Three-arm Randomized Clinical Trial Research Articles

Intralesional zinc sulfate 2% vs intralesional vitamin D in plantar warts: A clinicodermoscopic study.

Verrucae are benign proliferations seen in skin due to infection with papillomaviruses. There are different treatment strategies for warts but all of these treatments are painful, time consuming, expensive, and recurrence is common. To evaluate and compare the efficacy of intralesional 2% zinc sulfate solution vs vitamin D3 in the treatment of plantar warts, as well as reporting the side effects. This three-armed randomized clinical trial included 105 patients presented with plantar warts divided into three groups, 35 patients per group. The first group received intralesional 2% zinc sulfate, the second group received intralesional 2% vitamin D3, and the third group received normal saline. Four sessions were done, one every 2 weeks. At the end of the study, patients showing complete response were more in zinc group (71.4%), vitamin D3 group (62.9%) compared to saline group (40%). Most of the patients in zinc group showed severe pain during injection (48.6%), most of the patients in vitamin D3 group showed mild pain (80%), while most of the patients in saline group showed no pain (57.1%). Both intralesional 2% zinc sulfate and vitamin D3 are effective in treatment of plantar warts, with zinc sulfate being more effective.

Clinical effectiveness of 3 days preoperative treatment with recombinant human erythropoietin in total knee arthroplasty surgery: a clinical trial

The purpose of study is to evaluate the effect and complication of preoperative short-term daily recombinant human erythropoietin (rhEPO) treatment for blood-saving in patients undergoing unilateral primary total knee arthroplasty (TKA). This three-arm randomized clinical trial compared three different rhEPO-based treatment protocols for unilateral primary TKA. Group A: application of daily doses of rhEPO combined with iron supplement starting 3 days before surgery; Group B: application of daily doses of rhEPO combined with iron supplement starting the day of surgery; Group C: iron supplement alone. Perioperative hemoglobin (Hb) level gaps, total perioperative blood loss, reticulocyte levels and treatment-related complications were studied. A total of 102 patients were included (35, 35 and 32 patients in Groups A, B and C, respectively). Total blood loss (TBL) in Groups A, B and C was 490.84, 806.76 and 924.21 ml, respectively. Patients in Group A had a significant lower TBL than Groups B and C (A vs. B: P = 0.010; A vs. C: P < 0.001). There was no difference as for TBL between Groups B and C (P = 0.377). Group A patients had significant smaller Hb decline than Group C on the third and fifth postoperative day (P = 0.049, P = 0.037), as well as than Group B on the fifth postoperative day (P = 0.048). There was no difference as for Hb decline between Groups B and C. No difference was shown in levels of inflammatory biomarkers or blood-saving protocol-related complications among three groups. Daily dose of rhEPO combined with iron supplement administered 3 days before TKA procedures could significantly decrease perioperative blood loss and improve postoperative Hb levels, without significantly elevating risks of complication, when compared with admission of rhEPO on the day of surgery and iron supplement alone. Preoperative daily rhEPO treatment could be a more effective blood-saving protocol in TKA procedures.

Isometric exercise, acupuncture, and magnet therapy for knee osteoarthritis: randomized clinical trial

Introduction: Knee osteoarthritis is a common disease, particularly in the elderly population. Degenerative disorders of the cartilage cause pain and stiffness in the knee joint. As a result, patients frequently experience limitation in their daily activities. Purpose: To compare the effects of exercise, acupuncture, and magnet therapy on symptoms and physical function among middle-aged and elderly people with knee osteoarthritis. Materials and methods: We carried out a parallel three-arm randomized clinical trial in an outpatient clinic of the Department of Physical Medicine and Rehabilitation at a University Hospital. In total, 60 female patients of age ≥ 40 years with chronic knee osteoarthritis were randomly allocated to one of three groups of isometric exercise, acupuncture, and magnet therapy. The primary outcome measure was subjective pain rated according to the Visual Analog Scale. We also used the Western Ontario McMaster Universities Osteoarthritis Index for assessing and monitoring the symptoms of knee osteoarthritis in order to evaluate the efficacy of the interventions. An isometric exercise program was prescribed, consisting of three sessions per week for six weeks. Participants in the acupuncture group received three treatment sessions per week for six weeks, each lasting for 30 minutes. For pulsed electro-magnetic field therapy, a total of three 30-minute sessions per week for a period of 6 weeks were administered to each patient. Results: There were no statistically significant differences between the study groups in terms of the outcome measures (all p values &gt; 0.05). However, within-group analyses showed that there were significant differences regarding the clinical outcomes in each group (all p values &lt; 0.05). Conclusion: All three therapeutic modalities are effective and could be used as the first line of treatment for knee osteoarthritis. Moreover, it should be noted that the favorable outcomes remained at least two months after treatment concluded.

Biobehavioral effects of Tai Chi Qigong in men with prostate cancer: Study design of a three-arm randomized clinical trial

Fatigue is often one of the most commonly reported symptoms in prostate cancer survivors, but it is also one of the least understood cancer-related symptoms. Fatigue is associated with psychological distress, disruptions in sleep quality, and impairments in health-related quality of life. Moreover, inflammatory processes and changes related to the hypothalamic-pituitary-adrenal (HPA) axis and/or autonomic nervous system may also play a role in cancer-related fatigue. Thus, effective treatments for fatigue in prostate cancer survivors represent a current unmet need. Prior research has shown that Tai Chi Qigong, a mind-body exercise intervention, can improve physical and emotional health. Herein, we describe the protocol of the ongoing 3-arm randomized controlled Health Empowerment & Recovery Outcomes (HERO) clincal trial. One hundred sixty-six prostate cancer survivors with fatigue are randomized to a modified Tai Chi Qigong intervention (TCQ), intensity-matched body training intervention (BT), or usual care (UC) condition. Guided by biopsychosocial and psychoneuroimmunology models, we propose that TCQ, as compared to BT or UC will: i) reduce fatigue (primary outcome) in prostate cancer survivors; ii) reduce inflammation; and iii) regulate the expression of genes from two major functional clusters: a) inflammation, vasodilation and metabolite sensing and b) energy and adrenergic activation. Assessments are conducted at baseline, the 6-week midpoint of the intervention, and 1 week, 3 months, and 12 months post-intervention. If our findings show that TCQ promotes recovery from prostate cancer and its treatment, this type of intervention can be integrated into survivorship care plans as the standard of care. The study's findings will also provide novel information about underlying biobehavioral mechanisms of cancer-related fatigue. Trial registration numberNCT03326713; clinicaltrials.gov.

Effect of a Self-management Support Intervention on Asthma Outcomes in Older Adults

Older adults with asthma have worse control and outcomes than younger adults. Interventions to address suboptimal self-management among older adults with asthma are typically not tailored to the specific needs of the patient. To test the effect of a comprehensive, patient-tailored asthma self-management support intervention for older adults on clinical and self-management outcomes. Three-arm randomized clinical trial conducted between February 2014 and December 2017 at primary care practices and personal residences in New York City. Adults 60 years and older with persistent, uncontrolled asthma were identified from electronic medical records at an academic medical center and a federally qualified health center. Of 1349 patients assessed for eligibility, 406 met eligibility criteria, consented to participate, and were randomized to 1 of 3 groups: home-based intervention, clinic-based intervention, or control (usual care). A total of 391 patients received the allocated treatment. Screening for psychosocial, physical, cognitive, and environmental barriers to asthma control and self-management with actions to address identified barriers. The intervention was delivered in the home or primary care practices by asthma care coaches. Primary outcomes were the Asthma Control Test, Mini Asthma Quality of Life Questionnaire, Medication Adherence Rating Scale, metered dose inhaler technique, and emergency department visits for asthma care. Primary analyses compared intervention (home or clinic based) with usual care. Of the 391 patients who received treatment, 58 (15.1%) were men, and the mean (SD) age was 67.8 (7.4) years. After accounting for baseline scores, scores on the asthma control test were better in the intervention groups vs the control group (difference-in-differences at 3 months, 1.2; 95% CI, 0.2-2.2; P = .02; 6 months, 1.0; 95% CI, 0.0-2.1; P = .049; 12 months, 0.6; 95% CI, -0.5 to 1.8; P = .28; and overall, χ2 = 13.4, with 4 degrees of freedom; P = .01). Emergency department visits were lower at 12 months for the intervention groups vs the control group (16 [6.2%] vs 17 [12.7%]; P = .03; adjusted odds ratio, 0.8; 95% CI, 0.6-0.99; P = .03). Statistically significant improvements were observed for the intervention vs control patients in quality of life (overall effect: χ2 = 10.5, with 4 degrees of freedom; P = .01), medication adherence (overall effect: χ2 = 9.5, with 4 degrees of freedom; P = .049), and inhaler technique (metered-dose inhaler technique, correctly completed steps at 12 months, median [range]: 75% [0%-100%] vs 58% [0%-100%]). No significant differences in outcomes were observed between patients receiving the intervention in home vs practice settings. An intervention directed by patients' needs and barriers improved asthma outcomes and self-management behaviors among older adults. ClinicalTrials.gov identifier: NCT02316223.

Comparative effectiveness of family problem-solving therapy (F-PST) for adolescents after traumatic brain injury: Protocol for a randomized, multicenter, clinical trial.

IntroductionThe objective of this manuscript is to describe the methodology that will be used to test the comparative effectiveness, feasibility, and acceptability of three formats of family problem solving therapy (F-PST) for improving functional outcomes of complicated mild to severe adolescent TBI.MethodsThree-arm comparative effectiveness, randomized clinical trial (RCT) design. We describe the protocol of a three-arm RCT comparing the effectiveness of three modalities of F-PST to reduce executive dysfunction and behavior problems following TBI in adolescence. The RCT will compare the relative effectiveness among face-to-face; online and self-directed; and therapist-supported online modes of treatment.Ethics and disseminationIt is anticipated that findings from this work will inform future clinical care practices, with implications for treatment of other patient populations of youth with psychological symptoms arising from neurological conditions. Institutional review board approval will be obtained from all sites prior to commencement of the study.

Xinsuning capsule for the treatment of premature ventricualr contraction: a multicenter randomised clinical trial

BackgroundPremature ventricular contraction (PVC) is one of the most common cardiac disorders. Most of the antiarrhythmic chemical drugs (type I–IV) have important clinical effects, but none of them is satisfactory enough because of proarrhythmia and other side-effects. Xinsuning is a Chinese patent drug that has been commonly used in clinical practice in China and has potential advantages in treating arrhythmia. Findings from an experimental study in Oxford University showed that xinsuning could increase the effective refractory period, which suppressed tachyarrhythmias caused by re-entry mechanisms. This study aimed to assess the clinical effect of xinsuning for PVC. MethodsThis three-armed randomised clinical trial took place in 2014 in China (ChiCTR-TRC-14004180). Patients diagnosed with PVC were randomly assigned (2:2:1) to xinsuning (1·92 g in four capsules plus simulated mexiletine 100 mg in two capsules), mexiletine (simulated xinsuning 1·92 g plus mexiletine 100 mg), or placebo groups (simulated xinsuning 1·92 g and simulated mexiletine 100 mg). Each patient took the treatments three times daily for 4 weeks. The primary outcome was the change in the frequency of premature ventricular contractions detected by 24 h ambulatory electrocardiography. Findings861 patients from 39 hospitals were eligible for inclusion. 343 patients were assigned to the xinsuning group, 345 patients were assigned to the mexiletine group, and 173 patients were assigned to the placebo group. The mean reduction of the PVC frequency in the xinsuning, mexiletine, and placebo groups were 4604·67 (SD 6990·07), 4502·86 (5771·70), and 1512·47 (8311·14), respectively. The difference in PVC frequence between patients in the xinsuning and mexiletine groups versus placebo group was statistically significant (xinsuning vs placebo Z=6·2630, p<0·0001; mexiletine vs placebo Z=6·2856, p<0·0001). We detected no difference between the xinsuning and mexiletine group (Z=0·4806, p=0·6308). InterpretationXinsuning capsule is effective drug for PVC. Xinsuning can be used as a complementary or alternative therapy for PVC, especially for patients with contraindications of chemical drugs. This is a three-arms multicentre randomised clinical trial, with placebo and positive drugs control. Double-blind and double-simulation were used to reduce the performance bias. Patient's syndrome of traditional Chinese medicine was not considered as a factor for inclusion criteria and random allocation. This may weaken the effect of xinsuning. The interaction between xinsuning and mexiletine was not investigated. FundingShanxi Momentum Pharmaceutical Company.

One-Year Results of a Trial Comparing 2 Doses of Intravitreal Ziv-aflibercept versus Bevacizumab for Treatment of Diabetic Macular Edema

To report 1-year findings of a trial comparing 2 doses of intravitreal ziv-aflibercept (IVZ) with intravitreal bevacizumab (IVB) for treatment of center-involving diabetic macular edema (DME). Three-armed double-blind randomized clinical trial. A total of 123 eyes with center-involving DME. In this clinical trial, eyes with DME were randomly assigned to 2.5 mg intravitreal ziv-aflibercept (42 eyes), 1.25 mg intravitreal ziv-aflibercept (42 eyes), and 1.25 mg IVB injections (39 eyes), every 4 weeks for 3 loading injections and then every 4 weeks for IVB and every 8 weeks for ziv-aflibercept injections. The patients were followed up to 1 year with complete ophthalmologic examination and central macular thickness (CMT) measurement by optical coherence tomography. Change in best-corrected visual acuity (BCVA) at 1 year. Although no significant difference was evident between the 2 ziv-aflibercept groups at 1 year, BCVA change was significantly better in both ziv-aflibercept groups (-0.33±0.26 and-0.38±0.34 logarithm of the minimum angle of resolution (logMAR) equal to 16 and 18 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, for IVZ 2.5 and 1.25 mg, respectively) than in the IVB group (-0.26±0.35 logMAR, equal to 14 ETDRS letters) at final follow-up (P= 0.007 for IVZ 2.5 mg and P= 0.029 for IVZ 1.25 mg). Regarding CMT changes, there was no significant difference between the 2 ziv-aflibercept groups; however, a significantly greater reduction in CMT was observed in the ziv-aflibercept 2.5 mg group in comparison to the IVB group at 1 year (P= 0.029). Subgroup analysis disclosed no difference in BCVA outcomes at 1 year among the eyes with baseline BCVA >20/50. In the eyes with baseline BCVA ≤20/50, however, the improvement was significantly better at 1 year in both ziv-aflibercept groups compared with the IVB group (P= 0.002 for IVZ 2.5 mg and P= 0.001 for IVZ1.25 mg). The 1-year results of this trial disclosed more vision improvement with IVZ compared with IVB in the treatment of center-involving DME. This stronger effect of IVZ, however, was detected in the eyes with initial worse level of vision (≤20/50).

A hypertension emergency department intervention aimed at decreasing disparities: Design of a randomized clinical trial

Effective interventions to identify and treat uncontrolled hypertension (HTN), particularly in underrepresented populations that use the emergency department (ED) for primary care, are critically needed. Uncontrolled HTN contributes significantly to cardiovascular morbidity and mortality and is more frequently encountered among patients presenting to the ED as compared to the primary care setting. EDs serve as the point of entry into the health care system for high-risk patient populations, including minority and low-income patients. Previous studies have demonstrated that the prevalence of uncontrolled/undiagnosed HTN in patients presenting to the ED is alarmingly high. Thus ED engagement and early risk assessment/stratification is a feasible innovation to help close health disparity gaps in HTN. A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities (AHEAD2) trial, funded by the National Heart, Lung, and Blood Institute (NHLBI) is a three-arm single site randomized clinical pilot trial of adults presenting to the ED with Stage 2 hypertension (blood pressure [BP]>160/100) comparing (1) an ED-initiated Screening, Brief Intervention, and Referral for Treatment (SBIRT) focused on HTN, (2) the same ED-initiated SBIRT coupled with a Post-Acute Care Hypertension Transition Consultation by ED Clinical Pharmacists, and (3) usual care. The primary outcome is mean BP differences between study arms. Secondary outcomes are proportion of participants with BP control (BP<140/90mmHg), and improvements in HTN knowledge and medication adherence scores between study arms. The objective of this report is to describe the development of the AHEAD2 trial, including the methods, research infrastructure, and other features of the randomized clinical trial design.

Sham surgery versus labral repair or biceps tenodesis for type II SLAP lesions of the shoulder: a three-armed randomised clinical trial

BackgroundLabral repair and biceps tenodesis are routine operations for superior labrum anterior posterior (SLAP) lesion of the shoulder, but evidence of their efficacy is lacking. We evaluated the effect of...

Acupuncture and electro-acupuncture for people diagnosed with subacromial pain syndrome: A multicentre randomized trial.

Musculoskeletal disorders have been identified globally as the second most common healthcare problem for 'years lived with disability', and of these shoulder conditions are amongst the most common, frequently associated with substantial pain and morbidity. Exercise and acupuncture are often provided as initial treatments for musculoskeletal shoulder conditions but their clinical effectiveness is uncertain. This study compared group exercise with group exercise plus either acupuncture or electro-acupuncture in patients with subacromial pain syndrome. Two hundred and twenty-seven participants were recruited to a three-arm parallel-group randomized clinical trial. The primary outcome measure was the Oxford Shoulder Score. Follow-up was post treatment, and at 6 and 12months. Between-group differences (two comparisons: the exercise group versus each of the acupuncture groups) were analysed at 6months. A similar comparison across all follow-up time points was also conducted. Data were analysed on intention-to-treat principles with imputation of missing values. Treatment groups were similar at baseline, and all treatment groups demonstrated an improvement over time. Between-group estimates at 6months were, however, small and non-significant, for both of the comparisons. The analyses across all follow-up time points yielded similar conclusions. There was a high rate of missing values (22% for the Oxford Shoulder Score). A sensitivity analysis using complete data gave similar conclusions to the analysis with missing values imputed. In the current investigation, neither acupuncture nor electro-acupuncture were found to be more beneficial than exercise alone in the treatment of subacromial pain syndrome. These findings may support clinicians with treatment planning. Shoulder pain is common and associated with substantial morbidity. Acupuncture is a popular treatment for shoulder pain. The findings suggest that acupuncture and electro-acupuncture offer no additional benefit over exercise in the treatment of shoulder pain of musculoskeletal origin.

Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial

BackgroundPlacebo effects contribute substantially to outcome in most fields of medicine. While clinical trials typically try to control or minimize these effects, the potential of placebo mechanisms to improve outcome is rarely used. Patient expectations about treatment efficacy and outcome are major mechanisms that contribute to these placebo effects. We aimed to optimize these expectations to improve outcome in patients undergoing coronary artery bypass graft (CABG) surgery.MethodsIn a prospective three-arm randomized clinical trial with a 6 month follow-up, 124 patients scheduled for CABG surgery were randomized to either a brief psychological pre-surgery intervention to optimize outcome expectations (EXPECT); or a psychological control intervention focusing on emotional support and general advice, but not on expectations (SUPPORT); or to standard medical care (SMC). Interventions were kept brief to be feasible with a heart surgery environment; “dose” of therapy was identical for both pre-surgery interventions. Primary outcome was disability 6 months after surgery. Secondary outcomes comprised further clinical and immunological variables.ResultsPatients in the EXPECT group showed significantly larger improvements in disability (−12.6; −17.6 to −7.5) than the SMC group (−1.9; −6.6 to +2.7); patients in the SUPPORT group (−6.7; −11.8 to 1.7) did not differ from the SMC group. Comparing follow-up scores and controlling for baseline scores of EXPECT versus SUPPORT on the variable disability only revealed a trend in favor of the EXPECT group (P = 0.09). Specific advantages for EXPECT compared to SUPPORT were found for mental quality of life and fitness for work (hours per week). Both psychological pre-surgery interventions induced less pronounced increases in pro-inflammatory cytokine concentrations reflected by decreased interleukin-8 levels post-surgery compared to changes in SMC patients and lower interleukin-6 levels in patients of the EXPECT group at follow-up. Both pre-surgery interventions were characterized by great patient acceptability and no adverse effects were attributed to them. Considering the innovative nature of this approach, replication in larger, multicenter trials is needed.ConclusionsOptimizing patients’ expectations pre-surgery helps to improve outcome 6 months after treatment. This implies that making use of placebo mechanisms has the potential to improve long-term outcome of highly invasive medical interventions. Further studies are warranted to generalize this approach to other fields of medicine.Trial registrationEthical approval for the study was obtained from the IRB of the Medical School, University of Marburg, and the trial was registered at (NCT01407055) on July 25, 2011.

Patient and Partner Feedback Reports to Improve Statin Medication Adherence: A Randomized Control Trial.

Simple nudges such as reminders and feedback reports to either a patient or a partner may facilitate improved medication adherence. To test the impact of a pill bottle used to monitor adherence, deliver a daily alarm, and generate weekly medication adherence feedback reports on statin adherence. Three-month, three-arm randomized clinical trial (ClinicalTrials.gov identifier: NCT02480530). One hundred and twenty-six veterans with known coronary artery disease and poor adherence (medication possession ratio <80%). Patients were randomized to one of three groups: (1) a control group (n = 36) that received a pill-monitoring device with no alarms or feedback; (2) an individual feedback group (n = 36) that received a daily alarm and a weekly medication adherence feedback report; and (3) a partner feedback group (n = 54) that received an alarm and a weekly feedback report that was shared with a friend, family member, or a peer. The intervention continued for 3months, and participants were followed for an additional 3months after the intervention period. Adherence as measured by pill bottle. Secondary outcomes included change in LDL (mg/dl), patient activation, and social support. During the 3-month intervention period, medication adherence was higher in both feedback arms than in the control arm (individual feedback group 89%, partner feedback group 86%, control group 67%; p < 0.001 and = 0.001). At 6months, there was no difference in medication adherence between either of the feedback groups and the control (individual feedback 60%, partner feedback 52%, control group 54%; p = 0.75 and 0.97). Daily alarms combined with individual or partner feedback reports improved statin medication adherence. While neither an individual feedback nor partner feedback strategy created a sustainable medication adherence habit, the intervention itself is relatively easy to implement and low cost.

Comparison of design strategies for a three‐arm clinical trial with time‐to‐event endpoint: Power, time‐to‐analysis, and operational aspects

To optimize resources, randomized clinical trials with multiple arms can be an attractive option to simultaneously test various treatment regimens in pharmaceutical drug development. The motivation for this work was the successful conduct and positive final outcome of a three-arm randomized clinical trial primarily assessing whether obinutuzumab plus chlorambucil in patients with chronic lympocytic lymphoma and coexisting conditions is superior to chlorambucil alone based on a time-to-event endpoint. The inference strategy of this trial was based on a closed testing procedure. We compare this strategy to three potential alternatives to run a three-arm clinical trial with a time-to-event endpoint. The primary goal is to quantify the differences between these strategies in terms of the time it takes until the first analysis and thus potential approval of a new drug, number of required events, and power. Operational aspects of implementing the various strategies are discussed. In conclusion, using a closed testing procedure results in the shortest time to the first analysis with a minimal loss in power. Therefore, closed testing procedures should be part of the statistician's standard clinical trials toolbox when planning multiarm clinical trials.

Effect of Vocalization of the Holy Quran With and Without Translation on Pregnancy Outcomes: A Randomized Clinical Trial.

BackgroundDuring recent decades, research in Iran in the area of the Quran and medical science has been seriously engaged in. With respect to the tendency toward spirituality and alternative medicine, we tried to find other aspects of the influence of the Quran.ObjectivesThis study aimed to determine the effect of vocalizations of the Holy Quran with and without translation on the consequences of pregnancy (the prevalence of preterm delivery, caesarean delivery, and neonatal anthropometric indices) in women admitted to health care centers in Urmia, Iran.Materials and MethodsThis was a three-armed parallel-group randomized clinical trial in which 168 pregnant women (25-28 weeks) in their first and second pregnancies were divided into three groups of 56 (Holy Quran with translation, Holy Quran without translation, and control group) by randomized blocking. The intervention was implemented once a week for three weeks in the health center, and on other days of the week, the participants listened at home to a CD they were given. The intervention and the control groups all received routine pregnancy care once a week. These mothers were tracked during their labor. Outcomes including gestational age at delivery, delivery type, and neonatal anthropometric indices were recorded based on the mother’s records.ResultsThere was no statistically significant difference between the groups in terms of demographic and obstetric characteristics before the intervention. In comparison with the control group, the probability of preterm delivery was lower in the Holy Quran with translation group (odds ratio: 0.3, CI 95%: 0.1-1.2) and in the Holy Quran without translation group (0.6, 0.2-1.9) as compared to the control group. However, this difference was not statistically significant. Similarly, the probability of caesarean delivery was lower in the Holy Quran with translation group (0.6, 0.3-1.4) and the Holy Quran without translation group (0.5, 0.2-1.2) as compared to the control group. Based on one-way ANOVA, there was no statistically significant difference between the study groups regarding the infants’ anthropometric indices.ConclusionsBased on the results of this study, despite the lower prevalence of preterm labor and caesarean section in the intervention groups as compared to the control group, no statistically significant effect was seen. This was apparently due to the small sample size.

Chiropractic spinal manipulative therapy for cervicogenic headache: a study protocol of a single-blinded placebo-controlled randomized clinical trial.

Cervicogenic headache (CEH) is a secondary headache which affects 1.0–4.6 % of the population. Although the costs are unknown, the health consequences are substantial for the individual; especially considering that they often suffers chronicity. Pharmacological management has no or only minor effect on CEH. Thus, we aim to assess the efficacy of chiropractic spinal manipulative therapy (CSMT) for CEH in a single-blinded placebo-controlled randomized clinical trial (RCT). According to the power calculations, we aim to recruit 120 participants to the RCT. Participants will be randomized into one of three groups; CSMT, placebo (sham manipulation) and control (usual non-manual management). The RCT consists of three stages: 1 month run-in, 3 months intervention and follow-up analyses at the end of intervention and 3, 6 and 12 months. Primary end-point is headache frequency, while headache duration, headache intensity, headache index (frequency × duration × intensity) and medicine consumption are secondary end-points. Primary analysis will assess a change in headache frequency from baseline to the end of intervention and to follow-up, where the groups CSMT and placebo and CSMT and control will be compared. Due to two group-comparisons, the results with p values below 0.025 will be considered statistically significant. For all secondary end-points and analyses, the significance level of 0.05 will be used. The results will be presented with the corresponding p values and 95 % confidence intervals. To our knowledge, this is the first prospective manual therapy three-armed single-blinded placebo-controlled RCT to be conducted for CEH. Current RCTs suggest efficacy in headache frequency, duration and intensity. However a firm conclusion requires clinical single-blinded placebo-controlled RCTs with few methodological shortcomings. The present study design adheres to the recommendations for pharmacological RCTs as far as possible and follows the recommended clinical trial guidelines by the International Headache Society.Trial registration ClinicalTrials.gov identifier: NCT01687881, 2 December 2012

Randomized clinical trial of single-port, minilaparoscopic and conventional laparoscopic cholecystectomy

This three-armed randomized clinical trial, with blinding of patients and outcome assessors, tested the hypothesis that single-port (SP) and/or minilaparoscopic (ML) cholecystectomy are superior to conventional laparoscopic (CL) cholecystectomy. Patients eligible for elective laparoscopic cholecystectomy were randomized to SP, ML or CL procedures. The primary outcome was pain measured on a visual analogue scale twice daily during the blinded period. Secondary outcomes included duration of operation, technical performance score, complications, quality of life, cosmesis and patient satisfaction. Postoperative follow-up lasted 1 year. A total of 105 patients were randomized, 35 in each group. One conversion from a SP to a CL technique was necessary in a patient with chronic cholecystitis. Pain intensity was similar in the three groups, both during the blinded period (day 0 to 3; P = 0·865) and over the whole 7-day evaluation period (P = 0·911). The presence of clinically relevant between-group differences was ruled out (95 per cent confidence interval + 1·0 to - 0·5 for difference in pain scores between SP and CL groups, and - 0·8 to + 0·6 between ML and CL groups). Operating time was significantly longer for SP and ML than for CL cholecystectomy (P = 0·001). Postoperative complications included injury to the diaphragm (1), choledocholithiasis (1), wound infection (5) and hernia (1), all after SP cholecystectomy (P = 0·001). Twelve-month follow-up was complete in 99 patients (94·3 per cent). Cosmesis as rated by patients was significantly better at 6 months after SP and ML procedures (P = 0·043), but no difference was observed at 12 months (P = 0·229). SP and ML cholecystectomy had no advantage over the CL approach in terms of postoperative outcome. DRKS00000302 (German Registry of Clinical Trials).

The effect of pretreatment psychosocial factors on immune function and quality of life after brief presurgical stress management.

9031 Background: It is important to identify factors that predict who will benefit the most from psychosocial interventions in cancer populations. Methods: We examined the association between pretreatment psychosocial factors and subjective and objective outcomes from a brief cognitive-behavioral stress management program. This three-arm randomized clinical trial investigated the effects of a presurgical stress management (SM; n=53) compared to supportive attention (SA; n=54) and standard care (SC; n=52) on quality of life (QOL) and immune outcomes in men with prostate cancer scheduled for radical prostatectomy. We previously reported improved QOL 1 year after surgery in the SM and SA groups compared to the SC group and higher pro-inflammatory cytokines 48h after surgery in the SM group. We investigated the moderating effects of baseline psychosocial factors (social support (SS), dyadic adjustment (DA), distress (BSIGSI), and impact of event (IES)), on QOL (SF-36 physical (PCS) and mental (MCS) component scores) 1 year after surgery and immune response 48h after surgery. Results: Baseline SS and BSIGSI interacted with group in predicting PCS 1 year after surgery (p’s &lt;.05). Men who reported low baseline SS and were in SM had increased PCS 1 year after surgery compared to men with low SS in the SC group (b=.36, p&lt;.01). Conversely, men who reported high BSIGSI at baseline and were in SA had increased PCS 1 year after surgery compared to those in SM (b=11.14, p=.03), with SC having an intermediate nonsignificant effect. All four psychosocial factors (SS, DA, BSIGSI, IES) interacted with group in predicting changes in pro-inflammatory cytokines (interleukin (IL)-1, IL-6, IL-8, IL-10, tumor necrosis factor, and interferon) 48h post-surgery (all p’s &lt;.04). In all significant interactions, men who reported greater psychosocial vulnerability at baseline and were in SM had increased immune response 48h after surgery compared to psychosocially vulnerable men in either SC (all p’s &lt;.02) or SA (all p’s &lt;.02). Conclusions: These findings suggest that baseline psychosocial factors are important indicators of who may benefit most from a SM intervention on both subjective and objective outcomes.

Non-surgical treatment of hip osteoarthritis. Hip school, with or without the addition of manual therapy, in comparison to a minimal control intervention: Protocol for a three-armed randomized clinical trial

BackgroundHip osteoarthritis is a common and chronic condition resulting in pain, functional disability and reduced quality of life. In the early stages of the disease, a combination of non-pharmacological and pharmacological treatment is recommended. There is evidence from several trials that exercise therapy is effective. In addition, single trials suggest that patient education in the form of a hip school is a promising intervention and that manual therapy is superior to exercise.Methods/DesignThis is a randomized clinical trial. Patients with clinical and radiological hip osteoarthritis, 40-80 years of age, and without indication for hip surgery were randomized into 3 groups. The active intervention groups A and B received six weeks of hip school, taught by a physiotherapist, for a total of 5 sessions. In addition, group B received manual therapy consisting of joint manipulation and soft-tissue therapy twice a week for six weeks. Group C received a self-care information leaflet containing advice on "live as usual" and stretching exercises from the hip school. The primary time point for assessing relative effectiveness is at the end of the six weeks intervention period with follow-ups after three and 12 months.Primary outcome measure is pain measured on an eleven-point numeric rating scale. Secondary outcome measures are the hip dysfunction and osteoarthritis outcome score, patient's global perceived effect, patient specific functional scale, general quality of life and hip range of motion.DiscussionTo our knowledge this is the first randomized clinical trial comparing a patient education program with or without the addition of manual therapy to a minimal intervention for patients with hip osteoarthritis.Trial registrationClinicalTrials NCT01039337

Patient Preferences for Treatment of Achilles Tendon Pain

Discrete-choice experiments are based on the premise that any good or service can be described by its characteristics (or attributes), and the extent to which an individual values a good or service depends on the levels of these characteristics. Little is known about patient preferences for treatment of chronic musculoskeletal pain such as Achilles tendinopathy. A discrete-choice experiment was conducted in 58 adults with a history of Achilles tendon pain at the conclusion of a three-arm randomized clinical trial. Participants were asked to complete a questionnaire consisting of ten hypothetical treatment scenarios and some sociodemographic questions. For each scenario, participants were asked to choose which option they would prefer if seeking treatment for their painful Achilles tendon. A mixed logit model was estimated to quantify subject preferences and marginal willingness to pay for the treatment attributes. A response rate of 62% was achieved. A significant positive impact on utility was observed for chance of treatment success. A significant negative impact on utility was observed for cost, weeks before exercise can be completed free of pain, chance of side effects (p = 0.06), and injections as a stand-alone treatment. Respondents were willing to pay Australian dollars ($A)238 (95% CI -312, 788) for a 10% increase in the chance of treatment success. Study participants with Achilles tendon pain who had either participated or expressed an interest in participating in a randomized trial prefer a treatment that costs less, has a greater chance of success, has a shorter duration before being able to exercise free of pain, and has less likelihood of side effects. On average, participants preferred exercises over injections as a stand-alone treatment. Further research is required to confirm the findings in patients outside of the trial setting. Nevertheless, this study contributes to an area that is deficient in research by identifying priorities and marginal willingness to pay for attributes related to Achilles tendinopathy.