Cellulite and extracorporeal Shockwave therapy (CelluShock-2009) - a Randomized Trial

<p>Abstract</p> <p>Background</p> <p>Cellulite is a widespread problem involving females' buttocks and thighs based on the female specific anatomy. Given the higher number of fat cells stored in female fatty tissue in contrast to males, and the aging process of connective tissue leads to an imbalance between lipogenesis and lipolysis with subsequent large fat cells bulging the skin. In addition, microcirculatory changes have been suggested, however remain largely unknown in a controlled clinical setting. We hypothesize that the combination of extracorporeal shockwave and a daily gluteal muscle strength program is superior to the gluteal muscle strength program alone in cellulite.</p> <p>Methods/Design</p> <p>Study design: Randomized-controlled trial. IRB approval was granted at Hannover Medical School, Germany on May 22, 2009. For allocation of participants, a 1:1 ratio randomization was performed using opaque envelopes for the concealment of allocation. Reporting: according to CONSORT 2010. Eligible patients were females aged 18 or over and 65 or younger with cellulite with documented cellulite 1°-4° according to the Nürnberger score. Exclusion criteria were suspected or evident pregnancy, no cellulite, no informed consent or age under 18 years or above 65 years. Patients were recruited by advertisements in local regional newspapers and via the Internet. Analysis: Intention-to-treat. Outcome parameters: a) Photonumeric severity scale, b) Nürnberger Score, c) circumference measurements, d) capillary blood flow, e) tissue oxygen saturation, f) postcapillary venous blood flow. Intervention group: Six sessions of extracorporeal focused shock wave for six sessions (2000 impulses, 0,25 mJ/m2 every 1-2 weeks) at both gluteal and thigh regions plus a specific gluteal strength exercise training. Control group: Six sessions of sham extracorporeal focused shock wave for six sessions (2000 impulses, 0,01 mJ/m2 every 1-2 weeks) at both gluteal and thigh regions plus a specific gluteal strength exercise training. Follow-up: 12 weeks. Blinding was achieved for all participants enrolled in the trial, the photograph taking the digital images for the primary outcome measure, the two assessors of the outcome measures, all additional health care providers and for the analyst from the biometrical department. Only one researcher (BJ) was aware of the group assignment performing the randomisation and the extracorporeal shock wave therapy.</p> <p>Discussion</p> <p>This randomised-controlled trial will provide much needed evidence on the clinical effectiveness of focused extracorporal shock wave therapy as an adjunct to gluteal strength training in females suffering cellulite.</p> <p>ClinicalTrials.gov identifier</p> <p>NCT00947414</p

How can the practice nurse be more involved in the care of the chronically ill? The perspectives of GPs, patients and practice nurses

BACKGROUND: A well established "midlevel" of patient care, such as nurse practitioners and/or physician assistants, exits in many countries like the US, Canada, and Australia. In Germany, however there is only one kind of profession assisting the physician in practices, the practice nurse. Little is known about the present involvement of practice nurses in patients' care in Germany and about the attitudes of GPs, assistants and patients concerning an increased involvement. The aim of our study was to get qualitative information on the extent to which practice nurses are currently involved in the treatment of patients and about possibilities of increased involvement as well as on barriers of increased involvement. METHODS: We performed qualitative, semi-structured interviews with 20 GPs, 20 practice nurses and 20 patients in the Heidelberg area. The interviews were digitally recorded, transcribed and content-analysed with ATLAS.ti. RESULTS: Practice nurses are only marginally involved in the treatment of patients. GPs as well as patients were very sceptical about increased involvement in care. Patients were sceptical about nurses' professional background and feared a worsening of the patient doctor relationship. GPs also complained about the nurses' deficient education concerning medical knowledge. They feared a lack of time as well as a missing reimbursement for the efforts of an increased involvement. Practice nurses were mostly willing to be more involved, regarding it as an appreciation of their role. Important barriers were lack of time, overload with administrative work, and a lack of professional knowledge. CONCLUSION: Practice nurses were only little involved in patient care. GPs were more sceptical than patients regarding an increased involvement. One possible area, accepted by all interviewed groups, was patient education as for instance dietary counselling. New treatment approaches as the chronic care model will require a team approach which currently only marginally exists in the German health care system. Better medical education of practice nurses is indispensable, but GPs also have to accept that they cannot fulfil the requirement of future care alone

Validation and cultural adaptation of a German version of the Physicians' Reactions to Uncertainty scales

Contains fulltext : 51656.pdf ( ) (Open Access)BACKGROUND: The aim of the study was to examine the validity of a translated and culturally adapted version of the Physicians' Reaction to Uncertainty scales (PRU) in primary care physicians. METHODS: In a structured process, the original questionnaire was translated, culturally adapted and assessed after administering it to 93 GPs. Test-retest reliability was tested by sending the questionnaire to the GPs again after two weeks. RESULTS: The principal factor analysis confirmed the postulated four-factor structure underlying the 15 items. In contrast to the original version, item 5 achieved a higher loading on the 'concern about bad outcomes' scale. Consequently, we rearranged the scales. Good item-scale correlations were obtained, with Pearson's correlation coefficient ranging from 0.56-0.84. As regards the item-discriminant validity between the scales 'anxiety due to uncertainty' and 'concern about bad outcomes', partially high correlations (Pearson's correlation coefficient 0.02-0.69; p < 0.001) were found, indicating an overlap between both constructs. The assessment of internal consistency revealed satisfactory values; Cronbach's alpha of the rearranged version was 0.86 or higher for all scales. Test-retest-reliability, assessed by means of the intraclass-correlation-coefficient (ICC), exceeded 0.84, except for the 'reluctance to disclose mistakes to physicians' scale (ICC = 0.66). In this scale, some substantial floor effects occurred, with 29.3% of answers showing the lowest possible value. CONCLUSION: Dealing with uncertainty is an important issue in daily practice. The psychometric properties of the rearranged German version of the PRU are satisfying. The revealed floor effects do not limit the significance of the questionnaire. Thus, the German version of the PRU could contribute to the further evaluation of the impact of uncertainty in primary care physicians

Problems and needs for improving primary care of osteoarthritis patients: the views of patients, general practitioners and practice nurses

BACKGROUND: Osteoarthritis (OA) is highly prevalent and has substantial impact on quality of life as well as on healthcare costs. The general practitioner (GP) often is the first care provider for patients with this chronic disease. The aim of this study was to identify health care needs of patients with OA and to reveal possible obstacles for improvements in primary care management of OA patients. METHODS: We performed semi-structured interviews with a stratified sample of 20 patients, 20 GPs and 20 practice nurses. RESULTS: Diagnosing OA posed no major problem, but during the course of OA, GPs found it difficult to distinguish between complaints resulting from the affection of the joints and complaints related to a concomitant depression. Patients felt to be well informed about the degenerative nature of the disease and possible side effects of medications, but they lacked information on individual consequences of the disease. Therefore, the most important concerns of many patients were pain and fear of disability which they felt to be addressed by GPs only marginally. Regarding pain treatment, physicians and patients had an ambivalent attitude towards NSAIDs and opiates. Therefore, pain treatment was not performed according to prevailing guidelines. GPs felt frustrated about the impact of counselling regarding life style changes but on the other hand admitted to have no systematic approach to it. Patients stated to be aware of the impact of life style on OA but lacked detailed information e.g. on how to exercise. Several suggestions were made concerning improvement. CONCLUSION: GPs should focus more on disability and pain and on giving information about treatment since these topics are inadequately addressed. Advanced approaches are needed to increase GPs impact on patients' life style. Being aware of the problem of labelling patients as chronically ill, a more proactive, patient-centred care is needed

Skeletal muscle insulin resistance in zebrafish induces alterations in β-cell number and glucose tolerance in an age- and diet-dependent manner

Insulin resistance creates an environment that promotes β-cell failure and development of diabetes. Understanding the events that lead from insulin resistance to diabetes is necessary for development of effective preventional and interventional strategies, and model systems that reflect the pathophysiology of disease progression are an important component toward this end. We have confirmed that insulin enhances glucose uptake in zebrafish skeletal muscle and have developed a zebrafish model of skeletal muscle insulin resistance using a dominant-negative IGF-IR. These zebrafish exhibit blunted insulin signaling and glucose uptake in the skeletal muscle, confirming insulin resistance. In young animals, we observed an increase in the number of β-cells and normal glucose tolerance that was indicative of compensation for insulin resistance. In older animals, the β-cell mass was reduced to that of control with the appearance of impaired glucose clearance but no elevation in fasting blood glucose. Combined with overnutrition, the insulin-resistant animals have an increased fasting blood glucose compared with the control animals, demonstrating that the β-cells in the insulin-resistant fish are in a vulnerable state. The relatively slow progression from insulin resistance to glucose intolerance in this model system has the potential in the future to test cooperating genes or metabolic conditions that may accelerate the development of diabetes and provide new therapeutic targets