scholarly journals Effectiveness of Adding a Large Dose of Shoulder Strengthening to Current Nonoperative Care for Subacromial Impingement: A Pragmatic, Double-Blind Randomized Controlled Trial (SExSI Trial)

2021 ◽  
pp. 036354652110160
Author(s):  
Mikkel Bek Clausen ◽  
Per Hölmich ◽  
Michael Rathleff ◽  
Thomas Bandholm ◽  
Karl Bang Christensen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Shoulder Pain ◽  
Large Dose ◽  
Controlled Trial ◽  
Subacromial Impingement ◽  
Specific Patient ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Patient Reported

Background: A strong recommendation against subacromial decompression surgery was issued in 2019. This leaves nonoperative care as the only treatment option, but recent studies suggest that the dose of strengthening exercise is not sufficient in current nonoperative care. At this point, it is unknown if adding more strengthening to current nonoperative care is of clinical value. Purpose: To assess the effectiveness of adding a large dose of shoulder strengthening to current nonoperative care for subacromial impingement compared with usual care alone. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: In this double-blinded, pragmatic randomized controlled trial, we randomly allocated 200 consecutive patients referred to orthopaedic shoulder specialist care for long-standing shoulder pain (>3 months), aged 18 to 65 years and diagnosed with subacromial impingement using validated criteria, to the intervention group (IG) or control group (CG). Outcome assessors were blinded, and participants were blinded to the study hypothesis as well as to the treatment method in the other group. The CG received usual nonoperative care; the IG underwent the same plus an add-on intervention designed to at least double the total dose of shoulder strengthening. The primary outcome was the Shoulder Pain and Disability Index (SPADI; 0-100) at 4-month follow-up, with 10 points defined as the minimal clinically important difference. Secondary outcomes included shoulder strength, range of motion, health-related quality of life, and the Patient Acceptable Symptom State (PASS). Results: Intention-to-treat and per-protocol analyses showed no significant or clinically relevant between-group differences for any outcome. From baseline to 4-month follow-up, SPADI scores improved in both groups (intention-to-treat analysis; IG, –22.1 points; CG, –22.7 points; between-group mean difference, 0.6 points [95% CI, –5.5 to 6.6]). At 4 months after randomization, only 54% of the IG and 48% of the CG ( P = .4127) reached the PASS. No serious adverse events were reported. Conclusion: Adding a large dose of shoulder strengthening to current nonoperative care for patients with subacromial impingement did not result in superior shoulder-specific patient-reported outcomes. Moreover, approximately half of all randomized patients did not achieve the PASS after 4 months of nonoperative care, leaving many of these patients with unacceptable symptoms. This study showed that adding more exercise is not a viable solution to this problem. Registration: NCT02747251 ( ClinicalTrials.gov identifier)

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

scholarly journals Non- or Minimally Displaced Distal Radial Fractures in Adult Patients: Three Weeks versus Five Weeks of Cast Immobilization—A Randomized Controlled Trial

2018 ◽  
Vol 08 (01) ◽  
pp. 043-048 ◽  
Author(s):  
A. Bentohami ◽  
J. Vermeulen ◽  
N. L. Sosef ◽  
N. de Korte ◽  
T. S. Bijlsma ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Patient Reported Outcomes ◽  
Controlled Trial ◽  
Adult Patients ◽  
Cast Immobilization ◽  
Distal Radial Fractures ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Secondary Displacement

Background Patients with non- or minimally displaced distal radial fractures, that do not need repositioning, are mostly treated by a short-arm cast for a period of 4 to 6 weeks. A shorter period of immobilization may lead to a better functional outcome. Purpose We conducted a randomized controlled trial to evaluate whether the duration of cast immobilization for patients with non- or minimally displaced distal radial fractures can be safely shortened toward 3 weeks. Materials and Methods The primary outcomes were patient-reported outcomes measured by the Patient-Related Wrist Evaluation (PRWE) and Quick Disability of Arm, Shoulder and Hand (QuickDASH) score after 1-year follow-up. Secondary outcome measures were: PRWE and QuickDASH earlier in follow-up, pain (Visual Analog Scale), and complications like secondary displacement. Results Seventy-two patients (male/female, 23/49; median age, 55 years) were included and randomized. Sixty-five patients completed the 1-year follow-up. After 1-year follow up, patients in the 3 weeks immobilization group had significantly better PRWE (5.0 vs. 8.8 points, p = 0.045) and QuickDASH scores (0.0 vs. 12.5, p = 0.026). Secondary displacement occurred once in each group. Pain did not differ between groups (p = 0.46). Conclusion Shortening the period of immobilization in adult patients with a non- or minimally displaced distal radial fractures seems to lead to equal patient-reported outcomes for both the cast immobilization groups. Also, there are no negative side effects of a shorter period of cast immobilization. Therefore, we recommend a period of 3 weeks of immobilization in patients with distal radial fractures that do not need repositioning.

scholarly journals Matrix-Augmented Bone Marrow Stimulation With a Polyglycolic Acid Membrane With Hyaluronan vs Microfracture in Local Cartilage Defects of the Femoral Condyles: A Multicenter Randomized Controlled Trial

2020 ◽  
Vol 8 (5) ◽  
pp. 232596712092293
Author(s):  
Johannes Glasbrenner ◽  
Wolf Petersen ◽  
Michael J. Raschke ◽  
Matthias Steiger ◽  
René Verdonk ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Polyglycolic Acid ◽  
Tissue Formation ◽  
Bone Marrow Stimulation ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Patient Reported

Background: Microfracture (MF) is an established operative treatment for small, localized chondral defects of the knee joint. There is evidence from animal studies that matrix augmentation of bone marrow stimulation (m-BMS) can improve the quality of the repair tissue formation. Purpose: To evaluate the therapeutic outcome of a matrix made of polyglycolic acid and hyaluronan as compared with a conventional MF technique. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients between the ages of 18 and 68 years who had an articular femoral cartilage defect of 0.5 to 3 cm2 in the weightbearing area of the femoral condyles with indication for MF were included in this study. Patients were randomized and treated with either MF or m-BMS with Chondrotissue. Defect filling, as assessed on magnetic resonance imaging (MRI), at postoperative 12 weeks was defined as the primary outcome measure, with follow-up MRI at weeks 54 and 108. Follow-up data were also collected at 12, 54, and 108 weeks after surgery and included patient-reported clinical scores: visual analog scale for pain, Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee score, and 36-Item Short Form Health Survey. Results: MRI scans confirmed cartilage repair tissue formation in both groups 12 weeks after treatment. There was no significant difference between the m-BMS and MF groups in the percentage of defect filling at 12, 54, and 108 weeks postoperatively. No significant difference was found in terms of patient-reported clinical scores. Both groups showed significant improvement in 4 KOOS subscales—Pain, Activities of Daily Living, Sport and Recreation, and Quality of Life—at 54 and 108 weeks after treatment. Conclusion: This is the first randomized controlled trial comparing m-BMS with a polyglycolic acid matrix with hyaluronan with MF. The use of the Chondrotissue implant in m-BMS has been proven to be a safe procedure. No difference was found between m-BMS and MF in terms of patient-reported outcome scores and MRI assessment until postoperative 2 years. Long-term follow-up studies including histological assessment are desirable for further investigation. Registration: EUCTR2011-003594-28-DE (EU Clinical Trials Register).

Evaluation of the smoking intervention X:IT after the second year: A randomized controlled trial

2018 ◽  
Vol 47 (8) ◽  
pp. 885-889 ◽  
Author(s):  
Anette Andersen ◽  
Lotus S. Bast ◽  
Pernille Due ◽  
Lau C. Thygesen
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
First Year ◽  
Long Term Effects ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Smoking Intervention ◽  
Second Year ◽  
Cluster Randomized

Aims:Review studies on the long-term effects of school-based smoking interventions show mixed results. X:IT was a three-year cluster randomized controlled trial to prevent uptake of smoking among Danish students from age 13 years until age 15 years which previously proved effective in preventing smoking after the first year of intervention. The aim of this paper was to conduct the pre-planned analyses of the effects of the X:IT intervention on smoking after the second year. Methods: We used self-reported questionnaire data from students at baseline, first, second, and third follow-up ( n at second follow-up=3269, response rate=79.4%). Data from third follow-up were not suitable for analysis. Outcome measure: ‘current smoking’, dichotomised into smoke daily, weekly, monthly or more seldom versus do not smoke. We performed multilevel, logistic regression analyses of available cases and intention-to-treat (ITT) analyses, replacing missing outcome values by multiple imputation. Results: The prevalence of smoking increased from 5.8% at baseline to 17.0% at second follow-up among students at intervention schools, and from 7.6% to 18.7% among students at control schools. Analyses of available cases and ITT analyses did not support X:IT being effective in preventing smoking after the second year of intervention. Conclusions: Although X:IT was effective after the first year of intervention, we were not able to demonstrate any effects after the second year. Implementation of the intervention was lower in the second year compared to the first year which indicates that the missing effect of the intervention at second follow-up is due to lack of implementation.

scholarly journals Health Information and Monitoring of Sexually Transmitted Infections (SIM Study): a Randomized Controlled Trial Protocol for Enhancing Adherence to Syphilis Treatment and Follow-up

2021 ◽  
Author(s):  
Eliana Marcia Ros Wendland ◽  
Vanessa M. de Oliveira ◽  
Flavia Souza ◽  
Gerson Pereira ◽  
Antonio Gerbase
Keyword(s):  
Public Health ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Public Health Problem ◽  
Major Change ◽  
Mobile Technologies ◽  
Monitoring Methods ◽  
Intention To Treat ◽  
Randomized Controlled

Abstract Background: Syphilis has recently resurfaced as a significant public health problem. Since the 2000s, isolated syphilis outbreaks have increasingly occurred in North America, Europe, and Australia; in Brazil, there have been progressive increases in both congenital and acquired syphilis. There are several possible explanations, such as misdiagnosis of acquired syphilis, which could increase the number of untreated transmitters in the population; failure to initiate or complete treatment; and nontreatment of sexual partners (leading to reinfection). Mobile technologies have been successfully used to promote behaviour changes and can positively impact treatment and follow-up adherence in patients with infectious diseases. The purpose of this clinical trial is to evaluate treatment and monitoring methods in patients with syphilis, including follow-up by telephone, via a game in a smartphone app and at public health centres.Methods: The SIM study is a single-centre, randomized controlled trial with a 12-month follow-up period. The aim is to identify the most effective method of follow-up regarding patient compliance with treatment. The tests will be performed in a mobile unit in easily accessible locations. The goal is to perform 10,000 rapid tests for syphilis. Patients with a confirmed diagnosis according to VDRL tests will be randomized to one of three arms: telephone, smartphone game, or conventional in-person follow-up. All analyses will follow the intention-to-treat principle.Conclusion: If we find differences in effectiveness, a major change in the conventional approach for this patient population may be needed, potentially affecting current Brazilian health policy strategies.

scholarly journals A Randomized Controlled Trial Evaluating a Pain Assessment and Management Program for Respite Workers Supporting Children With Disabilities Part One: Pain-Related Knowledge and Perceptions

2021 ◽  
Vol 126 (4) ◽  
pp. 271-288 ◽  
Author(s):  
Lara M. Genik ◽  
Elisabeth L. Aerts ◽  
Paula C. Barata ◽  
Chantel C. Barney ◽  
Stephen P. Lewis ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pain Assessment ◽  
Controlled Trial ◽  
Management Program ◽  
Control Group ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Pain Knowledge

Abstract This parallel group randomized controlled trial tested effectiveness of the Let's Talk About Pain training on respite workers' (RW) pain-related knowledge and feasibility-confidence-skill ratings using between-group and within-group analyses. Fourteen children's respite organizations were randomized to pain or control training. Participants (nintervention = 66; ncontrol = 92) underwent a 3–3.5 hour training and completed measures at pre-, post-, and 4–6 week follow-up. Intention-to-treat (nintervention = 65; ncontrol = 92) and per-protocol (nintervention = 26–38; ncontrol = 40–57) analyses were conducted. Pain training participants demonstrated significantly higher pain knowledge and feasibility-confidence-skill ratings post-follow-up versus control group and significant increases in knowledge from pre-post. Significant gains were maintained from post-follow-up. Results represent a promising step towards enhancing pain-related care for children with IDD.

scholarly journals Efficacy of preoperative progressive resistance training in patients undergoing total knee arthroplasty: 12-month follow-up data from a randomized controlled trial

2019 ◽  
Vol 34 (1) ◽  
pp. 82-90 ◽  
Author(s):  
Birgit Skoffer ◽  
Thomas Maribo ◽  
Inger Mechlenburg ◽  
Christian Gaarden Korsgaard ◽  
Kjeld Søballe ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Resistance Training ◽  
Muscle Strength ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Significant Group ◽  
Randomized Controlled ◽  
Patient Reported

Objective: The aim of this study was to investigate the effect of adding four weeks preoperative progressive resistance training (PRT) to four weeks postoperative PRT on patient function, muscle strength, and other outcomes 12 months after total knee arthroplasty (TKA). Design: Twelve-month follow-up data from a previously published randomized controlled trial. Setting: Aarhus University Hospital, Silkeborg Regional Hospital, and Aarhus University. Subjects: A total of 59 patients scheduled for TKA were enrolled in a single-blinded, clinical randomized controlled trial. Interventions: Participants were randomized to preoperative PRT (intervention group) or to a control group who “lived as usual” the last four weeks before TKA. The intervention group completed four weeks preoperative and four weeks postoperative PRT, whereas the control group only completed four weeks postoperative PRT. Main follow-up measures were as follows: the 30-second Chair Stand Test (primary outcome), Timed Up and Go Test, walk tests, knee extensor, and knee flexor muscle strength and patient-reported outcomes. Statistical analyses were performed according to the intention-to-treat principle. Results: No significant group differences were observed for the primary outcome 30-second Chair Stand Test (4.0 repetitions versus 2.4 repetitions, P = 0.067) or for other functional performance outcomes. The intervention group had significantly higher weight-normalized knee extensor muscle strength (0.5 Nm/kg versus 0.2 Nm/kg, P = 0.002) and knee flexor muscle strength (0.3 Nm/kg versus 0.2 Nm/kg, P = 0.042) in the operated leg when compared to the control group. No significant group differences for patient-reported outcomes. Conclusion: The study supports the use of short-term high-intensity resistance training before TKA as it induces a long-lasting effect on muscle strength, while it may have no discernible effect on functional performance.

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