Effectiveness of Quickcast Versus Custom-Fabricated Thermoplastic Orthosis Immobilization for the Treatment of Mallet Fingers: A Randomized Clinical Trial

Hand ◽  
2021 ◽  
pp. 155894472098813
Author(s):  
Priscilla K. Cavanaugh ◽  
Cynthia Watkins ◽  
Christopher Jones ◽  
Mitchell G. Maltenfort ◽  
Pedro K. Beredjiklian ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Soft Tissue ◽  
Randomized Clinical Trial ◽  
Surgical Intervention ◽  
Extensor Tendon ◽  
Distal Phalanx ◽  
Mallet Finger ◽  
Secondary Surgery ◽  
Significant Difference ◽  
Extensor Lag

Background: Mallet finger is a common injury involving a detachment of the terminal extensor tendon from the distal phalanx. This injury is usually treated with immobilization in a cast or splint. The purpose of this study is to compare outcomes of mallet fingers treated with either a cast (Quickcast) or a traditional thermoplastic custom-fabricated orthosis. Methods: Our study was a prospective, assessor-blinded, single-center randomized clinical trial of 58 consecutive patients with the diagnosis of bony or soft tissue mallet finger treated with immobilization. Patients were randomized to either an orfilight thermoplastic custom-fabricated orthosis or a Quickcast orthosis. Patients were evaluated at 3, 6, and 10 weeks for bony and 4, 8, and 12 weeks for soft tissue mallets. Skin complications, pain with orthosis, compliance, need for surgical intervention, and extensor lag were compared between the 2 groups. Results: Both bony and soft tissue mallet finger patients experienced significantly less skin complications (33% vs 64%) and pain (11.2 vs 21.6) when using Quickcast versus an orfilight thermoplastic custom-fabricated orthosis. The soft tissue mallet group revealed a greater difference in pain, favoring Quickcast (6.2 vs 22). No significant difference in final extensor droop or need for secondary surgery was found between the 2 groups. Conclusions: Quickcast immobilization for the treatment of mallet finger demonstrated fewer skin complications and less pain compared with orfilight custom-fabricated splints.

scholarly journals Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Safa Najafi ◽  
Maryam Ansari ◽  
Vahid Kaveh ◽  
Shahpar Haghighat
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Single Dose ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Injection Site Reaction ◽  
Study Groups ◽  
Breast Cancer Patients ◽  
Significant Difference

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

Complications and surgical results of stone-directed antegrade pyelography compared to the retrograde pyelographic access method in percutaneous nephrolithotomy using ‘bull’s eye’ technique: A randomized clinical trial

2021 ◽  
pp. 205141582199372
Author(s):  
Dariush Irani ◽  
Abdolreza Haghpanah ◽  
Mohammad Mehdi Hosseini ◽  
Leila Malekmakan ◽  
Mohammad Ali Ashraf ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Percutaneous Nephrolithotomy ◽  
Renal Stones ◽  
Surgical Results ◽  
Retrograde Pyelography ◽  
Antegrade Approach ◽  
Antegrade Pyelography ◽  
Significant Difference ◽  
Bull's Eye

Objectives: This study aimed to evaluate the differences in outcomes and complications in stone-directed antegrade pyelography using the ‘bull’s eye’ technique in patients with renal stones versus the conventional method of percutaneous nephrolithotomy (PCNL). Although conventional PCNL access using retrograde pyelography is useful, it is time-consuming and may cause postoperative discomfort. Herein, we report our experience in the application of this new technique. Methods: Between January 2017 and June 2018, 100 patients participated in this randomized clinical trial. Stone-directed antegrade pyelography using the ‘bull’s eye’ technique under fluoroscopic guidance was used for percutaneous access in the intervention group. The second group, consisting of those who had undergone conventional PCNL using retrograde pyelography and ‘bull’s eye’ technique in the same period, were considered as the controls. Pre- and postoperative laboratory examinations, surgical results and complications were recorded and compared between the two groups. Results: A single calyceal puncture in partial staghorn and staghorn stone patients was sufficient in 72.2% of the antegrade group and in 78.9% of the retrograde group ( p=0.69). The double-puncture technique was necessary for 71.9% of renal pelvis stones in the antegrade group and for 9.4% in the retrograde group ( p<0.001). The antegrade approach reduced the mean operative time and analgesic requirement significantly ( p<0.001). No statistically significant difference, however, was found between the two groups regarding stone migration to the ureter, radiation time and postoperative complications. Conclusions: The stone-directed antegrade approach using the ‘bull’s eye’ technique is a safe and accurate method in PCNL access in patients with radiopaque and semi-opaque renal stones.

Dance Rhythms Improve Motor Symptoms in Individuals with Parkinson’s Disease: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Jéssica A. Moratelli ◽  
Kettlyn H. Alexandre ◽  
Leonessa Boing ◽  
Alessandra Swarowsky ◽  
Clynton L. Corrêa ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Clinical Trial ◽  
Parkinson's Disease ◽  
Randomized Clinical Trial ◽  
Rating Scale ◽  
Freezing Of Gait ◽  
Motor Symptoms ◽  
Score Change ◽  
Significant Difference ◽  
Binary Group

Background: Evidence-based practices involving dance modalities found in binary (two-beat rhythm) or quaternary (four-beat rhythm) show that dance positively influences the motor aspects of disease.Aim: This randomized clinical trial aimed to analyze the effect of two dance rhythm (binary and quaternary) on the balance, gait, and mobility in individuals with Parkinson’s disease (PD). Methods: Thirty-one individuals with PD were randomized into the binary group (n = 18) and the quaternary group (n = 13). Both groups participated in different dance rhythms lasting 12 weeks, twice a week, for 45 minutes. Results: The binary group showed a significant difference in balance (p = 0.003), freezing of gait (p = 0.007), as well as in the motor aspects of MDS-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), with emphasis on the total values with a score change of 3.23. In the quaternary group, significant differences were found in balance (p = 0.021) with a score change of -2.54 and in the motor aspects of the MDS-UPDRS Part III where the total values stood out with a change of 3.54. Discussion: When comparing the possible effects of binary and quaternary rhythms on the motor symptoms of individuals with PD, it was demonstrated that binary rhythm improved balance, freezing gait, and UPDRSIII. As for the quaternary rhythm, the benefits were in balance and the UPDRSIII. Conclusion: The binary and the quaternary rhythm dance protocols positively influenced the motor symptoms of individuals with PD after 12 weeks of intervention.

scholarly journals Effect of Acupressure on Stress and Anxiety of Patients with Multiple Sclerosis: A Sham-controlled Randomized Clinical Trial

2020 ◽  
Vol 10 (3) ◽  
pp. 270-283
Author(s):  
Mohammad Ali Nahayati ◽  
◽  
Seyed Abolfazl Vaghar Seyyedin ◽  
Hamid Reza Bahrami-Taghanki ◽  
Zahra Rezaee ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Test Scores ◽  
Sham Group ◽  
Applied Pressure ◽  
Intervention Group ◽  
T Test ◽  
Significant Difference ◽  
The Mean

Objective: Stress and anxiety are common in patients with Multiple Sclerosis (MS). These complications exacerbate the symptoms of MS. This study aims to evaluate the effect of acupressure on stress and anxiety of MS patients. Methods: In this randomized clinical trial, participants were 106 MS Patients referred to Multiple Sclerosis Society in Mashhad, Iran. After signing an informed consent form, they completed a demographic form and stress, and the Depression Anxiety Stress Scale - 42 items (DASS-42). Then, they were randomly assigned into intervention and sham groups by tossing a coin. Participants in the intervention group were asked apply a pressure on the Shenmen and Yin Tang acupoints for one month (once per day for 15 minutes), while the sham group applied pressure 2.5 cm below the Shenmen acupoint and 3 cm above the Yin Tang acupoint. Participants in each group were then completed the DASS-42 again one hour after the final session. Data were analyzed using chi-square test, Kolmogorov-Smirnov test, independent t-test, and Paired t-test. Results: In the intervention and sham groups, there was no statistically significant difference between the mean pre-test scores of stress (34.73±5.80 vs. 33.06±6.42) and anxiety (27.09±6.99 vs. 25.31±6.88), and neither between the mean post-test scores of stress (29.20±6.21 vs. 33.73±9.44) and anxiety (22.79±5.68 vs. 25.21±6.72) (P>0.05). However, comparison of DASS-42 scores between groups showed that the mean scores of stress and anxiety in the intervention group were significantly lower than in the sham group (P< 0.05). Conclusion: It seems that acupressure can be used along with other therapeutic and pharmacological interventions to reduce stress and anxiety in patients with MS.

scholarly journals Shear Bond Strength of Brackets Bonded with Self-Etching Primers Compared to Conventional Acid-Etch Technique: A Randomized Clinical Trial

2019 ◽  
Author(s):  
Nasrin Farhadian ◽  
Amirfarhang Miresmaeili ◽  
Vahid Shahidi Zandi
Keyword(s):  
Clinical Trial ◽  
Bond Strength ◽  
Randomized Clinical Trial ◽  
Shear Bond Strength ◽  
Allocation Concealment ◽  
Wilcoxon Test ◽  
Adhesive Remnant Index ◽  
Significant Difference ◽  
Acid Etch ◽  
Registration Number

Objectives: The purpose of this randomized clinical trial (RCT) was to compare the shear bond strength (SBS) of orthodontic brackets bonded to enamel with conventional acid-etch (AE) technique and self-etching primers (SEP). Materials and Methods: Twenty-two patients, requiring extraction of two bicuspids for orthodontic reasons, were recruited. In each individual, following blinding and allocation concealment, one intact premolar received conventional AE, whereas the contralateral premolar received SEP with a split-mouth design. Bonded brackets remained in the oral cavity for two months. Afterward, the teeth were extracted without debonding the brackets. SBS and adhesive remnant index (ARI) were measured using a Universal Instron machine and a stereomicroscope, respectively. Results: The mean SBS of the conventional AE and SEP groups was 9.53 and 9.20 MPa, respectively. Paired t-test showed no statistically significant difference between the two groups (P=0.096). Comparison of ARI between the two groups, using Wilcoxon test, indicated that significantly less adhesive remained on enamel with brackets bonded with SEP compared to brackets bonded with conventional AE (P<0.001) although the SBS was higher in the AE group. Conclusion: The present study indicated that although there is no significant difference in SBS between SEP and conventional AE for bonding orthodontic metal brackets, the amount of residual adhesive on the enamel surface is significantly less with SEP than with conventional AE. (IRCT registration number: IRCT201705099086N3).

scholarly journals O12 OPEN PREPERITONEAL INGUINAL HERNIA REPAIR, TREPP VERSUS TIPP IN A RANDOMIZED CLINICAL TRIAL

2021 ◽  
Vol 108 (Supplement_8) ◽  
Author(s):  
Willem Bökkerink ◽  
Giel Koning ◽  
Patrick Vriens ◽  
Roland Mollen ◽  
Willem Akkersdijk ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Inguinal Hernia ◽  
Hernia Repair ◽  
Learning Curve ◽  
Randomized Clinical Trial ◽  
Inguinal Hernia Repair ◽  
Recurrence Rates ◽  
Significant Difference ◽  
Related Quality

Abstract Aim The preperitoneal mesh position for inguinal hernia repair showed beneficial results regarding Chronic Postoperative Inguinal Pain (CPIP) with low recurrence rates. Two open preperitoneal techniques, the TransREctus Sheath PrePeritoneal (TREPP) and the TransInguinal PrePeritoneal (TIPP) technique, were compared in a randomized clinical trial with the hypothesis of less patients with CPIP after TREPP due to complete avoidance of nerve contact. Materials and Methods Adult patients with a primary unilateral inguinal hernia were randomized to either TREPP or TIPP in four hospitals. Prior to the trial’s start the study protocol was ethically approved and published. Outcomes included CPIP after 1 year (primary outcome) and recurrence rates, adverse events and Health related Quality of Life (secondary outcomes). Follow-up was performed at 2 weeks, 6 months and 1 year. Results Baseline characteristics were comparable in both groups. Pain was less often present after TREPP at 2 weeks and 6 months, but the CPIP at rest at 1 year was comparable 1.9% after TREPP vs 1.4% after TIPP, p = 0.535). The overall recurrence rate was higher in the TREPP group, 8.9% vs 4.6%, p = 0.022). Corrected for a learning curve for TREPP, no significant difference could be assessed (TREPP 5.7% and TIPP 4.8%, p = 0.591). Conclusions both the TREPP and TIPP technique resulted in a low incidence of CPIP after 1 year follow-up. The TREPP method can be considered a solid method for inguinal hernia repair if expertise is present. The learning curve of the TREPP techniques needs further evaluation.

scholarly journals Improving Rehabilitation for Patients with Intermittent Claudication: A Randomized Controlled Trial with a Mixed-Methods Evaluation (The CIPIC Rehab Study)

2021 ◽  
Author(s):  
Maj Siercke ◽  
Sanne Pagh Moller ◽  
Lau Caspar Thygesen ◽  
Henrik Sillesen ◽  
Dorthe Overgaard
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Clinical Trial ◽  
Mixed Methods ◽  
Usual Care ◽  
Randomized Clinical Trial ◽  
Intermittent Claudication ◽  
Walking Distance ◽  
Significant Difference

Aim: This study aimed to explore how qualitative data about rehabilitation for patients with intermittent claudication do provide an enhanced understanding of the quantitative experimental results. Background: The study was a randomized clinical trial comparing a rehabilitation intervention with usual care. A statistically significant difference between rehabilitation and usual care was found in walking distance, physical activity, quality of life and diet. The findings from the quantitative and qualitative analyses were analysed separately on their own tradition. In this study, mixed methods address whether the qualitative results could help explain the quantitative results and bring forward additional information. Design: Complex mixed-method intervention design with a convergent questionnaire variant. Methods: From April 2017- May 2019, patients diagnosed with intermittent claudication were included in a randomized clinical trial (N=118). In addition, qualitative interview informants from the intervention group were sampled from the quantitative study population for a survey (N=43) and focus group interviews (N=10). Interviews were conducted from April 2018-August 2019. Results: Integrated analyses identified how improvement in walking distance, physical activity, diet and quality of life was affected by team spirit, pedometer, education and fun exercise in a local setting. Quantitative and qualitative findings primarily confirmed and expanded each other; however, two discordant results were also evident. Conclusion: Our study adds empirical evidence regarding how a mixed-methods study can be used to obtain a more nuanced understanding of complex healthcare problems. The study provides new knowledge concerning how to set up a rehabilitation programme for patients with intermittent claudication.

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