Osteochondroplasty and Labral Repair for the Treatment of Young Adults With Femoroacetabular Impingement: A Randomized Controlled Trial

2020 ◽  
Vol 49 (1) ◽  
pp. 25-34 ◽  
Author(s):  
◽  
Olufemi R. Ayeni ◽  
Jon Karlsson ◽  
Diane Heels-Ansdell ◽  
Lehana Thabane ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Young Adults ◽  
Femoroacetabular Impingement ◽  
Short Form ◽  
Controlled Trial ◽  
Hip Pain ◽  
Labral Repair ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Secondary Outcomes

Background: Femoroacetabular impingement (FAI) is a condition known to cause hip pain in young adults. Purpose: To evaluate the efficacy of the surgical correction of FAI via arthroscopic osteochondroplasty with or without labral repair compared with arthroscopic lavage of the hip joint with or without labral repair. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 220 male and female participants aged 18 to 50 years with nonarthritic FAI suitable for surgical treatment were recruited for the trial at 10 clinical centers in Canada, Finland, and Denmark between October 2012 and November 2017, of whom 214 were included in the final analysis. In the osteochondroplasty group, cam- and/or pincer-type lesions were resected using fluoroscopic guidance. In the lavage group, the joint was washed out with 3 L of normal saline. Surgeons were instructed to repair the labrum in both groups if it was mechanically unstable once probed, showing visible displacement or chondrolabral separation. The primary outcome was patient-reported pain (using the 100-point visual analog scale [VAS]) at 12 months. Secondary outcomes included hip function (Hip Outcome Score [HOS] and International Hip Outcome Tool), physical and mental health (12-Item Short Form Health Survey), and health utility (EuroQol–5 Dimensions) at 12 months as well as any reoperations and other hip-related adverse events at 24 months. Results: At 12 months, there was no difference in pain (VAS) between the groups (mean difference [MD], 0.11 [95% CI, –7.22 to 7.45]; P = .98). Also, 88.3% (189/214) of participants had a labral tear, of which 60.3% were repaired. For the secondary outcomes, there were no significant differences between treatment groups, with the exception of the HOS activities of daily living domain in which lavage showed significant improvement compared with osteochondroplasty (MD, –5.03 [95% CI, −10.40 to −0.03]; P = .049). By 24 months, there were significantly fewer reoperations reported in the osteochondroplasty group (8/105) than the lavage group (19/104) (odds ratio, 0.37 [95% CI, 0.15-0.89]; P = .026). The primary reasons for a reoperation included hip pain (15/27; 55.6%) and a reinjury of the labrum (11/27; 40.7%). Conclusion: Both the osteochondroplasty and the lavage groups with or without labral repair for FAI had significantly improved pain or function significantly at 1 year. By 2 years, the reoperation rate was significantly lower in the osteochondroplasty group. Registration: NCT01623843 ( ClinicalTrials.gov identifier)

Peritoneal Ultrafiltration for Heart Failure: Lessons from a Randomized Controlled Trial

2019 ◽  
Vol 39 (5) ◽  
pp. 486-489
Author(s):  
Hari Dukka ◽  
Philip A. Kalra ◽  
Martin Wilkie ◽  
Sunil Bhandari ◽  
Simon J. Davies ◽  
...  
Keyword(s):  
Heart Failure ◽  
Randomized Controlled Trial ◽  
Peritoneal Dialysis ◽  
Short Form ◽  
Controlled Trial ◽  
Severe Heart Failure ◽  
Lessons Learned ◽  
Randomized Controlled ◽  
Ckd Stage ◽  
Patient Reported

Peritoneal ultrafiltration (PuF) has been employed for severe heart failure (HF), but evidence for its benefit is lacking. The Peritoneal Dialysis for Heart Failure (PDHF) study was a multicenter prospective randomized controlled trial which aimed to investigate this issue. The trial stopped early due to inadequate recruitment. We describe methods, trial activity, and lessons learned. The trial aimed to recruit 130 participants with severe diuretic-resistant HF (New York Heart Association [NYHA] 3/4) and chronic kidney disease (CKD) stage 3/4 on optimal medical treatment for ≥ 4 weeks from 6 UK centers. Participants were randomized to either continuation of conventional HF treatment or to additionally receiving PuF (1 overnight exchange using Icodextrin dialysate). Primary outcome was change in 6-minute walk test (6MWT) between baseline and 28 weeks (end of trial). Secondary outcomes were changes in patient reported quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire, short form 36 (SF 36) health survey results, hospitalization, and mortality. Over a 2-year period, 290 patients were screened from which only 20 met inclusion criteria and 10 were recruited. Reasons for ineligibility were fluctuating estimated glomerular filtration rate (eGFR), suboptimal HF treatment, frailty, and patients being too unwell for randomization. Barriers to recruitment included patient frailty, with some participants considered only when they were at end of life, unwillingness to engage in an invasive therapy, and suboptimal coordination between cardiology and renal services. This is a challenging patient group in which to perform research, and lessons learned from the peritoneal dialysis (PD)-HF trial will be helpful in the planning of future studies in this area.

scholarly journals Neuromuscular Exercises Improve Shoulder Function More Than Standard Care Exercises in Patients With a Traumatic Anterior Shoulder Dislocation: A Randomized Controlled Trial

2020 ◽  
Vol 8 (1) ◽  
pp. 232596711989610 ◽  
Author(s):  
Henrik Rode Eshoj ◽  
Sten Rasmussen ◽  
Lars Henrik Frich ◽  
Inge Hvass ◽  
Robin Christensen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Shoulder Instability ◽  
Standard Care ◽  
Controlled Trial ◽  
Clinical Signs ◽  
Shoulder Function ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Secondary Outcomes

Background: There is an important gap in knowledge about the effectiveness of nonoperative treatment (exercise) for patients with traumatic primary and recurrent anterior shoulder dislocations (ASDs). Purpose/Hypothesis: The purpose of this study was to assess the efficacy and safety of physical therapist–supervised, shoulder instability neuromuscular exercise (SINEX) versus self-managed, home-based, standard care shoulder exercise (HOMEX) in patients with traumatic ASDs. The hypothesis was that SINEX would have a larger effect and fewer adverse events compared with HOMEX. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: A total of 56 participants with radiographically verified, trauma-initiated primary or recurrent ASDs and self-reported decreased shoulder function were randomized to 12 weeks of either SINEX or HOMEX. The SINEX program consisted of 7 exercises, individually progressing from basic (2 × 20 repetitions each day) to elite (2 × 10 repetitions, 3 times weekly). The HOMEX program included 5 shoulder exercises performed 3 times weekly (2 × 10 repetitions). The primary outcome was the Western Ontario Shoulder Instability Index (WOSI) score, ranging from 0 (best possible) to 2100. The between-group minimal clinically important difference at 12 weeks was 250 points. Secondary outcomes included WOSI subdomain scores, patient-reported ratings of kinesiophobia and pain, objective shoulder function, patient satisfaction, and number of adverse events. Results: The between-group mean difference in the WOSI total score at 12 weeks significantly favored SINEX over HOMEX (–228.1 [95% CI, –430.5 to –25.6]). SINEX was furthermore superior to HOMEX in most of the secondary outcomes (3/4 subdomains of the WOSI and pain level during the past 7 days as well as clinical signs of anterior shoulder instability). Also, although not statistically significant, less than half the proportion of the SINEX patients compared with the HOMEX patients (3/27 [11%] vs 6/24 [25%], respectively; P = .204) underwent or were referred for shoulder stabilizing surgery. Satisfaction with both exercise programs was high, and no serious adverse events were reported. Conclusion: Neuromuscular shoulder exercise (SINEX) was superior to standard care exercise (HOMEX) in patients with traumatic ASDs. Further long-term follow-ups on treatment effects are needed. Registration: NCT02371928 ( ClinicalTrials.gov identifier).

scholarly journals Effects of Chinese medicine on patients with acute exacerbations of COPD: study protocol for a randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Hailong Zhang ◽  
Jiansheng Li ◽  
Xueqing Yu ◽  
Suyun Li ◽  
Haifeng Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Chinese Medicine ◽  
Short Form ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Acute Exacerbations

Abstract Background The incidence, mortality, and prevalence of chronic obstructive pulmonary disease (COPD) are high in China. Acute exacerbations of COPD (AECOPD) are important events in the management of COPD because they negatively impact health status, rates of hospitalization and readmission, and disease progression. AECOPD have been effectively treated with Chinese medicine for a long time. The aim of this proposed trial is to assess the therapeutic effect of Chinese medicine (CM) on AECOPD. Methods/design This proposed study is a multicenter, double-blind, parallel-group randomized controlled trial (RCT). We will randomly assign 378 participants with AECOPD into two groups in a 1:1 ratio. On the basis of health education and conventional treatment, the intervention group will be treated with CM, and the control group is given CM placebo according to CM syndrome. Patients are randomized to either receive CM or placebo, 10 g/packet, twice daily. The double-blind treatment lasts for 2 weeks and is followed up for 4 weeks. The main outcome is the COPD Assessment Test; secondary outcomes are treatment failure rate, treatment success rate, length of hospital stay, AECOPD readmission rate, intubation rate, mortality, dyspnea, the 36-item Short Form Health Survey, and the COPD patient-reported outcome scale. We will document these outcomes faithfully at the beginning of the study, 2 weeks after treatment, and at the 4 weeks follow-up. Discussion This high-quality RCT with strict methodology and few design deficits will help to prove the effectiveness of CM for AECOPD. We hope this trial will provide useful evidence for developing a therapeutic schedule with CM for patients with AECOPD. Trial registration ClinicalTrials.gov, NCT03428412. Registered on 4 February 2018.

Efficacy and Impact of an mHealth Intervention to promote Mental Wellness for American Indian and Alaska Native Teens and Young Adults: A Randomized Controlled Trial of the BRAVE Study (Preprint)

2020 ◽  
Author(s):  
Stephanie Craig Rushing ◽  
Allyson Kelley ◽  
Sheana Bull ◽  
David Stephens ◽  
Julia Wrobel ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Young Adults ◽  
Alaska Native ◽  
Help Seeking ◽  
Culturally Relevant ◽  
Controlled Trial ◽  
Text Message ◽  
Text Messages ◽  
Randomized Controlled ◽  
Mental Wellness

BACKGROUND Culturally-relevant interventions are needed to help American Indian and Alaska Native (AI/AN) teens and young adults navigate common risky situations involving family and friends, including drug and alcohol misuse, dating violence, and suicidality. We R Native – a multimedia health resource for Native teens and young adults – designed an intervention for Native youth, delivered via text message, that includes role model videos, mental wellness strategies, and links to culturally-relevant resources (hotlines, chat-lines, websites, etc.) and social support. OBJECTIVE This study aims to test the efficacy of BRAVE to improve participant’s physical, mental, and spiritual health, their use of mental wellness strategies, their help-seeking skills, and associated factors, including cultural resilience, identity, and cultural pride. METHODS The randomized controlled trial was carried out by the Northwest Portland Area Indian Health Board and the mHealth Impact Lab. The team recruited 2,334 AI/AN teens and young adults nationwide (15-24 years old) via social media channels and text message and enrolled 1,044 to participate. AI/AN teens and young adults enrolled in the study received either: 8 weeks of BRAVE text messages designed to improve mental health, help-seeking skills, and cultural resilience; or 8 weeks of STEM text messages, designed to elevate and re-affirm Native voices in science, technology, engineering, math and medicine (STEM); and then received the other set of messages. Primary and secondary outcomes were tested using linear mixed-effect models and linear regressions. RESULTS A total of 833 AI/AN teens and young adults were included in the analysis. Individuals in the BRAVE and STEM arms showed significant positive trends over the course of the study for all primary outcomes except cultural identity and help seeking behavior. Mean scores were significantly different for health (P<.001), resilience (P<.001), negative coping (P=.027), positive coping (P<.001), self-efficacy (P=.021), and self-esteem (P<.001). Changes in help-seeking self-efficacy were significant for those exhibiting risky behavior at baseline to exit (P=.01). Those who reported positive coping scores at baseline also reported better health on average, but no difference in risky drug and alcohol use (P<.001). The number of participants that used text messages to help themselves increased from 69% at 3-months (427/618) to 75% at 8-months (381/501) (P<.001). Similarly, the number of participants that used text messages to help a friend or family member increased from 22% at 3-months (138/616) to 55% at 8-months (272/498). CONCLUSIONS This is the first nationwide randomized controlled trial for AI/AN teens and young adults to test the efficacy of an mHealth intervention on mental wellness. The findings suggest that culturally-relevant multimedia, mHealth interventions can improve help-seeking behavior. Lessons learned from this study may help other AI/AN-serving organizations, prevention programs, policymakers, researchers, and educators as they support the next generation of AI/AN change-makers.

scholarly journals Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aaron Gazendam ◽  
◽  
Seper Ekhtiari ◽  
Nolan S. Horner ◽  
Nicole Simunovic ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pain Control ◽  
Shoulder Arthroscopy ◽  
Controlled Trial ◽  
Arthroscopic Surgery ◽  
Standard Of Care ◽  
Opioid Prescription ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Arthroscopic Knee

Abstract Background Opioids continue to be the analgesic of choice for postoperative pain control following arthroscopic knee and shoulder surgery. Despite their widespread use, there are limited evidence-based clinical practice guidelines for postoperative opioid prescribing. The Non-Opioid Prescriptions after Arthroscopic Surgery in Canada (NO PAin) Trial is a randomized controlled trial (RCT) designed to determine whether a non-opioid analgesia approach to postoperative pain, compared to usual care, reduces oral morphine equivalents (OME) consumed in patients undergoing outpatient knee and shoulder arthroscopy. Methods This is a multi-centre, RCT with a target sample size of 200 patients. Adult (18+ years of age) patients undergoing outpatient knee and shoulder arthroscopy will be randomized to a non-opioid postoperative protocol (intervention) or the current standard of care (control). The intervention will consist of a standardized non-opioid analgesic prescription, a limited rescue opioid prescription, and a patient education infographic. The control is defined as the treating surgeons’ pre-trial postoperative analgesic regimen. Exclusion criteria include chronic opioid use, concomitant open surgery, contraindications to the prescribed analgesics or ongoing workers compensation/litigation. The primary outcome is OMEs consumed at 6 weeks postoperatively. Secondary outcomes will include patient-reported pain and satisfaction, quantity of OMEs prescribed, number of opioid refills, and any adverse events up to 6 weeks postoperatively. Utilizing the intention to treat principle for all analyses, independent samples t-test and presented with a p-value as well as a mean difference (MD) with 95% confidence intervals (CIs) will be performed for primary and secondary outcomes. Discussion The ongoing opioid epidemic and overprescribing of opioids in orthopaedics serve as the rationale for this trial. There is a lack of evidence upon which to develop post-operative pain management guidelines for patients undergoing arthroscopic surgery. A prospective evaluation of this relatively inexpensive intervention will demonstrate whether an explicit effort to reduce the number of opioids prescribed results in a reduction in the amount of opioids consumed and help to inform future studies and guidelines. Trial registration The NO PAin trial has been prospectively registered with clinicaltrials.gov (NCT04566250).

scholarly journals Robotic natural orifice specimen extraction surgery versus traditional robotic-assisted surgery (NOTR) for patients with colorectal cancer: a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rui Luo ◽  
Fangfang Zheng ◽  
Haobo Zhang ◽  
Weiquan Zhu ◽  
Penghui He ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Natural Orifice ◽  
Specimen Extraction ◽  
Natural Orifice Specimen Extraction ◽  
Robotic Assisted ◽  
Randomized Controlled ◽  
Robotic Assisted Surgery ◽  
Secondary Outcomes

Abstract Background Natural orifice specimen extraction surgery for colorectal cancer has been introduced in order to reduce the abdominal incision, demonstrating major development potential in minimally invasive surgery. We are conducting this randomized controlled trial to assess whether robotic NOSES is non-inferior to traditional robotic-assisted surgery for patients with colorectal cancer in terms of primary and secondary outcomes. Method/design Accordingly, a prospective, open-label, randomized controlled, parallel-group, multicenter, and non-inferiority trial will be conducted to discuss the safety and efficacy of robotic natural orifice extraction surgery compared to traditional robotic-assisted surgery. Here, 550 estimated participants will be enrolled to have 80% power to detect differences with a one-sided significance level of 0.025 in consideration of the non-inferiority margin of 10%. The primary outcome is the incidence of surgical complications, which will be classified using the Clavien-Dindo system. Discussion This trial is expected to reveal whether robotic NOSES is non-inferior to traditional robotic-assisted surgery, which is of great significance in regard to the development of robotic NOSES for patients with colorectal cancer in the minimally invasive era. Furthermore, robotic NOSES is expected to exhibit superiority to traditional robotic-assisted surgery in terms of both primary and secondary outcomes. Trial registration ClinicalTrials.govNCT04230772. Registered on January 15, 2020.

scholarly journals Does regular strength training cause urinary incontinence in overweight inactive women? A randomized controlled trial

2021 ◽  
Author(s):  
Kari Bø ◽  
Lene Anette H. Haakstad ◽  
Gøran Paulsen ◽  
Anne Mette Rustaden
Keyword(s):  
Randomized Controlled Trial ◽  
Urinary Incontinence ◽  
Strength Training ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Sum Score ◽  
New Onset

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.

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