Efficacy and safety of laser therapy on axillary hyperhidrosis after one year follow-up: A randomized blinded controlled trial

2015 ◽  
Vol 47 (2) ◽  
pp. 173-179 ◽  
Author(s):  
Franck Marie Leclère ◽  
Javier Moreno-Moraga ◽  
Justo M. Alcolea ◽  
Peter M. Vogt ◽  
Josefina Royo ◽  
...  
2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
Xiankun Chen ◽  
Chuanjian Lu ◽  
Cecilia Stålsby-Lundborg ◽  
Yunying Li ◽  
Xiaoyan Li ◽  
...  

Background. The Sanfu herbal patch (SHP) has been widely used to treat allergic rhinitis (AR) in China. SHP has been reported to be effective for managing the symptoms of AR, but the evidence suffers from methodological limitations. Therefore, we designed a three-armed, randomized, and placebo-controlled trial to evaluate the efficacy and safety of SHP for persistent allergic rhinitis (PAR).Methods. The trial consists of 5 treatment sessions along with a one-year follow-up. This process is then repeated in the second and third years. Eligible participants diagnosed with PAR were randomized at a ratio of 2 : 2 : 1 into one of three groups: (a) SHP group; (b) placebo group; or (c) waiting-list group. The waiting-list group will receive no treatment in the first year but will receive SHP in the following two years. The primary outcome, total nasal symptoms score, is self-assessed at the beginning of each treatment session and during each annual follow-up. Secondary outcomes include the Rhinoconjunctivitis Quality-of-Life Questionnaire, allergic rhinitis attacks, and relief medications. The trial will be stopped if early termination criteria are met during the interim analysis.Ethics. This protocol has been approved by site ethics committee (number B2014-014-01) and is registered with ClinicalTrials.govNCT02192645.


VASA ◽  
2010 ◽  
Vol 39 (2) ◽  
pp. 169-174 ◽  
Author(s):  
Reich-Schupke ◽  
Weyer ◽  
Altmeyer ◽  
Stücker

Background: Although foam sclerotherapy of varicose tributaries is common in daily practice, scientific evidence for the optimal sclerosant-concentration and session-frequency is still low. This study aimed to increase the knowledge on foam sclerotherapy of varicose tributaries and to evaluate the efficacy and safety of foam sclerotherapy with 0.5 % polidocanol in tributaries with 3-6 mm in diameter. Patients and methods: Analysis of 110 legs in 76 patients. Injections were given every second or third day. A maximum of 1 injection / leg and a volume of 2ml / injection were administered per session. Controls were performed approximately 6 months and 12 months after the start of therapy. Results: 110 legs (CEAP C2-C4) were followed up for a period of 14.2 ± 4.2 months. Reflux was eliminated after 3.4 ± 2.7 injections per leg. Insufficient tributaries were detected in 23.2 % after 6.2 ± 0.9 months and in 48.2 % after 14.2 ± 4.2 months, respectively. Only 30.9 % (34 / 110) of the legs required additional therapy. In 6.4 % vein surgery was performed, in 24.5 % similar sclerotherapy was repeated. Significantly fewer sclerotherapy-sessions were required compared to the initial treatment (mean: 2.3 ± 1.4, p = 0.0054). During the whole study period thrombophlebitis (8.2 %), hyperpigmentation (14.5 %), induration in the treated region (9.1 %), pain in the treated leg (7.3 %) and migraine (0.9 %) occurred. One patient with a history of thrombosis developed thrombosis of a muscle vein (0.9 %). After one year there were just hyperpigmentation (8.2 %) and induration (1.8 %) left. No severe adverse effect occurred. Conclusions: Foam sclerotherapy with injections of 0.5 % polidocanol every 2nd or 3rd day, is a safe procedure for varicose tributaries. The evaluation of efficacy is difficult, as it can hardly be said whether the detected tributaries in the controls are recurrent veins or have recently developed in the follow-up period. The low number of retreated legs indicates a high efficacy and satisfaction of the patients.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marco Monticone ◽  
Igor Portoghese ◽  
Daniele Cazzaniga ◽  
Valentina Liquori ◽  
Giuseppe Marongiu ◽  
...  

Abstract Background General physiotherapy is a common means of rehabilitation after surgery for proximal humeral fracture (PHF). Better-targeted exercises seem worthy of investigation and the aim of this study was to assess the efficacy of a rehabilitation program including task-oriented exercises in improving disability, pain, and quality of life in patients after a PHF. Methods By means of a randomized controlled trial with one-year follow-up, 70 working patients (mean age of 49 ± 11 years; 41 females), who were selected for open reduction and internal fixation with plates caused by PHF, were randomized to be included in an experimental (n = 35) or control group (n = 35). There was a permuted-block randomization plan, and a list of program codes was previously created; subsequently, an automatic assignment system was used to conceal the allocation. The first group underwent a supervised rehabilitation program of task-oriented exercises based on patients’ specific job activities, and occupational therapy. The second group underwent general physiotherapy, including supervised mobility, strengthening and stretching exercises. Both groups individually followed programs of 60-min session three times per week for 12 weeks in the outpatient setting. The Disability Arm Shoulder Hand questionnaire (DASH; scores range from 0 to 100; primary outcome), a Pain intensity Numerical Rating Scale (scores range 0 to 10; secondary outcomes), and the Short-Form Health Survey (scores range from 0 to 100; secondary outcomes) assessed the interventions. Participants were evaluated before surgery, before and after rehabilitation (primary endpoint), and at the one-year follow-up (secondary endpoint). A linear mixed model analysis for repeated measures was carried out for each outcome measure (p < 0.05). Results Time, group and time by group showed significant effects for all outcome measures in favour of the experimental group. The DASH and the DASH work achieved clinically important between-group differences of 16.0 points (95% confidence interval [C.I.] 7.3 to 24.7) and 19.7 (95% C.I. 9.0 to 30.5) at follow-up, respectively. The NRS achieved a between-group difference of 2.9 (95% C.I. 1.0 to 3.9) at follow-up. As for SF-36, there were between-group differences ranging from 17.9 to 37.0 at follow-up. Conclusions A rehabilitation program based on task-oriented exercises was useful in improving disability, pain, and quality of life in working patients after PHFs. Improvements lasted for at least 12 months. Trial registration On 16/12/2019, the trial was retrospectively registered in the ISRCTN registry with the ID number 17996552.


2018 ◽  
Vol 1 ◽  
pp. 251581631880415
Author(s):  
Serena L Orr ◽  
Lawrence Richer ◽  
Nick Barrowman ◽  
Roger Zemek

Objective: To assess the feasibility of a randomized controlled trial protocol that aims to determine the efficacy and safety of oral dexamethasone compared to placebo for the prevention of migraine recurrence in children and adolescents visiting the pediatric emergency department (ED) with migraine. Methods: This study was a two-arm, parallel-group, randomized, placebo-controlled, double-blind pilot trial of patients presenting to the pediatric ED with migraine. Eligible participants were randomized at 1:1 ratio to receive either oral dexamethasone 0.6 mg/kg (maximum 15 mg) or matched placebo as a single dose. Efficacy and safety outcomes were assessed at discharge, 48 h and 7 days after discharge. The primary outcome of the trial was feasibility and was assessed through participant recruitment rate, follow-up completion rates, participant satisfaction ratings and comparison of enrolled versus non-enrolled participants. Efficacy and safety outcomes were not analyzed given that this was a pilot study. Results: Twelve participants were enrolled over the 6-month recruitment period. This represents 60% of the planned sample size and a 10.5% recruitment rate. No other feasibility issues were identified and patients expressed high satisfaction rates with their treatment: 90.9% were satisfied with their treatment at discharge and at 48-h follow-up and 81.8% were satisfied with their treatment at 7-day follow-up (81.8%). There were no significant differences observed when comparing enrolled participants to those not enrolled. Conclusion: This pilot randomized controlled trial is the first to assess dexamethasone in the pediatric ED for the prevention of migraine recurrence. The protocol is feasible but recruitment in a single center was lower than expected. Future pediatric ED migraine studies may use innovative or pragmatic trial designs to maximize feasibility from a recruitment standpoint.


2020 ◽  
Vol 34 (8) ◽  
pp. 1072-1082
Author(s):  
Dovile Naruseviciute ◽  
Raimondas Kubilius

Objectives: To evaluate and compare the efficacy of high-intensity laser therapy (HILT) and low-level laser therapy (LLLT) for plantar fasciitis. Design: A participant blind randomized controlled trial with parallel group design and an active comparator with follow-up at four weeks. Settings: Outpatient, University hospital. Subjects: Unilateral plantar fasciitis participants ( n = 102) were randomly assigned into two groups. Recruitment period was from January 2017 to April 2019. Interventions: Interventions included eight sessions of laser therapy over three weeks and single session of patient education. The HILT group ( n = 51) received HILT and the LLLT group ( n = 51) received LLLT. Main measures: Primary outcomes: visual analogue scale; secondary outcomes: pressure algometry, sonography of plantar fascia thickness (time frame: baseline to three-week and four-week follow-up) and numeric rating scale (0%–100%) for opinion of participants on effect of treatment (time frame: three weeks). Data presented: mean (SD) or n (%). Results: There was no statistically significant difference between the groups according to visual analogue scale (pain in general reduction in three weeks: 2.57(3.45) vs. 2.88(3.28) cm), pressure algometry (pain threshold difference between healthy and affected heel reduction in three weeks: 1.80(6.39) vs. 1.77(2.85) kg) and sonography measurements (plantar fascia thickness difference between healthy and affected heel reduction in three weeks: 0.19(0.56) vs. 0.30(0.57) mm). There was a statistically significant difference between the groups in participants’ opinion in favor to HILT group (efficacy of treatment better than 50%: 26(51%) vs. 37(73%)). Conclusion: No statistically significant difference between groups was observed.


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