Comparison the effect of lateral wedge insole and acupuncture in medial compartment knee osteoarthritis: A randomized controlled trial

BackgroundThere is lack of well-designed trials evaluating structural benefits of non-pharmacologic therapies in knee osteoarthritis (OA). In this parallel-group randomized controlled trial, we aim to compare the possible advantages of lateral wedge insole and acupuncture in patients with medial knee OA.MethodPatients with grade two or three of medial knee OA were randomly allocated to group one who received an in shoe lateral wedge and group two who underwent acupuncture. We assessed patients' pain, function and knee joint cartilage thickness before and after intervention. Paired t-test and independent samples t-test were used for in group and between group analyses. (Level of evidence: 2.)ResultsTwenty patients in each group were recruited in the study. Pain significantly decreased after therapy in both groups one and two (paired t test, P < 0.001, 95% CI: 1.62–3.25 and 1.58–3.20 respectively). Function improved in each group (paired t test, P = 0.001, 95% CI of 0.94–2.38 in group one and 0.97–2.43 in group two). A non-clinically statistically significant difference regarding the femoral and tibial cartilage thickness was obtained in both groups one (P = 0.005, CI: − 0.43–0.82 and P = 0.037, CI: − 0.44–0.80 respectively) and two (P = 0.025, CI: − 0.45–0.79 and P = 0.035, CI: − 0.29–0.96 respectively). Between groups analysis showed no significant difference regarding abovementioned measures.ConclusionBoth lateral wedge insole and acupuncture can be effective in the treatment of medial knee osteoarthritis without any superiority of one over the other.Iranian Registry of Clinical Trials: IRCT201201108235N1.URL: http://irct.ir/searchen.php     

电针结合雷火灸治疗寒湿型膝骨性关节炎的临床随机对照试验

文题释义：膝骨性关节炎：又称为膝关节增生性关节炎、退行性膝关节炎,是中老年人常见的一种慢性骨关节病,主要病理特点为关节软骨退变、破坏、软骨下骨硬化、关节边缘软骨下骨增生,进而引起滑膜炎症、半月板损伤、游离体形成及关节外组织炎症等一系列病变,临床症状以膝关节的疼痛、肿胀、变形及活动受限为主。白细胞介素6：是由CD4⁺T细胞、巨噬细胞等多种细胞产生的促炎性细胞因子,它能够对多种细胞产生促炎作用,在正常健康人群的血浆中其表达水平较低,在手术、炎症、感染等情况时其表达水平会显著上升。背景：雷火灸疗法及电针疗法均能有效改善膝骨性关节炎的相关症状,同时两种疗法兼具操作简单、廉价、实用性强等优点。目的：观察电针结合雷火灸与塞来昔布胶囊治疗寒湿型膝骨性关节炎的疗效差异。方法：选择2017年6月至2018年12月在广西中医药大学附属瑞康医院就诊的寒湿型膝骨性关节炎患者72例,其中男35例,女37例,采用随机数字表法分为2组：观察组(n=35)进行雷火灸(1次/d)结合电针治疗(1次/d),对照组(n=37)口服塞来昔布胶囊(1次/d),每个疗程14 d,两组均治疗2个疗程,疗程之间休息2 d。治疗前与治疗结束后进行目测类比评分、WOMAC评分、关节液相关炎性指标检测,并评估中医证候疗效有效率,并在治疗结束后进行1个月的随访。试验获得广西中医药大学附属瑞康医院伦理委员会批准,伦理批件号：KY2017-005。结果与结论：①两组试验过程中无严重不良反应发生;②观察组治疗结束后及随访1个月的目测类比评分、WOMAC评分(疼痛、僵硬、功能3项目评分)均较治疗前明显降低(P < 0.05);对照组治疗结束后及随访1个月的目测类比评分、WOMAC评分(疼痛、功能2项目评分)均较治疗前明显降低(P < 0.05);观察组治疗结束后及随访1个月的目测类比评分、WOMAC评分(疼痛、僵硬、功能3项目评分)均低于对照组(P < 0.05);③两组治疗结束后的白细胞介素6、肿瘤坏死因子α水平均较治疗前明显降低(P < 0.05),并且观察组两指标水平低于对照组(P < 0.05);④观察组的治疗总有效率高于对照组(97.1%,81.1%,P < 0.05);⑤结果表明,电针结合雷火灸治疗寒湿型膝骨性关节炎的临床效果明显且不良反应少,其与塞来昔布胶囊相比在疗效持久性方面更具优势。ORCID: 0000-0002-7859-7850(邓凯烽)中国组织工程研究杂志出版内容重点：组织构建;骨细胞;软骨细胞;细胞培养;成纤维细胞;血管内皮细胞;骨质疏松;组织工程     

Proximal fibular osteotomy for the management of medial compartment knee osteoarthritis: A systematic review and meta-analysis

BackgroundThe promising prospects of proximal fibular osteotomy (PFO) as an alternative treatment of knee osteoarthritis (KOA), which has gained popularity in recent years, has yet to be systematically evaluated. Hence, this meta-analysis aims to critically assess the clinical and radiological outcome of PFO in the management of medial compartment KOA.MethodsLiterature searches through PubMed, Scopus, CENTRAL, CINAHL, Google Scholar, and ProQuest databases were conducted, searching for eligible studies published from inception up to April 2020. Risk of bias assessments of randomized trials were performed via Cochrane RoB 2, while those of non-randomized studies with ROBINS-I tool. Random-effects model was utilized to estimate effect sizes.ResultsA total of 907 patients and 1012 knees were included in this meta-analysis. PFO successfully ameliorated patients’ knee function (Hedges’ g 1.90; 95% confidence interval (CI) 1.62–2.18; I² = 67%) and pain (visual analog scale: mean difference (MD) −4.13; 95% CI: −5.29 to −2.97), and also resulted in minimal complication rates, with peroneal nerve paresthesia being the most prevalent adverse event (5.93%; 95% CI: 2.15–11.25%), followed by peroneal nerve palsy (2.25%; 95% CI: 0.14–6.14%), fracture (0.56%; 95% CI: 0–1.74%), and recurrent deformity (0.54%; 95% CI: 0–1.74%). Furthermore, PFO was also associated with improved medial/lateral joint space ratio (MD 0.17; 95% CI: 0.15–0.19).ConclusionPFO yielded promising prospects in the management of medial compartment KOA, as shown by substantial improvements in clinical and radiological outcomes. However, considering the low quality of evidence, further studies with more diverse populations and higher quality of body evidence are required to confirm these findings.     

Effect of functional weightbearing versus non-weightbearing quadriceps strengthening exercise on contact force in varus-malaligned medial knee osteoarthritis: A secondary analysis of a randomized controlled trial

BackgroundKnee osteoarthritis progression may be related to altered knee loads, particularly in those with varus malalignment. Using randomized controlled trial data, this secondary analysis of complete datasets (n = 67) compared the effects of a functional weightbearing (WB) and non-weightbearing quadriceps strengthening exercise (NWB) program on measures of medial tibiofemoral joint contact force (MTCF) during walking.MethodsParticipants aged ≥50 years and with medial knee osteoarthritis and varus malalignment were randomly allocated to a 12-week, home-based, physiotherapist-prescribed exercise program comprised of WB exercises (n = 31), or NWB exercise (n = 36). Three-dimensional lower-body motion, ground reaction forces, and surface electromyograms from six lower-limb muscles were acquired during walking at baseline and at 12-weeks follow-up. An electromyogram-informed neuromusculoskeletal model estimated bodyweight (BW) normalized MTCF (peak and impulse), including external and muscular contributions to MTCF.ResultsThere was no between-group difference in the change in peak MTCF (−0.02 [−0.12, 0.09] BW) or MTCF impulse (−0.01 [−0.06, 0.03] BW·s). There was a between-group difference in the muscle contribution to peak MTCF (−0.08 [−0.15, −0.00] BW) and MTCF impulse (−0.04 [−0.08, −0.00] BW·s), whereby the muscle contribution reduced more in the NWB group over time compared to the WB group. There was also a between group-difference in the external contribution to peak MTCF (0.09 [0.01, 0.18] BW), but this reduced more in the WB group than in the NWB group.ConclusionsOur findings suggest no difference in MTCF between the two exercise programs, but differences in the contribution to MTCF between the two exercise programs were observed in those with medial knee osteoarthritis and varus malalignment.     

Pneumonia in multiple injured patients: a prospective controlled trial on early prediction using clinical and immunological parameters

OBJECTIVE AND DESIGN: In a prospective trial 266 multiple injured patients were included to evaluate clinical risk factors and immune parameters related to pneumonia. METHODS: Clinical and humoral parameters were assessed and multivariate analysis performed. RESULTS: The multivariate analysis (odds ratio with 95% confidence interval (CI)) revealed male gender (3.65), traumatic brain injury (TBI) (2.52), thorax trauma (AIS(thorax) > or = 3) (2.05), antibiotic prophylaxis (1.30), injury severity score (ISS) (1.03 per ISS point) and the age (1.02 per year) as risk factors for pneumonia. The main pathogens were Acinetobacter Baumannii (40%) and Staphylococcus aureus (25%). A tendency towards higher Procalcitonin (PCT) and Interleukin (IL)-6 levels two days after trauma was observed for pneumonia patients. CONCLUSION: The immune parameters (PCT, IL-6, IL-10, soluble tumor necrosis factor p-55 and p-75) could not confirm the diagnosis of pneumonia earlier than the clinical parameters.     

Long-term management of duodenal ulcer with pirenzepine and cimetidine: a double-blind controlled clinical trial

The effectiveness of pirenzepine in the prevention of duodenal ulcer relapses was assessed by means of a double-blind controlled trial versus cimetidine. Seventy duodenal ulcer out-patients endoscopically healed after a 6-week treatment with either pirenzepine or cimetidine were admitted to the trial. The former pirenzepine patients were treated again with pirenzepine: 1 tablet at breakfast and 2 tablets at bedtime (75 mg daily). The former cimetidine patients were treated again with cimetidine: 2 tablets at bedtime (400 mg daily). They received one placebo tablet at breakfast. Both treatments lasted 12 months. Tablets of a mild antacid were permitted only if necessary to relieve severe ulcer pain and heartburn. Patients underwent clinical and endoscopic assessments after 4, 8 and 12 months of treatment and whenever ulcer symptoms lasted more than 4-5 consecutive days. Only 47 out of the 70 patients that entered the trial underwent all clinical and endoscopic controls. Sixteen out of 23 patients on pirenzepine (70%) and 17 out of 24 patients on cimetidine (71%) did not relapse after 12 months. The difference is not statistically significant. Both treatments were well tolerated. The results show that pirenzepine was as effective as cimetidine in the prevention of duodenal ulcer relapses when administered at a dosage of 75 mg daily (of which 50 mg at bedtime) for one year.     

The effect of sodium meclofenamate in premenstrual asthma: A controlled clinical trial

We speculated that changes in endogenous prostaglandin synthesis might be responsible for the syndrome of premenstrual asthma (worsening of asthma in relation to menstruation). To test our hypothesis, we compared the effects of sodium meclofenamate, a prostaglandin synthesis inhibitor, and placebo on premenstrual asthma in a 4-month, double-blind, crossover study of 17 women with asthma. Day-by-day evaluation revealed that peak expiratory flow reached a nadir during menstruation on both meclofenamate and placebo therapy and varied inversely with menstrual symptoms and asthma symptoms. Meclofenamate therapy resulted in significant improvement in peak expiratory flow during the early premenstrual period but had no treatment effect on the exacerbation of asthma during the late premenstrual period and early menstruation. The overall improvement in pulmonary function caused by meclofenamate therapy was correlated with the treatment effect on menstrual symptoms. Meclofenamate caused a small, nonsignificant decrease in use of theophylline and oral beta-agonist agents, whereas corticosteroid use increased slightly but not significantly. This study demonstrates the temporal relationship between menstrual symptoms and asthma. The study also demonstrates that inhibition of prostaglandin synthesis does not prevent exacerbation of asthma in relation to menstruation.     

Efficacy of Hylan G-F 20 and Sodium Hyaluronate in the treatment of osteoarthritis of the knee -- a prospective randomized clinical trial

In this independent prospective randomized trial, we compared the clinical effectiveness, functional outcome and patient satisfaction following intra articular injection with two viscosupplementation agents - Hylan G-F-20 (n=199) and Sodium Hyaluronate (n=193) in patients with osteoarthritis (OA) of the knee. All patients were prospectively reviewed by blinded independent assessors at pre injection, 6 weeks, 3, 6, 12 months. Knee pain and patient satisfaction were measured on a visual analogue scale. Functional outcome was assessed using WOMAC, Oxford knee score and EuroQol EQ-5D scores. Knee pain on VAS improved from 6.7 to 3.2 by 6 weeks (p=0.02) and was sustained until 12 months (3.7, p=0.04) with Hylan G-F 20. In the Sodium Hyaluronate group, pain improved from 6.6 to 5.7 at 6 weeks (p>0.05) and to 4.1 at 3 months (p=0.04) but was sustained only until 6 months (5.9, p>0.05). Improvement in the WOMAC pain subscale was significantly superior in the Hylan G-F 20 group at 3 months (p=0.02), 6 months (p=0.01) and 12 months (p=0.007). There was no significant difference in the EQ-5D scores at 6 weeks and 3 months between the two groups. The numbers of treatment related adverse events were higher (39 vs. 30) in the Hylan G-F 20 group. One patient in the Hylan G-F 20 group who had a serious adverse event was also included in the final analysis. Although both treatments offered significant pain reduction, it was achieved earlier and sustained for a longer period with Hylan G-F 20. From this study, it appeared that the clinical effectiveness and general patient satisfaction are better amongst patients who received Hylan G-F 20.     

The SPIKES protocol does not influence the tolerance or effectiveness of intra-articular corticosteroid injection in the knees of osteoarthritis patients: A prospective,controlled, randomized single-blinded trial

BackgroundPatient user embracement involves behaviours of including and listening to the patient, appreciating their complaints, and identifying their needs, whether individual or collective. The aim of this study was to evaluate the influence of a user embracement protocol (SPIKES protocol) for patients with knee osteoarthritis (OA) immediately before intra-articular injection (IAI) relative to procedure tolerance and its effectiveness in the immediate, short and medium terms.MethodsThis was a randomized controlled trial. Patients received IAIs with triamcinolone hexacetonide (40 mg) preceded or not by the SPIKES protocol. The outcomes measured were: visual analogue scale for pain at rest, pain on movement and joint swelling; morning stiffness; Western Ontario McMaster Universities Index Functional Questionnaire (WOMAC); pain catastrophizing scale; McGill pain questionnaire; SF-36 questionnaire on quality of life; Trace State Anxiety Inventory (IDATE); and a Timed Up and Go functional test.ResultsOne hundred patients were randomized in the user embracement group (n = 50) or the control group (n = 50); 89% were women and 60% white, mean age was 67.1 (±7.3) years, and mean disease time was 6.3 (±6.2) years. No statistically significant differences were found between the groups for any variables at pre-procedure time, nor did the groups differ in their tolerance to the procedure or during the 12 weeks of follow up for any evaluated variables.ConclusionsNo benefit was identified by applying a user embracement protocol to patients with knee OA prior to IAI with corticosteroid, neither to tolerance at the time of the procedure nor to its effectiveness in the immediate, short, and medium terms.     

A controlled trial of real and simulated acupuncture in the management of chronic asthma

In 25 patients with moderate to severe asthma, we compared the therapeutic effectiveness of classic Chinese acupuncture with that of "placebo" acupuncture administered in a randomly ordered, subject- and evaluator-blind, crossover fashion twice weekly for 4 weeks. Real and placebo acupuncture periods were each preceded and followed by 3- to 4-week periods during which no acupuncture was administered. Outcome variables consisted of the following: daily symptoms and medication use self-scored on patient diaries, spirometry and whole body plethysmography performed once weekly during the entire course of the study and repeated serially during 3 hours after real and placebo acupuncture treatment, patients' self-assessment of acute efficacy of acupuncture therapy, and physician's physical findings before and after acupuncture treatment. Two-way analysis of variance failed to reveal a significant effect of either form of acupuncture on symptoms, medication use, or lung function measurements. Similarly, no significant acute effect of acupuncture on lung function, self-ratings of efficacy, or physician's physical findings was found by covariance analysis or the Wilcoxon signed-rank test. When data during the entire course of the study were examined on an individual basis by analysis of variance with repeated measures, only two subjects demonstrated significantly favorable responses to real versus placebo acupuncture, but one subject demonstrated the reverse, suggesting that these responses were not specifically related to acupuncture therapy. Thus, our findings failed to demonstrate any short- or long-term benefit of acupuncture therapy in the management of moderate to severe asthma.     

Medical and surgical management of reflux esophagitis. A 38-month report of a prospective clinical trial.

We compared the surgical and medical managements of reflux esophagitis in a prospective managements of reflux esophagitis in a prospective clinical trial. Patients wissigned to surgical (15 patients) and medical (16 patients) groups. A non-randomized medical group (20 patients) was also studied. Seventy three per cent of the surgical and 19 per cent of the medical group had an excellent to good response. A fair to poor response was observed in 81 per cent of medical and 27 per cent of surgical patients. Symptomatic improvement was accompanied by normal findings on acid infusion test and esophagoscopy. The histologic appearance of the squamous mucosa, however, remained abnormal in all but one patient. In patients who did well after operation there was improvement in resting lower-esophageal-sphincter pressures and absence of gastroesophageal reflux. The relative increases in pphincter pressure to graded increases in gastric pressure, however, remained abnormal in all but one patient.     

Comparison of local infiltration analgesia and interscalene block for postoperative pain management in shoulder arthroscopy: a prospective randomized controlled trial

Background/aimThe aim of this study was to compare the effects of local infiltration analgesia and interscalene brachial plexus block techniques on postoperative pain control and shoulder functional scores in patients undergoing arthroscopic rotator cuff repair.Materials and methodsSixty patients who underwent arthroscopic rotator cuff repair were prospectively included in the study. Patients were randomly divided into two groups. Group 1 was comprised of patients who had interscalene brachial plexus block, while group 2 was comprised of patients who had local infiltration analgesia. In group 1, interscalene block was applied with 20 mL 0.5% bupivacaine. In group 2, the Ranawat cocktail was used for local infiltration analgesia. Sixty milliliters of Ranawat cocktail was applied to the subacromial space and glenohumeral joint in equal amounts. Postoperative pain was assessed by the VAS score. Functional scores of the shoulder were also evaluated by Constant–Murley and UCLA scores. The time of first analgesic requirement and total analgesic consumption in the postoperative period were assessed. ResultsThe first analgesic requirement was significantly late in the interscalene brachial plexus block group (p = 0.000). There was no statistically significant difference between the groups in terms of total analgesic consumption (p = 0.204). In the postoperative 6th h, the VAS score was 2.43 in the interscalene brachial plexus block group, whereas 2.86 in the local infiltration analgesia group (p = 0.323). There was no statistically significant difference between the groups in terms of Constant–Murley shoulder and UCLA scores in the 3rd postoperative month (respectively, p = 0.929, p = 0.671). Besides, postoperative VAS scores and functional scores were negatively correlated (p < 0.01). Conclusion Local infiltration analgesia is an effective alternative to interscalene brachial plexus block for postoperative pain management and total analgesic consumption in arthroscopic rotator cuff repair. However, the interscalene brachial plexus block provides a longer postoperative painless period.     

Hyperproteic hypocaloric enteral nutrition in the critically ill patient: A randomized controlled clinical trial

Introduction:

Our aim was to evaluate the impact of hyperproteic hypocaloric enteral feeding on clinical outcomes in critically ill patients, particularly on severity of organic failure measured with the Sequential Organ Failure Assessment (SOFA).

Materials and Methods:

In a double blind clinical trial, 80 critically ill adult patients were randomized to hyperproteic hypocaloric or to isocaloric enteral nutrition; all patients completed follow-up of at least 4 days. Prescribed caloric intake was: Hyperproteic hypocaloric enteral nutrition (15 kcal/kg with 1.7 g/kg of protein) or isocaloric enteral nutrition (25 kcal/kg with 20% of the calories as protein). The main outcome was the differences in delta SOFA at 48 h. Secondary outcomes were intensive care unit (ICU) length of stay, days on ventilator, hyperglycemic events, and insulin requirements.

Results:

There were no differences in SOFA score at baseline (7.5 (standard deviation (SD) 2.9) vs 6.7 (SD 2.5) P = 0.17). The total amount of calories delivered was similarly low in both groups (12 kcal/kg in intervention group vs 14 kcal/kg in controls), but proteic delivery was significantly different (1.4 vs 0.76 g/kg, respectively P ≤ 0.0001). The intervention group showed an improvement in SOFA score at 48 h (delta SOFA 1.7 (SD 1.9) vs 0.7 (SD 2.8) P = 0.04) and less hyperglycemic episodes per day (1.0 (SD 1.3) vs 1.7 (SD 2.5) P = 0.017).

Discussion:

Enteral hyperproteic hypocaloric nutrition therapy could be associated with a decrease in multiple organ failure measured with SOFA score. We also found decreased hyperglycemia and a trend towards less mechanical ventilation days and ICU length of stay.     

A prospective,randomized, controlled trial comparing highly purified hMG with recombinant FSH in women undergoing ICSI: ovarian response and clinical outcomes

BACKGROUND: To assess the clinical profile and efficacy in assisted reproductive treatment of a new human-derived highly purified (HP) menotropin, we compared HP hMG and recombinant (r) FSHalpha use in ICSI within a prospective, randomized, controlled study. METHODS: 100 infertile women were treated with HP hMG (50 patients) or rFSHalpha (50 patients). All patients received the same daily gonadotrophin dose (150 IU) following GnRH agonist suppression (long regimen) until more than three follicles >17 mm and estradiol (E(2)) levels >600 pg/ml were reached. Patients were monitored with daily LH, FSH, hCG, estradiol (E(2)), progesterone, and testosterone measurements; and alternate day pelvic ultrasound. RESULTS: Treatment duration (11.1 +/- 0.4 versus 12.9 +/- 0.5 days, P < 0.05) and gonadotrophin dose (22.4 +/- 1.0 versus 27.0 +/- 1.5 ampoules, P < 0.05) were lower in the HP hMG group. Conversely, peak pre-ovulatory E(2) (1342 +/- 127 versus 933 +/- 109 pg/ml, P < 0.005); and area under the curve of E(2) (3491 +/- 350 versus 2602 +/- 349 pg/ml.day, P < 0.05), immunoreactive serum FSH (65.9 +/- 2.1 versus 48.8 +/- 1.8 IU/l.day, P < 0.001). and hCG (1.7 +/- 0.3 versus 0.0 +/- 0.0 IU/l/day, P < 0.001) during treatment were higher in the HP hMG group. Cycle cancellation rates, transferred embryo number, pregnancy rates per started cycle (30 versus 28%) and per embryo transfer (35 versus 35%) and miscarriage rates (6 versus 6%) were not significantly different. CONCLUSIONS: HP hMG treatment was associated with: (i) a more efficient patient response, as reflected by reduced treatment duration and gonadotrophin requirements; (ii) increased serum levels of hCG, E(2), and immunoreactive FSH during treatment; (iii) an ICSI outcome indistinguishable from rFSHalpha.     

The clinical effectiveness of guided self-help versus waiting-list control in the management of anxiety and depression: a randomized controlled trial

BACKGROUND: There are significant barriers to accessing effective psychological therapy in primary care resulting from a lack of suitably trained therapists to meet current demand. More efficient service delivery using minimal interventions (such as bibliotherapy) provided by paraprofessional therapists may be one method of overcoming these problems, and is the subject of attention in the UK and elsewhere. A randomized trial was conducted to test the clinical effectiveness of this model. Assistant psychologists delivered a guided self-help intervention to patients with anxiety and depression who were currently waiting for psychological therapy. METHOD: A total of 114 patients were randomized either to guided self-help or a waiting-list control group. All patients were followed up 3 months later, prior to starting conventional psychological therapy. Measures included self-reported adherence to the intervention, anxiety and depressive symptoms, social functioning and patient satisfaction. RESULTS: Adherence to the guided self-help intervention was acceptable and patients reported satisfaction with the intervention. However, there were no statistically significant differences between groups in anxiety and depression symptoms at 3 months. CONCLUSIONS: The results demonstrate that this model of guided self-help did not provide additional benefit to patients on a waiting list for psychological therapy. The results are considered in the context of possible internal and external validity threats, and compared with previous trials of minimal interventions. The implications of the results for the design of future minimal interventions are considered.     

Femoral component rotations in different gap tensions in total knee arthroplasty: A prospective randomized controlled trial

Background

In total knee arthroplasty (TKA), femoral component rotation is an important factor in the flexion stability and biomechanics of the patellofemoral joint. However, it remains unclear how much tension is appropriate when performing TKA using the gap technique.