Shoulder movement after breast cancer surgery: results of a randomised controlled study of postoperative physiotherapy

Breast screening programmes have facilitated more conservative approaches to the surgical and radiotherapy management of women diagnosed with breast cancer. This study investigated changes in shoulder movement after surgery for primary, operable breast cancer to determine the effect of elective physiotherapy intervention. Sixty-five women were randomly assigned to either the treatment (TG) or control group (CG) and assessments were completed preoperatively, at day 5 and at 1 month, 3, 6, 12 and 24 months postoperatively. The CG only received an exercise instruction booklet in comparison to the TG who received the Physiotherapy Management Care Plan (PMCP). Analyses of variance revealed that abduction returned to preoperative levels more quickly in the TG than in the CG. The TG women had 14degrees more abduction at 3 months and 7degrees at 24 months. Functional recovery at 1 month was greater in those randomised to the TG, with a dominant operated arm (OA) or receiving breast-conserving surgery. However, it was not possible to predict recovery over the 2 years postoperatively on the basis of an individual woman's recovery at 1 month postoperatively. The eventual recovery of abduction or flexion range of movement was not related to the dominance of the OA nor to the surgical procedure performed. The PMCP provided in the early postoperative period is effective in facilitating and maintaining the recovery of shoulder movement over the first 2 years after breast cancer surgery.

Physiotherapy after breast cancer surgery: results of a randomised controlled study to minimise lymphoedema

The development of secondary arm lymphoedema after the removal of axillary lymph nodes remains a potential problem for women with breast cancer. This study investigated the incidence of arm lymphoedema following axillary dissection to determine the effect of prospective monitoring and early physiotherapy intervention. Sixty-five women were randomly assigned to either the treatment (TG) or control group (CG) and assessments were made preoperatively, at day 5 and at 1, 3, 6, 12 and 24 months postoperatively. Three measurements were used for the detection of arm lymphoedema: arm circumferences (CIRC), arm volume (VOL) and multi-frequency bioimpedance (MFBIA). Clinically significant lymphoedema was confirmed by an increase of at least 200 ml from the preoperative difference between the two arms. Using this definition, the incidence of lymphoedema at 24 mo. was 21%, with a rate of 11% in the TG compared to 30% in the CG. The CIRC or MFBIA methods failed to detect lymphoedema in up to 50% of women who demonstrated an increase of at least 200 ml in the VOL of the operated arm compared to the unoperated arm. The physiotherapy intervention programme for the TG women included principles for lymphoedema risk minimisation and early management of this condition when it was identified. These strategies appear to reduce the development of secondary lymphoedema and alter its progression in comparison to the CG women. Monitoring of these women is continuing and will determine if these benefits are maintained over a longer period for women with early lymphoedema after breast cancer surgery.

Telemedicine for new neurological outpatients: putting a randomized controlled trial in the context of everyday practice

In a retrospective review, the telemedical management of 65 outpatients from a randomized controlled trial (RCT) of telemedicine for non-urgent referrals to a consultant neurologist was compared with the management of 76 patients seen face to face in the same trial, with that of 150 outpatients seen in the neurology clinics of district general hospitals and with that of 102 neurological outpatients seen by general physicians. Outcome measures were the numbers of investigations and of patient reviews. The telemedicine group did not differ significantly from the 150 patients seen face to face by neurologists in hospital clinics in terms of either the number of investigations or the number of reviews they received. Patients from the RCT seen face to face had significantly fewer investigations but a similar number of reviews to the other 150 patients seen face to face by neurologists (the disparity in the number of investigations may explain the negative result for telemedicine in that RCT). Patients with neurological symptoms assessed by general physicians had significantly more investigations and were reviewed significantly more often than all the other groups. Patients from the RCT seen by telemedicine were not managed significantly differently from those seen face to face by neurologists in hospital clinics but had significantly fewer investigations and follow-ups than those patients managed by general physicians. The results suggest that management of new neurological outpatients by neurologists using telemedicine is similar to that by neurologists using a face-to-face consultation, and is more efficient than management by general physicians.

Reactogenicity of yellow fever vaccines in a randomized, placebo-controlled trial

OBJECTIVE: To compare the reactogenicity of three yellow fever (YF) vaccines from WHO-17D and Brazilian 17DD substrains (different seed-lots) and placebo. METHODS: The study involved 1,087 adults eligible for YF vaccine in Rio de Janeiro, Brazil. Vaccines produced by Bio-Manguinhos, Fiocruz (Rio de Janeiro, Brazil) were administered ("day 0") following standardized procedures adapted to allow blinding and blocked randomization of participants to coded vaccine types. Adverse events after immunization were ascertained in an interview and in diary forms filled in by each participant. Liver enzymes were measured on days 0, 4-20 and 30 of the study. Viremia levels were measured on days 4 to 20 of follow-up. The immune response was verified through serologic tests. RESULTS: Participants were mostly young males. The seroconversion rate was above 98% among those seronegative before immunization. Compared to placebo, the excess risk of any local adverse events ranged from 0.9% to 2.5%, whereas for any systemic adverse events it ranged from 3.5% to 7.4% across vaccine groups. The excess risk of events leading to search for medical care or to interruption of work activities ranged from 2% to 4.5%. Viremia was detected in 3%-6% of vaccinees up to 10 days after vaccination. Variations in liver enzyme levels after vaccination were similar in placebo and vaccine recipients. CONCLUSIONS: The frequency of adverse events post-immunization against YF, accounting for the background occurrence of nonspecific signs and symptoms, was shown for the first time to be similar for vaccines from 17D and 17DD substrains. The data also provided evidence against viscerotropism of vaccine virus.

Short- and medium-term effects of manual therapy on cervical active range of motion and pressure pain sensitivity in latent myofascial pain of the upper trapezius muscle: a randomized controlled trial

Objective: The purpose of this study was to investigate effects of different manual techniques on cervical ranges of 17 motion and pressure pain sensitivity in subjects with latent trigger point of the upper trapezius muscle. 18 Methods: One hundred seventeen volunteers, with a unilateral latent trigger point on upper trapezius due to computer 19 work, were randomly divided into 5 groups: ischemic compression (IC) group (n = 24); passive stretching group (n = 20 23); muscle energy technique group (n = 23); and 2 control groups, wait-and-see group (n = 25) and placebo group 21 (n = 22). Cervical spine range of movement was measured using a cervical range of motion instrument as well as 22 pressure pain sensitivity by means of an algometer and a visual analog scale. Outcomes were assessed pretreatment, 23 immediately, and 24 hours after the intervention and 1 week later by a blind researcher. A 4 × 5 mixed repeated- 24 measures analysis of variance was used to examine the effects of the intervention and Cohen d coefficient was used. 25 Results: A group-by-time interaction was detected in all variables (P b .01), except contralateral rotation. The 26 immediate effect sizes of the contralateral flexion, ipsilateral rotation, and pressure pain threshold were large for 3 27 experimental groups. Nevertheless, after 24 hours and 1 week, only IC group maintained the effect size. 28 Conclusions: Manual techniques on upper trapezius with latent trigger point seemed to improve the cervical range of 29 motion and the pressure pain sensitivity. These effects persist after 1 week in the IC group. (J Manipulative Physiol 301 Ther 2013;xx:1-10)

Development and Assessment of an E-Learning Course on Breast Imaging for Radiographers: A Stratified Randomized Controlled Trial

Background: Mammography is considered the best imaging technique for breast cancer screening, and the radiographer plays an important role in its performance. Therefore, continuing education is critical to improving the performance of these professionals and thus providing better health care services. Objective: Our goal was to develop an e-learning course on breast imaging for radiographers, assessing its efficacy , effectiveness, and user satisfaction. Methods: A stratified randomized controlled trial was performed with radiographers and radiology students who already had mammography training, using pre- and post-knowledge tests, and satisfaction questionnaires. The primary outcome was the improvement in test results (percentage of correct answers), using intention-to-treat and per-protocol analysis. Results: A total of 54 participants were assigned to the intervention (20 students plus 34 radiographers) with 53 controls (19+34). The intervention was completed by 40 participants (11+29), with 4 (2+2) discontinued interventions, and 10 (7+3) lost to follow-up. Differences in the primary outcome were found between intervention and control: 21 versus 4 percentage points (pp), P<.001. Stratified analysis showed effect in radiographers (23 pp vs 4 pp; P=.004) but was unclear in students (18 pp vs 5 pp; P=.098). Nonetheless, differences in students’ posttest results were found (88% vs 63%; P=.003), which were absent in pretest (63% vs 63%; P=.106). The per-protocol analysis showed a higher effect (26 pp vs 2 pp; P<.001), both in students (25 pp vs 3 pp; P=.004) and radiographers (27 pp vs 2 pp; P<.001). Overall, 85% were satisfied with the course, and 88% considered it successful. Conclusions: This e-learning course is effective, especially for radiographers, which highlights the need for continuing education.

Hepatitis B vaccine in infants: a randomized controlled trial comparing gluteal versus anterolateral thigh muscle administration

A significantly diminished antibody response to hepatitis B vaccine has been demonstrated in adults when the buttock is used as the injection site. However, in Brazil, the buttock continues to be recommended as site of injection for intramuscular administration of vaccines in infants. In this age group, there are no controlled studies evaluating the immunogenicity of the hepatitis B vaccine when administered at this site. In the present study, 258 infants were randomized to receive the hepatitis B vaccine either in the buttock (n = 123) or in the anterolateral thigh muscle (n = 135). The immunization schedule consisted of three doses of hepatitis B vaccine (Engerix Bâ, 10 mug) at 2, 4 and 9 months of age. There were no significant differences in the proportion of seroconversion (99.3% x 99.2%), or in the geometric mean titer of ELISA anti-HBs (1,862.1 x 1,229.0 mIU/mL) between the two groups. This study demonstrates that a satisfactory serological response can be obtained when the hepatitis B vaccine is administered intramuscularly into the buttock.

Effects of microcurrents and physical exercise on the abdominal fat: a randomized controlled trial in patients with coronary artery disease

Objectives: Coronary artery disease are associated with decreased levels of physical activity, contributing to increases in abdominal fat and consequently the metabolic risk. The use of microcurrents is an innovative and effective method to increase lipolytic rate of abdominal adipocytes. This study aims to investigate the effects of microcurrents with a homebased exercise program on total, subcutaneous and visceral abdominal adipose tissue in subjects with coronary artery disease. Methods: This controlled trial included 44 subjects with myocardial infarction, randomly divided into Intervention Group 1 (IG1; n = 16), Intervention Group 2 (IG2; n = 12) and Control Group (CG; n = 16). IG1 performed a specific exercise program at home during 8 weeks, and IG2 additionally used microcurrents on the abdominal region before the exercise program. All groups were subjected to health education sessions. Computed Tomography was used to evaluate abdominal, subcutaneous and visceral fat, accelerometers to measure habitual physical activity and the semiquantitative Food Frequency Questionnaire for dietary intake. Results: After 8 weeks, IG2 showed a significantly decreased in subcutaneous fat (p ≤ 0.05) when compared to CG. Concerning visceral fat, both intervention groups showed a significant decrease in comparison to the CG (p ≤ 0.05). No significant changes were found between groups on dietary intake and habitual physical activity, except for sedentary activity that decreased significantly in IG2 in comparison with CG (p ≤ 0.05). Conclusions: This specific exercise program showed improvements in visceral fat in individuals with coronary artery disease. Microcurrent therapy associated with a home-based exercise program suggested a decreased in subcutaneous abdominal fat.

Penicillin at the late stage of leptospirosis: a randomized controlled trial

There is evidence that an early start of penicillin reduces the case-fatality rate of leptospirosis and that chemoprophylaxis is efficacious in persons exposed to the sources of leptospira. The existent data, however, are inconsistent regarding the benefit of introducing penicillin at a late stage of leptospirosis. The present study was developed to assess whether the introduction of penicillin after more than four days of symptoms reduces the in-hospital case-fatality rate of leptospirosis. A total of 253 patients aged 15 to 76 years with advanced leptospirosis, i.e., more than four days of symptoms, admitted to an infectious disease hospital located in Salvador, Brazil, were selected for the study. The patients were randomized to one of two treatment groups: with intravenous penicillin, 6 million units day (one million unit every four hours) for seven days (n = 125) and without (n = 128) penicillin. The main outcome was death during hospitalization. The case-fatality rate was approximately twice as high in the group treated with penicillin (12%; 15/125) than in the comparison group (6.3%; 8/128). This difference pointed in the opposite direction of the study hypothesis, but was not statistically significant (p = 0.112). Length of hospital stay was similar between the treatment groups. According to the results of the present randomized clinical trial initiation of penicillin in patients with severe forms of leptospirosis after at least four days of symptomatic leptospirosis is not beneficial. Therefore, more attention should be directed to prevention and earlier initiation of the treatment of leptospirosis.

Effects of self-administered exercises based on Tuina techniques on musculoskeletal disorders of professional orchestra musicians: a randomized controlled trial

Background Musicians are frequently affected by playing-related musculoskeletal disorders (PRMD). Common solutions used by Western medicine to treat musculoskeletal pain include rehabilitation programs and drugs, but their results are sometimes disappointing. Objective To study the effects of self-administered exercises based on Tuina techniques on the pain intensity caused by PRMD of professional orchestra musicians, using numeric visual scale (NVS). Design, setting, participants and interventions We performed a prospective, controlled, single-blinded, randomized study with musicians suffering from PRMD. Participating musicians were randomly distributed into the experimental (n = 39) and the control (n = 30) groups. After an individual diagnostic assessment, specific Tuina self-administered exercises were developed and taught to the participants. Musicians were instructed to repeat the exercises every day for 3 weeks. Main outcome measures Pain intensity was measured by NVS before the intervention and after 1, 3, 5, 10, 15 and 20 d of treatment. The procedure was the same for the control group, however the Tuina exercises were executed in points away from the commonly-used acupuncture points. Results In the treatment group, but not the control group, pain intensity was significantly reduced on days 1, 3, 5, 10, 15 and 20. Conclusion The results obtained are consistent with the hypothesis that self-administered exercises based on Tuina techniques could help professional musicians controlling the pain caused by PRMD. Although our results are very promising, further studies are needed employing a larger sample size and double blinding designs.

Cognitive stimulation for portuguese older adults with cognitive impairment: a randomized controlled trial of efficacy, comparative duration, feasibility and experiential relevance

Although some studies point to cognitive stimulation as a beneficial therapy for older adults with cognitive impairments, this area of research and practice is still lacking dissemination and is underrepresented in many countries. Moreover, the comparative effects of different intervention durations remain to be established and, besides cognitive effects, pragmatic parameters, such as cost-effectiveness and experiential relevance to participants, are seldom explored. In this work, we present a randomized con- trolled wait-list trial evaluating 2 different intervention durations (standard 1⁄4 17 vs brief 1⁄4 11 sessions) of a cognitive stimulation program developed for older adults with cognitive impairments with or without dementia. 20 participants were randomly assigned to the standard duration intervention program (17 sessions, 1.5 months) or to a wait-list group. At postintervention of the standard intervention group, the wait-list group crossed over to receive the brief intervention program (11 sessions, 1 month). Changes in neuropsychological, functionality, quality of life, and caregiver outcomes were evaluated. Experience during intervention and costs and feasibility were also evaluated. The current cognitive stimulation programs (ie, standard and brief) showed high values of experiential relevance for both intervention durations. High adherence, completion rates, and reasonable costs were found for both formats. Further studies are needed to definitively establish the potential efficacy, optimal duration, cost-effectiveness, and experiential relevance for participants of cognitive intervention approaches.

Effects of motive-oriented therapeutic relationship in a ten-session general psychiatric treatment of borderline personality disorder: a randomized controlled trial.

Background: Motive-oriented therapeutic relationship (MOTR) was postulated to be a particularly helpful therapeutic ingredient in the early treatment phase of patients with personality disorders, in particular with borderline personality disorder (BPD). The present randomized controlled study using an add-on design is the first study to test this assumption in a 10-session general psychiatric treatment with patients presenting with BPD on symptom reduction and therapeutic alliance. Methods: A total of 85 patients were randomized. They were either allocated to a manual-based short variant of the general psychiatric management (GPM) treatment (in 10 sessions) or to the same treatment where MOTR was deliberately added to the treatment. Treatment attrition and integrity analyses yielded satisfactory results. Results: The results of the intent-to-treat analyses suggested a global efficacy of MOTR, in the sense of an additional reduction of general problems, i.e. symptoms, interpersonal and social problems (F1, 73 = 7.25, p < 0.05). However, they also showed that MOTR did not yield an additional reduction of specific borderline symptoms. It was also shown that a stronger therapeutic alliance, as assessed by the therapist, developed in MOTR treatments compared to GPM (Z55 = 0.99, p < 0.04). Conclusions: These results suggest that adding MOTR to psychiatric and psychotherapeutic treatments of BPD is promising. Moreover, the findings shed additional light on the perspective of shortening treatments for patients presenting with BPD. © 2014 S. Karger AG, Basel.