Treatment Modalities for Notalgia Paresthetica Including OMT

2020 ◽  
pp. 25-29
Author(s):  
Danielle Cooley ◽  
Michael McAree ◽  
Neal Joshi ◽  
Wasif Peerzada
Keyword(s):  
Previous Treatment ◽  
Additional Treatment ◽  
Treatment Modalities ◽  
Osteopathic Manipulation ◽  
Manipulative Therapy ◽  
Combination Treatments ◽  
Patient Reported ◽  
Notalgia Paresthetica ◽  
Upper Thoracic ◽  
Comprehensive Literature Search

Background: Notalgia paresthetica (NP) is a type of neuropathy associated with pruritus, dysesthesias and sometimes pain. Most etiologies stem from trauma and entrapment of cutaneous branches of the upper thoracic nerves. Objectives: We report a case of NP treated with osteopathic manipulative therapy (OMT) along with a review of previous treatment modalities performed per the literature. Methods: A comprehensive literature search using PubMed was performed on NP and its treatment. Keywords used include notalgia paresthetica, treatment, osteopathic manipulation, neuropathy and pruritus. Results: Our patient reported a 30% reduction in severity of pruritus after receiving OMT, with full intention of following up in office for additional treatment. Conclusion: OMT monotherapy or combination treatments may prove to be efficacious with little to no added risk.

Selecting a PRO-CTCAE based subset for patient reported symptom monitoring during lung cancer treatment (Preprint)

2020 ◽  
Author(s):  
Evalien Veldhuijzen ◽  
Iris Walraven ◽  
Jose Belderbos
Keyword(s):  
Lung Cancer ◽  
Clinical Practice ◽  
Cancer Patients ◽  
Treatment Modalities ◽  
European Organization ◽  
Specific Patient ◽  
Symptom Monitoring ◽  
Lung Cancer Patients ◽  
Wide Range ◽  
Patient Reported

BACKGROUND The Patient Reported Outcomes Version of the Common Terminology Criteria of Adverse Events (PRO-CTCAE) item library covers a wide range of symptoms relevant for oncology care. To enable implementation of PRO-CTCAE-based symptom monitoring in clinical practice, there is a need to select a subset of items relevant for specific patient populations. OBJECTIVE The aim of this study was to develop a PRO-CTCAE subset relevant for patients with lung cancer. METHODS The PRO-CTCAE-based subset for lung cancer patients was generated using a mixed methods approach based on the European Organization for Research and Treatment of Cancer (EORTC) guidelines for developing questionnaires, consisting of a literature review and semi-structured interviews with both lung cancer patients and health care practitioners (HCPs). Both patients and HCPs were queried on the relevance and impact of all PRO-CTCAE items. Results were summarized and, after a final round of expert review, a selection of clinically relevant items for lung cancer patients was made. RESULTS A heterogeneous group of lung cancer patients (n=25) from different treatment modalities and HCPs (n=22) participated in the study. A final list of eight relevant PRO-CTCAE items was created: decreased appetite, cough, shortness of breath, fatigue, constipation, nausea, sadness, and pain (general). CONCLUSIONS Based on literature and both professional and patient input, a subset of PRO-CTCAE items has been identified for use in lung cancer patients in clinical practice. Future work is needed to confirm the validity and effectiveness of this PRO-CTCAE lung cancer subset internationally, and in the real-world clinical practice setting.

scholarly journals SAT0611-HPR LOW ADHERENCE TO RECOMMENDED PHYSICAL THERAPY IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS: A MIXED-METHOD CONTENT AND UTILIZATION ANALYSIS.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1266.2-1266
Author(s):  
E. Vanautgaerden ◽  
M. Kaerts ◽  
W. Dankaerts ◽  
K. De Vlam ◽  
T. Swinnen
Keyword(s):  
Physical Therapy ◽  
Disease Activity ◽  
Mixed Method ◽  
Axial Spondyloarthritis ◽  
Physical Therapists ◽  
Skills Training ◽  
Treatment Modalities ◽  
Patient Reported ◽  
Global Disease Activity ◽  
Therapy Sessions

Background:Patients with axial spondyloarthritis (axSpA) encounter limitations during daily activities and societal participation which seriously impart health-related quality of life. Optimal management of axSpA consists of combined pharmacological and non-pharmacological treatment modalities, including the encouragement of exercise and the consideration of physical therapy given the latter’s superior efficacy1. Few studies investigated the use of physical therapy and the alignment of treatment content with practice recommendations among patients with axSpA.Objectives:1) To estimate physical therapy use in patients with axSpA in a real life cohort; 2) to quantitatively and qualitatively describe the content of these physical therapy sessions; 3) explore possible determinants of physical therapy use and content.Methods:This cross-sectional study included 197 patients diagnosed with axSpA (Males/Females: 62.4/37.6%; mean±SD, age 42.6±12.0, BASDAI 3.7±2.1, BASFI 3.6±2.4, BASMI 3.1±1.8) and recruited during their routine consultation. The mixed-method approach included questionnaires (physical therapy use and content, medication, depression/anxiety (HADS), fear (TSK), physician global disease activity (PGDA)) and an in-depth qualitative interview (content of physical therapy). Interviews were analyzed using the Qualitative Analysis Guide of Leuven by two physical therapists. Spearman’s Rho correlations guided the exploration of determinants of physical therapy use and content.Results:Less than half (42.6%, n=84) of the axSpA of patients were in treatment with a physiotherapist. Most patients (40.0%) reported a physical therapy frequency of 1x/week. Session duration was typically 30 minutes (51.7% of the sample) and longer in fewer cases (30.0%). Exercise was in only 31.7% the cornerstone of their sessions. The majority of subjects (53.3%) were classified as receiving ‘passive therapy only’, with 10% of cases in the ‘exercise only’ and 36.7% in the ‘combination therapy’ groups. Interviews also revealed a lack of clear patient-centered treatment goals. We found moderate associations between physical therapy use/content parameters and medication, spinal mobility, fear, anxiety, depression, physician’s global disease activity versus (p<.05), but no relationship with patient-reported pain or disease activity.Conclusion:Despite the importance of exercise and the added value of physical therapy in axSpA, few patients engaged in physical therapy sessions that include exercise training of adequate dosage. Remarkably, physical therapy utilization seems to be predominantly guided by psychological factors. Professional education for physical therapists should therefore include skills training in the management of complex clinical presentations2. Last, future research should prepare the evidence-based implementation of state-of-the-art physical therapy guidelines in axSpA.References:[1]van der Heijde D, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017 Jun;76(6):978-991.[2]Swinnen TW, et al. Widespread pain in axial spondyloarthritis: clinical importance and gender differences. Arthritis Res Ther. 2018 Jul 27;20(1):156.Disclosure of Interests:Evelyne Vanautgaerden: None declared, Marlies Kaerts: None declared, Wim Dankaerts: None declared, Kurt de Vlam Grant/research support from: Celgene, Eli Lilly, Pfizer Inc, Consultant of: AbbVie, Eli Lilly, Galapagos, Johnson & Johnson, Novartis, Pfizer Inc, UCB, Thijs Swinnen: None declared

Morbidity and mortality of pelvic exenteration for cervical cancer at a German referral center.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e17505-e17505
Author(s):  
Jelena Boekhoff ◽  
Luisa terGlane ◽  
Uwe Wagner ◽  
Axel Hegele
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Pelvic Exenteration ◽  
Survival Rates ◽  
Operation Time ◽  
Previous Treatment ◽  
University Hospital ◽  
Treatment Modalities ◽  
Complication Rates ◽  
Recurrent Cervical Cancer

e17505 Background: The purpose of this study was to evaluate data regarding the outcome of pelvic exenteration (PE) when performed for advanced or recurring cervical cancer. Methods: A total of 24 patients underwent PE for cervical cancer at the University Hospital Marburg between 2011 and 2016. Their data were retrospectively assessed and statistically analyzed. Survival was evaluated using the Kaplan-Meyer method. Results: Mean age was 52.2 years (29.7 to 72.6 years), mean BMI was 23.4 kg/m2. Most common indication was squamous cell carcinoma, whereas 3 patients underwent PE for adenocarcinoma. The majority of the tumors (62.5%) were stage pT4. Negative margins could be achieved in 70.8%. Lymph nodes could be assessed in 55% and were tumor-afflicted in 20.8%. 45.8% were treated for recurrent cancer; median recurrence free time between previous treatment and PE was 16 months. Up-front PE was performed in 20.8%. Another 79.2% received treatment prior to PE: 20.8% received all 3 treatment modalities whereas 37.5% had two treatments before (29.2% underwent chemo- and radiotherapy, 8.3% had surgery and radiotherapy) and 20.8% underwent one type of treatment. Anterior PE (APE) and total PE (TPE) were performed in 62.5% and 37.5%, respectively. Median operation time was 324min. Blood products were administered perioperatively in 75%; 37.5% needed 2 or more. Median hospital stay was 25 days. Major complications (Clavien Dindo≥3) were observed in 41.7% and 16.7% had no complications. Overall Survival (OS) was 29.2%; median overall survival was 19.1 months. 2- and 3-year survival rates for curative PE were 50% and 35% respectively. 4 patients underwent PE with palliative intent. Overall survival correlated significantly with R1- (p = 0.012), N1- (p = 0.047) and M1-status p < 0.01), TPE (p = 0.034) and surgical time > 6 h (p = 0.003). Conclusions: In cases of advanced or recurrent cervical cancer gynecologists struggle to find suitable therapeutic options, especially since most patients have already received radio- and/or chemotherapy. PE is a valid option for selected patients that may represent a cure with tolerable complication rates.

scholarly journals A protocol for the Development of Core Outcome Sets for Endodontic Treatment modalities (COSET): an international consensus process

2021 ◽  
Author(s):  
Ikhlas El karim ◽  
Henry F Duncan ◽  
Siobhan Cushley ◽  
Venkatesh Nagendrababu ◽  
Lise-Lotte Kirkevang ◽  
...  
Keyword(s):  
Clinical Studies ◽  
Endodontic Treatment ◽  
Treatment Modalities ◽  
Core Outcome ◽  
Consensus Process ◽  
International Consensus ◽  
Core Outcome Sets ◽  
Key Stakeholders ◽  
Dental Practitioners ◽  
Patient Reported

Abstract BackgroundThe outcome of endodontic treatment is generally assessed using a range of patient and clinician-centred, non-standardised clinical and radiographic outcome measures. This makes it difficult to synthesise evidence for systematic analysis of the literature and the development of clinical guidelines. Core outcome sets (COS) represent a standardised list of outcomes that should be measured and reported in all clinical studies in a particular field. Recently, clinical researchers and guideline developers have focussed on the need for integration of a patient-reported COS with clinician-centred measures. This study aims to develop a COS that includes both patient reported outcomes and clinician centred measures for various endodontic treatment modalities to be used in clinical research and practice.MethodsTo identify reported outcomes (including when and how they are measured), systematic reviews and their included clinical studies, which focus on the outcome of endodontic treatment and were published between 1990 and 2020 will be screened. The COSs will be defined by a consensus process involving key stakeholders using semi-structured interviews and an online Delphi methodology followed by an interactive virtual consensus meeting. A heterogeneous group of key ‘stakeholders’ including patients, general dental practitioners, endodontists, endodontic teachers, clinical researchers, students and policy-makers will be invited to participate. Patients will establish, via interactive interviews, which outcomes they value and feel should be included in a COS. In the Delphi process, other stakeholders will be asked to prioritise outcomes identified from the literature and patients interviews, and will have the opportunity at the end of the first round to add outcomes that are not included, but which they consider relevant. Feedback will be provided in the second round, when participants will be asked to prioritise the list again. If consensus is reached, the remaining outcomes will be discussed at an online meeting and agreement established via defined consensus rules of outcome inclusion. If consensus is not reached after the second round, a third round will be conducted with feedback, followed by the online meeting. Following identification of a COS, we will proceed to identify how and when these outcomes are measured.DiscussionUsing a rigorous methodology, the proposed consensus process aims to develop a COS for endodontic treatment that will be relevant to stakeholders. The results of the study will be shared with participants and COS users. To increase COS uptake, it will also be actively shared with clinical guideline developers, research funders and the editors of general dental and endodontology journals.Study registrationThe study is registered in COMET (https://comet-initiative.org/Studies/Details/1879)

scholarly journals Translabyrinthine microsurgical resection of small vestibular schwannomas

2018 ◽  
Vol 129 (1) ◽  
pp. 128-136 ◽  
Author(s):  
Marc S. Schwartz ◽  
Gregory P. Lekovic ◽  
Mia E. Miller ◽  
William H. Slattery ◽  
Eric P. Wilkinson
Keyword(s):  
Facial Nerve ◽  
Vestibular Schwannoma ◽  
Sinus Thrombosis ◽  
Treatment Options ◽  
Previous Treatment ◽  
Cerebrospinal Fluid Leak ◽  
Neurofibromatosis Type ◽  
Additional Treatment ◽  
Vestibular Schwannomas ◽  
Tumor Control

OBJECTIVETranslabyrinthine resection is one of a number of treatment options available to patients with vestibular schwannomas. Though this procedure is hearing destructive, the authors have noted excellent clinical outcomes for patients with small tumors. The authors review their experience at a tertiary acoustic neuroma referral center in using the translabyrinthine approach to resect small vestibular schwannomas. All operations were performed by a surgical team consisting of a single neurosurgeon and 1 of 7 neurotologists.METHODSData from a prospectively maintained clinical database were extracted and reviewed. Consecutive patients with a preoperative diagnosis of vestibular schwannoma that had less than 1 cm of extension into the cerebellopontine angle, operated on between 2008 and 2013, were included. Patents with neurofibromatosis Type 2, previous treatment, or preexisting facial weakness were excluded. In total, 107 patients were identified, 74.7% of whom had poor hearing preoperatively.RESULTSPathologically, 6.5% of patients were found to have a tumor other than vestibular schwannoma. Excluding two malignancies, the tumor control rates were 98.7%, as defined by absence of radiographic disease, and 99.0%, as defined by no need for additional treatment. Facial nerve outcome was normal (House-Brackmann Grade I) in 97.2% of patients and good (House-Brackmann Grade I–II) in 99.1%. Complications were cerebrospinal fluid leak (4.7%) and sigmoid sinus thrombosis (0.9%), none of which led to long-term sequelae.CONCLUSIONSTranslabyrinthine resection of small vestibular schwannomas provides excellent results in terms of complication avoidance, tumor control, and facial nerve outcomes. This is a hearing-destructive operation that is advocated for selected patients.

Brain Infarction (Thalamus and Brainstem)

2018 ◽  
pp. 185-192
Author(s):  
Theodore G. Eckman ◽  
Jianguo Cheng
Keyword(s):  
Neuropathic Pain ◽  
Deep Brain Stimulation ◽  
Cerebrovascular Accident ◽  
Brain Infarction ◽  
Clinical Findings ◽  
Additional Treatment ◽  
Complex Interaction ◽  
Treatment Modalities ◽  
Motor Cortex Stimulation ◽  
Neuropathic Pain Condition

Central post-stroke pain (CPSP) is a central neuropathic pain condition resulting from lesions of a prior cerebrovascular accident (CVA) mainly affecting the spinothalamocortical tract. About 5%–10% of patients with CVAs develop CPSP. The pain is thought to be secondary to a complex interaction of central disinhibition, central sensitization, and an imbalance of stimuli, although the exact mechanism remains unknown. The pain is located within and associated with sensory dysfunction in a region affected by a prior CVA lesion. The pain is often described as burning, stabbing, and sharp. Allodynia, hyperalgesia, and evoked dysesthesia appear to be major clinical findings for this condition. There are no specific diagnostic criteria for CPSP, and treatment is often difficult. Medications such as tricyclic antidepressants and anticonvulsants are often used. Motor cortex stimulation and deep brain stimulation are active areas of research and offer hope that additional treatment modalities may be identified.

Tracheobronchial Obstruction from Esophageal Carcinoma: Bronchoscopic Treatment with Neodymium:Yttrium-Aluminum-Garnet Laser

1992 ◽  
Vol 101 (7) ◽  
pp. 556-559 ◽  
Author(s):  
Elie E. Rebeiz ◽  
Konstantinos Vergos ◽  
John F. Beamis ◽  
Stanley M. Shapshay
Keyword(s):  
Esophageal Carcinoma ◽  
Previous Treatment ◽  
Treatment Modalities ◽  
Poor General Condition ◽  
Lahey Clinic ◽  
Airway Caliber ◽  
Tracheobronchial Obstruction ◽  
Clinic Experience ◽  
The Mean ◽  
Neodymium:Yttrium Aluminum Garnet Laser

Tracheobronchial obstruction resulting from esophageal carcinoma is uncommon. Patients with advanced esophageal carcinoma with tracheobronchial obstruction usually present with severe dyspnea or hemoptysis or both and may die of suffocation. The Lahey Clinic experience using laser bronchoscopy for the palliation of symptoms of airway obstruction in patients with esophageal carcinoma is presented. From 1982 to 1990, nine patients were treated in 13 procedures using the neodymium:yttrium-aluminum-garnet laser. Of the patients, seven had undergone previous treatment of the primary tumor. Tumors were located in the trachea in seven patients and in the main stem bronchi in three patients. Improvement of the airway caliber was achieved in all patients with relief of the dyspnea. The mean hospital stay was 2 days. One patient lived 4 years after laser treatment with no recurrence of tumor, and one patient died 1 week after treatment as a result of his poor general condition. The rest of the patients lived 3 to 41 weeks, with a median survival of 35 weeks. No complications were related to the procedures, and in particular, no tracheoesophageal fistulas developed. Our experience indicates that bronchoscopic application of this laser in conjunction with other treatment modalities can improve the quality and duration of life in selected patients with esophageal carcinoma that invades and obstructs the trachea.

scholarly journals Differences in force-time parameters and electromyographic characteristics of two high-velocity, low-amplitude spinal manipulations following one another in quick succession

2020 ◽  
Vol 28 (1) ◽  
Author(s):  
Lindsay M. Gorrell ◽  
Philip J. Conway ◽  
Walter Herzog
Keyword(s):  
High Velocity ◽  
Spinal Manipulative Therapy ◽  
Peak Force ◽  
Manipulative Therapy ◽  
Force Application ◽  
Thoracic Spinal ◽  
Time Parameters ◽  
Force Time ◽  
Upper Thoracic ◽  
Low Amplitude

Abstract Background Spinal manipulative therapy is an effective treatment for neck pain. However, the mechanisms underlying its clinical efficacy are not fully understood. Previous studies have not systematically compared force-time parameters and electromyographic responses associated with spinal manipulation. In this study, force-time parameters and electromyographic characteristics associated with multiple manual high-velocity, low-amplitude cervical and upper thoracic spinal manipulations were investigated. The purpose of this analysis was to compare the force-time parameters and electromyographic characteristics between two spinal manipulations delivered following one another in quick succession if the first thrust was not associated with an audible cavitation. Methods Nine asymptomatic and eighteen symptomatic participants received six Diversified-style spinal manipulations to the cervical and upper thoracic spines during data collected February 2018 to September 2019. Peak force, rate of force application and thrust duration were measured using a pressure pad. Bipolar surface electrodes were used to measure the electromyographic responses and reflex delay times in sixteen neck, back and limb outlet muscles bilaterally. Differences in force-time parameters and electromyographic data were analyzed between the first and second thrust. Results Fifty-two spinal manipulations were included in this analysis. Peak force was greater (p < 0.001) and rate of force application faster (p < 0.001) in the second thrust. Furthermore, peak electromyographic responses were higher following the second thrust in asymptomatic (p < 0.001) and symptomatic (p < 0.001) subjects. Also, electromyographic delays were shorter in the symptomatic compared to the asymptomatic participants for the second thrust (p = 0.039). There were no adverse patient events. Conclusion When a second manipulation was delivered because there was not audible cavitation during the first thrust, the second thrust was associated with greater treatment forces and faster thrust rates. Peak electromyographic responses were greater following the second thrust.

Malignant Transformation in Craniopharyngiomas

Neurosurgery ◽  
2014 ◽  
Vol 75 (3) ◽  
pp. 306-314 ◽  
Author(s):  
Agbolahan A. Sofela ◽  
Samantha Hettige ◽  
Olimpia Curran ◽  
Sanj Bassi
Keyword(s):  
Radiation Therapy ◽  
Correlation Coefficient ◽  
Malignant Transformation ◽  
Rank Correlation ◽  
Previous Treatment ◽  
Treatment Modalities ◽  
Adjuvant Chemoradiotherapy ◽  
Poor Correlation ◽  
Widespread Belief ◽  
Tumor Types

Abstract BACKGROUND: Craniopharyngiomas are successfully managed with surgery and/or adjuvant chemoradiotherapy but have been documented to undergo malignant transformation (MT), albeit very rarely, with only 23 reported cases. The exact cause and pathogenesis of this MT are unknown, although the literature has suggested a possible correlation with radiotherapy. OBJECTIVE: To review the reported cases of malignancy, in particular looking at the incidence, tumor characteristics, previous treatment modalities, and median survival. METHODS: We conducted a PUBMED, SCOPUS, OVID SP, and INFORMA search with a combination of key words: craniopharyngioma, malignancy, transformation, neoplasm, radiation therapy, and anaplastic. We identified 23 cases relevant to our study. RESULTS: Median age at the time of diagnosis of malignant craniopharyngiomas was 31 years (range, 10-66 years); 52.6% of the patients were female. Histologically, the most common tumor types were squamous cell carcinoma (80.96%), with adamantinomatous cell type being the most common morphology (89.47%). We found that 21.7% of the cases were diagnosed as malignant craniopharyngioma at first biopsy. Of the rest, the median time from initial benign diagnosis to MT was 8.5 years (range, 3-55 years). Median overall survival after MT was 6 months (range, 2 weeks-5 years). Using the Spearman rank correlation, we found no correlation between the use of radiation therapy (correlation coefficient, −0.25; P &lt; .05) or its dosage (correlation coefficient, −0.26; P &lt; .05) and MT. CONCLUSION: Malignant craniopharyngiomas are rare and are associated with a poor prognosis. MTs occur years after the initial benign craniopharyngioma diagnosis and are associated with multiple benign craniopharyngioma recurrence. Results also show that, contrary to widespread belief, there is a poor correlation between radiotherapy and MT.

scholarly journals Patient-reported outcomes for tofacitinib with and without methotrexate, or adalimumab with methotrexate, in rheumatoid arthritis: a phase IIIB/IV trial

RMD Open ◽  
2019 ◽  
Vol 5 (2) ◽  
pp. e001040 ◽  
Author(s):  
Vibeke Strand ◽  
Eduardo Mysler ◽  
Robert J Moots ◽  
Gene V Wallenstein ◽  
Ryan DeMasi ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Controlled Trial ◽  
Inadequate Response ◽  
Link Type ◽  
Combination Treatments ◽  
Sf 36 ◽  
Patient Reported ◽  
Phase Iiib

ObjectiveTo provide the first direct comparison of patient-reported outcomes (PROs) following treatment with tofacitinib monotherapy versus tofacitinib or adalimumab (ADA) in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA) with inadequate response to MTX (MTX-IR).MethodsORAL Strategy (NCT02187055), a phase IIIB/IV, head-to-head, randomised controlled trial, assessed non-inferiority between tofacitinib 5 mg two times per day monotherapy, tofacitinib 5 mg two times per day+MTX and ADA 40 mg every other week+MTX. PROs assessed included the following: Patient Global Assessment of disease activity (PtGA), Pain, Health Assessment Questionnaire-Disability Index, Functional Assessment of Chronic Illness Therapy-Fatigue and 36-Item Short-Form Health Survey (SF-36) summary and domain scores.ResultsSubstantial improvements from baseline were reported across all PROs in all treatment arms, which, in the majority, met or exceeded minimum clinically important differences. Compared with tofacitinib monotherapy, tofacitinib+MTX combination treatment conferred significantly greater improvements in PtGA, Pain and SF-36 physical component summary scores at month 6. Statistically or numerically greater improvements were often, but not uniformly, reported for combination treatments compared with tofacitinib monotherapy at other time points.ConclusionTreatment with tofacitinib+MTX, ADA+MTX and tofacitinib monotherapy resulted in clinically meaningful improvements in PROs in MTX-IR patients with RA. These were comparatively greater with combination treatments versus tofacitinib monotherapy, although differences between treatment arms were small, limiting our ability to confer clinical meaning.Trial registration numberNCT02187055.

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