Single-blind Randomized Clinical Trial Research Articles

Randomized Clinical Trial to Compare Cryopreserved and Lyopreserved Umbilical Cord Tissue to Treat Complex Diabetic Foot Wounds.

To compare the incidence of infection, wound closure and time to wound closure in patients treated with cryopreserved (CPUT) and lyopreserved umbilical tissue (LPUT) in complex diabetic surgical wounds. This single-blinded 12-week randomized clinical trial compared cryopreserved and lyopreserved amniotic cord tissue to treat complex diabetic foot wounds. LPUT or CRAT was applied at baseline and again after four weeks. We enrolled subjects with UT2A-D and 3A-D wounds (depth to tendon, muscle, or bone with infection and/or PAD) and excluded subjects with ABI < 0.5 or TBI < 0.3, untreated osteomyelitis, and autoimmune diseases. We used a 3-D camera to evaluate wound area and volume. The mean baseline wound areas were 12.9 ± 10.7 cm2 for CPUT and 11.7 ± 7.0 cm2 for LPUT. The mean baseline wound volume was 7.5 ± 8.1 for CPUT and 9.2 ± 10.2 cm3 for LPUT. There was no difference between CPUT and LPUT in wound closure (36.8% vs 19.0%, P = .21) or infection (10.5% vs 4.8%, P = .60). There was no difference in mean wound area reduction between CPUT and LPUT (75.9 ± 32.3% vs 65.5 ± 38.4%, P = .41), nor in mean volume reduction (85.0 ± 30.8% vs 79.9 ± 31.9%, P = .61). In addition, there was no difference in wound closure trajectories for changes in area (P = .75) or volume (P = .43). Cryopreserved and lyopreserved amniotic tissue provided similar results in patients with complex diabetic foot wounds.

Pattern of Visual Analog Score Changes in Metastatic Urogenital Cancer Patients Undergoing Sympathectomy

This study aimed to evaluate the effectiveness of sympathectomy in reducing pain in patients with metastatic urogenital cancer. A single-blind randomized clinical trial involving five patients who underwent neurolytic ganglion impar block using a transcoccygeal approach, followed by radiofrequency ablation (RFA), was conducted. Five patients with metastatic urogenital cancer, averaging 58.4 ± 16.9 years old, showed a significant reduction in pain after sympathectomy. The average Visual Analog Scale (VAS) reduction was 2 points on the first day, 4 points on the third day, and 5 points on the fifth day. This pain reduction was accompanied by a decrease in the patients' dependence on opioid medication. Sympathectomy and radiofrequency ablation have proven effective in reducing pain in patients with metastatic urogenital cancer. These findings support the use of sympathectomy as part of comprehensive pain management in metastatic cancer patients, improving quality of life and reducing opioid usage. This approach offers a promising alternative for managing chronic pain in this patient population, particularly when oral therapy is insufficient.

Unveiling the efficacy of paroxetine and gabapentin in ulcerative colitis patients in remission with co-existing IBS-like symptoms: a single-blinded randomized clinical trial.

This clinical trial is designed to explore the efficacy of paroxetine and gabapentin in alleviating functional gastrointestinal symptoms, anxiety, depression, and quality of life in patients with ulcerative colitis during the remission stage. The study enrolled 97 patients with ulcerative colitis in remission who had reported functional gastrointestinal symptoms. Patients were measured in terms of quality of life, anxiety, depression, and IBS severity. One group received paroxetine at a dosage of 20 mg/day, and the other group received gabapentin at a dosage of 100 mg/day in the first month and 300 mg/day in the second and third months. The patients were followed up for 3 months. Anxiety (p < 0.001), depression (p = 0.012), and severity score levels (p = 0.045) among patients in the paroxetine group were significantly lower compared to the gabapentin group following the intervention. Paired evaluation in each treatment group revealed a significant reduction in the paroxetine group, while changes in the gabapentin group were not significant. Quality-of-life scores among patients in the paroxetine group were significantly higher compared to the gabapentin group following the intervention (p < 0.001). The rate of improvement in gastrointestinal functional symptoms, anxiety, depression, and quality of life is significantly superior with paroxetine compared to gabapentin. https://irct.behdasht.gov.ir/trial/69397, identifier RCT20220417054557N1.

Large Language Model Influence on Diagnostic Reasoning

Large language models (LLMs) have shown promise in their performance on both multiple-choice and open-ended medical reasoning examinations, but it remains unknown whether the use of such tools improves physician diagnostic reasoning. To assess the effect of an LLM on physicians' diagnostic reasoning compared with conventional resources. A single-blind randomized clinical trial was conducted from November 29 to December 29, 2023. Using remote video conferencing and in-person participation across multiple academic medical institutions, physicians with training in family medicine, internal medicine, or emergency medicine were recruited. Participants were randomized to either access the LLM in addition to conventional diagnostic resources or conventional resources only, stratified by career stage. Participants were allocated 60 minutes to review up to 6 clinical vignettes. The primary outcome was performance on a standardized rubric of diagnostic performance based on differential diagnosis accuracy, appropriateness of supporting and opposing factors, and next diagnostic evaluation steps, validated and graded via blinded expert consensus. Secondary outcomes included time spent per case (in seconds) and final diagnosis accuracy. All analyses followed the intention-to-treat principle. A secondary exploratory analysis evaluated the standalone performance of the LLM by comparing the primary outcomes between the LLM alone group and the conventional resource group. Fifty physicians (26 attendings, 24 residents; median years in practice, 3 [IQR, 2-8]) participated virtually as well as at 1 in-person site. The median diagnostic reasoning score per case was 76% (IQR, 66%-87%) for the LLM group and 74% (IQR, 63%-84%) for the conventional resources-only group, with an adjusted difference of 2 percentage points (95% CI, -4 to 8 percentage points; P = .60). The median time spent per case for the LLM group was 519 (IQR, 371-668) seconds, compared with 565 (IQR, 456-788) seconds for the conventional resources group, with a time difference of -82 (95% CI, -195 to 31; P = .20) seconds. The LLM alone scored 16 percentage points (95% CI, 2-30 percentage points; P = .03) higher than the conventional resources group. In this trial, the availability of an LLM to physicians as a diagnostic aid did not significantly improve clinical reasoning compared with conventional resources. The LLM alone demonstrated higher performance than both physician groups, indicating the need for technology and workforce development to realize the potential of physician-artificial intelligence collaboration in clinical practice. ClinicalTrials.gov Identifier: NCT06157944.

Acupuncture-assisted lifestyle intervention improve the metabolic status and spontaneous brain activity of type 2 diabetes Mellitus patients: a randomized, clinical trial

BackgroundAggressive weight management in patients with type 2 diabetes mellitus has demonstrated numerous metabolic advantages, however, existing therapies for weight control have not reached satisfactory results. This study aimed to evaluate the efficacy and safety of acupuncture in the weight management of type 2 diabetes mellitus (T2DM) patients by using a randomized, sham-controlled clinical trial design.MethodsIn this single-blind randomized clinical trial, 102 overweight adult T2DM patients were randomized into two groups. The control group receives diet, exercise, and sham acupuncture intervention, whereas the acupuncture group receives diet and exercise and acupuncture intervention, both for 1 month. Body weight and other anthropometric and laboratory indices were assessed at baseline and endpoint, meanwhile, the body fat content and spontaneous brain activity were measured by functional magnetic resonance imaging(fMRI)as the exploratory outcomes.ResultsNo significant difference was observed between the studied parameters at the baseline. The body weight and BMI were significantly reduced both in the control and acupuncture groups after intervention, without statistical difference between the two groups. What’s interesting is that compared to the control, the acupuncture group displayed a greater improvement in central fat tissue. It notes that the acupuncture group achieved significant liver fat content reduction than the sham acupuncture group. At the same time, the spontaneous brain activity in the occipital lobe and parietal lobe significantly increased in the acupuncture group.ConclusionOne month of acupuncture treatment preferentially improved ectopic fat deposition and was accompanied by changes in brain activity compared with the control group, even before significant changes in total body weight had occurred. further studies of longer duration are necessary for validation.Trial registration: The protocol of this clinical trial is registered at the Acupuncture-Moxibustion Clinical Trial Registry (AMCTR, http://www.acmctr.org/, No. AMCTR-IOR-20000341).

The Effectiveness of Anemia Treatment with Injectable Iron within 48 to 72 Hours before Coronary Artery Bypass Surgery on Cardiac Function and Postoperative Outcome: A Randomized Clinical Trial

Background: Anemia is considered as one of the risk factors affecting the outcomes after cardiac surgery. Accordingly, the improvement of iron deficiency anemia through injection or oral may be associated with the improvement of post-procedure results, especially the improvement of cardiovascular function. This study was aimed at investigating the effectiveness of iron treatment shortly before surgery in reducing the need for blood transfusion and improving myocardial performance parameters (left ventricular ejection fraction) in coronary bypass surgery patients. Methods: This study was a single-blind randomized clinical trial. In total, 60 candidates for coronary bypass surgery having iron deficiency anemia before the operation were randomly divided into two groups treated with injectable iron supplement (iron sucrose at a dose of 200 mg/200 ml of normal saline injected in 30 minutes) 48 to 72 hours before surgery or without therapeutic intervention. The patients were examined during and after the operation in terms of surgical outcomes. Results: Treatment with injectable iron before surgery was associated with improvement in serum hemoglobin level after surgery and a significant reduction in the need for intraoperative and postoperative transfusions. Preoperative treatment of iron deficiency was associated with a reduction in the length of hospitalization of the patients after surgery. Conclusion: Treatment of iron deficiency anemia within 48 to 72 hours before surgery will improve the condition of patients’ anemia and compensate serum hemoglobin, reduce the need for blood transfusion during surgery and the length of hospitalization of the patients after surgery.

The Severity of Wound Infection in Washing the Primary Prep Area with 70% Alcohol and Normal Saline in the Orthopedic Surgery Prepped with Povidone-Iodine: A Randomized Clinical Trial

Background: Despite significant advances in patient treatment, infection remains a complication after surgery. The present study compared the incidence and severity of wound infection with two methods of washing the primary prep area with 70% alcohol and normal saline in patients who are candidates for orthopedic surgery in Kowsar Hospital of Sanandaj, Iran. Methods: This single-blinded randomized clinical trial was conducted on 190 candidates for upper limb orthopedic surgery aged 18 to 65. Patients were randomly assigned to two alcohol and normal saline groups based on the table of random numbers. The primary outcome of this clinical trial was the incidence and severity of wound infection after surgery, which was measured by the standard scale of the Asepsis index. The results were analyzed using SPSS version 23, and statistical values less than 0.05 were considered significant. Results: Patients’ hospitalization duration in the intervention group was (3.02±1.04 days) and in the control group (2.86±1.03 days) showed no significant statistical difference (p=0.297). The frequency of wound infection in the alcohol group was lower than in the normal saline group. this difference was statistically significant (p=0.023). Also, the severity of wound infection in the 70% alcohol group (Mean=5.12, SD=3.19) was lower than in the normal saline group (Mean=7.69, SD=4.12). This difference was statistically significant (p&lt;0.001). Conclusion: The present clinical trial showed that the incidence and severity of wound infection after surgery were lower in the group washing the skin of the surgical area with alcohol compared to the group washing with normal saline.

Ultrasound-Guided Quadratus Lumborum Block Using Bupivacaine versus Bupivacaine–Magnesium Sulfate as Postoperative Analgesia in Open Appendectomy in Middle Age Group

Abstract Background The QLB is an effective analgesic technique for various abdominal wall incisions. The QLB covers T7 to L1 dermatomes by the spread of LA drugs either into the paravertebral space or in the thoracolumbar plane, through iliohypogastric and ilioinguinal nerves, A and C fiber nociceptors, mechanoreceptors and high-density network of lumbar sympathetic fibers. Objective To assess the analgesic sparing effect of adding magnesium sulfate to Bupivacaine in Quadratus lumborum block in patients undergoing open appendectomy under general anesthesia. Patients and Methods After approval of the anaesthesiology department and scientific and ethical committees, this prospective single blind randomized clinical trial study was conducted in Ain Shams University Hospitals. Sixty patients scheduled for open appendectomy under general anaesthesia were included in this study. Patients were randomized using a random number table and the use of a closed envelopes technique to receive quadratus lumborum either magnesium sulphate and bupivacaine or bupivacaine only, each group constitutes of 30 patients. Results We found that the addition of magnesium sulfate to bupivacaine in QLB in open appendectomy in middle age group provides a prolonged duration of postoperative analgesia, with reduced analgesic requirements, a better quality of analgesia in terms of NRS compared to bupivacaine alone group. Conclusion The addition of magnesium sulfate to Bupivacaine in lateral QLB in open appendectomy surgery provides a prolonged duration of postoperative analgesia, with reduced analgesic requirements, a better quality of analgesia in terms of NRS compared to bupivacaine alone group.

Effect of Intravenous versus Intrathecal Dexmedetomidine on Potentiation of Spinal Anesthesia in Lower Abdominal Surgeries in Pediatric Patients

Abstract Background regional anesthesia in children was first studied by August Bier in 1899. Since then, spinal anesthesia was practiced for years, and several cases were published in 1909- 1910. After some years, it fell into disuse owing to the introduction of various muscle relaxants and inhalational agents. Aim of the Work to compare the effectiveness and feasibility of dexmedetomidine intravenously and intra-thecally in potentiation and prolongation of spinal anesthesia in pediatric population undergoing lower abdominal surgeries. Patients and Methods this study is a prospective randomized single-blind Clinical trial. study setting pediatric surgery operating theatre, Ain Shams University Hospitals, Cairo, Egypt. Study Period 6 months. This study was carried out on children aging from 1year till 7 years of age who were undergo elective lower abdominal surgeries. Results the major obstacle for routine use of spinal anesthesia in pediatric patients is the short block duration provided with the plain SAB hence the use of adjuvants to overcome this defect were considered. The current clinical trial attempts to synthesize the evidence regarding the safety and efficacy of dexmedetomidine as an adjuvant with the most common spinal anesthetic, bupivacaine. The intrathecal route appear more effective in prolongation of duration of motor block and maintaining an adequate sensory level with slower two segment regression course which can be explained by the previously speculated anti-nociceptive effects of the intrathecal route of dexmedetomidine and its action at the level of spinal cord. Intravenous route seems to provide deeper level of sedation when compared to intrathecal route which can be explained by its higher level and bioavailability in the blood which provides a more satisfactory centrally inhibiting action. Conclusion dexmedetomidine as an adjunct to spinal anesthesia in pediatric lower abdominal surgeries either intravenous or intrathecal can potentiate the motor and sensory block and provide good postoperative analgesia without exerting hemodynamic compromise or significant adverse events. While intrathecal route provide better prolongation of the motor and sensory blockade and also provide longer postoperative analgesia than intravenous route.

Effect of brimonidine on visual indices in patients with acute optic neuritis: A single blind randomized clinical trial

PurposeThis study investigates brimonidine's potential effect on visual functions, particularly contrast sensitivity (CS), an indicator of retinal ganglion cell function. MethodsIn this single-blind, randomized clinical trial, 60 patients (aged 23–56) with first-episode acute optic neuritis within seven days of symptom onset were randomly assigned to brimonidine or control groups. The intervention group received brimonidine three times daily for three months, while the control group received synthetic tears with the same dosage and frequency. Primary outcomes were changes in CS, visual acuity (VA), and color vision at one and three months post-treatment. Repeated measures ANOVA was used to assess statistically significant and partial eta squared (η2) values, mean differences, and clinically significance important were reported. ResultsAll participants completed the study without complications. VA improved significantly in both groups by follow-up end (p < 0.001), with significant improvement from first to third month only in the brimonidine group (p < 0.001). The mean VA difference between groups was not statistically and clinically significant. CS showed statistically significant improvement within both groups (p < 0.001) and between groups (p < 0.001), with a large effect size (partial η2 = 0.28). The mean CS difference between groups (14.5) was clinically considerable. No significant changes in color vision were observed between groups (p = 0.96). ConclusionBrimonidine significantly improved contrast sensitivity compared to placebo and was well-tolerated. Its neuroprotective effects suggest it may be beneficial in treating optic neuritis and preserving retinal ganglion cell function. Trial registrationProspectively registered at Iranian Clinical Trial Registration; Registration date 3 December 2022; Registration number: IRCT20221127056631N1

Comparative Effects of Gaze Stabilization Exercises and Cawthorne-Cooksey Exercises on Craniovertebral Angle and Vestibulo-Ocular Reflex in IT Students

Background: Vestibular dysfunction affects balance and spatial orientation, leading to symptoms like dizziness and impaired gaze stability. Forward head posture (FHP) is common among IT students due to prolonged screen time, exacerbating vestibular and postural issues.Objective: To compare the effects of Gaze Stabilization Exercises (GSE) and Cawthorne-Cooksey Exercises (CCE) on craniovertebral angle (CVA) and vestibulo-ocular reflex (VOR) among IT students.Methods: A single-blinded randomized clinical trial was conducted on 50 IT students aged 19-25 years with FHP. Participants were randomly assigned to GSE (n=25) or CCE (n=25) groups. Interventions were performed thrice weekly for 3 weeks. CVA and VOR were assessed pre- and post-intervention using a goniometer and clinical scale, respectively. Data were analyzed using SPSS version 27 with Wilcoxon signed-rank and Mann-Whitney U tests.Results: Post-intervention, Group B (CCE) showed a significant increase in CVA (mean rank 26.80, U = 280.000, p = 0.527). Group A (GSE) demonstrated a significant reduction in VOR (mean rank 30.80, U = 180.00, p = 0.003).Conclusion: GSE effectively improved VOR, while CCE significantly enhanced CVA, indicating the potential for targeted rehabilitation in addressing vestibular and postural dysfunctions.

The Effect of Rood's Ontogenic Motor Patterns on Trunk Control and Balance in Spastic Diplegic Cerebral Palsy Children

Background: Cerebral palsy (CP) is a non-progressive neuromotor disorder affecting movement, muscle tone, and posture due to brain injury during early development. Effective interventions are essential for improving functional outcomes in children with spastic diplegic CP.Objective: This study aimed to evaluate the effects of Rood's Ontogenic Motor Patterns (ROMP) on trunk control and balance in children with spastic diplegic cerebral palsy.Methods: A single-blinded randomized clinical trial was conducted with 22 children aged 3-10 years, diagnosed with spastic diplegic CP. Participants were randomly assigned to two groups: Group A received Functional Electrical Stimulation with ROMP, and Group B received conventional physical therapy. The intervention lasted five weeks, with three sessions per week. Outcomes were assessed using the Modified Ashworth Scale, Gross Motor Function Measurement Scale (GMFM-88), and Pediatric Berg Balance Scale. Data were analyzed using SPSS 27.Results: Group A showed significant improvement in balance (PBBS: pre 13.81 ± 1.64, post 24.18 ± 4.67; p=0.017) and GMFM-88 scores (pre 9.95 ± 109.50, post 15.73 ± 173.0; p&lt;0.001). Spasticity reduced significantly in the ROMP group (MAS: pre 11.50 ± 126.50, post 7.30 ± 73.00; p=0.010).Conclusion: ROMP significantly improved balance and reduced spasticity in children with spastic diplegic CP compared to conventional therapy, suggesting its potential integration into rehabilitation programs.

Effects of Home-Based Daily Respiratory Muscle Training on Swallowing Outcomes in Patients with Chronic Stroke: Protocol for a Randomized Controlled Trial.

(1) Background: Swallowing disorders are common following a stroke. This study aims to evaluate the effects of a home-based daily intervention focused on inspiratory and expiratory muscle training on swallowing outcomes in patients with chronic stroke. (2) Methods: This manuscript presents the protocol of a single-blind randomized clinical trial. Patients with chronic stroke will be randomly assigned to either an experimental or a control group. The experimental group will undergo daily home-based respiratory muscle training in addition to standard speech and language therapy, while the control group will receive only the standard intervention. The main outcome measures will include the aspiration risk, the strength of respiratory muscles, and peak cough flow. (3) Results: It is hypothesized that patients receiving home-based respiratory training in addition to standard therapy will achieve significant improvements in aspiration risk, respiratory muscle strength, and cough efficacy in comparison with those included in the control group. The results will be published as a manuscript. (4) Conclusions: This study aims to provide evidence on the effectiveness of home-based respiratory muscle training in enhancing swallowing function and respiratory parameters in patients with chronic stroke.

Culturally Adapted Lifestyle Intervention for South Asian Adults With Cardiovascular Risk Factors

South Asian adults in the US experience excess cardiovascular disease (CVD) compared with other racial and ethnic groups. The effectiveness and reach of guideline-recommended lifestyle interventions have not been evaluated in this population. To evaluate whether a culturally adapted, group lifestyle intervention will improve CVD risk factors more effectively than written health education materials among US South Asian adults. This single-blind randomized clinical trial was conducted from March 6, 2018, to February 11, 2023 at community sites in the Chicago, Illinois, metropolitan area. South Asian adults aged 18 to 65 years who were overweight or obese, had no history of CVD events, and had at least 1 additional CVD risk factor (hypertension, dyslipidemia, prediabetes, or diabetes) were eligible for inclusion. A 16-week, culturally adapted, group-based lifestyle intervention led by community health coaches. Lifestyle modification counseling was delivered in English, Gujarati, Hindi, and Urdu. Participants tracked their diet and physical activity (PA) and received 4 optional group maintenance sessions between months 5 and 11 of follow-up. The intervention was delivered in person prior to the onset of the COVID-19 pandemic and via videoconference starting in March 2020. The control group received written health education materials, delivered monthly. Primary outcomes were the between-group differences in CVD risk factor changes from baseline to 12 months, including weight, systolic blood pressure (SBP), diastolic blood pressure (DBP), glycated hemoglobin (HbA1c), and total cholesterol, estimated using multivariate mixed-effects regression models. Secondary outcomes were self-reported diet quality, PA, and self-efficacy, estimated using univariate mixed-effects regression models. Among 549 randomized participants, 318 (57.9%) were women, and mean (SD) participant age was 49.2 (9.5) years. Mean differences in CVD risk factor changes from baseline to 12 months in the intervention vs control group were calculated for weight (mean difference, -0.07 kg; 95% CI, -0.55 to 0.42), SBP (mean difference, 0.47 mm Hg; 95% CI, -1.85 to 2.79), DBP (mean difference, 0.44 mm Hg; 95% CI, -1.06 to 1.95), cholesterol (mean difference, -2.47 mg/dL; 95% CI, -8.51 to 3.57), and HbA1c (mean difference, -0.07%; 95% CI -0.20% to 0.07%). Intervention participation was associated with greater improvements in dietary quality, PA, and self-efficacy than control. In the SAHELI randomized clinical trial, a culturally adapted, group lifestyle intervention was not more effective than written health education materials for CVD risk factor reduction among US South Asian adults, but the intervention was associated with small improvements in self-reported health behaviors. Effective CVD prevention interventions for this elevated-risk population require further investigation. ClinicalTrials.gov Identifier: NCT03336255.

Comparing the effects of neck stabilization exercises versus dynamic exercises among patients having nonspecific neck pain with forward head posture: a randomized clinical trial

BackgroundNonspecific neck pain (NSNP) is a well-established global burden affecting. It is also a common problem in Pakistan. The burden of neck pain is also increasing day by day due to poor work ergonomics, and increased use of computers and mobiles after the pandemic. An individual’s poor posture is often associated with forward head posture (FHP). Limited evidence is available about the effects of neck stabilization (NSE) and dynamic exercises (NDE) for nonspecific neck pain particularly in patients with FHP. This aimed to compare the effects of NSE versus NDE among patients having NSNP with FHP in reducing pain, disability, forward head posture and improving neck range of motion.MethodsIt is a single-blinded randomized clinical trial with 60 patients aged 18–40 years, with moderate intensity NSNP for > 3 weeks and < 6 months along with FHP with a moderate disability on neck disability index (NDI) randomly assigned to the treatment groups. Group 1 was doing NSE and group 2 was doing NDE. Transcutaneous Electical Nerve Stimulation, cold packs, and stretching exercises were given to both groups. A total of 9 sessions (3 sessions/ week) were given to participants. NDI questionnaire, Visual analogue scale (VAS), goniometry, and plumb line measurement tool were used as baseline and assessment at the end of 3rd week. The data was analyzed on SPSS version 21. Descriptive analysis was performed. Independent t-test was used for between group comparison and paired t-test used for within group comparison. A p-value less than 0.05 was considered statistically significant.ResultsAfter treatment within-group analysis of both NSE and NDE showed significant (p < 0.001) improvement in pain on VAS, all ROMs of the neck including flexion, extension, left and right lateral flexion and left rotation, plumb line and NDI score with very large effect size. However, between-group analysis showed non-significant differences (p > 0.05) for post-treatment mean VAS, neck ROM, NDI and plumb line measurement.ConclusionBetween NSE and NDE, no one is more beneficial than another. Both are equally effective in alleviating pain, increasing ROM, decreasing functional disability, and improving forward head posture in patients with NSNP.Trial RegistrationRegistered trial at ClinicalTrials.gov Identifier: NCT05298631, 28/03/2022, prospectively registered.

The Comparison of 940nm and 810nm Diode Laser Effects on the Repair of Inferior Alveolar Sensory Nerve Injury: A Clinical Trial.

Healing of the inferior alveolar nerve injury during dental procedures is one of the biggest concerns of dentists. There are still debates on different treatment modalities. This study aimed to compare the effect of 940nm and 810nm diode lasers on the repair of the inferior alveolar sensory nerve. In this single-blinded randomized clinical trial, 39 patients with inferior alveolar nerve injury were divided into three groups: 1. 810nm laser irradiated, 2. 940nm laser irradiated, and 3. No laser irradiation (control group). All patients were treated in 12 sessions (3 days per week) and evaluated using a complete clinical neurosensory test (CNT), including brushstroke, 2-point discrimination, pinprick nociception, and thermal discrimination before and after treatment. The mean dysesthesia of the patient treated with 810nm diode laser was significantly lower than the control group in all sessions (the 1st (p= 0.003), 3rd (p= 0.008), 7th (p= 0.006), and 12th sessions (p= 0.005)). The 810nm laser resulted in more satisfaction in patients than the control group in almost all sessions (1st (p< 0.001), 7th (p= 0.028), and 12th (p= 0.006)). More patient satisfaction was seen in the 1st and 3rd sessions in the 810nm laser than in the 980nm laser (p< 0.001 and p= 0.003, respectively). 810nm diode laser can be better than 940nm in repairing inferior alveolar sensory nerve damage.

Non- or minimally displaced distal radius fractures in adult patients < 50 years of age

BackgroundCurrently, non- or minimally displaced distal radius fractures are treated by 3 to 5 weeks of cast immobilisation. Many patients with a distal radius fracture suffer from long-term functional restrictions, which might be related to stiffness due to cast immobilisation. Current literature indicates that 1 week of immobilisation might be safe; however, no level 1 evidence is available. This trial aims to compare 1 week of brace immobilisation with 3 weeks of cast immobilisation in patients with distal radius fractures that do not need reduction.MethodsThe aim of this trial is to evaluate the non-inferiority of 1 week of brace immobilisation in patients with non- or minimally displaced distal radius fractures. A two-armed single blinded multicentre randomised clinical trial will be conducted in three hospitals. Adult patients, between 18 and 50 years old, independent for activities of daily living, with a non- or minimally displaced distal radius fracture can be included in this study. The intervention group is treated with 1 week of brace immobilisation, and the control group with 3 weeks of cast immobilisation. Primary outcome is the patient-reported outcome measured by the Patient-Related Wrist Evaluation score (PRWE) at 6 months. Secondary outcomes are patient-reported outcome measured by the Quick Disabilities of the Arm, Shoulder and Hand score at 6 weeks and 6 months, PRWE at 6 weeks, range of motion, patient-reported pain score measured by VAS score, radiological outcome (dorsal/volar tilt, radial height, ulnar variance, presence of intra-articular step off), complications and cost-effectiveness measured by the EuroQol 5 Dimension questionnaire, Medical Consumption Questionnaire and Productivity Cost Questionnaire.DiscussionThis study will provide evidence on the optimal period of immobilisation in non-operatively treated displaced and reduced distal radius fractures. Both treatment options are accepted treatment protocols and both treatment options have a low risk of complications. Follow-up will be according to the current treatment protocol. This study will provide level 1 evidence on the optimal period and way of immobilisation for non- or minimally displaced distal radius fractures in adult patients.Trial registrationABR 81638 | NL81638.029.22 | www.toetsingonline.nl. 18th of October 2023

Effect of the nurse-led Hospital Elder Life Program on delirium reduction among delirious patients with COVID-19: A randomized clinical trial.

Infectious diseases, such as COVID-19, are high-risk factors for delirium. However, the implementation of nonpharmacological interventions faces major challenges during an infectious disease pandemic. To evaluate the effect of the nurse-led Hospital Elder Life Program (NL-HELP) on delirium reduction among delirious patients with COVID-19. A single-blind randomized clinical trial. This study recruited 122 delirious patients with COVID-19 from internal medicine wards at West China Hospital in China between January 30 and March 31, 2023. Participants were randomized to the NL-HELP group (n = 62) or the usual care group (n = 60). Patients in the intervention group received the NL-HELP protocol three times daily for 7 days. Patients in the control group received usual care. The primary outcome was the absence/presence of delirium during the intervention period measured by the 3-min Diagnostic Confusion Assessment Method. Fewer patients remained delirious in the NL-HELP group than in the control group. There were significantly more delirium-free days in the NL-HELP group than in the usual care group. There were no statistically significant differences between the two groups in terms of delirium severity, length of hospital stay, delirium at 30 days after discharge, 30-day readmission, 30-day mortality, physical function or quality of life. This study demonstrated that NL-HELP could reduce the presence of delirium in delirious patients. No effect was observed in terms of shortening the length of hospital stay, reducing 30-day mortality, or improving quality of life. NL-HELP may be effective in reducing the presence of delirium in delirious patients. Further research is needed to determine whether the NL-HELP can improve patient outcomes (e.g. mortality and quality of life) in a larger study. Caregivers of delirious patients were invited to provide intervention strategies to prevent or abate delirium, including environmental management, orientation communications and identification of alert signs. This study was prospectively registered at the Chinese Clinical Trial Registry (https://www.chictr.org.cn/) Identifier: ChiCTR2300067874.

Pain, function and peritendinous effusion improvement after dry needling in patients with long head of biceps brachii tendinopathy: a single-blind randomized clinical trial

Introduction Long head of biceps brachii tendinopathy, a frequent source of anterior shoulder pain, may lead to discomfort and diminished function. The objective of this study is to assess the efficacy of dry needling and transcutaneous electrical nerve stimulation in these patients. Patients and methods Thirty patients were randomized into dry needling and transcutaneous electrical nerve stimulation groups and assessed before treatment, 8 and 15 days after treatment using a visual analogue scale, shoulder pain and disability index, pressure pain threshold, tissue hardness, and biceps peritendinous effusion. Results Both treatments significantly reduced the visual analogue scale in immediate (p < 0.001), short-term (p < 0.01), and medium-term effects (p < 0.01). Dry needling outperformed transcutaneous electrical nerve stimulation for the pain (p < 0.01) and disability (p < 0.03) subscales of the shoulder pain and disability index in the short-term and medium-term effects, respectively. Pressure pain threshold increased after both treatments but didn’t last beyond 8 days. Neither treatment showed any improvements in tissue hardness of the long head of biceps brachii muscle. Notably, only the dry needling group significantly reduced biceps peritendinous effusion in both short-term and medium-term effects (p < 0.01). Conclusions Dry needling showed non-inferior results to transcutaneous electrical nerve stimulation in reducing pain and disability and demonstrated even superior results in reducing biceps peritendinous effusion (see Graphical ). Trial registration The Institutional Review Board of the China Medical University Hospital (CMUH107-REC2-101) approved this study, and it was registered with Identifier NCT03639454 on ClinicalTrials.gov.

Multiple mediation analysis of a task-shared psychosocial intervention for perinatal anxiety: Exploratory findings from a randomized controlled trial in Pakistan

BackgroundThe “Healthy Mother Healthy Baby” (HMHB) study is a phase three, single-blind randomized clinical trial conducted at Holy Family Hospital (HFH) in association with Rawalpindi Medical University (RMU). We aimed to examine the mediators of a specialized psychosocial approach based on Cognitive Behavioural Therapy principles, targeting pregnant women experiencing anxiety. The HMHB intervention was effective in treating perinatal anxiety symptoms and preventing future depressive episodes. MethodsThe trial randomized participants into two arms: the HMHB intervention or Enhanced Usual Care (EUC), following World Health Organization guidelines. The HMHB intervention comprised strategies to strengthen social support networks, improving mother-baby bonding and strategies to deal with interpersonal conflicts, economic challenges, and societal gender preferences using cognitive and behavioural techniques and culturally resonant illustrations. Participants underwent rigorous data collection at three pivotal timepoints: baseline, third trimester, and 6-weeks postnatal. The primary outcome was anxiety symptom severity scores using the Hospital Anxiety and Depression Scale (HADS) at 6-weeks post-childbirth. Four potential mediators – social support, behavioural activation, perceived stress, and pregnancy experience – were assessed in the third trimester of pregnancy. ResultsA total of 1200 participants were randomized to the HMHB and EUC arms. In the six-week follow-up time point, 379 participants remained in the EUC group, and 387 continued in the HMHB group. Post-intervention, HMHB participants displayed significant improvements in postnatal anxiety and depression scores. Mediation analyses revealed social support and pregnancy hassles as significant mediators of the intervention's effect on postnatal anxiety outcomes, while only social support emerged as a significant mediator for depression outcomes. ConclusionThe HMHB intervention showed promising results in improving anxiety and depression scores among pregnant women. Significant mediation effects suggest the importance of targeting social support and managing pregnancy-related hassles for optimal intervention effectiveness.