Self-controlled Clinical Trial Research Articles

Effect of minocycline on lumbar radicular pain: a prospective pilot study

Introduction: Pain is an unpleasant sensory and emotional experience. Evidence suggests a role for microglia in chronic pain and inhibition of microglia leads to decrease of chronic pain intensity in animal models. Minocycline, a semisynthetic tetracycline derivative, is a selective inhibitor of microglia. Several studies have shown pain intensity improvement by minocycline in animal model of pain, but a few studies showed effectiveness on chronic pain improvement in humans. This prospective, self-controlled clinical trial investigated whether minocycline is effective for chronic pain management. Methods: Twenty-two patients, between the ages of 20 and 80 years with radicular lumbar pain with a numerical rating scale >4, who were unresponsive to other medications and had pain duration of >6 weeks were included in the trial. Results: Pain intensity, neuropathic pain and life quality scores assessed before and after treatment. All scores showed significant improvement after 2 weeks of treatment: 56%, 74% and 14%, respectively. Conclusion: Findings of this study suggest minocycline can effectively improve patients’ pain scores and quality of life, even in those with long-term duration of chronic pain and warrants further study.

Treatment of Post-mastectomy Lymphedema with Herbal Medicine: An Innovative Pilot Study.

Background:Lymphedema of the arms or legs is a difficult clinical problem yet devoid of effective treatment. Lymphedema is the result of obstructed lymphatic flow secondary to chronic infection, parasitic infestation, or postsurgical obstruction (eg, after axillary dissections). We arranged this clinical trial to investigate whether patients with limb lymphedema can benefit from a standard dose of Astragalus plus Paeoniae rubra to improve the symptomatology, functional capacity, and quality of life (QOL).Method:The pilot study was designed as a self-control clinical trial. Patients with post-mastectomy lymphedema were recruited. A double-herb formulation (Astragalus, Paeoniae rubra) with standard dosage was administered orally in a powdered form, 6 times per week for 6 months. Outcome measurements included standard limb volume changes measured by water displacement method; handgrip strength; and QOL for limb lymphedema questionnaire (LYMQOL).Results:There were no reported adverse effects or complications; there were no episodes of infection during the period of study. There was a tendency of limb volume reduction by 6 months, which, however, did not reach statistical significance. There was a significant improvement in appearance and symptom scores as was assessed with the LYMQOL questionnaire.Conclusions:The oral herbal formula improved the symptomatology and QOL among the pilot group of patients with post-mastectomy lymphedema. Side effects were absent, and there was a trend of lymphedema reduction.

Effect Evaluation of Strychnos nux-vomica L. with Integrative Methods for Bortezomib-Induced Peripheral Neuropathy in Multiple Myeloma Patients: A Self-Controlled Clinical Trial

To explore the clinical effect and adverse reactions of Strychnos nux-vomica in bortezomib-induced peripheral neuropathy (BIPN) of patients with multiple myeloma (MM). A total of 19 MM patients with BIPN were enrolled and Nux Vomica Capsule (NVC, 0.4 g, thrice daily) were orally administrated for 30 days. Comparative analysis on parameters between pre- and post-therapy, including peripheral neuropathy (PN) grade, neurotoxicity score, Chinese medicine (CM) syndrome score, total neuropathy score (TNS), coagulation function, and serum nerve growth factor (NGF) levels were conducted. The adverse events were monitored. In BIPN of MM patients who received NVC, PN grade was lowered, neurotoxicity score was obviously decreased (P⩽0.01), and both CM syndrome score and TNS were remarkably decreased (P<0.01). After the therapy, activated partial thromboplastin time was prolonged (P<0.01) and fibrinogen was declined (P<0.05), showing improvement in the hypercoagulable state of patients. No significant difference of NGF recovery degrees was detected between pre- and post-therapy (P>0.05). No evident adverse reactions were observed during the course of treatment. Strychnos nux-vomica L. has significantly effect with a good safety in treatment of BIPN in MM patients.

The Effectiveness of Waist-Shaped and Straight-Shaped Interdental Brushes in Cleaning Implant Overdenture Attachments: A Self-Controlled Clinical Trial.

Elderly patients often find it challenging to remove plaque accumulated on the attachments of implant overdentures (IODs) using conventional cleaning instruments. Further, excessive plaque accumulation can lead to peri-implant diseases and occasionally to respiratory diseases. Therefore, here, we aimed to compare the effectiveness of waist-shaped interdental brushes (WIBs) with that of straight-shaped interdental brushes (SIBs) in plaque removal from the locator attachments of IODs. Twenty participants with 2 locator attachments retaining mandibular IODs participated in this study. After the baseline cleaning, the participants refrained from oral hygiene maintenance for 3 days. A dentist cleaned 1 of the attachments using the WIB and the other attachment using the SIB. The pre- and post-cleaning modified plaque index (mPLI) scores were recorded. After another 3 days free from oral hygiene maintenance, the trained participants repeated the same cleaning procedure using the WIB and SIB. Pre- and post-cleaning mPLI scores were recorded. Regardless of the type of brush used, the post-cleaning mPLI scores were lower than the pre-cleaning scores. After the cleaning procedure, the overall mean mPLI score was lower in the WIB group than in the SIB group. The post-cleaning mPLI scores at the line angles and on the axial surfaces of the attachments were also lower in the WIB group than in the SIB group. There was no difference in the cleaning effectiveness between the dentist and participants when they used the same type of interdental brush. The WIB was significantly more efficient in plaque removal than the SIB, especially at the line-angle sites.

Clinical study of cell sheets containing allogeneic keratinocytes and fibroblasts for the treatment of partial-thickness burn wounds

Objective: To evaluate the efficacy and safety of cell sheets containing allogeneic keratinocytes and fibroblasts in the treatment of partial-thickness burn wounds. Methods: The cell sheets containing allogeneic keratinocytes and fibroblasts were constructed using polyurethane biofilm as carrier. Then gross observation and histological observation were conducted. From April 2016 to December 2017, Changhai Hospital of Naval Medical University recruited patients with acute partial-thickness burn wounds that met the inclusion criteria for this prospective and positively self-controlled clinical trial. Recruitment of 40 acute partial-thickness burn wounds were planned with each selected single wound being not smaller than 10 cm×10 cm and not more than 5% total body surface area (TBSA). Each wound was equally divided into two areas, which were recruited into cell sheet group and conventional treatment group according to the random number table. The wounds in cell sheet group were covered by cell sheet and then sterile gauze as secondary dressings. Depending on the wound healing and exudation, the sterile gauze was replaced every 1 to 3 day (s) after the treatment was started, and the cell sheet was replaced every 7 days (namely dressing changing). The wounds in conventional treatment group were covered by sulfadiazine silver cream gauze and then dressed with sterile gauze, with the dressings changed every 2 to 3 days depending on wound exudation. On treatment day 5, 7, 10, and 14, the wound healing rates in the two groups were calculated. The complete wound healing time, the total number of dressing changes, and the status of wound infection during treatment were recorded. The Visual Analogue Scale was used to score the pain at the first dressing change. Scar formation of patients was followed up for 6 to 12 months after injury. Safety indicators including vital signs, laboratory examination indexes, and adverse reactions during treatment were observed. Data were statistically analysed with Wilcoxon rank sum test and Bonferroni correction. Results: (1) Each prepared cell sheet had a diameter of about 8 cm and was about 49 cm(2) in size, containing 2 or 3 layers of keratinocytes and fibroblasts. (2) A total of 43 patients were enrolled, of whom 3 patients dropped out of the study. Of the 40 patients who completed the treatment, there were 22 males and 18 females who were aged 1 to 57 year (s), with total burn area of 2% to 26% TBSA. (3) On treatment day 5, 7, 10, and 14, the wound healing rates in cell sheet group were significantly higher than those in conventional treatment group (Z=4.205, 4.258, 3.495, 2.521, P<0.05 or P<0.01). The complete wound healing time in cell sheet group was 7 (6, 8) days, which was significantly shorter than 11 (7, 14) days in conventional treatment group (Z=4.219, P<0.01). The total number of wound dressing changes in cell sheet group was 1 (1, 2) times, which was significantly less than 6 (4, 7) times in conventional treatment group (Z=5.464, P<0.01). (4) The wounds in cell sheet group in 31 patients healed before the first dressing change. The pain score of wounds in the first dressing change in cell sheet group of 9 patients was 1 (0, 1) point, while the pain score of wounds in the first dressing change in conventional treatment group of 40 patients was 2 (1, 3) points. There was no obvious infection in the wounds in both groups of 40 patients before the wound healing. Nine patients completed the follow-up after the trial. In 6 patients, no scar formation was observed in cell sheet group or conventional treatment group. The color of wounds in cell sheet group was consistent with normal skin, and there was only a small amount of pigment deposition in the wounds of conventional treatment group. Three patients developed pigment deposition only in the wounds of cell sheet group but obvious scars in conventional treatment group. (5) The abnormal fluctuations of vital signs including body temperature, blood pressure, heart rate, respiratory rate, and laboratory examination indexes of all patients during treatment were alleviated through the process of burn wound healing. No obvious adverse reactions or abnormalities related to the treatment were observed. Conclusions: The cell sheet containing allogeneic keratinocytes and fibroblasts can reduce the number of dressing changes, accelerate wound epithelialization, shorten wound healing time, reduce pain during dressing change in the treatment of partial-thickness burn wounds, and it may reduce scar hyperplasia after wound healing because of accelerating wound epithelization. Its clinical application is simple, safe, and effective.

Acupuncture for Poststroke Dysphagia: A Pilot, Nonrandomized, Self-Controlled Trial.

Objective To evaluate the effectiveness and safety of acupuncture treatment for dysphagia as a complication of stroke. Methods and Design. This is a multicenter, pragmatic, nonrandomized, self-controlled clinical trial. A total of 39 patients were recruited from several Chinese medicine outpatient clinics and hospital-affiliated speech therapy outpatient clinics in Hong Kong. 26 patients completed all the 24 sessions of acupuncture treatment within two months, and only 12 of them were used as self-control. For the self-control group, the retrospective clinical data was taken from the electronic patient records with patient consent. The descriptive swallowing function data were converted into the quantitative Royal Brisbane Hospital Outcome Measure for Swallowing (RBHOMS) scores by two registered speech therapists through a validation process. And the data were validated by reaching consensus between the two speech therapists. All subjects underwent a baseline assessment before commencement of treatment, and outcome assessments were conducted upon the completion of treatment. The primary outcome measure is the RBHOMS score, which is a swallowing disability rating scale for monitoring difficulties in daily swallowing function. Secondary outcome measures include the Chinese version of the Swallow Quality-of-Life Questionnaire and adverse events. All the primary and secondary outcomes were assessed at baseline as well as at the end of acupuncture treatment (month 2). Results A total of 39 participants aged 46 to 89 years were enrolled in the study, and the male-to-female ratio was 15 : 11. The mean baseline RBHOMS score of all 39 participants was 5.92 ± 2.23. The mean retrospective RBHOMS score of the 12 subjects who were used as self-control was 5.67 ± 1.72 before enrollment, while the mean RBHOMS score of the 26 participants who completed all the 24 sessions of treatment was 6.92 ± 2.07. There were statistically significant differences between the RBHOMS score at the completion of treatment and baseline (p=0.006), and retrospective data (p=0.042). Moreover, a significant difference was also found in terms of swallow quality-of-life score before and after acupuncture treatment (p < 0.01). Conclusions This pilot study provides preliminary evidence for the effectiveness of acupuncture for poststroke dysphagia. The findings from this trial can be used as a foundation for future full-scale randomized controlled clinical trials to assess the efficacy and safety of acupuncture for poststroke dysphagia. Ethics and Dissemination. The ethical approval of the clinical research study was granted by the Research Ethics Committee of both New Territories East and West Cluster of Hong Kong. Written informed consent was obtained from all participants, and the study was undertaken according to the ICH-GCP Guidelines. Trial Registration. This trial is registered with ChiCTR-TRC-12002621 and the registration date is 2012-10-26.

Hyperelastic tape modifies the kinematics of the pronated foot in young women: self-controlled clinical trial

Abstract Introduction: Excessive pronation has been linked to increased risk of developing lower limb injuries. In this respect, assessing the effectiveness of therapeutic resources, such as hyperelastic taping, becomes relevant. Objective: evaluate the influence of adhesive hyperelastic taping on excessive pronation of the ankle-foot complex in young women. Method: Self-controlled clinical trial of ten women with excessive pronation (Foot Posture Index ≥ 6). Three-dimensional gait was assessed according to the Vicon Oxford Foot Model before and after taping. Hyperelastic tape was applied on the side with greater pronation (experimental side) and the opposite side was used as control (control side). The segments evaluated were the hindfoot, midfoot and forefoot. The Shapiro-Wilk normality, paired t and Wilcoxon tests were applied and Significance was set at p &lt;0.05. Results: No change (p&gt; 0.05) was observed in the hindfoot on the experimental or control side; the midfoot showed a decrease in arch height (p &lt;0.05) only on the experimental side; forefoot eversion (p &lt;0.05) declined only on the experimental side. Conclusion: The use of hyperelastic tape reduced forefoot eversion; however, this decrease is not clinically desirable, since excessive pronation in a closed chain increased in the sample of young women studied.

Effects of nicorandil infusion on ECG parameters in patients with unstable angina pectoris and percutaneous coronary intervention.

BackgroundPercutaneous coronary intervention (PCI) is effective in treating patients with acute coronary syndrome (ACS) but is associated with some serious complications. Nicorandil is an anti‐anginal agent acting to improve microvascular circulation and to increase coronary blood flow. The objective of this article is to evaluate the effects of intracoronary injection followed with continuous intravenous injection of nicorandil on ECG parameters in patients with unstable angina pectoris (UA) undergoing PCI.MethodsA single‐center, self‐controlled clinical trial was conducted at the Second Hospital of Tianjin Medical University between January 2019 and April 2019. Sixty‐three consecutive patients with UA who received coronary angiography and selective PCI were enrolled. ECG was recorded and analyzed before and 24 hr after nicorandil infusion.ResultsPatients were divided into three groups: control group (n = 23, aged 63.43 ± 12.55 years), short‐term, and prolonged use with nicorandil group (n = 20 and 20, aged 66.45 ± 8.06 years and 65.80 ± 9.49 years, respectively). Clinical characteristics and ECG parameters were similar before PCI among three groups (p > .05). In nicorandil treatment groups, intervals of QTd and Tp‐e in patients post‐PCI were significantly shorter than that in control and pre‐PCI (p < .05).ConclusionsNicorandil infusion reduces QTd and Tp‐e interval in patients with UA. Further studies will be needed to determine whether these electrophysiological changes are associated with a reduction of ventricular arrhythmias and improved outcomes.

Esthetic appearances of anatomic contour zirconia crowns made by additive wet deposition and subtractive dry milling: A self-controlled clinical trial

Statement of problemAnatomic contour zirconia crowns are widely used in clinical dental practice because of their mechanical reliability and improved appearance. However, few studies have performed clinical evaluations of the esthetics of these crowns in terms of color and translucency gradient. PurposeThe purpose of this clinical trial was to compare the esthetic effect and color-matching behaviors of anatomic contour zirconia crowns manufactured with 3-dimensional (3D) gel deposition and dry milling methods. Material and methodsTwenty-seven premolar teeth of 27 participants received 2 identical anatomic contour zirconia crowns fabricated by additive 3D gel deposition or dry milling. Color differences (ΔE) between the crown and natural control teeth were measured by a dental shade-matching device. Subjective color matching was rated by professionals using an extended visual rating scale for appearance match (EVRSAM) and by participants using a visual analog scale (VAS). Data were analyzed by using repeated measures ANOVA, the Bonferroni test, paired Student t test, Pearson chi-square test, and Wilcoxon test (α=.05). ResultsSignificant differences were found in ΔE between zirconia crown and core types (P<.05); however, there was no significant interaction between these factors (P>.05). The average ΔE of crowns made by wet deposition and dry milling were 2.45 ±1.60 and 4.55 ±1.54 (P<.05). The mean crown ΔE was significantly higher if a gold cast post-and-core was placed rather than a prefabricated fiber post and composite core (P<.05). Consistent with these findings, subjective color matching was significantly higher in the wet deposition group than in the dry milling group as rated by EVRSAM and VAS (P<.05). ConclusionsAnatomic contour zirconia crowns fabricated by additive wet deposition were better matched to adjacent teeth and had excellent esthetics in terms of color and translucency gradient.

Time efficiency and quality of outcomes in a model-free digital workflow using digital impression immediately after implant placement: A double-blind self-controlled clinical trial.

To assess the clinical and laboratory time efficiency and quality of outcomes for posterior single implant crowns by means of a model-free digital workflow using digital impressions immediately after implant placement. Forty patients missing a single posterior tooth received implant therapy. For within-subject comparison, digital impressions were taken immediately after implant placement and conventional impressions after implant healing. Two monolithic zirconia crowns were fabricated using a laboratory-based CAD-CAM system. One crown was produced from the immediate digital impression and a model-free digital workflow (test group), and the second crown was produced from the conventional impression and a hybrid workflow (control group). Clinical and laboratory time was recorded. Quality of outcomes was evaluated double-blinded. A paired-sample t test was applied for statistical analysis. The total mean chairside time (impression and delivery) was 23.2min (95%CI 22.2, 24.3) in the test group and 25.7min (95%CI 24.4, 26.9) in the control group (p=0.013). Significantly less laboratory time was needed in the model-free digital workflow (13.6min, 95%CI 11.5, 15.6) as compared to the model-based hybrid workflow (29.9min, 95%CI 25.7, 34.2) (p<0.05). At crown delivery, 4/40 (test) and 12/40 (control) had no need of chairside adjustments, and 6/40 (test) and 5/40 (control) implant crowns were in need of additional laboratory interventions. The fabrication of posterior single implant crowns using digital impressions taken immediately after implant placement and a model-free, laboratory-based digital workflow was more time efficient and resulted in similar quality of outcomes as a hybrid workflow using conventional impressions.

Boron-rich diet may regulate blood lipid profile and prevent obesity: A non-drug and self-controlled clinical trial

Background: Boron is an element commonly found in nature. The main boron source for organisms is through food and drinking water. In recent years, it is suggested that the “boron-rich diet” can affect human health positively. However, more detailed studies are needed.Objective: The aim of this study was to examine the effect of increased dietary boron intake on some biochemical parameters in humans.Material and methods: Thirteen healthy women consumed diets containing 10 mg more boron than their routine diet for one month. This boron intake was provided with the increase of boron-rich foods such as dried fruits, avocado, and nuts in the diet. Some biochemical and hematologic parameters were determined in blood, urine and saliva samples taken before and after a boron-rich diet.Results: Serum, salivary, and urine boron concentrations increased 1.3, 1.7, 6.0 fold, respectively. The most significant clinically change was found in the lipid profile. Serum total, LDL, VLDL cholesterol, and triglyceride levels decreased significantly. Body weight, body fat weight, and Body Mass Index also decreased. Significant changes in serum TSH and salivary buffering capacity were also found.Conclusion: Increasing the intake of boron through dietary means might contribute to beneficial effects on lipid metabolism, obesity, and thyroid metabolism; salivary boron may reflect serum boron; and boron may be used as a cariostatic agent in dentistry. An increased intake of other dietary factors such as fiber, potassium, iron, vitamin A, and vitamin E in the boron-rich foods might have been responsible of the effects described. To our knowledge, this study is the first clinical study in which dietary boron intake is increased via foods.

Minimally invasive approach for improving aesthetic in a patient with tetracycline-stained teeth by bleaching: A clinical evaluation

ObjectiveTo compare 16% carbamide peroxide (CP) with a higher concentration of hydrogen peroxide (HP) for bleaching teeth in office or at-home to erase tetracycline stains on teeth. Materials and methodsIn a randomized, self-controlled clinical trial, we assigned eligible subjects to group A with 40% HP compared with 16% CP or group B with 45% CP compared with 16% CP on the split maxillary arch and followed the manufacturers’ instructions. Tooth color changes were measured with vita 3D-bleached guide and colorimeter at baseline and three-time assessment. Tooth sensitive intensity was evaluated using numeric rating scales, and oral soft and hard tissue examination was recorded. Patient satisfaction survey was conducted at the last tooth color evaluation. ResultsThere were 20 subjects enrolled. The color changes by the end of the study were A1 (40% HP) = 8.22, A2 (16% CP) = 8.20, B1 (45% CP) = 11.27, B2 (16% CP) = 8.26 respectively. All groups experienced significant shade reductions by bleaching, the 45% CP group had significantly greatest color changes compared with the other groups (p = 0.03). For tooth sensitivity evaluation, significant differences were observed in 40% HP group (p = 0.01), but with mild level. None patients suffered oral soft or hard tissue abnormalities before and after treatment. Patients were more in favor of using 45% CP according to the questionnaire results. ConclusionThe 3 whitening agents were effective and safe for the whitening of tetracycline-stained teeth, the 45% CP agent had quicker whitening efficacy with low tooth sensitivity and positive feedback. Clinical significance45% of high-concentration CP whitener by at-home using, brought faster and superior efficacy to bleaching tetracycline-stained teeth while had the equal intensity of tooth sensitivity.

Clinical Efficiency and Patient Preference of Immediate Digital Impression after Implant Placement for Single Implant-Supported Crown.

To evaluate the time efficiency and patient preference of three impression techniques by comparing immediate digital impression performed directly after implantation with regular digital impression and conventional implant impression performed 3 months after implantation. Twenty consecutive patients with a missing single molar or premolar who received implant treatment were recruited into this prospective self-controlled clinical trial. Three different impression techniques were performed after implant surgery on all the participants: An intraoral scanning (IOS) impression performed immediately after implant placement (immediate digital impression) was compared with a regular digital impression and a classic polyether impression (conventional implant impression) performed 3 months after implant surgery. The operating time of each impression technique was recorded. Patients were asked to complete a visual analogue scale (VAS) questionnaire on their perception of the three techniques to describe their satisfaction and preference. Statistical analyses were performed with the Wilcoxon signed rank test. The clinical time of the immediate digital impression (10.97 ± 2.1 min) was significantly shorter than that of the conventional implant impression (14.45 ± 3.0 min) (P < 0.05). The mean time of the immediate digital impression (10.97 ± 2.1 min) was statistically the same as that of the regular digital impression (10.23 ± 2.7 min) (P > 0.05). Participants' subjective evaluation indicated higher satisfaction with the immediate digital impression than with the regular digital impression and the conventional implant impression. The immediate digital impression was more efficient than the conventional implant impression and had the same efficiency as the regular digital impression. Among the three impression techniques, the participants showed higher satisfaction with the immediate digital impression.

BIOLAP: biological versus synthetic mesh in laparo-endoscopic inguinal hernia repair: study protocol for a randomized, multicenter, self-controlled clinical trial

BackgroundInguinal hernia repair is one of the most common surgical operations globally; more than 20 million groin herniae are repaired annually worldwide. Recurrence after an inguinal hernia operation is a considerable clinical problem. Another remaining problem after hernia surgery is the occurrence of chronic pain. Up to now, the use of synthetic meshes is the standard procedure, but there is increasing evidence that biological meshes could be advantageous concerning the occurrence of chronic pain due to different postoperative remodeling, without the disadvantages of a life-long implant.We hypothesize that the use of a biological mesh reduces postoperative pain without being inferior in terms of recurrence rate compared with a synthetic mesh.Methods/designThe trial compares possible the advantages of biological matrices to synthetic meshes in laparo-endoscopic inguinal hernia repair. Four hundred and ninety-six patients with primary bilateral inguinal herniae in 20 German hernia centers will be enrolled. Biological mesh is used for one of the bilateral herniae, the other side will be operated on with a synthetic mesh. Randomization will preset which side is repaired with which material and trial participants will not be informed about the location of each mesh type. The primary endpoints will be intensity of postoperative local pain and the incidence of recurrent hernia after 2 years.DiscussionThere is no reasonably sized trial that assesses the use of biological meshes in laparo-endoscopic inguinal hernia repair.Our self-controlled trial design allows a direct comparison of the two meshes with very few confounding factors as well as minimizing the exclusion criteria. As we compare CE-certified medical devices in their designated indication the medical risk is not different compared to routine clinical care. Due to the common nature of bilateral inguinal hernia, a high recruitment rate is achievable. Because guidelines for hernia repair have stressed the need for reliable data on the already frequent use of biological meshes, we can expect our trial to have a direct implication on hernia-repair standards.Trial registrationGerman Clinical Trials Register, ID: DRKS00010178. Registered on 16.June.2016. BIOLAP underwent full external peer review as part of the funding process with the German Research Foundation.

Changes in insulin resistance and inflammatory factors in cataract patients with glaucoma after phacoemulsification and trabeculectomy: a self-controlled trial

Background and objective: Cataract with glaucoma can adversely affect visual acuity and corneal endothelial cells. Studies have shown that after phacoemulsification combined with trabeculectomy in patients with cataract and glaucoma, blood lipid ratio and insulin sensitivity are associated with intraocular pressure, visual acuity and corneal endothelial cells, which may be used for the evaluation of efficacy. Interleukins are the main mediators of the inflammatory response and are involved in the pathogenesis of cataract. In this trial, we will examine the postoperative changes in interleukin-10, interleukin-2 and interleukin-1β levels in patients with cataract with glaucoma, and analyze the correlation between insulin sensitivity and corneal endothelial cell density to assess whether inflammatory factors can be used to evaluate efficacy. Participants and methods: This prospective, single-center, open-label, self-controlled clinical trial will include 160 patients with cataract combined with glaucoma, 35–65 years of age, from the Department of Ophthalmology, First Affiliated Hospital of Kunming Medical University, China. All patients will receive phacoemulsification and trabeculectomy, and will be followed up at 5 days, and at 1 and 3 months. Patient recruitment will begin on December 30, 2019 and end on December 30, 2020. Analysis of the results will be performed from May 1, 2021 to May 30, 2021. This study is scheduled to end on June 30, 2021. This study was approved by the Medical Ethics Committee, First Affiliated Hospital of Kunming Medical University, China, on December 15, 2013 (approval No. 20131215085), and will be performed in accordance with the principles of the Declaration of Helsinki, adopted by the World Medical Association. Study protocol version is 1.0. Written informed consent to participate will be obtained from each participant. Results: The primary outcome measure will be serum interleukin-2 level, as an index of the inflammatory response, 3 months after surgery. Secondary outcome measures will include serum interleukin-2 level before and 5 days and 1 month after surgery, serum levels of interleukin-1β, interleukin-10, C-reactive protein and tumor necrosis factor-α, best corrected visual acuity, endothelial cell density, mean cell area, coefficient of variation, insulin sensitivity index and intraocular pressure before and 5 days and 1 and 3 months after surgery, and incidence of adverse reactions at 5 days and 1 and 3 months after surgery. From January 2014 to June 2017, our team undertook and completed a small-sample study of 80 cataract patients (95 eyes) with glaucoma. The best corrected visual acuity was significantly improved, endothelial cell density and intraocular pressure were significantly reduced, interleukin-1β, interleukin-2, interleukin-10, C-reactive protein and tumor necrosis factor-α levels were significantly decreased (P Conclusion: The trial will confirm whether phacoemulsification combined with trabeculectomy has a good therapeutic effect in patients with cataract combined with glaucoma, and clarify whether the effect is associated with the regulation of insulin sensitivity index, corneal endothelial cells and inflammatory factors. Trial registration: This study was registered with the Chinese Clinical Trial Registry on September 10, 2019 (registration number: ChiCTR1900025837).

Efficacy and safety of small-incision open reduction and internal fixation with absorbable screws for anterior cruciate ligament tibial eminence avulsion fractures: a self-controlled clinical trial

Background and objective: Anterior cruciate ligament tibial eminence avulsion fractures are repaired via early open reduction. Choosing the best fixation method in accordance with the bone size can effectively promote restoration of the cruciate ligament to its normal anatomical position and achieve bone healing. The use of absorbable screws for internal fixation of anterior cruciate ligament tibial eminence avulsion fractures reportedly promotes fracture healing, but the efficacy and safety need further clarification. The present study aims to observe the efficacy and safety of open reduction and internal fixation with absorbable screws through a small incision in the repair of anterior cruciate ligament tibial eminence avulsion fracture. Participants and methods: This prospective, single-center, self-controlled trial will include 72 patients with anterior cruciate ligament tibial eminence avulsion fractures. Open reduction and internal fixation with absorbable screws will be performed through a small incision. All patients will be followed up at 3, 6, and 12 months postoperatively. This study was approved by the Medical Ethics Committee of No. 1 Hospital of Longnan City, China in December 2014 (approval number: S2014-064-02). Protocol version is 1.0. Written informed consent regarding the study protocol and surgery procedure will be obtained from the participants’ family members or the participants themselves. Results: The primary outcome measure is the recovery of knee function assessed by the Lysholm Knee Scoring Scale score at 12 months postoperatively. Secondary outcome measures are the Lysholm Knee Scoring Scale scores preoperatively and 3 and 6 months postoperatively, the International Knee Documentation Committee scores, knee range of motion, knee morphology on radiographs and magnetic resonance images preoperatively and 3, 6, and 12 months postoperatively, and the incidences of adverse reactions 3, 6, and 12 months postoperatively. In our pilot study involving 50 patients with anterior cruciate ligament tibial eminence avulsion fractures (50 knees) from October 2015 to January 2018, no patient had joint stiffness or fracture redisplacement on radiography 3 months postoperatively. The mean knee range of motion was significantly larger at 6 months postoperatively compared with preoperatively (P Conclusion: This trial will assess the efficacy and safety of open reduction and internal fixation with absorbable screws through a small incision to restore knee function in patients with anterior cruciate ligament tibial eminence avulsion fracture. Trial registration: This study was registered with the Chinese Clinical Trial Registry on March 13, 2019 (registration number: ChiCTR1900021865).

Effects of Cryotherapy on Chemotherapy-Induced Peripheral Neuropathy: Self-Controlled Clinical Trial

Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent and disabling side effect of cancer treatment. We evaluated the preventive effects of cryotherapy in a self-controlled trial.

A Modified Strategy Using Barbed Sutures for Wound Closure in Total Joint Arthroplasty: A Prospective, Randomized, Double-Blind, Self-Controlled Clinical Trial.

BackgroundBarbed suture has reported time-saving and safety benefits for wound closure in total joint arthroplasty (TJA). However, this technique requires further investigation. The aim of this study was to use a prospective, randomized, self-controlled study to further determine the efficiency and safety of this technology and to introduce our modified suturing method through a randomized, self-controlled trial.Material/MethodsFrom August 2015 to December 2016, 84 patients (hip 46, knee 38) who had undergone primary simultaneous bilateral total knee or hip arthroplasties were enrolled in this study. Barbed sutures were randomized and used on one side, and traditional sutures (Vicryl) were used on the other side.ResultsClosure time was shorter with the barbed sutures: 6.25 min (12.00 min vs. 18.25 min, p=0.000) for hip and 5.54 min (13.18 min vs. 18.71 min, p=0.000) for knee. There was no difference in the complication rate for the 2 groups. The total cost of our suturing strategy (Quill) was 872.3 RMB, which is 375.1 RMB higher than the total cost of the standard suture method (Vicryl). However, the traditional barbed suturing method (Quill) cost 2195.6 RMB.ConclusionsBarbed suturing was a fast and safe method for wound closure in TJA. We also recommend our modified suturing strategy, especially in countries where operation cost was not associated with operation time.

The Glucose-Lowering Effect of Foxtail Millet in Subjects with Impaired Glucose Tolerance: A Self-Controlled Clinical Trial

Foxtail millet has relatively low starch digestibility and moderate glycemic index compared to other grains. Since there are still no clinical researches regarding its long-term effect on blood glucose, this self-controlled study was conducted to investigate the glucose-lowering effect of foxtail millet in free-living subjects with impaired glucose tolerance (IGT). Fifty g/day of foxtail millet was provided to enrolled subjects throughout 12 weeks and the related clinical parameters were investigated at week 0, 6 and 12, respectively. After 12 weeks of foxtail millet intervention, the mean fasting blood glucose of the subjects decreased from 5.7 ± 0.9 mmol/L to 5.3 ± 0.7 mmol/L (p < 0.001) and the mean 2 h-glucose decreased from 10.2 ± 2.6 mmol/L to 9.4 ± 2.3 mmol/L (p = 0.003). The intake of foxtail millet caused a significant increase of serum leptin (p = 0.012), decrease of insulin resistance (p = 0.007), and marginal reduction of inflammation. Furthermore, a sex-dependent difference in glucose-lowering effect of foxtail millet was observed in this study. Foxtail millet could improve the glycemic control in free-living subjects with IGT, suggesting that increasing the consumption of foxtail millet might be beneficial to individuals suffering from type 2 diabetes mellitus.

Assessment of CAD-CAM zirconia crowns designed with 2 different methods: A self-controlled clinical trial

Statement of problemIn computer-aided design and computer-aided manufacturing (CAD-CAM) dentistry, the correlation method is an efficient way to design complete crowns. However, the occlusal relationship and patient satisfaction with prostheses fabricated using this method remain unclear. PurposeThe purpose of this clinical trial was to compare the occlusion of monolithic zirconia crowns designed using the correlation and library methods. Material and methodsTwenty-three teeth of 21 participants received 2 monolithic zirconia crowns designed by using the correlation or the library method. Defective teeth were scanned using an intraoral scanner to obtain references and working casts from before and after the preparation. Before cementation, the occlusal relationship of both crowns and patient satisfaction were evaluated, and the occlusal adjustment time was recorded. ResultsThe correlation method resulted in less lateral occlusal interference of the crowns than the library method (P<.01). The occlusal adjustment times of the correlation and library conditions were 455.8 ±357.1 seconds and 575.3 ±488.0 seconds, respectively (P>.05). Relative occlusal force was significantly higher in the correlation than in the library condition and was related to before preparation relative occlusal force (r=0.706, P<.01). The visual analog score before occlusal adjustment was higher in the correlation than in the library condition (P<.05). The occlusal contacts, occlusal contact distributions, and number of occlusal contacts did not differ between conditions (P>.05). ConclusionsBetter eccentric occlusion and reduced lateral occlusal interference were obtained when the correlation method was used to design crowns. The correlation method yielded higher relative occlusal force, which helped to restore the original occlusal force.