Graduated compression stockings to treat acute leg pain associated with proximal DVT

2014 ◽  
Vol 112 (12) ◽  
pp. 1137-1141 ◽  
Author(s):  
Stan Shapiro ◽  
Thierry Ducruet ◽  
Philip Wells ◽  
Marc Rodger ◽  
Michael Kovacs ◽  
...  
Keyword(s):  
Rating Scale ◽  
Controlled Trial ◽  
Venous Blood ◽  
Secondary Analysis ◽  
Pain Severity ◽  
Leg Pain ◽  
First Episode ◽  
Venous Blood Flow ◽  
Compression Stockings ◽  
Anatomical Extent

SummaryAcute deep venous thrombosis (DVT) causes leg pain. Elastic compression stockings (ECS) have potential to relieve DVT-related leg pain by diminishing the diameter of distended veins and increasing venous blood flow. It was our objective to determine whether ECS reduce leg pain in patients with acute DVT. We performed a secondary analysis of the SOX Trial, a multicentre randomised placebo controlled trial of active ECS versus placebo ECS to prevent the post-thrombotic syndrome.The study was performed in 24 hospital centres in Canada and the U.S. and included 803 patients with a first episode of acute proximal DVT. Patients were randomised to receive active ECS (knee length, 30–40 mm Hg graduated pressure) or placebo ECS (manufactured to look identical to active ECS, but lacking therapeutic compression). Study outcome was leg pain severity assessed on an 11-point numerical pain rating scale (0, no pain; 10, worst possible pain) at baseline, 14, 30 and 60 days after randomisation. Mean age was 55 years and 60% were male. In active ECS patients (n=409), mean (SD) pain severity at baseline and at 60 days were 5.18 (3.29) and 1.39 (2.19), respectively, and in placebo ECS patients (n=394) were 5.38 (3.29) and 1.13 (1.86), respectively. There were no significant differences in pain scores between groups at any assessment point, and no evidence for subgroup interaction by age, sex or anatomical extent of DVT. Results were similar in an analysis restricted to patients who reported wearing stockings every day. In conclusion, ECS do not reduce leg pain in patients with acute proximal DVT.

The Effectiveness Of 30-40 Mm Hg Compression Stockings To Treat Acute Leg Pain Associated With Proximal Deep Vein Thrombosis: Results From The Sox Randomized Controlled Trial

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1126-1126
Author(s):  
Susan R. Kahn ◽  
Stan Shapiro ◽  
Adrielle H Houweling ◽  
Thierry Ducruet ◽  
Philip S. Wells ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Controlled Trial ◽  
Self Report ◽  
Leg Pain ◽  
Venous Blood Flow ◽  
Pain Intensity Score ◽  
Compression Stockings ◽  
Pain Scores ◽  
Time Point

Abstract Background Acute deep venous thrombosis (DVT) is associated with leg pain and discomfort. Elastic compression stockings (ECS) have the potential to improve DVT-related leg pain by reducing the diameter of distended veins, increasing venous blood flow and reducing venous hypertension. To date, however, the effect of ECS on DVT-related leg pain has not been studied. In the SOX Trial, a randomized trial of active ECS vs. placebo ECS to prevent the post-thrombotic syndrome, we measured leg pain intensity at baseline and at several time-points during follow-up. Objective In a secondary, non-prespecified analysis of the SOX Trial, to determine whether active ECS, compared with placebo (sham) stockings, are effective to reduce leg pain associated with acute proximal DVT. Methods We did a multicenter (24 centres in Canada and U.S.) randomized placebo controlled trial of active ECS vs. placebo ECS after a first, symptomatic proximal DVT. Active ECS were knee length, 30-40 mm Hg (Class II) graduated ECS. Placebo ECS were manufactured to appear identical to active ECS but lacked therapeutic compression. Study stockings were worn on the DVT-affected leg daily and continued for up to 2 years. Exclusion criteria were >10 days since DVT diagnosis, not planned to be treated with anticoagulants, known peripheral arterial disease or limb phlegmasia, anticipated lifespan < 6 months, inability of patient or caregiver to apply ECS, thrombolysis to treat DVT, geographically inaccessible for follow-up visits or unable to give informed consent. Leg pain intensity was assessed on a 10-point Visual Analog Scale (0, no pain; 10, worst possible pain) via patient self-report at baseline, 14 days, 1 month and 60 days after randomization. We compared mean pain scores at each time point in the active ECS vs. placebo ECS groups using t-tests. We repeated this analysis, restricted to patients who reported daily stockings use at the 1 month visit (the first visit at which frequency of stocking use was assessed). We conducted pre-specified subgroup analyses by age, sex, and extent of DVT. Results are presented as mean difference (95% confidence interval [CI]) in pain intensity score between groups. All statistical tests were 2-sided and significance was set at P<0.05. Results 410 patients were randomized to active ECS and 396 to placebo ECS. One and 2 patients, respectively, were found to be ineligible soon after randomization and excluded from the analysis. Mean time from DVT diagnosis to randomization was 4.7 days. Baseline characteristics were similar in the 2 groups (60% male, mean age 55.1 years, highest proximal extent of DVT was iliac or femoral vein in 70% and popliteal vein in 30%, 87% were out-patients). Pain scores diminished over time in both groups. There were no differences between groups in pain scores at any time-point (Table), and no evidence for subgroup interaction by age category, sex or anatomical extent of DVT (not shown). Conclusions In a large randomized placebo-controlled trial in patients with symptomatic proximal DVT, leg pain improved at each follow-up visit to a similar degree in patients randomized to active ECS and placebo ECS, and we did not find evidence for benefit of active ECS to reduce pain associated with acute proximal DVT. As our first follow-up assessment was 14 days after DVT, we were unable to evaluate if active ECS had a beneficial or detrimental effect on pain scores during the first 2 weeks after DVT. Disclosures: No relevant conflicts of interest to declare.

scholarly journals A randomised controlled trial of ‘clockwise’ ultrasound for low back pain

2016 ◽  
Vol 72 (1) ◽  
Author(s):  
Adriaan Louw ◽  
Kory Zimney ◽  
Merrill R. Landers ◽  
Mark Luttrell ◽  
Bob Clair ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Rating Scale ◽  
Controlled Trial ◽  
Numeric Rating Scale ◽  
Leg Pain ◽  
Control Group ◽  
Low Back ◽  
Lumbar Flexion ◽  
Experimental Group

Aims: To examine how the choice of words explaining ultrasound (US) may influence the outcome of physiotherapy treatment for low back pain (LBP).Methods: Sixty-seven patients with LBP < 3 months were randomly allocated to one of three groups – traditional education about US (control group [CG]), inflated education about US (experimental group [EG]) or extra-inflated education about US (extra-experimental group [EEG]). Each patient received the exact same application of US that has shown clinical efficacy for LBP (1.5 Watts/cm2 for 10 minutes at 1 Megahertz, pulsed 20% over a 20 cm2 area), but received different explanations (CG, EG or EEG). Before and immediately after US,measurements of LBP and leg pain (numeric rating scale), lumbar flexion (distance to floor) and straight leg raise (SLR) (inclinometer) were taken. Statistical analysis consisted of mixed-factorial analyses of variance and chi-square analyses to measure differences between the three groups, as well as meeting or exceeding minimal detectable changes (MDCs) for pain, lumbar flexion and SLR.Results: Both EG and EEG groups showed a statistically significant improvement for SLR (p < 0.0001), while the CG did not. The EEG group participants were 4.4 times (95% confidence interval: 1.1 to 17.5) more likely to improve beyond the MDC than the CG. No significant differences were found between the groups for LBP, leg pain or lumbar flexion.Conclusion: The choice of words when applying a treatment in physiotherapy can alter the efficacy of the treatment.

Do we still need compression bandages? Haemodynamic effects of compression stockings and bandages

2006 ◽  
Vol 21 (3) ◽  
pp. 132-138 ◽  
Author(s):  
H Partsch
Keyword(s):  
Flow Velocity ◽  
Venous Blood ◽  
Haemodynamic Effects ◽  
Venous Blood Flow ◽  
Compression Stockings ◽  
Venous Flow ◽  
Elastic Compression ◽  
Compression Bandages ◽  
Interface Pressures ◽  
Pumping Function

Objective: To compare haemodynamic data obtained with elastic compression stockings and inelastic compression material applied with different pressure ranges on the lower extremities. Methods: Haemodynamic effects of compression therapy were demonstrated by measuring venous flow velocity, venous volume, venous reflux and venous pumping function using radioisotopes, phlebography, water displacement volumetry, duplex, air plethysmography, foot volumetry and phlebodynamometry. Results: Light-compression stockings are able to increase venous blood flow velocity in the supine position and to prevent leg swelling after prolonged sitting and standing. In the upright position an interface pressure of more than 50 mmHg is needed for an intermittent occlusion of incompetent veins and for a reduction of ambulatory venous hypertension during walking. Such high interface pressures may rather be achieved by short-stretch, multilayer bandages than by an elastic stocking. Conclusion: Elastic compression stockings exerting interface pressures up to 40 mmHg are effective in preventing or reducing oedema. Multilayer compression bandages with a pressure over 40 mmHg additionally improve severely disturbed venous pumping function.

scholarly journals Association of metabolic syndrome and change in Unified Parkinson's Disease Rating Scale scores

Neurology ◽  
2017 ◽  
Vol 89 (17) ◽  
pp. 1789-1794 ◽  
Author(s):  
Maureen Leehey ◽  
Sheng Luo ◽  
Saloni Sharma ◽  
Anne-Marie A. Wills ◽  
Jacquelyn L. Bainbridge ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Metabolic Syndrome ◽  
Parkinson's Disease ◽  
Parkinson Disease ◽  
Rating Scale ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Long Term Study ◽  
Scale Scores ◽  
Disease Rating

Objective:To explore the association between metabolic syndrome and the Unified Parkinson’s Disease Rating Scale (UPDRS) scores and, secondarily, the Symbol Digit Modalities Test (SDMT).Methods:This is a secondary analysis of data from 1,022 of 1,741 participants of the National Institute of Neurological Disorders and Stroke Exploratory Clinical Trials in Parkinson Disease Long-Term Study 1, a randomized, placebo-controlled trial of creatine. Participants were categorized as having or not having metabolic syndrome on the basis of modified criteria from the National Cholesterol Education Program Adult Treatment Panel III. Those who had the same metabolic syndrome status at consecutive annual visits were included. The change in UPDRS and SDMT scores from randomization to 3 years was compared in participants with and without metabolic syndrome.Results:Participants with metabolic syndrome (n = 396) compared to those without (n = 626) were older (mean [SD] 63.9 [8.1] vs 59.9 [9.4] years; p < 0.0001), were more likely to be male (75.3% vs 57.0%; p < 0.0001), and had a higher mean uric acid level (men 5.7 [1.3] vs 5.3 [1.1] mg/dL, women 4.9 [1.3] vs 3.9 [0.9] mg/dL, p < 0.0001). Participants with metabolic syndrome experienced an additional 0.6- (0.2) unit annual increase in total UPDRS (p = 0.02) and 0.5- (0.2) unit increase in motor UPDRS (p = 0.01) scores compared with participants without metabolic syndrome. There was no difference in the change in SDMT scores.Conclusions:Persons with Parkinson disease meeting modified criteria for metabolic syndrome experienced a greater increase in total UPDRS scores over time, mainly as a result of increases in motor scores, compared to those who did not. Further studies are needed to confirm this finding.ClinicalTrials.gov identifier:NCT00449865.

Cognitively-oriented psychotherapy for early psychosis (COPE): Preliminary results

1998 ◽  
Vol 172 (S33) ◽  
pp. 93-100 ◽  
Author(s):  
H. Jackson ◽  
P. McGorry ◽  
J. Edwards ◽  
C. Hulbert ◽  
L. Henry ◽  
...  
Keyword(s):  
Negative Symptoms ◽  
Rating Scale ◽  
Controlled Trial ◽  
Early Psychosis ◽  
First Episode ◽  
Psychotic Episode ◽  
Control Group ◽  
Psychiatric Rating ◽  
Psychiatric Rating Scale ◽  
Randomised Controlled

Background The present study describes the results of the pilottesting of a therapy we have developed for people with first-episode psychosis. Cognitively-oriented psychotherapy for early psychosis (COPE) is aimed at facilitating the adjustment of the person, and at preventing or alleviating secondary morbidity in the wake of the first psychotic episode.Method Eighty people formed three groups: those who were offered and accepted COPE (COPE subjects); those who refused COPE (refusal subjects); and those who were offered neither COPE nor any other continuing treatment from our service (control subjects). The individuals were assessed prior to, and at the end of, COPE treatment (a 12-month period) on the Integration/Sealing Over, Explanatory Model, Scale for the Assessment of Negative Symptoms, Brief Psychiatric Rating Scale, Quality of Life, SCL–90–R, and Beck Depression Inventory measures.Results People who received COPE obtained significantly superior scores (P < 0.05) to the control group on four of the seven measures but only significantly out-performed the refusal group on one of the seven measures (P<0.05). The COPE group performed significantly worse on the BDI than the refusal group (P < 0.05). Effect sizes are also provided for each measure.Conclusions There seems to be a place for psychological therapy in this group of people butour results need to be replicated in a more definitive randomised controlled trial and such a study is now in progress.

scholarly journals Clinical efficacy and safety of lurasidone in schizophrenia: 8 week randomized double blind active controlled trial

2020 ◽  
Vol 7 (5) ◽  
pp. 817
Author(s):  
Unnati Saxena ◽  
Anuradha Nischal ◽  
Anil Nischal ◽  
Abbas Ali Mahdi ◽  
Manu Agarwal ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Side Effect ◽  
Rating Scale ◽  
Controlled Trial ◽  
Treatment Modalities ◽  
First Episode ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Syndrome Scale ◽  
Negative Syndrome

Background: Schizophrenia comprises a group of disorders with heterogeneous etiologies, it includes patients whose clinical presentations, treatment response, and courses of illness vary. This study was carried to study the clinical efficacy and safety of Lurasidone versus Risperidone on psychopathology and cognition in patients with first episode of schizophrenia.Methods: Patients diagnosed with first episode of schizophrenia were enrolled in the study. Patients were randomized to 80 mg/d (n = 27) of Lurasidone or 6mg/d (n = 27) of Risperidone. Efficacy assessments included Positive and Negative Syndrome Scale (PANSS) scores, Schizophrenia cognition rating scale (SCoRS). IL-6 estimation was done and safety assessment was done using UKU side effect rating scale.Results: During the eight weeks of study; significant improvement was observed in PANSS total and all its subscale scores with both Lurasidone and Risperidone. Mean change in PANSS scores were not significant between the groups (-32.93 vs -35.33 p>0.05). Mean change in SCoRS scores were significantly higher in Lurasidone group as compared to risperidone group (-8.43 vs -2.34, p<0.001). Significant reduction in the IL-6 levels with both the groups but mean change in IL-6 levels were not significant between the group (-10.47 vs -8.31, p>0.05). UKU side effect rating scores were significantly higher with Risperidone as compared to Lurasidone (p<0.001).Conclusions: Lurasidone is as effective as Risperidone in improving psychopathology in patient of schizophrenia. Lurasidone proved more efficacious in improving cognition as compared to Risperidone. Both the treatment modalities are efficacious in lowering IL-6 levels. Lurasidone causes less adverse effects as compared to Risperidone.

Merino wool graduated compression stocking increases lower limb venous blood flow: A randomized controlled trial

2011 ◽  
Vol 28 (3) ◽  
pp. 227-237 ◽  
Author(s):  
Thomas Charles ◽  
Deborah Mackintosh ◽  
Bridget Healy ◽  
Kyle Perrin ◽  
Mark Weatherall ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Blood Flow ◽  
Lower Limb ◽  
Controlled Trial ◽  
Venous Blood ◽  
Compression Stocking ◽  
Venous Blood Flow ◽  
Merino Wool ◽  
Randomized Controlled

scholarly journals Lactobacillus acidophilus DDS-1 and Bifidobacterium lactis UABla-12 Improve Abdominal Pain Severity and Symptomology in Irritable Bowel Syndrome: Randomized Controlled Trial

Nutrients ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 363
Author(s):  
Christopher J. Martoni ◽  
Shalini Srivastava ◽  
Gregory J. Leyer
Keyword(s):  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Lactobacillus Acidophilus ◽  
Symptom Severity ◽  
Rating Scale ◽  
Controlled Trial ◽  
Pain Severity ◽  
Bowel Habits ◽  
Severity Scores ◽  
Irritable Bowel

This randomized, double-blind, placebo-controlled, multi-center study investigated the clinical efficacy of two probiotic strains on abdominal pain severity and symptomology in irritable bowel syndrome (IBS). Three hundred and thirty adults, aged 18 to 70 years, with IBS according to Rome IV criteria were allocated (1:1:1) to receive placebo, Lactobacillus acidophilus DDS-1 (1 × 1010 CFU/day) or Bifidobacterium animalis subsp. lactis UABla-12 (1 × 1010 CFU/day) over six weeks. The primary outcome was the change in Abdominal Pain Severity - Numeric Rating Scale (APS-NRS). Over the intervention period, APS-NRS was significantly improved in both probiotic groups vs. placebo in absolute terms (DDS-1: −2.59 ± 2.07, p = 0.001; UABla-12: −1.56 ± 1.83, p = 0.001) and in percentage of significant responders (DDS-1: 52.3%, p < 0.001); UABla-12 (28.2%, p = 0.031). Significant amelioration vs. placebo was observed in IBS Symptom Severity Scale (IBS-SSS) scores for L. acidophilus DDS-1 (−133.4 ± 95.19, p < 0.001) and B. lactis UABla-12 (−104.5 ± 96.08, p < 0.001) groups, including sub-scores related to abdominal pain, abdominal distension, bowel habits and quality of life. Additionally, a significant normalization was observed in stool consistency in both probiotic groups over time and as compared to placebo. In conclusion, L. acidophilus DDS-1 and B. lactis UABla-12 improved abdominal pain and symptom severity scores with a corresponding normalization of bowel habits in adults with IBS.

Interleukin-6 and total antioxidant capacity levels following N-acetylcysteine and a combination nutraceutical intervention in a randomised controlled trial for bipolar disorder

2020 ◽  
Vol 32 (6) ◽  
pp. 313-320
Author(s):  
C.C. Bortolasci ◽  
C. Voigt ◽  
A. Turner ◽  
M. Mohebbi ◽  
L. Gray ◽  
...  
Keyword(s):  
Antioxidant Capacity ◽  
Interleukin 6 ◽  
Total Antioxidant Capacity ◽  
Rating Scale ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Secondary Analysis ◽  
Adjunctive Treatment ◽  
Serum Samples ◽  
Total Antioxidant

AbstractObjective:The aims of this study were to evaluate changes in inflammatory and oxidative stress levels following treatment with N-acetylcysteine (NAC) or mitochondrial-enhancing agents (CT), and to assess the how these changes may predict and/or moderate clinical outcomes primarily the Montgomery-Åsberg Depression Rating Scale (MADRS).Methods:This study involved secondary analysis of a placebo-controlled randomised trial (n = 163). Serum samples were collected at baseline and week 16 of the clinical trial to determine changes in Interleukin-6 (IL-6) and total antioxidant capacity (TAC) following adjunctive CT and/or NAC treatment, and to explore the predictability of the outcome or moderator effects of these markers.Results:In the NAC-treated group, no difference was observed in serum IL-6 and TAC levels after 16 weeks of treatment with NAC or CT. However, results from a moderator analysis showed that in the CT group, lower IL-6 levels at baseline was a significant moderator of MADRS χ2 (df) = 4.90, p = 0.027) and Clinical Global Impression-Improvement (CGI-I, χ2 (df) = 6.28 p = 0.012). In addition, IL-6 was a non-specific but significant predictor of functioning (based on the Social and Occupational Functioning Assessment Scale (SOFAS)), indicating that individuals with higher IL-6 levels at baseline had a greater improvement on SOFAS regardless of their treatment (p = 0.023).Conclusion:Participants with lower IL-6 levels at baseline had a better response to the adjunctive treatment with the mitochondrial-enhancing agents in terms of improvements in MADRS and CGI-I outcomes.

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