Diagnostic accuracy of fluorescence microlymphography for detecting limb lymphedema.

OBJECTIVES: Fluorescence microlymphography (FML) is a minimally invasive technique for visualization of the cutaneous lymphatic network. The aim of the study was to assess the accuracy and safety of FML in patients with unilateral lymphedema. METHODS: This was a cross sectional study. Patients with unilateral leg swelling were assessed and compared with the unaffected contralateral limb. FML was performed in all index legs and the contralateral leg by injecting 0.1 mL of fluorescein isothiocyanate (FITC)-labeled dextran intradermally in both limbs at the same level. The most prominent swelling of the affected limb was the anatomical reference. The spread of the dye in the lymphatic capillaries of the skin was measured in all dimensions by epiluminator intravital microscopy and the maximum dye spread value 10 min after injection was used for statistical analysis. The contralateral leg served as control. Test accuracy and receiver operator characteristic (ROC) analysis was performed to assess threshold values that best predict lymphedema. RESULTS: Between March 2008 and February 2014 seventy patients with unilateral chronic leg swelling were clinically diagnosed with lymphedema. The median age was 45 (IQR 27-56) years. Of those, 46 (65.7%) were female and 71.4% had primary and 28.6% secondary lymphedema. Sensitivity, specificity, positive and negative likelihood ratio, and positive and negative predictive value were 94.3%, 78.6%, 4.40, 0.07, 81.5%, and 93.2% for the 12 mm cut off level and 91.4%, 85.7%, 6.40, 0.10, 86.5%, and 90.9% for the 14 mm cut off level, respectively. The area under the ROC curve was 0.89 (95% CI: 0.83-0.95). No major adverse events were observed. CONCLUSIONS: FML is an almost atraumatic and safe technique for detecting lymphedema in patients with leg swelling. In this series the greatest accuracy was observed at a cut off level of ≥14 mm maximum spread.

Diurnal changes of lower leg volume in obese and non-obese subjects.

BACKGROUND/AIM: Obesity is a risk factor for chronic venous disease. However, the mechanisms behind this association are poorly understood. We tested the hypothesis that obese subjects have a higher diurnal leg volume increase compared with non-obese subjects. METHODS: In this prospective cohort study including obese (body mass index, BMI ≥30 kg m(-)(2)) and non-obese (BMI ≤25 kg m(-)(2)) subjects without venous insufficiency, lower leg volume was assessed by optoelectronic volumetry in the morning and in the evening. All subjects underwent duplex ultrasound and light reflection rheography (venous pump power and venous refill time, VRT) to investigate lower extremity venous function. A pedometer was carried between the morning and evening visit to assess the daily number of footsteps. A backward multivariable linear regression model was used to determine factors associated with diurnal lower leg volume increase. RESULTS: Forty-two limbs in 24 obese subjects and 29 limbs in 15 non-obese subjects were analyzed. Obese subjects had larger common femoral vein diameters (17.1±2.4 vs 15.5±2.4 mm, P<0.01) and slower peak, mean and minimal velocities (25.1±10.6 vs 44.3±14.3 cm s(-1); 6.8±2.4 vs 12.7±5.6 cm s(-1); -0.2±6.4 vs -6.3±11.9 cm s(-1); P<0.01 for all) than non-obese subjects. VRT was shorter in obese subjects (40.5±15.0 vs 51.0±12.1 s, P<0.01) and decreased significantly in the course of the day only in obese subjects (P<0.01). Obesity, male gender, CEAP (Clinical-Etiology-Anatomy-Pathophysiology) class, total time between the two visits and difference between morning and evening VRT were positively associated with higher lower leg volume increase; morning VRT and the total number of footsteps showed a negative association (P<0.04 for all). CONCLUSION: Obesity was found to be an independent predictor of higher diurnal leg volume increase. One potential mechanism is a progressive failure of venous valve function in the course of the day in obese subjects.

Management of uncomplicated varicose veins - a case vignette for a clinical decision proposal.

Venous disorder is common in the general population. Uncomplicated varicose veins represent a significant proportion of the disease burden, and can impact considerably on quality of life, producing a wide spectrum of symptoms. Little is known about the natural course of the disease at this stage and the treatment strategy employed is often not based on robust scientific evidence. The aim of this article is to elucidate the options to manage uncomplicated varicose veins. There are likely to be significant geographic differences in the treatment strategy employed, and it is hoped that we will arouse discussion among physicians regarding the management of this very common medical condition. The reader will be asked for their preferred treatment choice for a given clinical case vignette.

The influence of abdominal pressure on lower extremity venous pressure and hemodynamics: a human in-vivo model simulating the effect of abdominal obesity.

OBJECTIVE: To demonstrate that abdominal pressure impacts venous flow and pressure characteristics. METHODS: Venous pressure at the femoral vein was measured in 6 non-obese subjects (mean BMI 22 ± 2 kg/m(2)) that were exposed to a circumferential cuff placed around the abdominal trunk and inflated to 20 and 40 mmHg. In a second step non-obese subjects (n = 10, BMI 21.8 ± 1.8 kg/m(2)) exposed to this cuff compression were studied for duplexsonographic parameters at the femoral vein. Duplexsonographic results were compared to subjects with abdominal obesity (n = 22, BMI 36.2 ± 5.9 kg/m(2)) in whom duplexsonographic parameters at the femoral vein were studied without cuff compression. RESULTS: Intravenous pressure increased with pressure application in all participants (p = 0.0025). Duplex examination of 10 non-obese subjects revealed increasing venous diameter (p < 0.0001) and decreasing venous peak and mean velocity (all p < 0.0001) when cuff pressure was applied. Duplex parameters with cuff pressure application of 20 and 40 mmHg respectively, were similar to those in obese subjects that were studied without pressure application. CONCLUSIONS: External abdominal pressure application creates venous stasis in lower limbs. Results of this study indicate that abdominal obesity might induce resistance to venous backflow from the lower limbs.

Ease of application of medical compression-stocking systems for the treatment of venous ulcers.

OBJECTIVE: To evaluate the ease of application of two-piece, graduated, compression systems for the treatment of venous ulcers. METHODS: Four kits used to provide limb compression in the management of venous ulcers were evaluated. These have been proven to be non-inferior to various types of bandages in clinical trials. The interface pressure exerted above the ankle by the under-stocking and the complete compression system and the force required to pull the over-stocking off were assessed in vitro. Ease of application of the four kits was evaluated in four sessions by five nurses who put stockings on their own legs in a blinded manner. They expressed their assessment of the stockings using a series of visual analogue scales (VASs). RESULTS: The Sigvaris Ulcer X((R)) kit provided a mean interface pressure of 46 mmHg and required a force in the range of 60-90 N to remove it. The Mediven ulcer kit exerted the same pressure but required force in the range of 150-190 N to remove it. Two kits (SurePress Comfort and VenoTrain Ulcertec) exerted a mean pressure of only 25 mmHg and needed a force in the range of 100-160 N to remove them. Nurses judged the Ulcer X and SurePress kits easiest to apply. Application of the VenoTrain kit was found slightly more difficult. The Mediven kit was judged to be difficult to use. CONCLUSIONS: Comparison of ease of application of compression-stocking kits in normal legs revealed marked differences between them. Only one system exerted a high pressure and was easy to apply. Direct comparison of these compression kits in leg-ulcer patients is required to assess whether our laboratory findings correlate with patient compliance and ulcer healing.

Impact of long-term corticosteroid therapy on the distribution pattern of lower limb atherosclerosis.

OBJECTIVE: Ectopic calcification and mediacalcinosis can be promoted by corticosteroid use. Aim of the present investigation is to describe macrovascular disease features in patients with long-term corticosteroid therapy and symptomatic lower limb peripheral arterial occlusive disease (PAD). METHODS: A consecutive series of 2783 patients undergoing clinical and angiographic work-up of PAD were screened for long-term (>5 years) corticosteroid use (group A). Comparison was performed to a randomly selected age-, sex- and risk factor-matched PAD control cohort from the same series without corticosteroid use (group B). Patients with diabetes mellitus or severe renal failure were excluded. Arterial calcification was evaluated by qualitative assessment on radiographic images. Severity of atherosclerotic lesions was analysed from angiographic images using a semi-quantitative score (Bollinger score). RESULTS: In general, 12 patients (5 males, mean age 78.5 +/- 9.0 years) with 15 ischaemic limbs qualified to be enrolled in group A and were compared to 23 matching control patients (6 2 males, mean age 79.5 +/- 6 years) with 32 ischaemic limbs. Incompressibility of ankle arteries determined by measurement of the ankle-brachial index was seen in 12 limbs (80%) in group A compared to 3 limbs (9%) in group B (p = 0.0009). No significant difference was found comparing group A and B for segmental calcification, whereas comparison of the atherosclerotic burden using the angiographic severity score showed a significantly higher score at the infragenicular arterial level in group A (p = 0.001). CONCLUSION: Findings suggest that the long-term corticosteroid therapy is associated with a distally accentuated, calcifying peripheral atherosclerosis inducing arterial incompressibility. This occlusion pattern is comparable to patients with renal failure or diabetes. Further research is required to support our observations.

Renal insufficiency is independently associated with a distal distribution pattern of symptomatic lower-limb atherosclerosis.

OBJECTIVES: The purpose of this study was to assess the impact of renal insufficiency (RI) on the distribution pattern of peripheral arterial disease (PAD). We hypothesised that RI is associated with a distally accentuated involvement of the peripheral arterial tree. DESIGN: This is a retrospective analysis. MATERIALS AND METHODS: Analysis was based on a consecutive series of 2709 patients with chronic PAD of atherosclerotic origin undergoing primary endovascular treatment of lower-extremity arteries. Atherosclerotic pattern was grouped into femoropopliteal (n=2085) and infragenicular (n=892) disease according to target lesions treated while using iliac disease (n=1133) as reference. Univariable and multivariable multinomial regression analyses were performed to assess relation with RI. Results are shown as relative risk ratio (RRRs) with 95% confidence intervals (95% CIs). A p<0.05 was considered statistically significant. RI was defined as glomerular filtration rate (GFR)<60 ml min(-1) 1.73 m(-2). RESULTS: Presence of RI was an independent risk factor for a centrifugal lesion pattern (RRR 1.48, 95% CI: 1.17-1.86, p=0.001). Moreover, a decrease in GFR by 10 ml min(-1) 1.73 m(-2) was associated with an RRR of 1.08 for below-the-knee arterial disease (95% CI: 1.03-1.13, p=0.003). CONCLUSION: Presence and severity of RI are independent predictors of a distal obstructive pattern in patients with symptomatic PAD.

Determinants of haemodialysis access survival.

BACKGROUND: Vascular access patency is of vital importance for patients requiring haemodialysis. This analysis validates potential risk factors and benefits in patients undergoing vascular access procedures. PATIENTS AND METHODS: Vascular access procedures performed over a two-year period were retrospectively analysed. Clinical data and concomitant medication were retrieved from files as were surgical data following a standardized data capture sheet. Outcome parameters were primary (PP) and secondary patency (SP) as well as freedom from repeated revascularization. Minimal follow-up with functioning access was 679 days. RESULTS: During the observation period, 244 patients (mean age 62.2 +/- 0.9 years, 60.7 % male patients, 36.1 % pre-emptive, 31.1 % late referral) underwent vascular accesses procedures. PP and SP were 35.6 % and 45.6 %, respectively, at 540 days. Presence of diabetes mellitus was associated with decreased PP (OR: 0.6, 95 %-CI: 0.3 - 1.0) and SP (OR: 0.4, 95 %-CI: 0.2 - 0.7), whereas female gender was associated with lower SP (OR: 0.6, 95 %-CI: 0.3 - 0.9) and freedom from repeated revascularization rates (OR: 0.6, 95 %-CI: 0.3 - 1.0). In contrast, presence of hyperparathyreoidism was associated with higher SP (OR: 1.7, 95 %-CI: 1.0 - 3.0) and freedom from repeated revascularization (OR: 1.7, 95 %-CI: 1.0 - 3.0) rates. CONCLUSIONS: Haemodialysis access performs worst in patients with diabetes mellitus and in women. The benefit of hyperparathyroidism should be interpreted as hypothesis generating.

Cystic adventitial degeneration: ectopic ganglia from adjacent joint capsules.

Cystic adventitial degeneration is a rare non-atherosclerotic cause of peripheral arterial occlusive disease, mainly seen in young men without other evidence of vascular disease. Diagnosis will be established by clinical findings and by ultrasound or angiography and can be treated by excision or enucleation of the affected arterial segment or by percutaneous ultrasound-guided aspiration. However, the etiology of adventitial cysts remains unknown. We report a case of cystic adventitial degeneration showing a connection between the joint capsule and the adventitial cyst, supporting the theory that cystic adventitial degeneration may represent ectopic ganglia from adjacent joint capsules.

Vascular birthmarks.

Vascular birthmarks can be classified into hemangioma and vascular malformations. Hemangioma are frequent tumours of early infancy demonstrating endothelial hyperplasia, a history of rapid neonatal growth and slow involution during later childhood. Treatment of hemangioma is dependent of stage and type of the lesion. Given the current availability of drugs, lasers, and other techniques to treat hemangioma safely, philosophy of "benign neglect" should not be considered anymore. Vascular malformations show a normal endothelial turnover, being present at birth and growing commensurately with the child. Exact diagnosis by employing modern diagnostic means,which are able to differentiate low-flow from high flow lesions is important for further therapeutic management. Beside conservative treatment strategies, use of laser, sclerotherapy, interventional embolization and surgical treatment are possible management options. Patients should receive multidisciplinary care in qualified vascular centres.

Ultrasound-assisted versus conventional catheter-directed thrombolysis for acute iliofemoral deep vein thrombosis: 1-year follow-up data of a randomized-controlled trial.

Essentials Acute iliofemoral deep vein thrombosis can be treated with catheter-directed thrombolysis (CDT). We performed a randomized trial comparing conventional CDT versus ultrasound-assisted CDT (USAT). Clinical and duplex sonographic outcomes at 12 months were similar in the CDT and USAT groups. In both groups, incidence of postthrombotic syndrome was very low with good quality of life. SUMMARY: Background In patients with acute iliofemoral deep vein thrombosis (IFDVT), catheter-directed thrombolysis (CDT) aims to prevent the postthrombotic syndrome (PTS). Adding intravascular high-frequency, low-power ultrasound energy to CDT does not seem to improve the immediate thrombolysis results but its impact on clinical outcomes at 12 months is not known. Patients/Methods In this randomized-controlled trial, 48 patients (mean age 50 ± 21 years; 52% women) with acute IFDVT were randomized to conventional CDT (n = 24) or ultrasound-assisted CDT (USAT; n = 24). In both groups, a fixed-dose thrombolysis regimen (20 mg r-tPA over 15 h) was used, followed by routine stenting of residual venous obstruction. At 12 months, PTS and venous disease severity (Villalta score and revised Venous Clinical Severity Score [rVCSS]), disease-specific quality of live (QOL; CIVIQ-20) and duplex-sonographic outcomes were assessed. Results Among the 45 surviving patients, 40 (89%; 95% confidence interval [CI] 76-96%) patients were free from PTS (defined as Villalta score < 5 points; 83%, 95% CI 61-95% in the USAT and 96%, 95% CI 77-100% in the CDT group), with a similar mean total Villalta score of 2.3 ± 2.9 vs. 1.7 ± 1.6, and a mean total rVCSS of 3.0 ± 3.5 vs. 2.7 ± 2.9 in the USAT and the CDT groups, respectively. Both groups had good disease-specific QOL with a CIVIQ-20 score of 29.4 ± 11.8 vs. 26.1 ± 7.8, respectively. Primary (100% vs. 92%) and secondary (100% vs. 96%) iliofemoral patency rates and presence of femoro-popliteal venous reflux (39% vs. 33%) were similar in both groups. Conclusion The addition of intravascular ultrasound energy to conventional CDT for the treatment of acute IFDVT did not have any impact on relevant clinical or duplex sonographic outcomes, which were favorable in both study groups. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier:NCT01482273.

Does infection affect amputation rate in chronic critical leg ischemia?

BACKGROUND: Aim was to analyze the association between local infection and amputation rate in patients with chronic critical limb ischemia (CLI) with or without successful revascularization. PATIENTS AND METHODS: We performed a retrospective analysis of 56 consecutive patients with 57 critically ischemic legs seen at the University Hospital Bern. Patients with CLI were selected if ischemic lesions and follow-up of more than 2 months were documented. Infection was suggested when 2 of the following criterion were present: temperature > 37 degrees C, C-reactive protein > 50 mg/L, leukocytes > 10 x 10(3)/microliter ("2 of 3" criterion), or a putrid secretion was documented ("secretion" criterion). RESULTS: In patients with successful revascularization (n = 39), there was a significant shift from 10.3% major to 33.3% minor amputations (Chi Square p value = 0.014) as compared to patients without or with failed revascularization (n = 18) with 44.4% and 11.1% (Chi Square p value = 0.008), respectively. An infection was suggested in 22 of 53 limbs (41.5%) according to the "2 of 3" criterion, and 30 of 57 limbs (52.6%) satisfying the "secretion" criterion. Both criteria, were significantly more common in patients undergoing amputation as compared to patients without amputation (p = 0.001). Multiple lesions were more common in patients with major amputations (p = 0.026). CONCLUSION: Successful revascularization effectively reduces major amputations and leads to healing of ischemic ulcers. Secondary foot infections are frequent. Infections are associated with a significantly higher rate of minor and major amputations, also in patients with successful revascularization, and should be treated adequately as well as in time with antibiotics.

Visual disturbance following sclerotherapy for varicose veins, reticular veins and telangiectasias: a systematic literature review.

The objective of the study was to review the literature reporting visual disturbance (VD)following sclerotherapy for varicose veins. Underlying mechanisms will be discussed. A literature search of the databases Medline and Google Scholar was performed. Original articles including randomized trials, case series and case reports reporting VD in humans following sclerotherapy for varicose veins were included. Additional references were also obtained if they had been referenced in related publications. The search yielded 4948 results of which 25 reports were found to meet the inclusion criteria. In larger series with at least 500 included patients the prevalence of VD following sclerotherapy ranges from 0.09% to 2%. In most reports foam sclerotherapy was associated with VD (19); exclusive use of liquid sclerosant was reported in two cases, some reports included foam and liquid sclerosant (4). There were no persistent visual disorders reported. VD occurred with polidocanol and sodium tetradecyl sulphate in different concentrations (0.25­3%). Various forms of foam preparation including various ways of foam production and the liquid ­air ratio (1 or 2 parts of liquid mixed with 3, 4 or 5 parts of air) were reported in association with the occurrence of VD. VDs following sclerotherapy for varicose veins are rare and all reported events were transient. Bubble embolism or any kind of embolism seems unlikely to be the only underlying mechanism. A systemic inflammatory response following sclerotherapy has been suggested. Further research to clarify the mechanism of action of sclerosants is required.

Compression hosiery for occupational leg symptoms and leg volume: a randomized crossover trial in a cohort of hairdressers.

OBJECTIVE: Occupational leg symptoms are highly prevalent in the general population and impair the psychic state of health. We investigated hairdressers, a cohort exposed to prolonged standing during work, in a randomized crossover trial. We hypothesized that hairdressers wearing low-strength compression hosiery would benefit from less leg volume increase and discomfort. METHODS: One hundred and eight hairdressers were randomized to wear medical compression stockings (MCS; 15-20 mmHg) in a crossover study. The effect of MCS on symptoms and on lower leg volume was compared with no compression treatment. Symptoms were assessed with a comprehensive questionnaire, categorized using factor analysis with varimax rotation and correlated with leg volume changes. RESULTS: Wearing MCS reduced the symptom score for pain and feelings of swelling (range 0-4) by an average of 0.22 (12%, P < 0.001). Sleep disturbance, feeling of unattractive legs and depressiveness improved with MCS compared with no MCS. Subjects initially obliged to refrain from wearing stockings showed a significant decrease of pain and feelings of swelling as well (by 0.10 [6%], P = 0.015). Wearing MCS was associated with a decrease of lower leg volume by an average of 19 mL (P < 0.001), with preference in older hairdressers (P < 0.001). The effects of wearing MCS on symptoms and on leg volume were not correlated with each other. CONCLUSIONS: Individuals working in a standing profession experience leg pain, feelings of swelling, heaviness and various other disturbing feelings. These symptoms can be alleviated by wearing low-strength MCS.

Treatment for long-segment femoro-popliteal obstructions: initial experience with a 4-F compatible self-expanding nitinol stent and review of the literature.

AIM: The aim of this paper was to evaluate the efficacy of a novel 4-F compatible self-expanding Nitinol stent for the treatment of long femoro-popliteal obstructions. METHODS: This retrospective analysis includes patients with femoro-popliteal obstructions ≥ 120 mm in length, treated with a novel Nitinol stent (Pulsar-18) between February 2010 and December 2011. Patients were categorized as either intermittent claudication (IC) or critical limb ischemia (CLI). Primary endpoint was primary patency, secondary endpoints were target lesion revascularization (TLR). RESULTS: A total of 31 patients (IC: N=18 and CLI: N=13) were included in the present series. Mean age was 73.3 ± 10.1 years and 71% (22/31) of the patients were male. Primary intervention was performed in 77.4% (24/31) of the patients and re-do revascularization in the remaining. Mean lesion length of femoro-popliteal obstructions was 163.5 ± 32.5 mm. Technical success was obtained in all patients. Mean follow-up duration was 316 ± 198 days. Primary patency rates were 83.3% in IC and 80.0% in CLI patients at 6 months and 64.1% and 54.9% at 12 months, respectively (P=0.84). Target lesion revascularization occurred in 5.6% of IC and 20.0% of CLI patients at 6 months and in 14.1% and 36.0% at 12 months, respectively (P=0.43). CONCLUSION: Endovascular stenting of long femoro-popliteal lesions using the Pulsar-18 stent provides acceptable results with patency and restenosis rates comparable with data from literature for stenting of long femoro-popliteal obstructions.

Use of biomarkers or echocardiography in pulmonary embolism: the Swiss Venous Thromboembolism Registry.

BACKGROUND: Cardiac biomarkers and echocardiography for assessing right ventricular function are recommended to risk stratify patients with acute non-massive pulmonary embolism (PE), but it remains unclear if these tests are performed systematically in daily practice. DESIGN AND METHODS: Overall, 587 patients with acute non-massive PE from 18 hospitals were enrolled in the Swiss Venous Thromboembolism Registry (SWIVTER): 178 (30%) neither had a biomarker test nor an echocardiographic evaluation, 196 (34%) had a biomarker test only, 47 (8%) had an echocardiogram only and 166 (28%) had both tests. RESULTS: Among the 409 (70%) patients with biomarkers or echocardiography, 210 (51%) had at least one positive test and 67 (16%) had positive biomarkers and right ventricular dysfunction. The ICU admission rates were 5.1% without vs. 5.6% with testing (P = 0.78), and thrombolysis or embolectomy were performed in 2.8% vs. 4.9%, respectively (P = 0.25). In multivariate analysis, syncope [odds ratio (OR): 3.49, 95% confidence interval (CI): 1.20-10.15; P = 0.022], tachycardia (OR: 2.31, 95% CI: 1.37-3.91; P = 0.002) and increasing age (OR: 1.02; 95% CI: 1.01-1.04; P < 0.001) were associated with testing of cardiac risk; outpatient status at the time of PE diagnosis (OR: 2.24, 95% CI: 1.49-3.36; P < 0.001), cancer (OR: 1.81, 95% CI: 1.17-2.79; P = 0.008) and provoked PE (OR: 1.58, 95% CI: 1.05-2.40; P = 0.029) were associated with its absence. CONCLUSION: Although elderly patients and those with clinically severe PE were more likely to receive a biomarker test or an echocardiogram, these tools were used in only two-thirds of the patients with acute non-massive PE and rarely in combination.

[Design of a multicenter study for assessing the effectiveness of extracorporeal shockwave therapy in epicondylitis humeri radialis]. / Design einer Multizenterstudie zum Wirksamkeitsnachweis der Extrakorporalen Stosswellentherapie (ESTW) bei Epicondylitis humeri radialis.

INTRODUCTION: Previously published studies concerning, extracorporeal shock-wave therapy (ESWT) in the treatment of lateral epicondylitis do not fulfil the biometric standards of modern clinical research. The objective of the trial is to show that ESWT is effective in the treatment of chronic LE. METHOD: A prospective, randomized, placebo-controlled, single-blinded, multicenter trial with an independent blinded observer was designed. The effectiveness of ESWT is evaluated by comparison with a control group in which sham-ESWT is performed, both under local anaesthesia. Outcome is determined on the basis of the Roles/Maudsley-Score. Inclusion criteria are a history of at least 6 months of LE and failure of conventional treatment. The therapy includes 3 sessions of low energy ESWT with 2000 impulses (energy flux density 0.07-0.09 mJ/mm2). Sample size is 272 patients. STATUS: Randomisation started in October 1998 and is planned over a period of two and a half years. CONCLUSION: Only a randomised clinical trial with adequate control of placebo effects and observer bias can provide the required evidence for the efficiency of ESWT in the treatment of lateral epicondylitis of the elbow.

[Effect of extracorporeal shockwave therapy on vascular regulation. Infrared thermography in epicondylitis humeri radialis]. / Einfluss der Extrakorporalen Stosswellentherapie auf die Gefässregulation. Infrarotthermographie bei Epicondylitis humeri radialis.

BACKGROUND: Extracorporeal shockwave therapy (ESWT) is recommended as an alternative treatment for lateral epicondylitis (LE). An influence on the blood perfusion is considered to be one possible effect. Infrared thermography is used in this trial to measure effects of ESWT on the thermal regulation in the target area. METHODS: 33 patients with chronic LE were examined in a prospective, placebo-controlled single blind study with an independent observer. 3 x 2000 impulses of an energy flux density ED+ 0.22 mJ/mm2 were applied under local anaesthesia as verum-ESWT. Placebo-ESWT was performed under the same conditions. One elbow was treated, the other served as control. Before and after each shockwave application and after 12 weeks skin temperature was measured on both elbows at three predefined points by infrared thermography. RESULTS: While a significant decrease in the skin temperature was found on the treated and sham-treated sides opposed to the contralateral side, there was no difference between the real shockwave treatment and placebo therapy. Responder and Non-responder to the treatment could not be distinguished during the therapy. DISCUSSION: Infrared thermography was proved to be a valuable additional technical instrument for diagnosis of LE, but is not an appropriate instrument to predict the clinical outcome in patients treated with ESWT. A noted reduction of skin temperature on the treated side is not due to specific effects of the shockwaves. It is unlikely that ESWT as applied has an influence on thermal regulation in the target area. These findings are supported by negative results of experimental and clinical trials.