average, the evidence varied from low to very low certainty. CONCLUSIONS: While multimodal non-pharmacological interventions may reduce pain and disability for up to 3 to 6 months of follow-up when compared with inert treatment, the evidence was very uncertain about their effects. Better quality and larger trials are needed to improve the certainty of evidence. REGISTRATION: PROSPERO CRD42019124501.


Subject(s)
Chronic Pain , Musculoskeletal Manipulations , Adult , Humans , Neck Pain/therapy , Network Meta-Analysis , Chronic Pain/therapy , Pain Measurement
12.
Musculoskeletal Care ; 20(4): 721-730, 2022 12.
Article in English | MEDLINE | ID: mdl-35229444

ABSTRACT

INTRODUCTION: In most patients, shoulder pain has a neuromusculoskeletal cause. However, it might conceal other types of disorders, hiding a non-neuromusculoskeletal condition. The main aim of this scoping review is to map and summarise findings to identify red flags for gastrointestinal and hepatic diseases in the assessment of patients with shoulder pain. METHODS: Five databases were searched up to 31 May 2021. Additional studies have been identified through grey literature, and the reference lists of the included studies have been screened. Any study design and publication type have been considered to be eligible for inclusion. No time, geographical setting and language restrictions have been applied. RESULTS: A total of 157 records have been identified, with 40 studies meeting the inclusion criteria (37 case reports, 2 retrospective studies and 1 systematic review with meta-analysis). The most prevalent red flags associated with shoulder pain were abdominal pain (14 cases) and abdominal discomfort (3 cases), reported by 47% of patients. As for comorbidities, hepato-gastric, cardiac, visceral and systemic diseases were the most common ones. CONCLUSION: Abdominal pain, right and left hypochondriac pain, and epigastric pain represent the most prevalent symptoms in patients with an abdominal disease that could mimic a shoulder problem. Clinicians should be encouraged to screen for red flags when assessing patients with shoulder pain.


Subject(s)
Research Design , Shoulder Pain , Humans , Shoulder Pain/diagnosis , Shoulder Pain/etiology , Retrospective Studies , Abdominal Pain
13.
Arch Phys Med Rehabil ; 103(9): 1839-1847, 2022 09.
Article in English | MEDLINE | ID: mdl-35192799

ABSTRACT

OBJECTIVE: Primary: To evaluate the completeness of reporting of randomized controlled trials (RCTs) published in rehabilitation journals through the evaluation of the adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist and investigate the relationship between reporting and risk of bias (ROB). Secondary: To study the association between completeness of reporting and the characteristics of studies and journals. DATA SOURCES: A random sample of 200 RCTs published between 2011 and 2020 in 68 rehabilitation journals indexed under the "rehabilitation" category in the InCites Journal Citation Report. STUDY SELECTION: One reviewer evaluated the completeness of reporting operationalized as the adherence to the CONSORT checklist. Two independent reviewers evaluated the ROB using the Cochrane risk-of-bias 2.0 tool. DATA EXTRACTION: Overall adherence and adherence to each CONSORT section were calculated. Regression analyses investigated the association between completeness of reporting, ROB, and other characteristics (quartile range, publication modalities, study protocol registration). DATA SYNTHESIS: The mean overall CONSORT adherence across studies was 65%. Studies with high ROB have less adherence than those with low ROB (-5.5%; CI, -10.9 to 0.0). There was a 10.2% (% CI, 6.2-14.3) increase in adherence if the RCT protocol was registered. Studies published in first quartile journals displayed an overall adherence of 11.7% (% CI 17.1-6.4) higher than those published in the fourth quartile. CONCLUSIONS: Reporting completeness is still suboptimal and is associated with ROB, journal impact ranking, and registration of the study protocol. Trial authors should improve adherence to the CONSORT guideline, and journal editors should adopt new strategies to improve the reporting.


Subject(s)
Periodicals as Topic , Abstracting and Indexing , Checklist , Guideline Adherence , Humans , Randomized Controlled Trials as Topic , Research Report
14.
Neurourol Urodyn ; 41(2): 573-584, 2022 02.
Article in English | MEDLINE | ID: mdl-35094428

ABSTRACT

BACKGROUND: Female athletes may be at higher risk of developing pelvic floor dysfunction (PFD). However, despite the great number of epidemiologic studies, the interventions have not been standardized. AIM: The present scoping review aimed to map and summarize the literature to identify the available interventions for PFD among female athletes. METHODS: Seven databases were searched up to May 2021. Studies considering female athletes practising sports at any performance level with any type of PFD were eligible for inclusion. Any clinical intervention and any context were considered. No language, study design, and publication type restrictions were applied. Additional studies were identified through gray literature and the reference lists of articles included. The results were presented numerically and thematically. RESULTS: From 2625 initial records, 35 studies met inclusion criteria. The majority of articles were narrative reviews, considering athletes with urinary incontinence practising multiple or high-impact sports. Authors discussed a wide range of interventions: preventive (n = 8); conservative (n = 35), pharmacological (n = 12), and surgical (n = 10). In particular, the Pelvic Floor Muscle Training was considered in 30 studies. CONCLUSIONS: This is the first scoping review to provide a comprehensive overview of the topic. Besides the great number of available interventions, specific programs and randomized controlled clinical trials for female athletes are still limited. Findings highlighted evident gaps in the primary research confirming that the current management is based on expert opinion. This review may be useful for the overall management, and it may represent a starting point for future research.


Subject(s)
Sports , Urinary Incontinence , Athletes , Female , Humans , Pelvic Floor , Urinary Incontinence/therapy
15.
Disabil Rehabil ; 44(10): 2011-2019, 2022 05.
Article in English | MEDLINE | ID: mdl-32931339

ABSTRACT

PURPOSE: The aim of this qualitative study is to investigate, from patient's perspective, the aspects of the relationship between low back pain and sexual life on physical, psychological and social aspects of individual's life. In addition, this study aims to explore patients' opinions on the role of health care providers in addressing and treating low back pain-related sexual problems. MATERIALS AND METHODS: Semi-structured interviews were conducted with 26 outpatients referred to physical therapy for subacute or chronic non-specific low back pain; the questions investigated the presence of sexual disability and aspects related to patient's behaviour. Two independent physical therapists, supervised by a third expert physical therapist and a clinical psychologist proficient in qualitative methodology, performed thematic content analysis to identify categories and themes. RESULTS: Patients with low back pain consider sexual disability severely limiting and correlated to pain. This study emphasized the perception of invalidity, the importance of the relationship with the partner, the emotions and gender roles in the couple, and the relevance for health care providers to take part in the clinical management. The physical therapist is believed to be a qualified figure to address this issue and specific suggestions on sexual activity could be useful. CONCLUSION: Sexual disability in patients with subacute or chronic LBP acquires an important and individual meaning that can be investigated within the therapeutic context, especially by physical therapists.Implications for RehabilitationSexual disability related to low back pain is considered an important and meaningful topic from the patient's perspective.This reflects the importance of the emotional relationship with the partner.Within the therapeutic context, it is important to provide information to help manage pain during sexual activity.The physical therapist is seen to be a qualified figure to address this issue.


Subject(s)
Disabled Persons , Low Back Pain , Humans , Low Back Pain/psychology , Low Back Pain/therapy , Physical Therapy Modalities , Qualitative Research , Sexual Behavior
16.
Neurourol Urodyn ; 40(6): 1424-1432, 2021 08.
Article in English | MEDLINE | ID: mdl-34058016

ABSTRACT

AIMS: This systematic review aimed to assess the completeness of exercise reporting in randomized controlled trials (RCTs) on pelvic floor muscle training (PFMT) for women with pelvic organ prolapse (POP). METHODS: MEDLINE, Cochrane Central, CINHAL, Embase, SCOPUS, and PEDro databases were searched up to October 2020. Full-text RCTs comparing PFMT to any type of intervention among women with any type and stage of POP were eligible for inclusion. Completeness of intervention was evaluated with t20he template for intervention description and replication (TIDieR) and the consensus on exercise reporting template (CERT). Inter-rater agreement for each item of the tools was calculated. RESULTS: Twenty-six RCTs were included. None of the studies completely reported all intervention descriptors. On average 57.1% (6.8 ± 2.4; out of 12) of the overall TIDieR items and 35.3% (6.7 ± 2.9; out of 19) of the CERT were well described. In particular, 7 and 5 items were completely reported more than 50% of the time for the TIDieR and CERT, respectively. Frequent shortcomings were the undetailed reporting of information regarding tailoring and modifications of exercises and their adherence. Detailed descriptions of exercise repetitions to enable replication were missing in 53.8%. According to the CERT, only 11.5% of the RCTs sufficiently described the main providers' characteristics. CONCLUSION: The completeness of PFMT reporting for women with POP is still below desirable standards and it is insufficient to ensure transferability into practice. The present results may add relevant knowledge and contribute to improving adequate reporting of exercise.


Subject(s)
Pelvic Floor , Pelvic Organ Prolapse , Exercise , Exercise Therapy , Female , Humans , Pelvic Organ Prolapse/therapy , Randomized Controlled Trials as Topic
17.
J Shoulder Elbow Surg ; 30(11): 2648-2659, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34020002

ABSTRACT

BACKGROUND: Rotator cuff (RC) tears have been widely studied as many treatment strategies have been recommended. However, optimal management for patients with RC tears is still unclear. PURPOSE: The main aim of this systematic review was to analyze randomized controlled trials using meta-analysis to compare repair to conservative treatments for patients with any type of RC tear. METHODS: MEDLINE, Cochrane Library (CENTRAL database), PEDro, and Scopus databases were used. Two independent reviewers selected randomized controlled trials that compared surgical to conservative treatments for RC tear patients. The studies included were assessed using Cochrane Risk of Bias 2 tools, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used to evaluate the certainty of evidence and to summarize the study conclusions. RESULTS: Six trials were included. Pooled results showed improvement in function and pain perception in favor of the repair group at 6 months (mean difference 1.26, 95% CI -2.34, 4.85, P = .49; and -0.59, 95% CI -0.84, -0.33, P < .001, respectively), at 12 months (mean difference 5.25, 95% CI 1.55, 8.95, P = .005, for function; and -0.41, 95% CI -0.70, -0.12, P = .006, for pain) and at 24 months (mean difference 5.57, 95% CI 1.86, 9.29, P = .003, for function; and -0.92, 95% CI -1.31, -0.52, P < .001, for pain) in RC tear patients. However, these differences did not reach the minimum clinically important difference. The certainty of evidence ranged from low to moderate because of imprecision in the studies included. CONCLUSIONS: Overall analysis showed that in patients with RC tear, repair compared with conservative treatment could result in increased pain reduction and functional improvement at 6, 12, and 24 months. Even if these effects were often statistically significant, their clinical relevance was limited. Moreover, the certainty of body of evidence ranged from low to moderate.


Subject(s)
Rotator Cuff Injuries , Rotator Cuff , Arthroplasty , Arthroscopy , Conservative Treatment , Humans , Neurosurgical Procedures , Rotator Cuff/surgery , Rotator Cuff Injuries/surgery , Treatment Outcome
18.
J Sex Med ; 18(3): 646-655, 2021 03.
Article in English | MEDLINE | ID: mdl-33531255

ABSTRACT

BACKGROUND: While the effects of androgens on muscle are well described in hypogonadal men, literature is still scarce on muscular strength or size variations in transmen; in this population there are no data regarding the relative effect of testosterone (T) and its metabolite dihydrotestosterone on muscle. AIM: Our primary objective was to compare the effects on muscle strength of 54-week administration of testosterone undecanoate (TU) combined with the 5α-reductase inhibitor dutasteride (DT) or placebo (PL). Secondary outcomes included evaluation of body composition, bone, cutaneous androgenic effects, and metabolic variations. METHODS: In this randomized, double-blind PL-controlled pilot trial, 16 ovariectomized transmen were randomized to receive TU 1,000 mg IM at week 0, 6, 18, 30, 42 plus a PL pill orally daily (TU + PL, n = 7) or plus DT 5 mg/d (TU + DT, n = 7). OUTCOMES: At week 0 and 54 the following parameters were evaluated: isokinetic knee extension and flexion peak torque and handgrip strength, body composition, and bone mineral density, biochemical, hematological, and hormonal parameters. RESULTS: Handgrip and lower limb strength increased significantly in both groups with no differences between the 2 groups. Fat mass decreased and lean mass increased significantly similarly in both groups. Metabolic parameters remained stable in the 2 groups except for high-density lipoprotein cholesterol that was reduced in both groups. Hepatic and renal function remained normal in both groups and no major adverse effects were registered in either group. CLINICAL IMPLICATIONS: These results may be particularly relevant for transmen experiencing cutaneous androgenic adverse events such as acne and androgenetic alopecia and in light of the development of non-5α-reduced androgens. STRENGTHS & LIMITATIONS: The strength of this study was the randomized, double-blind PL-controlled design, while the small number of subjects was definitely the biggest limitation. CONCLUSION: For the first time we demonstrated that the addition of DT does not impair the anabolic effects of T on muscles in transmen previously exposed to T, supporting the hypothesis that the conversion in dihydrotestosterone is not essential for this role. Gava G, Armillotta F, Pillastrini P, et al. A Randomized Double-Blind Placebo-Controlled Pilot Trial on the Effects of Testosterone Undecanoate Plus Dutasteride or Placebo on Muscle Strength, Body Composition, and Metabolic Profile in Transmen. J Sex Med 2021;18:646-655.


Subject(s)
Hand Strength , Metabolome , Body Composition , Double-Blind Method , Dutasteride/therapeutic use , Humans , Male , Muscle Strength , Pilot Projects , Testosterone/analogs & derivatives
19.
J Clin Epidemiol ; 131: 43-50, 2021 03.
Article in English | MEDLINE | ID: mdl-33227447

ABSTRACT

OBJECTIVES: The main aims of this metaresearch study conducted among high-impact rehabilitation journals were: 1) to evaluate if the use of reporting guidelines (RGs) was declared and 2) to categorize the declared use as appropriate or inappropriate. STUDY DESIGN AND SETTING: Cross-sectional analysis of a random sample of 200 studies published in the period 2010-2019 in five generic rehabilitation journals with the highest 5-year impact factor. Randomized controlled trials, systematic reviews, observational studies, and diagnostic studies were included. Prevalence with 95% confidence intervals (CIs) was estimated for the main outcomes. RESULTS: Among the 200 selected studies, 17.5% (95% CI: 12.2-22.8%) declared using RGs. Among these studies, 48.6% (95% CI: 32-65.1%) declared an appropriate use. There was an increasing trend over time for authors to report the use of RGs (OR: 1.31; 95% CI: 1.13-1.53). Systematic reviews (n = 54) reported more frequently the use of RGs than other study designs (35.2%). CONCLUSION: In high-impact rehabilitation journals, a small minority of article authors declared the use of RGs. In approximately half of these studies, RGs were used inappropriately. There is an urgent need to improve the use of RGs in this field of research.


Subject(s)
Guideline Adherence/statistics & numerical data , Periodicals as Topic , Rehabilitation/methods , Research Design , Research Report/standards , Cross-Sectional Studies , Humans
20.
Neurourol Urodyn ; 40(1): 55-64, 2021 01.
Article in English | MEDLINE | ID: mdl-33137211

ABSTRACT

AIMS: The aims of the present scoping review were to systematically map and summarize findings to identify any study that reported epidemiological data on pelvic floor dysfunction (PFD) among male and female athletes. METHODS: Six medical databases were searched up to March 2020. No language, study design, and publication type restrictions were applied. Additional studies were identified through gray literature and the reference lists of articles were screened. The results were presented numerically and thematically. RESULTS: A total of 4358 records were identified with an initial search. A hundred studies met the criteria for inclusion. The number of studies published annually increased over the years. Cross-sectional studies (n = 62), urinary incontinence (n = 64), multiple sports (n = 58), and female athletes (n = 83) are the most investigated study design, condition, sport, and population, respectively. Only 12 studies explored PFD in the male population. Authors focused selectively on elite athletes in 21 studies. CONCLUSIONS: This is the first scoping review to provide a comprehensive overview of the topic. The major gaps in the literature include studies focused on male participants, other PFD (e.g., anal incontinence, pelvic organ prolapse, and pelvic pain), with appropriate study design. This review may be useful to raise awareness of the issue among clinicians and stakeholders in sport and it may represent a starting point for future research.


Subject(s)
Athletes/statistics & numerical data , Athletic Injuries/physiopathology , Pelvic Floor Disorders/etiology , Pelvic Floor/physiopathology , Sports/physiology , Cross-Sectional Studies , Female , Humans , Male , Pelvic Floor Disorders/pathology
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