Single-blind Randomized Clinical Trial Research Articles

Comparison of telerehabilitation methods for patients with systemic sclerosis in the COVID-19 Era: A randomized controlled study

Study DesignThis was a single-blinded randomized clinical trial. IntroductionSystemic sclerosis (SSc) is an autoimmune connective tissue disease that progresses with fibrosis. Patients with SSc need to be protected against epidemic diseases and provided for in terms of rehabilitation needs. Purpose of the StudyTo compare the effects of real-time telerehabilitation (RTT) and asynchronous telerehabilitation (AT) on individuals with SSc. MethodsForty-two participants with SSc with a mean age of 44.17 ± 11.05 years were included in the study. The patients were randomly divided into three groups, RTT (n = 16), AT (n = 16), and control (n = 16) groups. A structured rehabilitation program was performed in real-time (RTT group) and asynchronously (AT group) for 40 minutes per day, in three sessions per week for 8 weeks. The participants' finger and wrist joint range of motion (ROM), upper extremity functions, grip strength, superficial sense of touch, activities of daily living (ADL), and general health status were assessed at baseline and after treatment. ResultsAfter 8 weeks, there were improvements in finger ROM (effect size [ES] = 0.23 to 0.60), wrist ROM (ES = 0.45 to 0.83), upper extremity functions (ES = 0.61 to 1.00), and ADL parameters (ES = 0.74) in the RTT group (p < 0.05). Also, there were improvements in finger ROM (ES = 0.16 to 0.45) and hand functions (ES = 0.54 to 0.55) in the AT group (p < 0.05). The RTT and AT groups had better hand functions and finger ROM than the control group in (p < 0.05). In addition, the RTT group had better wrist ROM than the control group (p = 0.008). RTT was superior to AT only in lateral pinch strength (p = 0.025). DiscussionExperimental groups achieved a statistically significant change in ROM, upper extremity functions and ADL over time in concordance with prior investigations. Changes in grip strength, superficial sense of touch, and general health status scores differed from previous investigations and the between-group comparison was not statistically significant. ConclusionsBoth RTT and AT may be effective in individuals with SSc, and RTT has additional benefits.

The efficacy in shoulder range of motion of a snapping manual maneuver added to a standardized exercise protocol in axillary web syndrome: a randomized controlled trial

Purpose Axillary Web Syndrome (AWS) is a common sequela after surgical axillary lymph node dissection (ALND) often manifesting with reduced range of motion (ROM) of the limb, which requires rehabilitation. Notwithstanding, a standardized rehabilitation protocol is currently lacking in clinical practice. Our primary objective was therefore to evaluate the effectiveness of the use of a snapping manual maneuver (SMM, used in our clinical practice) to increase ROM during abduction (ABD) when compared with a standardized stretching exercise (SSE) protocol. A three-year follow-up of the enrolled patients was also carried out to determine the incidence of Breast Cancer-Related Lymphedema (BCRL). Materials and methods Between July 2013 and January 2019, we conducted a single-blinded randomized clinical trial. A total of 60 patients, who underwent ALND in our hospital, came to our clinic under medical advice or on voluntary access and reported AWS symptoms. The patients were randomly assigned into two equally divided groups. The treatment of group one consists in the execution of a supervised SSEs protocol, while group two additionally received a manual snapping maneuver. Patients of both groups received two treatment sessions within two weeks. At the end of the session, they were asked to continue the exercises autonomously on a daily basis, three times per day, for one month. Results There were no statically significant differences in ROM at our one-month follow-up and the incidence of BCRL was equally distributed after three years. Conclusions The use of the manual snapping maneuver in addition to stretching once per week for two weeks does not appear to improve the outcome of the patients in comparison with stretching alone and does not appear to be related to lymphedema in our 3 years follow-up.

Comparative evaluation of the caesarean section rate in term nulliparas with labour dystocia following augmentation with oxytocin alone versus with oxytocin and drotaverine

Background: Labour dystocia is the commonest indication for emergency caesarean section in nulliparas, and occurs when the progress of labour is abnormally slow. Labour dystocia may be caused by abnormalities in uterine contractions, slow cervical dilatation, or mechanical disproportion between the foetal presenting part and the maternal pelvis. Augmentation of labour with oxytocin is the traditional management for labour dystocia as it enhances uterine contractions. At times, despite good uterine contractions, dystocia persists due to cervical smooth muscle spasms or mechanical factors, thereby increasing the caesarean section rate. Drotaverine is a musculotropic antispasmodic and can relieve smooth muscle spasms. Aim/objective: This study compared the caesarean section rate in term nulliparas with labour dystocia that were augmented with oxytocin and placebo versus with oxytocin and drotaverine Methods: This study was a single-blinded randomized clinical trial conducted between January and August 2021. It involved 156 term nulliparous women with labour dystocia that were randomized into two groups for augmentation of labour. Each group had 78 parturients that were managed with either oxytocin with a placebo or oxytocin with drotaverine. They were monitored till delivery and the caesarean section rate in both groups was compared. Data obtained were analysed with SPSS version 23 software. The level of significance was set at 0.05, P&lt; 0.05 was statistically significant. Results: The two groups were similar in their sociodemographic characteristics. In this study 21(13.5%) women had emergency caesarean section while 135(86.5%) had vaginal delivery following augmentation. The caesarean section rate in the oxytocin-placebo was similar to the oxytocin-drotaverine group (10 (12.8%) vs 11 (14.1%), p=0.82). The majority, 14 (67%) of the caesarean sections were due to mechanical factors, 4 (19%) were due to functional dystocia and 3(14%) were due to foetal distress. Conclusion: The use of drotaverine with oxytocin in managing labour dystocia did not improve the caesarean section rate as the majority of the cases had mechanical dystocia.

Comparison of Immediate Effect of High-power Pain Threshold Ultrasound and Deep Transverse Friction Massage on Active Myofascial Trigger Points

Introduction: The study was conducted to compare the immediate effect of high-power pain threshold ultrasound (HPPTUS) and deep transverse friction massage (DTFM) as a traditional technique on the treatment of upper trapezius active myofascial trigger points in male patients with mechanical neck pain.&#x0D; Materials and Methods: In this parallel single-blind randomized clinical trial study, 60 men with mechanical neck pain (mean age: 30.57±6.19 years) who met the inclusion and exclusion criteria were randomly assigned to HPPTUS and DTFM as the control group. A visual analog scale (VAS), pain pressure threshold (PPT), and range of motion (ROM) of cervical lateral flexion (CLF) were assessed before and after treatment.&#x0D; Results: Analysis of pre- and post-treatment findings showed that the VAS (P&lt;0.01), PPT (P&lt;0.01), and ROM of CLF (P&lt;0.01) improved significantly in both groups while ROM of CLF increased significantly more in the HPPTUS group. An indirect correlation was found between the pre-treatment ROM of CLF and ROM of CLF improvement in both groups. A significant indirect correlation was observed between pre-treatment VAS and ROM of CLF improvement in the HPPTUS group. In the DTFM group a significant indirect correlation was found between pre-treatment ROM of CLF and VAS improvement.&#x0D; Conclusion: The results showed that HPPTUS can be used as an effective treatment for active trigger points (TP). It seems that this method is more effective than deep transverse friction massage.&#x0D;

519-P: Randomized Clinical Trial to Compare Cryopreserved and Lyopreserved Placental Cord Tissue to Treat Complex Diabetic Foot Surgical Wounds—A Proof of Concept Study

Objective: To compare the incidence of infection, healing and time to heal in patients treated with cryopreserved (CPAT) and lyopreserved amniotic tissue (LPAT) in complex diabetic surgical wound (CDFW). Methods: This single-blinded 12-week randomized clinical trial compared cryopreserved and lyopreserved amniotic cord tissue to treat complex diabetic foot wounds (CDFW). LPAT 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&amp;lt;0.5 or TBI&amp;lt;0.3, untreated osteomyelitis, and autoimmune diseases. We used a 3-D camera to evaluate wound area and volume. The Chi-squared test was used to compare clinical outcomes and the Wilcoxon Ranked Sum Test to compare wound area and volume. Results: The mean baseline wound areas were 12.9cm2 ±10.7 for CPAT and 11.7cm2 ±7.0 for LPAT. The mean baseline wound volume were 7.5cm3 ±8.1 for CPAT and 9.2cm3±10.2 for LPAT. There was no difference between CPAT and LPAT in healing (36.8% vs. 19.0%, p=0.21) and infection (10.5% vs. 9.5%, p=0.72). There was no difference in mean wound area reduction between CPAT and LPAT (75.9± 32.3% vs. 65.5±38.4%, p=0.41), nor in mean volume reduction (85.0±30.8% vs. 79.9±31.9%, p=0.61). When we stratified wound dimensions, there was no difference between CPAT and LPAT in subjects that had 90-99% wound volume reduction (36.8% vs. 47.6%), 70-89% wound volume reduction (15.8% vs 19.0%) and 0-69% wound volume reduction (10.5% vs. 19.0%). There was no difference between CPAT and LPAT in subjects that had 90-99% wound area reduction 90-99% (10.5% vs. 23.8%), 70-89% (26.3% vs. 19.0%) and 0-69% (26.3% vs. 38.1%). Conclusion: Cryopreserved and Lyopreserved amniotic tissue provided similar results in patients with complex diabetic foot wounds. Disclosure L.A.Lavery: Research Support; AstraZeneca, Tissue tech, American Diabetes Association, PolarityTE, Inc., Microbion, Jarvis, Integra Lifesciences Holdings Corp, Smith+Nephew. A.L.Killeen: Research Support; 3M/KCI, AstraZeneca, BioTissue surgical, Hologenix, LLC, Integra LifeSciences, Kent Imaging Inc., Microbion, PolarityTE, Inc., Smith+Nephew, Stark Enterprises, LLC, Xyken, VasoActiv, ViOptix. M.A.Suludere: None. P.Crisologo: None. Funding Smith &amp; Nephew

Transcutaneous Tibial Nerve Stimulation for Primary Dysmenorrhea: A Protocol for a Randomized Controlled Trial.

Primary dysmenorrhea (PD) is a painful menstruation that can persist for the duration of a woman's fertile life. Non-steroidal anti-inflammatory drugs, hormonal therapy, physiotherapy techniques, etc., are the main treatments. The main objective of this study is to evaluate the effectiveness of transcutaneous posterior tibial nerve stimulation (TTNS) in PD patients. The study will consist of a single-blind randomized clinical trial, parallel-assigned with two arms. Women with PD (18-43 years) with regular menstrual cycles and at least 4 points in VAS will be randomly divided into experimental (TTNS) and placebo (simulated stimulation) groups during 12 treatment sessions (1 session/week) and several follow-ups: monthly during treatment and 1, 3 and 6 months after. Maximum and mean pain intensity, pain duration, pain severity, number of anti-inflammatory drugs, quality of life, sleep quality, overall improvement, treatment satisfaction and secondary effects will be measured once a month every 6 months and at 3 and 6 months. The Student's t-test for independent samples or the Mann-Whitney U test will be used. The literature shows effective physiotherapeutic techniques for PD in the short term, which do not act on causes and have limitations. The TTNS technique can be used in transcutaneous and percutaneous modalities, with similar effectiveness, but the transcutaneous causes less discomfort. TTNS modulates pain, and long-term benefits could be achieved at low cost and without patient discomfort.

Comparison of telehealth and supervised phase III cardiac rehabilitation in regional Australia: protocol for a non-inferiority trial

IntroductionExercise-based cardiac rehabilitation programmes (ExCRP) promote recovery and secondary prevention for individuals with cardiovascular disease (CVD). Despite this, enrolment and adherence to ExCRP in rural locations is low. Telehealth programmes...

The effects of virtual logotherapy on health-promoting lifestyle among single-parent adolescent girls during the coronavirus disease 2019 pandemic: a randomized clinical trial

Single-parent adolescents are vulnerable individuals and it is necessary to improve their health, particularly during epidemics. This study aimed to investigate the effects of virtual logotherapy (VL) on health-promoting lifestyle (HPL) among single-parent adolescent girls during the COVID-19 pandemic. This single-blind randomized clinical trial was conducted on 88 single-parent adolescent girls recruited from the support organization for vulnerable individuals in Tehran, Iran. They were randomly allocated to a control and an intervention group through block randomization. Participants in the intervention group received VL in three–five person groups in 90 min biweekly sessions. The Adolescent Health Promotion Short-Form was used to assess HPL. Data were analyzed using the SPSS software (v. 26.0) and through the independent-sample t, Chi-square, Fisher’s exact, and Mann–Whitney U tests. There was no significant difference between the intervention and the control groups respecting the pretest mean score of HPL (73.58±16.74 vs. 72.80±9.30; P=0.085). However, the posttest mean score of HPL in the intervention group (82 with an interquartile range of 78–90) was significantly more than the control group (71.50 with an interquartile range of 63.25–84.50) (P=0.001). Moreover, after adjusting the effects of the significant between-group differences respecting pretest mean scores, the pretest–posttest differences of the mean scores of HPL and all its dimensions in the intervention group were significantly more than the control group (P<0.05). VL is effective in significantly improving HPL among single-parent adolescent girls. Healthcare authorities are recommended to use VL for health promotion among single-parent adolescents.Trial registrationThis research was registered (17/05/2020) in the www.thaiclinicaltrials.org with registration number: TCTR20200517001.

The Effect of Topical Nifedipine versus Diltiazem on the Acute Anal Fissure: A Randomized Clinical Trial.

Background: The anal fissure is one of the most common anorectal diseases that is associated with reduced quality of life and productivity loss. We aimed to compare the efficacy of topical nifedipine and diltiazem for the treatment of acute anal fissure (AAF). Methods: This single-blind randomized clinical trial was conducted at Ziaeian hospital, Tehran. Patients with an acute fissure diagnosis were allocated to two groups. Group A applied 3 grams of 0.3% nifedipine cream on the peri-anal area, three times a day, for 8 weeks. Group B also applied the same amount of 2% diltiazem-ointment on the peri-anal area for the same period. The primary outcome was fissure remission in the 8th week of the treatments. The duration of pain relief, the side effect of treatment, and the recurrence rate were also compared between the groups. Results: After 8 weeks of treatment, a remission rate of 77.4% was shown in the nifedipine group which was significantly higher than the diltiazem group with a remission rate of 54% (P=0.01). Applying nifedipine ointment is associated with earlier pain relief compared with diltiazem (P<0.001). After 6 months of follow-up, the relapse rate was not statistically different between the nifedipine and diltiazem groups (16.3% versus 21.4%, respectively). Conclusion: The application of topical nifedipine is associated with shorter pain relief and more remission rate for AAF compared with topical diltiazem. However, both methods were not different in terms of related side effects and AAF recurrence rate.

Head elevation during preoxygenation can delay desaturation time: A randomized-controlled trial

BackgroundPreoxygenation before anesthesia induction is an important part of airway management to reduce the risk of hypoxemia when the patient is apneic. The effectivity of preoxygenation is influenced by several things such as patient's head position. This study aimed to compare preoxygenation between various degrees of head elevation (20°, 30°, and 45°) and 0° or no elevation position towards desaturation time before tracheal intubation in patients undergoing general anesthesia. MethodThis was a single-blinded randomized clinical trial of 48 patients, assigned into four groups (0°, 20°, 30°, and 45° head elevation group). All subjects were preoxygenated for 3 min with 100% oxygen. Induction of anesthesia was started with fentanyl and propofol, followed by rocuronium after the patient lost consciousness. Time was recorded from the beginning of induction until the oxygen saturation decreased to 93% or a time limit of 5 min was reached. ResultThe desaturation time in 45° head elevation group was significantly the longest, followed by 30°, 20°, and 0° group (224,0 ± 49,4; 196,4 ± 41,7; 187,2 ± 29,8; and 166,1 ± 51,3 s, respectively; P < 0.05). ConclusionsPatients with 45° head elevation had significant longer mean desaturation time compared to 0° and 20° head elevation group. In patients undergoing general anesthesia, preoxygenation with head elevation slowed down the time for desaturation before tracheal intubation compared to the conventional position. Clinical trial registrationNCT05688722.

A Comparative Study of Nasal Fiberoptic Intubation with Laryngeal Mask Airway Fiberoptic Intubation in Children with a Difficult Airway

Background: Considering that the gold standard for intubation in children with a difficult airway is the use of fiberoptic bronchoscopy, and few studies have evaluated its application in children, the present study aimed at comparing two bronchoscopic techniques of nasal fiberoptic tracheal intubation (FOI-Nasal) and fiberoptic intubation via laryngeal mask airway (FOI-LMA) in children with a difficult airway.&#x0D; Methods: A single-blind randomized clinical trial was performed on 40 six-month-old to six-year-old children that were divided into two groups each consisting of 20 patients. The participants were all candidates for elective surgery with clinical criteria for the anticipated difficult intubation. FOI-Nasal and FOI-LMA were performed in the first and second groups, respectively. Mean arterial pressure (MAP), heart rate (HR), and blood oxygen saturation levels (SpO2) were assessed and recorded before anesthesia (T1), immediately before bronchoscopy (T2), and immediately after intubation with endotracheal tube (T3). Moreover, ETCO2, the first successful insertion attempt, and the intubation time were recorded, as well.&#x0D; Results: The results of the present study revealed that parameters including MAP, HR, and SpO2 at times T1, T2, and T3 were not significantly different between the two groups after adjusting for potential confounding factors (P&gt; 0.05). However, ETCO2 in FOI-Nasal group with a mean of 38.40 ± 3.57 was significantly higher than that of the FOI-LMA group with a mean of 34.35 ± 3.15 (P = 0.001). In addition, the intubation time in the FOI-LMA group with a mean of 32.40 ± 7.45 was significantly shorter than that of the FOI-Nasal group with a mean of 51.75 ± 9.97 (P &lt;0.001). The success rate in the first attempt in the FOI-Nasal group with the value of 70% was lower than that of the FOI-LMA group with the value of 90%; however, this difference was not statistically significant (P&gt; 0.05).&#x0D; Conclusion: According to the results of the present study, the intubation time in the FOI-LMA group was significantly shorter than that of the FOI-Nasal group. Moreover, the success rate of the first attempt in the FOI-LMA group was higher than that of the FOI-Nasal group. Therefore, it can be stated that FOI-LMA as compared to FOI-Nasal can be regarded as an easier technique, with a shorter intubation time, a higher success rate, and a greater stability of children’s hemodynamic parameters.

Effectiveness of Conditioned Open-label Placebo With Methadone in Treatment of Opioid Use Disorder

Methadone treatment is the most effective evidence-based treatment for opioid use disorder (OUD), but challenges related to dosing and premature treatment dropout argue for adjunct interventions to improve outcomes. One potential behavioral intervention with low risk involves harnessing placebo effects. To determine the effect of a pharmacologically conditioned open-label placebo (C-OLP) on 90-day methadone dose, retention, drug use, withdrawal, craving, quality of life, and sleep. This 2-arm, open-label, single-blind randomized clinical trial was conducted between December 5, 2017, and August 2, 2019, in an academically affiliated community opioid treatment program. Analyses were conducted between October 1, 2019, and April 30, 2020. A total of 320 newly enrolled adults seeking treatment for moderate to severe OUD were assessed for study eligibility; 131 met eligibility criteria, provided informed consent, and were randomized to either C-OLP or treatment as usual (TAU) in an unequal-block (3:2) manner. Exclusion criteria were pregnancy, hospital/program transfers, and court-ordered treatment. Participants randomized to C-OLP received pharmacologic conditioning and a placebo pill and methadone, and participants randomized to TAU were given methadone only. Participants met with the study team 5 times: at baseline (treatment intake) and 2, 4, 8, and 12 weeks postbaseline. Interactions were balanced between the 2 groups. Outcomes included 90-day methadone dose (primary) and treatment retention, drug use, withdrawal, craving, quality of life, and sleep quality (secondary). Analyses were conducted as intention-to-treat. Of the 131 people enrolled in the study, 54 were randomized to TAU and 77 to C-OLP. Mean (SD) age was 45.9 (11.2) years; most of the participants were Black or African American (83 [63.4%]) and male (84 [64.1%]). No significant group differences were observed in the mean (SD) 90-day methadone dose (83.1 [25.1] mg for group TAU, 79.4 [19.6] mg for group C-OLP; t = 0.621991; P = .43), but the groups differed significantly in their retention rates: 33 (61.1%) for TAU and 60 (77.9%) for C-OLP (χ21 = 4.356; P = .04; number needed to treat for the beneficial outcome of 3-month treatment retention, 6; 95% CI, 4-119). C-OLP participants also reported significantly better sleep quality. In this randomized clinical trial, C-OLP had no effect on the primary outcome of 90-day methadone dose. However, C-OLP participants were significantly more likely to remain in treatment. These findings support the use of C-OLP as a methadone treatment adjunct, but larger trials are needed to further examine the use of C-OLP. ClinicalTrials.gov Identifier: NCT02941809.

Effectiveness of TECAR Therapy on Clinical Symptoms and Neurophysiological Parameters of Patients with Carpal Tunnel Syndrome: A Randomized Clinical Trial

Background: Carpal tunnel syndrome (CTS) is the most typical peripheral entrapment neuropathy. To date, various non-invasive methods have been used to manage CTS. This study investigates the effectiveness of Transfer Energy Capacitive and Resistive (TECAR), a new physical agent modality, on symptoms and neurophysiological parameters in patients with CTS. Methods: In this single-blind randomized clinical trial, 29 patients with mild or moderate CTS were randomly assigned to two groups. Group 1 received TECAR therapy with a frequency of 500 Hz and an intensity of 30 to 50%, 2 sessions/week, in addition to wrist splints and vitamin B supplements for 4 weeks. Group 2 also received a wrist splint and vitamin B for 4 weeks without TECAR therapy. The Visual Analog Scale (VAS), Boston Carpal Tunnel Questionnaire (BCTQ-SSS and FSS), as well as clinical and neurophysiological findings, were assessed before and 8 weeks after treatment. Within and between-group comparisons were made after the intervention period. Results: VAS and the Boston Carpal Tunnel Questionnaire (FSS and SSS) showed significant changes. Clinical CTS tests and electrophysiological parameters did not show significant differences before and after the study. From a clinical perspective (pain relief and functional improvement), the TECAR therapy group showed more definite changes. Conclusions: TECAR can be considered an effective non-invasive treatment for patients with mild to moderate CTS.

Effects of backward walking exercise using lower body positive pressure treadmill on knee symptoms and physical function in individuals with knee osteoarthritis: a protocol for RCT

ObjectivesThe primary aim is to compare the effects of backward walking exercise to forward walking exercise on knee pain, knee functions, and thigh muscle strength in individuals with mild to moderate knee osteoarthritis using lower body positive pressure, in addition to mobility functions, balance, and self-reported health status.MethodsThe study is a single blind randomized clinical trial with two independent groups. This study will enroll 26 participants with mild to moderate knee osteoarthritis. The participants will be randomized into either experimental group (backward walking exercise) or control group (forward walking exercise). Both groups will use lower body positive pressure treadmill for walking exercise. Both groups will perform regular conventional exercise and worm-up exercise before walking exercise. The treatment will be three times a week for six weeks. Walking session will be up to 30 min each session. Data collection will be collected during pre- and post- intervention including primary outcomes including numeric pain rating scale (NPRS), knee injury and osteoarthritis outcome score (KOOS), and thigh muscle strength test. The secondary outcomes include five times sit to stand test (FTSTS), 3-meter backward walk test (3MBWT), timed up and go test (TUG), four square step test (FSST), functional reach test (FRT), 10-meter walk test (10-MWT), six minute walk test (6MWT), medical outcomes study short form 12 (SF-12), patient health questionnaire -9 (PHQ-9), and rapid assessment of physical activity (RAPA). An independent t-test will be used to evaluate the effect of treatment on the outcome measures.ResultsNot applicable.ConclusionUsing lower body positive pressure may have promising results against knee osteoarthritis. Moreover, walking backward exercise using lower body positive pressure might add more benefits to individuals with knee osteoarthritis and help clinicians in decision making.Trial registration: This study was registered in ClinicalTrails.gov (ID: NCT05585099).

Effects of spinal manipulation or mobilization as an adjunct to neurodynamic mobilization for lumbar disc herniation with radiculopathy: a randomized clinical trial

ABSTRACT Objectives To determine the long-term clinical effects of spinal manipulative therapy (SMT) or mobilization (MOB) as an adjunct to neurodynamic mobilization (NM) in the management of individuals with Lumbar Disc Herniation with Radiculopathy (DHR). Design Parallel group, single-blind randomized clinical trial. Setting The study was conducted in a governmental tertiary hospital. Participants Forty (40) participants diagnosed as having a chronic DHR (≥3 months) were randomly allocated into two groups with 20 participants each in the SMT and MOB groups. Interventions Participants in the SMT group received high-velocity, low-amplitude manipulation, while those in the MOB group received Mulligans’ spinal mobilization with leg movement. Each treatment group also received NM as a co-intervention, administered immediately after the SMT and MOB treatment sessions. Each group received treatment twice a week for 12 weeks. Outcome Measures The following outcomes were measured at baseline, 6, 12, 26, and 52 weeks post-randomization; back pain, leg pain, activity limitation, sciatica bothersomeness, sciatica frequency, functional mobility, quality of life, and global effect. The primary outcomes were pain and activity limitation at 12 weeks post-randomization. Results The results indicate that the MOB group improved significantly better than the SMT group in all outcomes (p < 0.05), and at all timelines (6, 12, 26, and 52 weeks post-randomization), except for sensory deficit at 52 weeks, and reflex and motor deficits at 12 and 52 weeks. These improvements were also clinically meaningful for neurodynamic testing and sensory deficits at 12 weeks, back pain intensity at 6 weeks, and for activity limitation, functional mobility, and quality of life outcomes at 6, 12, 26, and 52 weeks of follow-ups. The risk of being improved at 12 weeks post-randomization was 40% lower (RR = 0.6, CI = 0.4 to 0.9, p = 0.007) in the SMT group compared to the MOB group. Conclusion This study found that individuals with DHR demonstrated better improvements when treated with MOB plus NM than when treated with SMT plus NM. These improvements were also clinically meaningful for activity limitation, functional mobility, and quality of life outcomes at long-term follow-up. Trial Registration Pan-African Clinical Trial Registry: PACTR201812840142310.

Comparison of the Dexmedetomidine and Sufentanil Added to Spinal Anesthesia with Bupivacaine for Hemodynamic Stability and Postoperative Analgesia in Elective Cesarean Section Surgery: A Single-Blinded Randomized Clinical Trial

Background: Hemodynamic instability, including hypotension and bradycardia, can occur due to spinal anesthesia by bupivacaine. However, it is possible to reduce the chance of hemodynamic changes by the reduction of the dose of bupivacaine and/or the addition of adjunctive agents. Objective: This study aimed to compare the effects of the addition of intrathecal dexmedetomidine and sufentanil to spinal anesthesia with bupivacaine in elective cesarean section (CS). Methods: This prospective single-blinded randomized clinical trial with parallel groups was performed on 60 pregnant women who were candidates for elective CS in Imam Reza Hospital in Kermanshah, Iran. In addition to receiving 10 mg of hyperbaric bupivacaine 0.5%, they were randomly divided into two groups to receive intrathecal sufentanil 5 μg (30 cases) or dexmedetomidine 5 μg (30 cases). Changes in blood pressure, heart rate, and occurrence of side effects (e.g., nausea, vomiting, headache, and shivering) were recorded within 1 h after the injections. Moreover, the postoperative analgesia rate and duration (using a visual analog scale [VAS]) were recorded within the first 24 h after the completion of the CS. Headache severity (using a VAS) was also measured during the first week after CS. Results: Patients declared their satisfaction with analgesia after surgery. No significant difference was found between the two groups in terms of heart rate and systolic and diastolic blood pressure changes during the first 60 min. Similarly, no significant difference was observed between the two groups in terms of the severity of incision pain in the first 24 h after CS surgery. On days 3, 4, and 5, none of the patients in the sufentanil and bupivacaine group had headaches (VAS=0), but patients in the dexmedetomidine and bupivacaine group had some degree of headache (P=0.040). Conclusions: Based on the results, intrathecal administration of bupivacaine with either sufentanil or dexmedetomidine in CS did not have significantly different effects, except for slightly more severe headaches in the dexmedetomidine group. Therefore, no superiority of one drug over the other was observed for intrathecal administration with bupivacaine in CS.

Does a New Modification of the Two-Step Injection Technique for Inferior Alveolar Nerve Block Reduce Pain Compared to the Conventional Technique? A Randomized Clinical Trial.

The ability to control pain is an essential part of dental procedures and the need for optimal pain control and reduction of discomfort is the primary concern of every dentist. This study aims to compare the pain and vital signs during inferior alveolar nerve block between conventional and a new modification of the two-step injection techniques. In this institutional single-blind randomized clinical trial, attendees of dental school at Mazandaran University of Medical Sciences from February to May 2022 were included. Inclusion criteria were 20-60 years old and healthy (ASA1) individuals who were willing to participate in this study. Individuals who were taking medications affecting their understanding of pain and patients with active infections at the injection site were excluded. These individuals were divided into two groups. First, superficial anesthesia was performed and afterward, conventional and two-step injection techniques were performed. For the two-step injection method, 6 mm of the needle was injected into the mucosa and one-third of the local anesthetic solution was released from the computer-controlled injection toolkit. Afterward, a 25 mm 30-gauge needle was reinserted into the previous hole delivering the remaining local anesthetic. The pain during injection was measured by a patient-reported numerical rating scale (NRS). Moreover, vital signs were monitored immediately before and after the injection. Kolmogorov-Smirnov test, Mann-Whitney U test, independent T-test, and Fisher's exact χ 2 test were performed for statistical analysis (α = 0.05). This study involved 32 adults aged between 20 and 50 years old with 1 : 1 female/male sex distribution. The pain score was significantly higher in the conventional injection technique compared to the two-step injection technique in all sex and age groups. There were no significant differences in vital signs between the conventional and two-step injection techniques. There was no significant difference in the mean pain scores of females and males, regardless of their injection techniques. Utilizing the two-step injection technique in patients for inferior alveolar block reduces pain during injection without altering patients' vital signs significantly. This trial is registered with IRCT20220106053646N1.

Relationship Between the Underlying Factors and the Treatment Results of Platelet-Rich Plasma (PRP) Injection in Degenerative Knee Disease; A Blinded Randomized Study

Background: To investigate the therapeutic effects of PRP injection + conservative treatment as the intervention group versus normal saline injection + conservative treatment as the control group. Objectives: This study we determined the effects of underlying factors, including age, gender, and body mass index (BMI), on the therapeutic effects of PRP. Methods: In this single-blinded randomized clinical trial, 60 patients with grade 2 knee OA with an age of 40 - 65 years were enrolled. In the intervention group, leukocyte-poor PRP with double spinning, and in the control group, normal saline was injected with a similar protocol. All patients in both groups were also provided with a conservative protocol, including oral celecoxib 100 mg BID for four weeks, modifying physical activity, and 15 sessions of physiotherapy. Results: Demographic characteristics (age, gender, and BMI) and pre-treatment scores were similar between the two groups (all P &gt; 0.05). The WOMAC score was improved from pre-treatment to first week post-treatment in both groups (from 54.89 ± 3.4 to 64.9 ± 3.7 in the intervention group and from 53.7 ± 3.1 to 63.8 ± 3.9 in the control group). It means that PRP + conservative treatment was effective, similar to normal saline + conservative treatment. After adjusting BMI as an underlying variable, it was indicated that in the patients with lower BMI, PRP + conservative provided a better outcome in comparison to saline + conservative treatment (P = 0.014 and P = 0.019, respectively). Also, the comparison of functional scores changes with age as an underlying variable, demonstrating that younger cases obtained a better response from PRP + conservative rather than normal saline + conservative (P = 0.012 and P = 0.007, respectively). Conclusions: PRP seems to be an appropriate choice for treatment of moderate osteoarthritis, especially in younger patients and those with lower BMI.

The Effects of Tracheal Suction with N-acetylcysteine on Incidence of Ventilator-associated Pneumonia

Background: Correct endotracheal tube suction is one of the effective methods to prevent ventilator-associated infection. Many studies have reported that normal saline and N-acetylcysteine (NAC) in the trachea lead the translocation of bacteria to lower levels and increase the risk of pneumonia. Objectives: The present study sought to examine the effect of tracheal suction with NAC on the incidence of ventilator-associated pneumonia (VAP). Methods: This single-blind randomized clinical trial study was conducted on 60 patients admitted to the intensive care unit (ICU) of the Khatam Al-Anbia Hospital in Zahedan, Iran, in 2020. The patients were selected using the convenience sampling method and assigned into two intervention and control groups by permutation block randomization. Before the intervention, the patients were evaluated using the Modified Clinical Pulmonary Infection Score (MCPIS), and the patients with scores &lt; 5 on this scale were included in the study. Suctioning tracheal secretions in the intervention group was performed by pouring 2 cc of NAC into the tracheal tube during suction. The same suction procedure was performed for the patients in the control group by pouring 2 cc of normal saline into the tracheal tube in a standard way. The intervention was conducted for five days. After the intervention, the MCPIS scale was administered once more for the two groups. The collected data were analyzed using the independent samples t-test and chi-square test with SPSS software (version 25). Results: The independent samples t-test showed no significant difference between the intervention and control groups regarding the incidence of pneumonia (P = 0.31). Conclusions: Despite the effect of NAC on the incidence rate of pneumonia in patients under mechanical ventilation, there was no significant difference between NAC and normal saline in reducing the incidence of pneumonia. However, since NAC leads to no specific complication in patients, it can be safely used in the suction of tracheal lobule secretions in patients under ventilators. In this regard, further studies should examine the use of NAC for suctioning during tracheal tube obstruction by secretions.

Aerobic exercise improves central blood pressure and blood pressure variability among patients with resistant hypertension: results of the EnRicH trial.

Central blood pressure (BP) and BP variability are associated with cardiovascular disease risk. However, the influence of exercise on these hemodynamic parameters is unknown among patients with resistant hypertension. The EnRicH (The Exercise Training in the Treatment of Resistant Hypertension) was a prospective, single-blinded randomized clinical trial (NCT03090529). Sixty patients were randomized to a 12-week aerobic exercise program or usual care. The outcome measures include central BP, BP variability, heart rate variability, carotid-femoral pulse wave velocity, and circulating cardiovascular disease risk biomarkers including high-sensitivity C-reactive protein, angiotensin II, superoxide dismutase, interferon gamma, nitric oxide, and endothelial progenitor cells. Central systolic BP decreased by 12.22 mm Hg (95% CI, -1.88 to -22.57, P = 0.022) as did BP variability by 2.85 mm Hg (95% CI, -4.91 to -0.78, P = 0.008), in the exercise (n = 26) compared to the control group (n = 27). Interferon gamma -4.3 pg/mL (95%CI, -7.1 to -1.5, P = 0.003), angiotensin II -157.0 pg/mL (95%CI, -288.1 to -25.9, P = 0.020), and superoxide dismutase 0.4 pg/mL (95%CI, 0.1-0.6, P = 0.009) improved in the exercise compared to the control group. Carotid-femoral pulse wave velocity, heart rate variability, high-sensitivity C-reactive protein, nitric oxide, and endothelial progenitor cells were not different between groups (P > 0.05). In conclusion, a 12-week exercise training program improved central BP and BP variability, and cardiovascular disease risk biomarkers in patients with resistant hypertension. These markers are clinically relevant as they are associated with target organ damage and increased cardiovascular disease risk and mortality.