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1.
Hirofumi Ochi Masaaki Niino Yasuhiro Onizuka Katsutoshi Hiramatsu Masakazu Hase Jang Yun André Matta Shinichi Torii 《Advances in therapy》2018,35(10):1598-1611
Introduction
The long-term safety of dimethyl fumarate (DMF) in patients with relapsing-remitting multiple sclerosis (RRMS) has been studied in mainly Caucasian patients. The present interim analysis aimed to evaluate the 72-week safety of DMF in Japanese patients with RRMS.Methods
Safety data of Japanese subjects enrolled in the 24-week randomised, double-blind, placebo-controlled APEX study (Part I) and its following open-label extension (Part II) were analysed at 72 weeks from the beginning of Part I. In Part I, subjects were randomised to DMF treatment or matching placebo while all subjects received DMF treatment during Part II. Adverse events (AEs) reported throughout the study period were recorded.Results
Overall, 109 Japanese subjects completed 72 weeks of treatment. The incidence of AEs and serious AEs was 95% and 19%, respectively, in the DMF group compared with 84% and 18%, respectively, in the placebo group at 24 weeks. Common AEs (at least 5%) reported with treatment included nasopharyngitis, flushing, hot flush, gastrointestinal events, pruritus, rash, headache, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST). AEs led to discontinuation of DMF in 5% of patients and included MS relapse, flushing, abdominal pain, liver disorder and increased ALT/AST. After an initial decrease from baseline of 17% in the DMF group at week 24, the mean lymphocyte counts stabilised and were maintained until week 72. No opportunistic/serious infections nor malignancies were reported with DMF treatment. The incidences of AEs, serious AEs, and discontinuation due to AEs were similar between the DMF and the placebo groups.Conclusion
The 72-week safety profile of DMF in Japanese patients with RRMS was consistent with previous studies that enrolled mostly Caucasian patients, with a lower incidence of flushing and related symptoms and a lower reduction in the lymphocyte count compared with previous reports.Trial Registration
ClinicalTrials.gov identifier NCT01838668.Funding
Biogen Japan Ltd.2.
Carl Todd DO 《Journal of bodywork and movement therapies》2018,22(2):281-286
Background
Chronic fatigue syndrome (CFS) is a general term used to describe a number of medical conditions that lead to persistent levels of fatigue and distress.Objectives
Osteopathic manipulative treatment (OMT) combined with shoulder exercises to resolve musculoskeletal sports injury may have also led to a reduction in pain and improved strength with the patient reporting a change in CFS levels.Clinical features
19-year-old male student, (statue 194cm and mass 80kg) who had played county level cricket and hockey. Presented with a two-year history of left shoulder pain (VAS 8/10) and a diagnosis of chronic fatigue syndrome.Intervention and outcomes
OMT was performed over four clinical visits throughout a four a month period. Management goal was pain reduction, neural regulation, and facilitation of breathing mechanics to improve lymphatic drainage and restoration of shoulder strength and control.Conclusion
Clinically a reduction in pain (VAS 8/10–0/10) over four treatments appeared to correlate with improved shoulder strength. It was also reported that due to pain reduction, CFS might have improved. 相似文献3.
Delia Colombo Giuseppe Banfi Nicoletta Cassano Alessandra Graziottin Gino Antonio Vena Giovanni Gualberto Fiori Emanuela Zagni Luca Stingeni Sergio Chimenti Enzo Berardesca Giuseppe Micali Giuseppe Albertini Clara De Simone Gilberto Bellia On behalf of the GENDER ATTENTION study group 《Advances in therapy》2017,34(6):1349-1363
Introduction
Female sex has been shown to be a risk factor for the development of adverse drug reactions; however, this has not been studied for cyclosporine (CsA). The aim of this study was to investigate, in Italian dermatological practice, the influence of gender and menopause and related hormones on the incidence of adverse events (AEs) during CsA treatment in psoriatic patients.Methods
Multicenter, prospective, observational study conducted from May 2011 to June 2013. Patients with plaque psoriasis, undergoing a new CsA administration course, or about to start it, were enrolled in the outpatient clinics of Italian dermatological centers. During the 2–6 months of study duration, patients had to note all AEs that occurred in a diary that was reviewed by the investigators at the follow-up visit. Sex hormone levels were measured within 7 days from the start date of a menstrual cycle.Results
A total of 969 adult psoriatic patients were enrolled in the study, divided into four cohorts: fertile women and corresponding age-matched men; postmenopausal women and corresponding age-matched men. A significant difference in the percentage of patients with AEs was observed between fertile and postmenopausal women, but not between women and age-matched men. AE incidence rate was about 37% higher in fertile women than in age-matched men and about 18% higher in postmenopausal women than in age-matched men, but differences were not statistically significant. Incidence rate ratio of fertile vs. postmenopausal women was 0.67, reaching statistical significance. AEs were mild or moderate in severity in the great majority of patients of all cohorts and postmenopausal women had significantly less grade 1–2 AEs compared to fertile women, but more grade 3–4 AEs. FSH levels were significantly higher in postmenopausal women reporting no AEs, and DHEA sulfate levels were about 10% higher in men with no AEs, compared to those reporting at least one AE. Cortisol levels were slightly though significantly higher in postmenopausal women with no AE.Conclusions
A better understanding of sex- and hormone-related influences on drug responses may help to improve drug safety and efficacy, by permitting one to tailor pharmacological treatments to individual subjects or defined patient cohorts.Funding
Novartis Farma S.p.A., Italy.4.
Huai Wu Yuan Ren Jie Ji Ya Jie Lin Han Feng Chen Guo Ping Peng Ben Yan Luo 《Clinical therapeutics》2018,40(12):2041-2049
Purpose
The differences of discontinuation risk between intensive and mild-to-moderate statin therapy in patients with acute ischemic stroke is not clear. This study aimed to clarify whether intensive statin therapy resulted in a significant increase in discontinuation early after discharge.Methods
This multicenter registry study enrolled consecutive hospitalized patients with ischemic stroke or transient ischemic attack. All the patients were prescribed statin therapy at discharge. Intensity of statin therapy was defined according to the 2013 American College of Cardiology/American Heart Association guideline on the treatment of blood cholesterol. A logistic regression model was used to analyze the association between statin therapy intensity and discontinuation.Findings
This study included 505 patients, of whom 64 and 441 received intensive and moderate statin therapy, respectively (mean follow-up, approximately 6 months). The rates of discontinuation of intensive and moderate statin therapy were 31.3% and 10.7% (P < 0.001), respectively. Variables with significant differences between the intensive and moderate statin therapy groups were included in the adjusted logistic regression model. Intensive statin therapy significantly increased discontinuation risk by 273.0% (odds ratio = 3.730; 95% CI, 2.013–6.911; P < .001) compared with moderate statin therapy. The result was consistent in most subgroups, except for patients with National Institutes of Health Stroke Scale scores ≥4.Implications
In stroke secondary prevention, intensive statin therapy may significantly increase the risk of early discontinuation compared with moderate statin therapy. Future clinical trials that involve a comparison between intensive and moderate statin therapy for stroke secondary prevention should address the differences in discontinuation between these 2 groups. 相似文献5.
Purpose
Omalizumab has demonstrated clinical efficacy in severe allergic asthma by reducing exacerbation rates and increasing quality of life. However, data concerning its sustained effect after treatment discontinuation are still needed.Methods
: This analysis was an observational pilot study (simple within-subjects design) of 12 patients experiencing severe asthma, treated with omalizumab, for 1 year after treatment discontinuation. We prospectively analyzed clinical measurements (pulmonary functions, inhaled corticosteroid [ICS] doses, Asthma Control Test [ACT] scores, skin prick test [SPT] positivity, fraction of exhaled nitric oxide, and exacerbation rates) and laboratory test results (eosinophils and total immunoglobulin E levels) at the time of discontinuation and 6 and 12 months thereafter. Baseline data (before the treatment period; range, 11–61 months) were collected retrospectively. The treatment effect until discontinuation was calculated. To determine its persistence, repeated measures were compared with baseline levels and analyzed by using a general linear model for repeated measures or the Friedman ANOVA, and χ2 tests in case of normality assumption violation or frequencies. Post hoc analysis was applied by using a simple or repeated contrasts analysis or Wilcoxon signed rank test with Bonferroni correction.Findings
: We proved a significant reduction in ICS doses and SPT reactivity and an increase in ACT score during the retrospective treatment phase. Moreover, persistence of these statistically significant effects was recorded 6 months after treatment discontinuation. ACT score and ICS doses (but not SPT reactivity) remained improved for 12 months after discontinuation of omalizumab treatment.Implications
Omalizumab treatment exhibited sustained treatment benefit after its discontinuation for patients experiencing severe allergic asthma. 相似文献6.
Purpose
Monotherapy with either aspirin or clopidogrel is recommended for long-term use after discontinuation of dual-antiplatelet therapy (DAPT) for acute coronary syndrome (ACS) management after percutaneous coronary intervention (PCI). The present study is to evaluate the cost-effectiveness of clopidogrel versus aspirin after 12-month DAPT for patients with ACS who underwent PCI in China.Methods
A 2-part model was developed to estimate the cost-effectiveness of clopidogrel compared with aspirin. The short-term part was a decision tree that included health states such as myocardial infarction (MI), stroke, MI and stroke, cardiovascular death, and death from other causes with a treatment horizon of 1 year (base case), 2 years or 3 years after 12-month DAPT. Major bleeding was included. The long-term (lifetime) part was a Markov model that included different health states such as MI, after MI, stroke, after stroke, and death. Drug acquisition cost and other direct medical costs were based on pricing records, literature, and expert panels. Clinical outcomes and utilities were based on literature. The model output included incremental cost-effectiveness ratio of quality-adjusted life-years (QALYs) and total costs per patient. Both 1-way sensitivity analysis and probabilistic sensitivity analysis (PSA) were conducted.Findings
In the base–case scenario, the total costs of the treatment with clopidogrel and aspirin were ¥12,590 ($1849/€1590) and ¥10,642 ($1563/€1344), respectively; the total QALYs of the 2 patient populations were 9.7341 and 9.6894, respectively. The incremental cost-effectiveness ratio of ¥43,593 ($6402/€5515) per QALY gained was lower than 3 times of gross domestic product (GDP) per capita in China (¥161,940, $23,786/€20,449). Both 1-way sensitivity analysis and PSA confirmed the robustness of the results. PSA results indicated that clopidogrel was cost effective versus aspirin in 80.5% of the simulations, considering >3 times the GDP per capita as the threshold. Results in other scenarios (clopidogrel or aspirin for 2 or 3 years after 12-month DAPT) also indicated that clopidogrel was more cost effective than aspirin for patients with ACS after 12-month DAPT.Implications
Compared with aspirin monotherapy, clopidogrel monotherapy for 1 year after 12-month DAPT was cost effective for patients with ACS who underwent PCI in China. Furthermore, when the duration of clopidogrel the monotherapy extended up to 3 years, clopidogrel was still cost effective compared with aspirin. The study was limited by lack of high-quality efficacy data among the Chinese population. 相似文献7.
James G. Krueger Leon Kircik Firas Hougeir Adam Friedman Xiaojun You Nisha Lucas Steven J. Greenberg Marianne Sweetser Wanda Castro-Borrero Peter McCroskery Jacob Elkins 《Advances in therapy》2016,33(7):1231-1245
Introduction
Cutaneous adverse events (AEs) have been observed in clinical studies of daclizumab high-yield process (HYP) in relapsing-remitting multiple sclerosis (RRMS). Here, we report cutaneous AEs observed in the randomized, double-blind, active-comparator DECIDE study (ClinicalTrials.gov identifier, NCT01064401).Methods
DECIDE was a randomized, double-blind, active-controlled phase 3 study of daclizumab HYP 150 mg subcutaneous every 4 weeks versus interferon (IFN) beta-1a 30 mcg intramuscular (IM) once weekly in RRMS. Treatment-emergent AEs were classified and recorded by investigators. Investigators also assessed the severity of each AE, and whether it met the criteria for a serious AE. Cutaneous AEs were defined as AEs coded to the Medical Dictionary for Regulatory Activities System Organ Class of skin and subcutaneous tissue disorders. The incidence, severity, onset, resolution, and management of AEs were analyzed by treatment group.Results
Cutaneous AEs were reported in 37% of daclizumab HYP-treated patients and 19% of IFN beta-1a-treated patients. The most common investigator-reported cutaneous AEs with daclizumab HYP were rash (7%) and eczema (4%). Most patients with cutaneous AEs remained on treatment (daclizumab HYP, 81%; IM IFN beta-1a, 90%) and had events that were mild or moderate (94% and 98%) and subsequently resolved (78% and 82%). Most patients with cutaneous AEs did not require treatment with corticosteroids or were treated with topical corticosteroids (daclizumab HYP, 73%; IM IFN beta-1a, 81%). Serious cutaneous AEs were reported in 14 (2%) daclizumab HYP patients and one (<1%) IM IFN beta-1a patient.Conclusion
There was an increased risk of cutaneous AEs with daclizumab HYP. While physicians should be aware of the potential for serious cutaneous AEs, the typical cutaneous AEs were mild-to-moderate in severity, manageable, and resolved over time.Funding
Biogen and AbbVie Biotherapeutics Inc.Trial registration
ClinicalTrials.gov identifier, NCT01064401.8.
Kamal Medlej Amin Antoine Kazzi Ahel El Hajj Chehade Mothana Saad Eldine Ali Chami Rana Bachir Dina Zebian Gilbert Abou Dagher 《The Journal of emergency medicine》2018,54(1):47-53
Background
The placement of a central venous catheter for the administration of vasopressors is still recommended and required by many institutions because of concern about complications associated with peripheral administration of vasopressors.Objective
Our aim was to determine the incidence of complications from the administration of vasopressors through peripheral venous catheters (PVC) in patients with circulatory shock, and to identify the factors associated with these complications.Methods
This was a prospective, observational study conducted in the emergency department (ED) of a tertiary care medical center. Patients presenting to the ED with circulatory shock and in whom a vasopressor was started through a PVC were included. Research fellows examined the i.v. access site for complications twice daily during the period of peripheral vasopressor administration, then daily up to 48 h after treatment discontinuation or until the patient expired.Results
Of the 55 patients that were recruited, 3 (5.45% overall, 6% of patients receiving norepinephrine) developed complications; none were major. Two developed local extravasation and one developed local thrombophlebitis. All three complications occurred during the vasopressor infusion, none in the 48 h after discontinuation, and none required any medical or surgical intervention. Two of the three complications occurred in the hand, and all occurred in patients receiving norepinephrine and with 20-gauge catheters.Conclusions
The incidence of complications from the administration of vasopressors through a PVC is small and did not result in significant morbidity in this study. Larger prospective studies are needed to better determine the factors that are associated with these complications, and identify patients in whom this practice is safe. 相似文献9.
Krista Beth Highland Audrey Schoomaker Winifred Rojas Josh Suen Ambareen Ahmed Zhiwei Zhang Sarah Fink Carlin Christian E. Calilung Michael Kent Christin McDonough Chester C. Buckenmaier 《Archives of physical medicine and rehabilitation》2018,99(1):91-98
Objective
To examine the feasibility and preliminary effectiveness of an individualized yoga program.Design
Pilot randomized controlled trial.Setting
Military medical center.Participants
Patients (N=68) with chronic low back pain.Interventions
Restorative Exercise and Strength Training for Operational Resilience and Excellence (RESTORE) program (9–12 individual yoga sessions) or treatment as usual (control) for an 8-week period.Main Outcome Measures
The primary outcome was past 24-hour pain (Defense & Veterans Pain Rating Scale 2.0). Secondary outcomes included disability (Roland-Morris Disability Questionnaire) and physical functioning and symptom burden (Patient-Reported Outcomes Measurement Information System-29 subscales). Assessment occurred at baseline, week 4, week 8, 3-month follow-up, and 6-month follow-up. Exploratory outcomes included the proportion of participants in each group reporting clinically meaningful changes at 3- and 6-month follow-ups.Results
Generalized linear mixed models with sequential Bonferroni-adjusted pairwise significance tests and chi-square analyses examined longitudinal outcomes. Secondary outcome significance tests were Bonferroni adjusted for multiple outcomes. The RESTORE group reported improved pain compared with the control group. Secondary outcomes did not retain significance after Bonferroni adjustments for multiple outcomes, although a higher proportion of RESTORE participants reported clinically meaningfully changes in all outcomes at 3-month follow-up and in symptom burden at 6-month follow-up.Conclusions
RESTORE may be a viable nonpharmacological treatment for low back pain with minimal side effects, and research efforts are needed to compare the effectiveness of RESTORE delivery formats (eg, group vs individual) with that of other treatment modalities. 相似文献10.
Alexandra E. Jacob Darryl L. Kaelin Abbey R. Roach Craig H. Ziegler Kathrin LaFaver 《PM & R》2018,10(11):1164-1172
Background
Functional movement disorders (FMDs) are conditions of abnormal motor control thought to be caused by psychological factors. These disorders are commonly seen in neurologic practice, and prognosis is often poor. No consensus treatment guidelines have been established; however, the role of physical therapy in addition to psychotherapy has increasingly been recognized. This study reports patient outcomes from a multidisciplinary FMD treatment program using motor retraining (MoRe) strategies.Objective
To assess outcomes of FMD patients undergoing a multidisciplinary treatment program and determine factors predictive of treatment success.Design
Retrospective chart review.Setting
University-affiliated rehabilitation institute.Patients
Thirty-two consecutive FMD patients admitted to the MoRe program from July 2014–July 2016.Intervention
Patients participated in a 1-week, multidisciplinary inpatient treatment program with daily physical, occupational, speech therapy, and psychotherapy interventions.Main Outcome Measurements
Primary outcome measures were changes in the patient-rated Clinical Global Impression Scale (CGI) and the physician-rated Psychogenic Movement Disorder Rating Scale (PMDRS) based on review of standardized patient videos. Measurements were taken as part of the clinical evaluation of the program.Results
Twenty-four of the 32 patients were female with a mean age of 49.1 (±14.2) years and mean symptom duration of 7.4 (±10.8) years. Most common movement phenomenologies were abnormal gait (31.2%), hyperkinetic movements (31.2%), and dystonia (31.2%). At discharge, 86.7% of patients reported symptom improvement on the CGI, and self-reported improvement was maintained in 69.2% at the 6-month follow-up. PMDRS scores improved by 59.1% from baseline to discharge. Longer duration of symptoms, history of abuse, and comorbid psychiatric disorders were not significant predictors of treatment outcomes.Conclusions
The majority of FMD patients experienced improvement from a 1-week multidisciplinary inpatient rehabilitation program. Treatment outcomes were not negatively correlated with longer disease duration or psychiatric comorbidities. The results from our study are encouraging, although further long-term prospective randomized studies are needed.Level of Evidence
III 相似文献11.
Theodore Wein Alberto Esquenazi Wolfgang H. Jost Anthony B. Ward Grace Pan Rozalina Dimitrova 《PM & R》2018,10(7):693-703
Background
Poststroke distal lower limb spasticity impairs mobility, limiting activities of daily living and requiring additional caregiver time.Objective
To evaluate the efficacy, safety, and sustained benefit of onabotulinumtoxinA in adults with poststroke lower limb spasticity (PSLLS).Design
A multicenter, randomized, double-blind, phase 3, placebo-controlled trial (NCT01575054).Setting
Sixty study centers across North America, Europe, Russia, the United Kingdom, and South Korea.Patients
Adult patients (18-65 years of age) with PSLLS (Modified Ashworth Scale [MAS] ≥3) of the ankle plantar flexors and the most recent stroke ≥3 months before study enrollment.Interventions
During the open-label phase, patients received ≤3 onabotulinumtoxinA treatments (≤400 U) or placebo at approximately 12-week intervals. Treatments were into the ankle plantar flexors (onabotulinumtoxinA 300 U into ankle plantar flexors; ≤100 U, optional lower limb muscles).Main Outcome Measurements
The double-blind primary endpoint was MAS change from baseline (average score at weeks 4 and 6). Secondary measures included physician-assessed Clinical Global Impression of Change (CGI), MAS change from baseline in optional muscles, Goal Attainment Scale (GAS), and pain scale.Results
Of 468 patients enrolled, 450 (96%) completed the double-blind phase and 413 (88%) completed the study. Small improvements in MAS observed with onabotulinumtoxinA during the double-blind phase (onabotulinumtoxinA, –0.8; placebo, –0.6, P = .01) were further enhanced with additional treatments through week 6 of the third open-label treatment cycle (onabotulinumtoxinA/onabotulinumtoxinA, –1.2; placebo/onabotulinumtoxinA, –1.4). Small improvements in CGI observed during the double-blind phase (onabotulinumtoxinA, 0.9; placebo, 0.7, P = .01) were also further enhanced through week 6 of the third open-label treatment cycle (onabotulinumtoxinA/onabotulinumtoxinA, 1.6; placebo/onabotulinumtoxinA, 1.6). Physician- and patient-assessed GAS scores improved with each subsequent treatment. No new safety signals emerged.Conclusions
OnabotulinumtoxinA significantly improved ankle MAS, CGI, and GAS scores compared with placebo; improvements were consistent and increased with repeated treatments of onabotulinumtoxinA over 1 year in patients with PSLLS.Level of Evidence
I 相似文献12.
Hiroaki Watanabe Takuya Odagiri Yasuyuki Asai 《Journal of pain and symptom management》2018,55(6):1546-1549
Context
Acute suppurative sialadenitis (hereafter referred to as sialadenitis) is accompanied by pain and fever and can diminish the quality of life in end-stage cancer patients; however, its incidence is not clear.Objectives
We conducted this study to elucidate the incidence of sialadenitis in end-stage cancer patients.Methods
Retrospective review and observational study based on patients' medical records.Subjects
About 726 consecutive cancer patients who died on the palliative care unit of our hospital between April 2012 and November 2016 were included.Measurements
Median duration between sialadenitis onset and death, concomitant treatment, average infusion volume per day, site of onset, symptoms, effectiveness of antibiotic treatment, and mean duration until symptomatic relief.Results
The incidence of sialadenitis was 2.9% (21 of 726 cases). The median duration from onset to death was 20 days (range 2–112); concomitant treatment included opioids in 11 patients (55%), anticholinergic drugs in six patients (28%), steroids in three patients (14%), and oxygen inhalation in five patients (23%); average infusion volume per day was 588 ± 307 mL; site of onset was submandibular gland in 12 patients (57%) and parotid gland in nine patients (42%); and symptoms were pain in 18 patients (85%) and fever in 13 patients (61%). Antibiotic treatment was administered in 18 patients (85%), and the mean duration until symptomatic relief was 4.0 ± 1.5 days.Conclusion
Sialadenitis is a rare complication in end-stage cancer patients; however, it is important to recognize that it can be associated with severe symptoms, including fever and pain. 相似文献13.
Mingxing Zhao Wei Gao Long Zhang Wei Huang Sihua Zheng Guanliang Wang Brian Y. Hong Baoyong Tang 《PM & R》2018,10(1):36-44
Background
Ankle sprains occur frequently among young and active people, accounting for almost 2 million injuries per year. Previous reports suggest that acupressure therapy for acute ankle sprains may shorten the recovery time.Objective
To evaluate whether acupressure therapy can improve ankle sprain recovery compared with standard RICE (rest, ice, compression, and elevation) treatment.Design
A randomized controlled trial was conducted. The study protocol was registered in the Chinese Clinical Trial Registry with the study registration number: ChiCTR-TRC-14004794.Setting
Department of Traditional Chinese Medicine Orthopedics, PLA No.60 Center Hospital, Dali, China, and Department of Orthopedics, Xixi Hospital of Hangzhou, Hangzhou China, between June 2014 and January 2016.Patients
A total of 68 patients with acute ankle sprains were assessed for study eligibility, and a total of 62 patients were included in the present study.Methods
All patients with ankle sprains seen by the Orthopedics Department within 48 hours since the time of injury were identified. Consenting patients were randomized to either (1) standard treatment (ST group), (2) standard treatment + acupressure (AP group), or (3) standard treatment + mock acupressure (mock AP group).Main Outcome Measurements
Outcomes of interest included a volumetric measurement of the foot, ankle, and lower leg), range of ankle movement, and visual analog pain scores. The American Orthopedic Foot and Ankle Score) and SF12v2 scores were used to assess quality of life.Results
Among the 62 randomized patients, the mean (95% confidence interval [CI]) volumetric measurement of the foot, ankle, and lower leg in the AP group decreased from 185.24 (95% CI 142.80-227.67) to 62.14 (95% CI 44.03-80.25) after 3 sessions of acupressure treatment. This was a statistically significant difference (P < .01) compared with the means of ST group (119.00; 95% CI 89.14-148.86) and mock AP group (118.18; 95% CI 83.99-152.37). After the first treatment, the mean range of ankle movement, visual analog pain scores, and American Orthopedic Foot and Ankle Scores of the AP group were 31.67 (95% CI 27.78-35.55), 3.33 (95% CI 2.97-3.70), and 55.86 (95% CI 50.03-61.69), respectively. These scores were statistically better (P < .01) than the mean of the ST and mock AP group scores. In addition, the mean SF12v2 scores of AP group at 4 and 8 weeks were 109.95 (95% CI 107.29-112.62) and 119.67 (95% CI 119.27-120.05), respectively. These scores were also significantly greater than those of the ST group and mock AP groups (P < .01).Conclusion
Acupressure therapy may improve recovery after acute ankle sprain injury, yielding shortened time of disability and improved quality of life.Level of Evidence
I 相似文献14.
Pradeep Suri Kristin Delaney Sean D. Rundell Daniel C. Cherkin 《Archives of physical medicine and rehabilitation》2018,99(8):1533-1539.e2
Objective
To examine the predictive validity of the Subgrouping for Targeted Treatment (STarT Back) tool for classifying people with back pain into categories of low, medium, and high risk of persistent disabling back pain in U.S. primary care.Design
Secondary analysis of data from participants receiving usual care in a randomized clinical trial.Setting
Primary care clinics.Participants
Adults (N = 1109) ≥18 years of age with back pain. Those with specific causes of back pain (pregnancy, disc herniation, vertebral fracture, spinal stenosis) and work-related injuries were not included.Interventions
Not applicable.Main Outcome Measures
The original 9-item version of the STarT Back tool, administered at baseline, stratified patients by their risk (low, medium, high) of persistent disabling back pain (STarT Back risk group). Persistent disabling back pain was defined as Roland-Morris Disability Questionnaire scores of ≥7 at 6-month follow-up.Results
The STarT Back risk group was a significant predictor of persistent disabling back pain (P<.0001) at 6-month follow-up. The proportion of individuals with persistent disabling back pain at follow-up was 22% (95% confidence interval [CI] 18-25) in the low-risk group, 62% (95% CI 57-67) in the medium-risk group, and 80% (95% CI 75-85) in the high-risk group. The relative risk of persistent disabling back pain was 2.9 (95% CI 2.4-3.5) in the medium-risk group compared to the low-risk group, and 3.7 (95% CI 3.1-4.4) in the high-risk group.Conclusions
The STarT Back risk groups successfully separated people with back pain into distinct categories of risk for persistent disabling back pain at 6-month follow-up in U.S. primary care. These results were very similar to those in the original STarT Back validation study. This validation study is a necessary first step toward identifying whether the entire STarT Back approach, including matched/targeted treatment, can be effectively used for primary care in the United States. 相似文献15.
Gregory E. Lutz Michael R. Nicoletti George E. Cyril Julian R. Harrison Christopher Lutz Jennifer L. Solomon Paul M. Cooke James F. Wyss Richard J. Herzog Peter J. Moley 《PM & R》2018,10(3):245-253
Background
Although lumbar zygapophyseal joint synovial cysts are fairly well recognized, they are an uncommon cause of lumbosacral radicular pain. Nonoperative treatments include percutaneous aspiration of the cysts under computed tomography or fluoroscopic guidance with a subsequent corticosteroid injection. However, there are mixed results in terms of long-term outcomes and cyst reoccurrence. This study prospectively evaluates percutaneous ruptures of zygapophyseal joint (Z-joint) synovial cysts for the treatment of lumbosacral radicular pain.Objectives
Primary: To determine whether percutaneous rupture of symptomatic Z-joint synovial cysts leads to sustained improvements in radicular pain and function. Secondary: To assess the rates of cyst recurrence and progression to surgical intervention following percutaneous rupture of symptomatic Z-joint synovial cysts.Design
Prospective cohort study.Setting
Outpatient academic spine practice.Participants
Adults with primary radicular pain due to a facet synovial cyst.Methods
Participants underwent fluoroscopically guided percutaneous Z-joint synovial cyst ruptures under standard-of-care practice. Data on pain, physical function, satisfaction, and progression to surgery were collected at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after rupture. An intention-to-treat analysis was used for assessment of patient-reported outcome measures.Main Outcome Measures
The Numerical Rating Scale, Oswestry Disability Index, and modified North American Spine Society questionnaires were used to measure pain, function, and satisfaction with the procedure, respectively.Results
Thirty-five participants were included in the study, and data were analyzed by an independent researcher. Statistically significant changes in Oswestry Disability Index were reported at 2 weeks, 3 months, and 1 year postintervention (P = .034, .040, and .039, respectively). A statistically and clinically significant relief of current pain was reported at 2 weeks (P = .025) and 6 weeks (P = .014) with respect to baseline. Patients showed significant improvements for best pain at 6 weeks with respect to baseline (P = .031). Patients’ worst pain showed the greatest amount of improvement with clinically meaningful changes at all time points compared with baseline. Patient-reported satisfaction was found nearly 70% of the time at all time points. Forty percent (14/35) of participants required repeat cyst rupture, and 31% (11/35) required surgical interventions.Conclusions
There were statistically and clinically significant improvements in pain and function after percutaneous rupture of Z-joint synovial cysts. In addition, the outcomes support previous retrospective studies indicating that approximately 40% of patients will need surgery. This study provides further research to determine the utility of this procedure and to precisely define a subset of ideal candidates.Level of Evidence
Level II. 相似文献16.
17.
Jasper D. Bier Janneke J.W. Sandee-Geurts Raymond W.J.G. Ostelo Bart W. Koes Arianne P. Verhagen 《Archives of physical medicine and rehabilitation》2018,99(1):65-71
Objective
To evaluate whether current Dutch primary care clinicians offer tailored treatment to patients with low back pain (LBP) or neck pain (NP) according to their risk stratification, based on the Keele STarT (Subgroup Targeted Treatment) Back-Screening Tool (SBT).Design
Prospective cohort study with 3-month follow-up.Setting
Primary care.Participants
General practitioners (GPs) and physiotherapists included patients (N=284) with nonspecific LBP, NP, or both.Interventions
Patients completed a baseline questionnaire, including the Dutch SBT, for either LBP or NP. A follow-up measurement was conducted after 3 months to determine recovery (using Global Perceived Effect Scale), pain (using Numeric Pain Rating Scale), and function (using Roland Disability Questionnaire or Neck Disability Index). A questionnaire was sent to the GPs and physiotherapists to evaluate the provided treatment.Main Outcome Measures
Prevalence of patients' risk profile and clinicians' applied care, and the percentage of patients with persisting disability at follow-up. A distinction was made between patients receiving the recommended treatment and those receiving the nonrecommended treatment.Results
In total, 12 GPs and 33 physiotherapists included patients. After 3 months, we analyzed 184 patients with LBP and 100 patients with NP. In the LBP group, 52.2% of the patients were at low risk for persisting disability, 38.0% were at medium risk, and 9.8% were at high risk. Overall, 24.5% of the patients with LBP received a low-risk treatment approach, 73.5% a medium-risk, and 2.0% a high-risk treatment approach. The specific agreement between the risk profile and the received treatment for patients with LBP was poor for the low-risk and high-risk patients (21.1% and 10.0%, respectively), and fair for medium-risk patients (51.4%). In the NP group, 58.0% of the patients were at low risk for persisting disability, 37.0% were at medium risk, and 5.0% were at high risk. Only 6.1% of the patients with NP received the low-risk treatment approach. The medium-risk treatment approach was offered the most (90.8%), and the high-risk approach was applied in only 3.1% of the patients. The specific agreement between the risk profile and received treatment for patients with NP was poor for low-risk and medium-risk patients (6.3% and 48.0%, respectively); agreement for high-risk patients could not be calculated.Conclusions
Current Dutch primary care for patients with nonspecific LBP, NP, or both does not correspond to the recommended stratified-care approach based on the SBT, as most patients receive medium-risk treatment. Most low-risk patients are overtreated, and most high-risk patients are undertreated. Although the stratified-care approach has not yet been validated in Dutch primary care, these results indicate there may be substantial room for improvement. 相似文献18.
Francisco Rodriguez-Fontan Nicolas S. Piuzzi Matthew J. Kraeutler Cecilia Pascual-Garrido 《PM & R》2018,10(12):1353-1359
Background
Bone marrow aspirate concentrate (BMC) is one of the few cell-based therapies available as a possible biological treatment for early osteoarthritis (OA). Its efficacy, safety, and benefit compared with other treatments are still to be determined.Objective
To assess the clinical outcomes of patients undergoing intra-articular injection of BMC for the treatment of early knee and hip OA.Design
Prospective, cohort study.Setting
Single institution, quaternary level of care.Patients
Nineteen patients (16 female and 3 male), totaling 25 joints (10 knees, 15 hips), treated with intra-articular BMC for early OA between 2014 and 2016. The mean age at time of the procedure was 58 ± 12.7 years (range, 30-80 years). The mean follow-up was 13.2 ± 6.3 months (range, 6-24 months). Inclusion criteria included ≥18 years; knee OA, Kellgren–Lawrence grade I-II; hip OA, Tönnis grade I-II; first-time intra-articular BMC therapy, after unsuccessful symptomatic and conservative treatments (ie, physical therapy, analgesics and anti-inflammatory drugs) for 6 months. Exclusion criteria included pregnancy; malignancy; rheumatologic diseases; infection; Kellgren–Lawrence grade III-IV; Tönnis grade III; and previous intra-articular injections or surgery.Interventions
All patients had autologous bone marrow aspirate harvested from the iliac crest and centrifuged to achieve BMC, for intra-articular injection.Main Outcome Measurements
The hypothesis was formulated before the study. Patient-reported outcomes measures were assessed preoperatively and at last follow-up using the Western Ontario and McMaster Universities Arthritis Index.Results
Western Ontario and McMaster Universities Arthritis Index improved from a baseline of 40.8 ± 18.3% to 20.6 ± 17% (P < .001) at final follow-up. The satisfaction rate was 63.2%. The minimal clinically important difference threshold of 9.15 points was reached by 64% of the patients. Two patients were converted to total hip arthroplasty at 8 months after BMC injection.Conclusions
Intra-articular injections of BMC for the treatment of early knee or hip OA were safe and demonstrated satisfactory results in 63.2% of patients. Future studies are necessary to determine the efficacy of this technique and its safety profile.Level of Evidence
II 相似文献19.
Gema Bodes Pardo Enrique Lluch Girbés Nathalie A. Roussel Tomás Gallego Izquierdo Virginia Jiménez Penick Daniel Pecos Martín 《Archives of physical medicine and rehabilitation》2018,99(2):338-347
Objective
To assess the effect of a pain neurophysiology education (PNE) program plus therapeutic exercise (TE) for patients with chronic low back pain (CLBP).Design
Single-blind randomized controlled trial.Setting
Private clinic and university.Participants
Patients with CLBP for ≥6 months (N=56).Interventions
Participants were randomized to receive either a TE program consisting of motor control, stretching, and aerobic exercises (n=28) or the same TE program in addition to a PNE program (n=28), conducted in two 30- to 50-minute sessions in groups of 4 to 6 participants.Main Outcomes Measures
The primary outcome was pain intensity rated on the numerical pain rating scale which was completed immediately after treatment and at 1- and 3-month follow-up. Secondary outcome measures were pressure pain threshold, finger-to-floor distance, Roland-Morris Disability Questionnaire, Pain Catastrophizing Scale, Tampa Scale for Kinesiophobia, and Patient Global Impression of Change.Results
At 3-month follow-up, a large change in pain intensity (numerical pain rating scale: ?2.2; ?2.93 to ?1.28; P<.001; d=1.37) was observed for the PNE plus TE group, and a moderate effect size was observed for the secondary outcome measures.Conclusions
Combining PNE with TE resulted in significantly better results for participants with CLBP, with a large effect size, compared with TE alone. 相似文献20.
Charles Quesada Benjamin Pommier Camille Fauchon Claire Bradley Christelle Créac’h François Vassal Roland Peyron 《Archives of physical medicine and rehabilitation》2018,99(11):2203-2215.e1