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 GoPerio - impact of a personalized video and an automated two-way text-messaging system in oral hygiene motivation: study protocol for a randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Valentin Garyga ◽  
Florian Pochelu ◽  
Béatrice Thivichon-Prince ◽  
Walid Aouini ◽  
Julie Santamaria ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Motivational Interviewing ◽  
Oral Hygiene ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Personalized Video

Abstract Background Oral hygiene is of paramount importance for the preservation of oral health, and for patients affected by periodontal disease establishing an effective oral hygiene routine is the first step of therapy. Several clinical frameworks have been developed to foster behavior change, such as motivational interviewing. However, two obstacles can be identified. First, patients tend to forget the advice they were given during the consultation. Second, it is hard to maintain motivation in the long term, thus leading to relapse. An innovative eHealth solution was designed with the aim to tackle both obstacles and supplement the current clinical standard of care. The primary objective is to compare the full mouth plaque scores of study groups (eHealth plus standard of care versus standard of care only) at 8 weeks of follow up. The main secondary objective is to compare the full mouth bleeding score at 8 weeks of follow up. Methods/design The “GoPerio” study is a multicenter, randomized, controlled trial assessing the impact of a novel eHealth concept for oral hygiene motivation (personalized video of oral hygiene routine available for the patient via a cloud server plus interactive text messages) in addition to the current standard of care (motivational interviewing plus tooth scaling and polishing). The minimum sample size required is 86 patients. Participants will be randomized (allocation ratio 1:1): test group (eHealth plus standard of care) versus control group (standard of care only). The primary outcome is oral hygiene as measured by the full mouth (six sites per tooth) plaque control record (PCR) index. The main secondary outcome is gingival inflammation as measured by the full mouth (six sites per tooth) bleeding on probing (BOP) index. Both the primary and the main secondary outcomes are evaluated by blinded and calibrated examiners at 8 weeks of follow up. The other secondary outcomes are patient satisfaction and patient behavior change and motivation. Discussion The study will investigate the value of an innovative eHealth approach to strengthen patient motivation for oral hygiene. If proven effective, such an approach would supplement the current clinical standard of care, resulting in improved clinical outcomes with negligible impact on productivity in a dental practice. Trial registration ClinicalTrials.gov, NCT03109808. Registered on 12 April 2017. Sponsor: Hospices Civils de Lyon. BP 2251, 3 quai des Célestins, 69,229 Lyon cedex 02. Protocol version: 1.0 as of 21 September 2016.

scholarly journals POS0844 EFFECTS OF SERIAL LOCALLY APPLIED WATER-FILTERED INFRARED A RADIATION IN PATIENTS WITH SYSTEMIC SCLEROSIS WITH SEVERE RAYNAUD’S SYNDROME RECEIVING PROSTAGLANDINE TREATMENT – A RANDOMIZED CONTROLLED TRIAL

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 676.1-676
Author(s):  
P. Klemm ◽  
J. Bär ◽  
I. Aykara ◽  
K. Frommer ◽  
E. Neumann ◽  
...  
Keyword(s):  
Wound Healing ◽  
Randomized Controlled Trial ◽  
Systemic Sclerosis ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Hyperthermia Treatment ◽  
Applied Water ◽  
Randomized Controlled ◽  
Secondary Outcomes

Background:More than 95% of patients with systemic sclerosis (SSc) suffer from Raynaud’s syndrome (RS) leading to digital ulcerations (DU). In severe RS, intravenous application of prostaglandins is required. Moreover, these patients profit from an additional non-pharmacological treatment using hyperthermia to increase vasodilatation and perfusion, and to reduce pain.Serial locally applied water-filtered infrared A radiation (sl-wIRAR) is a hyperthermia treatment modality using infrared heat radiation in the range of 780-1400nm with high tissue penetration and low thermal load on the skin surface [1]. wIRAR has both, temperature-dependent and non-dependent effects, which do not inherit thermal energy transfer and/or relevant temperature changes [1]. It is therefore not only used in acute and chronic wound healing as it promotes perfusion, alleviates pain and has anti-infectious effects [2], but is also used in oncology [3] and rheumatology [4].Objectives:We conducted a randomized controlled trial with a follow-up visit after 2 weeks to evaluate the value of a high-frequent hyperthermia treatment using sl-wIRAR in comparison to a low-frequent hyperthermia treatment (our standard) in SSc patients with severe RS receiving Iloprost treatment.Methods:Eligible patients had SSc according to the 2013 ACR/EULAR classification criteria, were 18 to 80 years old and had RS requiring treatment with Iloprost in an in-patient setting. Key exclusion criteria were contraindications to any hyperthermia treatment such as infection or heat insensitivity. The trial was conducted at Campus Kerckhoff of Justus-Liebig University Giessen. Eligible patients were equally randomized to the intervention group (IG) receiving additional sl-wIRAR treatment (2 treatments for 30 min per day for 8 days) plus the standard of care (Iloprost treatment over 8 days plus daily carbon dioxide hand baths of 20 min) and the control group (CG) receiving only the standard of care. Primary outcome was the between-group difference in pain measured on a numeric rating scale (NRS) after intervention. Key secondary outcomes included a change in RS frequency, RS duration, and a change in Interleukin (IL) -6 and VEGF levels.Results:From 01.03.2020 to 31.12.2020 49 SSc patients met the inclusion criteria. 42 patients were enrolled (IG: 21, CG: 21). 38 patients (IG:19, CG: 19) completed the full trial period and were analyzed. There was no statistically significant between-group difference in pain levels (NRS) (p=0.284, Z -1.082 (Mann-Whitney U Test)) and thus the primary outcome was not met. Therefore, all p values for secondary outcomes are nominal. Intensity (Visual analogue scale 0-100mm) and duration (min) of RS were reduced in the IG (mean ± standard error) -14.579 ± 7.214 mm (p=0.058) and -2.917 ± 1.510 min (p=0.08), respectively. Intra- and inter-group comparison of IL-6 and VEGF levels showed no relevant change.Conclusion:The additive and frequent use of sl-wIRAR in the treatment of SSc patients with RS requiring Iloprost treatment does not improve outcomes regarding pain levels, RS intensity or frequency nor IL-6 and VEGF levels when compared to Iloprost treatment and low-frequent hyperthermia application.References:[1]Hoffmann G. Clinical applications of water-filtered infrared-A (wIRA) – a review. Phys Med Rehab Kuror. 2017;27(05):265–274.[2]Hoffmann G, Harte M, Mercer JB. Heat for wounds – water-fil- tered infrared-a (wIRA) for wound healing – a review. GMS Ger Med Sci. 2016;14:Doc08.[3]Notter M, Thomsen AR, Nitsche M, et al. Combined wIRA-hyperthermia and hypofractionated re-irradiation in the treatment of locally recurrent breast cancer: evaluation of therapeutic outcome based on a novel size classification. Cancers (Basel). 2020;12(3): 606.[4]Klemm P, Eichelmann M, Aykara I et al. Serial locally applied water-filtered infrared a radiation in axial spondyloarthritis – a randomized controlled trial, International Journal of Hyperthermia, 37:1, 965-970.Acknowledgements:We acknowledge the help of Carina Schreiyäck.This study was in part supported by the Dr. med. h.c. Erwin Braun Foundation, Basel, a charitable, nonprofit Swiss scientific foundation approved by the Swiss Federal Administration. The foundation supports clinical investigation of waterfiltered infrared-A. The foundation was not involved in any content- or decision-related aspect of the study.This study was prospectively registered at www.drks.de (German Registry of Clinical Studies): DRKS00021098Disclosure of Interests:None declared

Infection risk for Bactiseal Universal Shunts versus Chhabra shunts in Ugandan infants: a randomized controlled trial

2019 ◽  
Vol 23 (3) ◽  
pp. 397-406 ◽  
Author(s):  
Edith Mbabazi-Kabachelor ◽  
Meghal Shah ◽  
Kerry A. Vaughan ◽  
John Mugamba ◽  
Peter Ssenyonga ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Shunt Infection ◽  
Clinical Equipoise ◽  
Clinical Trial Registration ◽  
Low Resource ◽  
Randomized Controlled ◽  
Secondary Outcomes

OBJECTIVEClinical and economic repercussions of ventricular shunt infections are magnified in low-resource countries. The efficacy of antibiotic-impregnated shunts in this setting is unclear. A previous retrospective cohort study comparing the Bactiseal Universal Shunt (BUS) and the Chhabra shunt provided clinical equipoise; thus, the authors conducted this larger randomized controlled trial in Ugandan children requiring shunt placement for hydrocephalus to determine whether there was, in fact, any advantage of one shunt over the other.METHODSBetween April 2013 and September 2016, the authors randomly assigned children younger than 16 years of age without evidence of ventriculitis to either BUS or Chhabra shunt implantation in this single-blind randomized controlled trial. The primary outcome was shunt infection, and secondary outcomes included reoperation and death. The minimum follow-up was 6 months. Time to outcome was assessed using the Kaplan-Meier method. The significance of differences was tested using Wilcoxon rank-sum, chi-square, Fisher’s exact, and t-tests.RESULTSOf the 248 patients randomized, the BUS was implanted in 124 and the Chhabra shunt in 124. There were no differences between the groups in terms of age, sex, or hydrocephalus etiology. Within 6 months of follow-up, there were 14 infections (5.6%): 6 BUS (4.8%) and 8 Chhabra (6.5%; p = 0.58). There were 14 deaths (5.6%; 5 BUS [4.0%] vs 9 Chhabra [7.3%], p = 0.27) and 30 reoperations (12.1%; 15 BUS vs 15 Chhabra, p = 1.00). There were no significant differences in the time to primary or secondary outcomes at 6 months’ follow-up (p = 0.29 and 0.17, respectively, Wilcoxon rank-sum test).CONCLUSIONSAmong Ugandan infants, BUS implantation did not result in a lower incidence of shunt infection or other complications. Any recommendation for a more costly standard of care in low-resource countries must have contextually relevant, evidence-based support.Clinical trial registration no.: PACTR201804003240177 (http://www.pactr.org/)

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 Efficacy and safety of duloxetine for postoperative pain after total knee arthroplasty in centrally sensitized patients: study protocol for a randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shicheng Wang ◽  
Wensheng Wang ◽  
Long Shao ◽  
Jing Ling
Keyword(s):  
Clinical Trial ◽  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Pain Control ◽  
Controlled Trial ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Total Knee ◽  
Postoperative Residual

Abstract Background Postoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group. Methods This randomized controlled trial includes patients with knee osteoarthritis on a waiting list for primary unilateral TKA. Patients with preoperative CS will be randomly allocated to the perioperative duloxetine treatment group (duloxetine group) or the care-as-usual control group (placebo group). Patients in the duloxetine group will receive a half-dose of preemptive duloxetine (30 mg/day) for a week before surgery and a full-dose of duloxetine (60 mg/day) for six weeks after surgery. The primary outcome is the intensity of residual pain at six months after TKA, including the visual analogue scale, 11-point numeric rating scale, the sensory dimension of the brief pain inventory, and the pain subscale of the Knee injury and Osteoarthritis Outcome Score. The secondary outcome measures will include the pain and function related outcomes. All of the patients will be followed up at one, three, and six months after surgery. All adverse events will be recorded and immediately reported to the primary investigator and ethics committee to decide if the patient needs to drop out from the trial. Discussion This clinical trial will convey the latest evidence of the efficacy and safety of the application of duloxetine in postoperative pain control in CS patients who are scheduled for TKA. The study results will be disseminated at national and international conferences and published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn) registration number: ChiCTR2000031674. Registered 07 April 2020.

scholarly journals Efficacy of metformin and fermentable fiber combination therapy in adolescents with severe obesity and insulin resistance: study protocol for a double-blind randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Edward C. Deehan ◽  
Eloisa Colin-Ramirez ◽  
Lucila Triador ◽  
Karen L. Madsen ◽  
Carla M. Prado ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Randomized Controlled Trial ◽  
Combination Therapy ◽  
Gut Microbiome ◽  
Controlled Trial ◽  
Fecal Microbiota ◽  
Metabolic Effects ◽  
Microbiota Composition ◽  
Randomized Controlled ◽  
Secondary Outcomes

Abstract Background Accumulating evidence suggests that the metabolic effects of metformin and fermentable fibers are mediated, in part, through diverging or overlapping effects on the composition and metabolic functions of the gut microbiome. Pre-clinical animal models have established that the addition of fiber to metformin monotherapy improves glucose tolerance. However, possible synergistic effects of combination therapy (metformin plus fiber) have not been investigated in humans. Moreover, the underlying mechanisms of synergy have yet to be elucidated. The aim of this study is to compare in adolescents with obesity the metabolic effects of metformin and fermentable fibers in combination with those of metformin or fiber alone. We will also determine if therapeutic responses correlate with compositional and functional features of the gut microbiome. Methods This is a parallel three-armed, double-blinded, randomized controlled trial. Adolescents (aged 12–18 years) with obesity, insulin resistance (IR), and a family history of type 2 diabetes mellitus (T2DM) will receive either metformin (850 mg p.o. twice/day), fermentable fibers (35 g/day), or a combination of metformin plus fiber for 12 months. Participants will be seen at baseline, 3, 6, and 12 months, with a phone follow-up at 1 and 9 months. Primary and secondary outcomes will be assessed at baseline, 6, and 12 months. The primary outcome is change in IR estimated by homeostatic model assessment of IR; key secondary outcomes include changes in the Matsuda index, oral disposition index, body mass index z-score, and fat mass to fat-free mass ratio. To gain mechanistic insight, endpoints that reflect host-microbiota interactions will also be assessed: obesity-related immune, metabolic, and satiety markers; humoral metabolites; and fecal microbiota composition, short-chain fatty acids, and bile acids. Discussion This study will compare the potential metabolic benefits of fiber with those of metformin in adolescents with obesity, determine if metformin and fiber act synergistically to improve IR, and elucidate whether the metabolic benefits of metformin and fiber associate with changes in fecal microbiota composition and the output of health-related metabolites. This study will provide insight into the potential role of the gut microbiome as a target for enhancing the therapeutic efficacy of emerging treatments for T2DM prevention. Trial registration ClinicalTrials.gov NCT04578652. Registered on 8 October 2020.

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