Virtually optimized insoles for offloading the diabetic foot: A randomized crossover study

Integration of objective biomechanical measures of foot function into the design process for insoles has been shown to provide enhanced plantar tissue protection for individuals at-risk of plantar ulceration. The use of virtual simulations utilizing numerical modeling techniques offers a potential approach to further optimize these devices. In a patient population at-risk of foot ulceration, we aimed to compare the pressure offloading performance of insoles that were optimized via numerical simulation techniques against shape-based devices. Twenty participants with diabetes and at-risk feet were enrolled in this study. Three pairs of personalized insoles: one based on shape data and subsequently manufactured via direct milling; and two were based on a design derived from shape, pressure, and ultrasound data which underwent a finite element analysis-based virtual optimization procedure. For the latter set of insole designs, one pair was manufactured via direct milling, and a second pair was manufactured through 3D printing. The offloading performance of the insoles was analyzed for forefoot regions identified as having elevated plantar pressures. In 88% of the regions of interest, the use of virtually optimized insoles resulted in lower peak plantar pressures compared to the shape-based devices. Overall, the virtually optimized insoles significantly reduced peak pressures by a mean of 41.3 kPa (p < 0.001, 95% CI [31.1, 51.5]) for milled and 40.5 kPa (p < 0.001, 95% CI [26.4, 54.5]) for printed devices compared to shape-based insoles. The integration of virtual optimization into the insole design process resulted in improved offloading performance compared to standard, shape-based devices.Clinical trial registration: ISRCTN19805071, www.ISRCTN.org.     

The Dutch consensus on the diabetic foot

In 1996 the Dutch Diabetes Federation installed a consensus committee to formulate practical guidelines for daily practice to prevent, diagnose and treat foot-related complications in patients with diabetes mellitus. A list of definitions was formulated. A new ulcer classification was introduced. Pathophysiology, diagnostic and therapeutic strategies were discussed with special attention for patients with a high risk foot and for prevention instruction. After several rounds of implementation the definite document was unanimously accepted in the fall of 1998.     

Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial

Background

The referral letter plays a key role both in the communication between primary and secondary care, and in the quality of the health care process. Many studies have attempted to evaluate and improve the quality of these referral letters, but few have assessed the impact of their quality on the health care delivered to each patient.

Methods

A cluster randomized trial, with the general practitioner office as the unit of randomization, has been designed to evaluate the effect of a referral intervention on the quality of health care delivered. Referral templates have been developed covering four diagnostic groups: dyspepsia, suspected colonic malignancy, chest pain, and chronic obstructive pulmonary disease. Of the 14 general practitioner offices primarily served by University Hospital of North Norway Harstad, seven were randomized to the intervention group. The primary outcome is a collated quality indicator score developed for each diagnostic group. Secondary outcomes include: quality of the referral, health process outcome such as waiting times, and adequacy of prioritization. In addition, information on patient satisfaction will be collected using self-report questionnaires. Outcome data will be collected on the individual level and analyzed by random effects linear regression.

Discussion

Poor communication between primary and secondary care can lead to inappropriate investigations and erroneous prioritization. This study’s primary hypothesis is that the use of a referral template in this communication will lead to a measurable increase in the quality of health care delivered.

Trial registration

This trial has been registered at ClinicalTrials.gov. The trial registration number is NCT01470963     

A randomized, placebo-controlled, double-blind trial of supplemental docosahexaenoic acid on cognitive processing speed and executive function in females of reproductive age with phenylketonuria: A pilot study

Low blood docosahexaenoic acid (DHA) is reported in patients with phenylketonuria (PKU); however, the functional implications in adolescents and adults are unknown. This pilot study investigated the effect of supplemental DHA on cognitive performance in 33 females with PKU ages 12–47 years. Participants were randomly assigned to receive DHA (10 mg/kg/day) or placebo for 4.5 months. Performance on cognitive processing speed and executive functioning tasks was evaluated at baseline and follow up. Intention-to-treat and per protocol analyses were performed. At follow up, biomarkers of DHA status were significantly higher in the DHA-supplemented group. Performance on the cognitive tasks and reported treatment-related adverse events did not differ. While no evidence of cognitive effect was seen, a larger sample size is needed to be conclusive, which may not be feasible in this population. Supplementation was a safe and effective way to increase biomarkers of DHA status (www.clinicaltrials.gov; Identifier: NCT00892554).     

Radix/Rhizoma Notoginseng extract (Sanchitongtshu) for ischemic stroke: A randomized controlled study

Agents of sanchi have been widely used as a complementary medicine for stroke in China. Sanchitongshu is a new Chinese patent medicine extracted from sanchi which has stronger anti-platelet activity than other agents of sanchi. Our aim was to investigate the synergistic action of low dose of aspirin combined with sanchitongshu capsule in the treatment of patients with light and moderate ischemic stroke in acute and subacute stages.This was a multi-center, double-blinded, randomized controlled clinical trial conducted in four hospitals in China from July 2004 to 2006. 140 patients of ischemic stroke in anterior cerebral circulation within 30 days of onset were enrolled. Participants were assigned either to receive aspirin (50 mg per day) and sanchitongshu capsule (200 mg three times a day) or aspirin (50 mg per day) and placebo capsule.Low dose of aspirin combined with sanchitongshu capsule significantly ameliorated neurological deficit (increased score of ESS: t = −5.02, p < 0.0001) and activities of daily living (increased score of BI: t = −2.4, p = 0.0178) after treatment compared with aspirin alone. Adverse reaction which occurred equally in both arms, was light to moderate and disappeared without special treatment.Sanchitongshu capsule, as a complementary medicine to aspirin, was effective in improving outcomes after ischemic stroke. It was a safe drug in our trial.     

Effects of chromium supplementation on lipid profile in patients with type 2 diabetes: A systematic review and dose-response meta-analysis of randomized controlled trials

BackgroundThe purpose of this study was to determine the influence of chromium supplementation on lipid profile in patients with type 2 diabetes mellitus (T2DM).MethodsA systematic search was performed in Scopus, Embase, Web of Science, the Cochrane library and PubMed databases to find randomized controlled trials (RCTs) related to the effect of chromium supplementation on lipid profile in patients with T2DM, up to June 2020. Meta-analyses were performed using the random-effects model, and I² index was used to evaluate heterogeneity.ResultsThe primary search yielded 725 publications. 24 RCTs (with 28 effect size) were eligible. Our meta-analysis indicated that chromium supplementation resulted in a significant decrease in serum levels of triglyceride (TG) (MD: -6.54 mg/dl, 95 % CI: -13.08 to -0.00, P = 0.050) and total cholesterol (TC) (WMD: -7.77 mg/dl, 95 % CI: -11.35 to -4.18, P < 0.001). Furthermore, chromium significantly increases high-density lipoprotein (HDL) (WMD: 2.23 mg/dl, 95 % CI: 0.07–4.40, P = 0.043) level. However, chromium supplementation did not have significant effects on low-density lipoprotein (LDL) (WMD: -8.54 mg/dl, 95 % CI: -19.58 to 2.49, P = 0.129) level.ConclusionChromium supplementation may significantly improve lipid profile in patients with T2DM by decreasing TG and TC and increasing HDL. However, based on our analysis, chromium failed to affect LDL. It should be noted that the lipid-lowering properties of chromium supplementation were small and may not reach clinical importance.     

Role of mesenchymal stromal cells derivatives in diabetic foot ulcers: a controlled randomized phase 1/2 clinical trial

Background: Diabetes-related foot complications have been identified as the most common isolated cause of morbidity among patients with diabetes and the leading cause of amputation. Therefore, new strategies to stimulate skin regeneration may provide a novel therapeutic approach to reduce non-healing ulcer disease. Recently, we demonstrated in proof-of-concept in humans that administration of allogeneic bone marrow mesenchymal stromal cellss derivatives (allo-hBM-MSCDs) is effective in a similar way to the use of allogeneic bone marrow mesenchymal stromal cellss (allo-hBM-MSCs) in grade 2 diabetic foot ulcers (DFUs).Aim: To assess the safety and efficacy profile of the allo-hBM-MSCDs relative to the conventional approach (PolyMen® dressing) in 1/2 clinical trial phases in patients with grade 1 and 2 DFUs.Methods: In the present study, we used 2 doses of allo-hBM-MSCDs (1 mL) or 1 dose of allo-hBM-MSCs (1 × 106 cells) intradermally injected around wounds and assessed their safety and effectiveness, relative to the conventional approach (PolyMem dressing). Allo-hBM-MSCDs and allo-hBM-MSCs were produced in a certified Good Manufacturing Practice-type Laboratory. Patients with grade 1 and 2 DFUs were randomized to receive allo-hBM-MSCDs (n=12), allo-hBM-MSCs (n=6) or conventional treatment (PolyMem dressing) (n=10). The wound-healing process was macroscopically evaluated until the complete closure of the ulcers.Results: No adverse events were reported. Patients with grade 1 and 2 DFUs treated with either allo-hBM-MSCDs or allo-hBM-MSCs, achieved greater percentages of wound closure, enhanced skin regeneration in shorter times and a greater ulcer-free survival relative to the patients who received conventional treatment. Finally, through proteomic analysis, we elucidated the proteins and growth factors that are secreted by allo-hBM-MSCs and relevant to the wound-healing process. In addition, by combining proteomics with Gene Ontology analysis, we comprehensively classified secreted proteins on both biological process and molecular function.Conclusions: In this phase 1/2 trial, our cumulative results suggest that 2 doses of allo-hBM-MSCDs combined with a wound dressing are a safe and effective treatment for grade 1 and 2 DFUs.     

A causal proportional hazards estimator for the effect of treatment actually received in a randomized trial with all-or-nothing compliance

Survival data from randomized trials are most often analyzed in a proportional hazards (PH) framework that follows the intention-to-treat (ITT) principle. When not all the patients on the experimental arm actually receive the assigned treatment, the ITT-estimator mixes its effect on treatment compliers with its absence of effect on noncompliers. The structural accelerated failure time (SAFT) models of Robins and Tsiatis are designed to consistently estimate causal effects on the treated, without direct assumptions about the compliance selection mechanism. The traditional PH-model, however, has not yet led to such causal interpretation. In this article, we examine a PH-model of treatment effect on the treated subgroup. While potential treatment compliance is unobserved in the control arm, we derive an estimating equation for the Compliers PROPortional Hazards Effect of Treatment (C-PROPHET). The jackknife is used for bias correction and variance estimation. The method is applied to data from a recently finished clinical trial in cancer patients with liver metastases.     

No effect of a traditional Chinese medicine, Hochu-ekki-to, on antibody titer after influenza vaccination in man: A randomized, placebo-controlled, double-blind trial

BACKGROUND: It was shown that a traditional Chinese medicine, Hochu-ekki-to (HET), had adjuvant effects in influenza vaccination in an animal experiment. This, however, could not be assessed in a clinical study. METHODS: Thirty-two healthy subjects were randomly assigned to two groups (control and HET groups) in a double-blind manner. HET subjects (n=17) took 7.5 g of HET/day for two weeks; control subjects took the same amount of indistinguishable placebo. Then subjects were vaccinated against influenza (H1N1, H3N2 and B/Shandong). Hemagglutinin titers and natural killer (NK) activity were measured at weeks 0, 1, 2, 4, and 12. RESULTS: Antiinfluenza titers against the three viruses were increased continuously for the first two weeks and leveled off. However, there were no significant differences in any titers between the two groups. NK activity peaked at week 2 without any inter-group differences. CONCLUSION: We could not find any adjuvant effects of HET in this experimental condition.     

Overexpression of the gap junction protein Cx43 as found in diabetic foot ulcers can retard fibroblast migration

Poor healing of DFUs (diabetic foot ulcers) is a major clinical problem that can be extremely debilitating and lead to lower limb amputation. In the normal acute wound, the Cx43 (connexin 43) gap junction protein is down-regulated at the wound edge as a precursor to cell migration and healing. In fibroblasts from the human chronic DFU wound edge there was a striking and significant 10-fold elevation of Cx43 protein, as well as a 6-fold increase in N-cadherin and a 2-fold increase in ZO-1 (zonular occludin-1), compared with unwounded skin. In streptozotocin diabetic rats, Cx43 was found to be up-regulated in intact dermal fibroblasts in direct proportion to blood glucose levels and increased 2-fold further in response to wounding of the skin. To mimic diabetes, NIH 3T3 fibroblasts were cultured under different concentrations of glucose or mannitol and Cx43 protein intercellular communication and migration rates were determined. Cultures of fibroblasts in very high (40 mM) glucose conditions showed significantly elevated Cx43 protein levels, as shown by immunostaining and Western blotting, and significantly increasing gap junctional communication, as shown by dye transfer. In scratch wound-healing assays, increased levels of Cx43 from high glucose resulted in repressed filopodial extensions and significantly slower migration rates than in either standard conditions (5.5 mM glucose) or the osmotic control of mannitol. Conversely, when glucose-induced Cx43 up-regulation was prevented with Cx43shRNA (Cx43 short-hairpin RNA) transduction, the fibroblasts extended long filopodia and migrated significantly faster. Cx43 protein was up-regulated in fibroblasts in DFUs as well as after high glucose exposure in culture which correlated with inhibition of fibroblast migration and is likely to contribute to impaired wound healing.     

Treatment of duodenal ulcers by antacid (Al-Mg-hydroxy-carbonate). A controlled, randomized, prospective, multicentre clinical trial

TISACID (a new, modern Hungarian Al-containing antacid) with a high acid-neutralizing capacity (greater than 26.8 mmol/g) also enhances gastric mucosal defense mechanisms (prostaglandin-dependent gastroprotection). A simple-blind, prospective, randomized, parallel multicentre clinical trial has been performed on both the clinical efficacy and possible side effects of TISACID monotherapy (Al-Mg-hydroxy-carbonate) on informed patients suffering from active duodenal ulcers. The study groups were as follows: Group "A": 3 g/day of TISACID (acid-neutralizing capacity = 78 mmol, n = 85), Group "B": 6 g/day of TISACID (acid-neutralizing capacity = 156 mmol, n = 88), Group "C": 12 g/day of TISACID (acid-neutralizing capacity = 312 mmol, n = 68), Group "D": (as control): (1.0 g/day cimetidine (HISTODIL, RGH, Budapest, n = 91). The total number of patients: 332. It was found that: 1. The new Hungarian antacid compound (both tablet and suspension) can essentially accelerate the healing rate of duodenal ulcers. 2. The cumulative healing rate of ulcers and the decrease of complaints can be achieved equally by relatively low doses of TISACID monotherapy and cimetidine alone. 3. There were no differences between the clinical potency and side-effects of TISACID tablet and suspension.     

Eradication of Helicobacter pylori does not reduce the incidence of gastroduodenal ulcers in patients on long-term NSAID treatment: double-blind, randomized, placebo-controlled trial

BACKGROUND: Helicobacter pylori and nonsteroidal antiinflammatory drugs (NSAIDs) are the major causes of gastroduodenal ulcers. Studies on the benefit of eradication of H. pylori in NSAID users yielded conflicting results. OBJECTIVE: To investigate whether H. pylori eradication in patients on long-term NSAIDs reduces the incidence of gastroduodenal ulcers. METHODS: Patients on long-term NSAID treatment and who are H. pylori positive on serologic testing, were randomly assigned to either H. pylori eradication (omeprazole, amoxicillin, and clarithromycin) or placebo. Primary endpoint was the presence of endoscopic gastric or duodenal ulcers 3 months after randomization. RESULTS: One hundred sixty-five (48%) of a total of 347 patients were on gastroprotective medication. At endoscopy, gastroduodenal ulcers were diagnosed in 6 (4%) and 8 (5%) patients in the eradication and placebo group, respectively (p = .65). During follow-up of 12 months, no symptomatic ulcers or ulcer complications developed. No significant differences were found in the development of gastroduodenal erosions, dyspepsia, or in quality of life. CONCLUSION: H. pylori eradication therapy in patients on long-term NSAID treatment had no beneficial effect on the occurrence of ulcers, erosions, or dyspepsia. Ulcer rates in both study arms are remarkably low, in both patients with and without gastroprotective therapy.     

自体骨髓干细胞移植联合奥扎格雷对糖尿病足的临床疗效探究

目的探讨自体骨髓干细胞移植联合奥扎格雷对糖尿病足（DF）的临床疗效。 方法选取2017年7月至2018年8月期间于重庆市大渡口区人民医院收治的99例DF患者为研究对象,随机分为奥扎格雷组、移植组与联合组3组各33例。全部患者入院后均给予DF的常规治疗,奥扎格雷组、移植组、联合组分别给予奥扎格雷、自体骨髓干细胞移植、自体骨髓干细胞移植联合奥扎格雷,比较干预前、干预后12周的临床症状体征、DF严重程度、生存质量的变化,以及干预后12周的新生侧支血管的分级情况。定性资料采用χ²检验或Wilcox秩和检验,定量资料组内干预前后比较采用配对t检验,多组比较先采用方差分析,然后采用Tukey检验进行两两比较。采用Pearson相关系数探讨截肢组患者生活质量评分的相关因素。 结果3组患者干预前的基线资料、疼痛、冷感、间歇性跛行的评分、踝肱指数（ABI）、Wagner分级、糖尿病特异性生活质量量表（DSQL）各维度评分与总分比较,差异无统计学意义（P > 0.05）,具有可比性。组内比较,3组干预后的疼痛、冷感、间歇性跛行的评分、DSQL生理功能、心理（精神）因素、社会关系等维度评分与总分均低于干预前,Wagner分级、ABI优于干预前,差异有统计学意义（P < 0.05）。组间比较,联合组干预后的疼痛、冷感、间歇性跛行的评分、DSQL生理功能、心理（精神）因素等维度评分与总分分别为0.83±0.36、0.83±0.31、1.36±0.63、8.9±3.2、7.5±2.5、23.7±9.2,均低于奥扎格雷组的1.13±0.39、1.26±0.59、1.89±0.73、12.5±5.2、10.1±3.1、31.7±8.8及移植组的1.08±0.33、1.11±0.55、1.72±0.60、10.9±3.6、9.3±3.3、28.8± 7.6,差异有统计学意义（F = 5.001、5.598、3.953、2.230、9.610,P均< 0.05）。联合组干预后的ABI为0.55±0.21,高于奥扎格雷组的0.43±0.20及移植组的0.42±0.16,差异有统计学意义（F = 4.051,P < 0.05）。联合组干预后的社会关系维度评分、Wagner分级为1级的比例分别为5.0±2.1、81.8%,高于奥扎格雷组的6.3±2.3、54.5%,差异有统计学意义（F = 3.953,χ²= 6.983,P均 < 0.05）。观察组干预后的新生侧支血管分级优于奥扎格雷组,差异有统计学意义（P < 0.05）。 结论自体骨髓干细胞移植联合奥扎格雷能缓解DF患者的临床症状,促进溃疡愈合,促进移植术后的血管新生,提高生存质量,值得临床推广应用。     

The amputation and survival of patients with diabetic foot based on establishment of prediction model

ObjectiveThe objective of this paper is to study the establishment of predictive models and the amputation and survival of patients with diabetic foot.MethodsA total of 200 inpatients with diabetic foot were selected as the research subject in this study. The amputation and survival status of diabetic foot patients were followed up by telephone. The relevant indicators were screened by cluster analysis. The predictive model was established respectively based on proportional hazard regression analysis, back propagation neural network (BPNN) and BPNN based on genetic algorithm optimization, and the reliability of the three prediction models (PM) was evaluated and compared.ResultsThe risk factors for amputation were severe ulcer disease, glycosylated hemoglobin and low-density lipoprotein cholesterol. The risk factors for death were cerebrovascular disease, severe ulcer disease and peripheral arterial disease. In case that the outcome was amputation, the PM of BPNN and the PM of BPNN based on genetic algorithm optimization have obviously higher AUC (area under the receiver operating characteristic curve) than the PM of proportional hazard regression analysis, and the difference was statistically significant (P < 0.05). Among the three PMs, the PM based on BPNN had the highest AUC, sensitivity and specificity (SAS). In case that the outcome was death, the PM of BPNN and the PM of BPNN based on genetic algorithm optimization had almost the same AUC, and were obviously higher than the PM based on proportional hazard regression analysis. The difference was statistically significant (P < 0.05). The PM based on BPNN and the BPNN based on genetic algorithm optimization had higher SAS than the PM based on COX regression analysis.ConclusionThe PM of BPNN and BPNN based on genetic algorithm optimization have better prediction effect than the PM based on proportional hazard regression analysis. It can be used for amputation and survival analysis of diabetic foot patients.     

3D finite element model of the diabetic neuropathic foot: A gait analysis driven approach

Diabetic foot is an invalidating complication of diabetes that can lead to foot ulcers. Three-dimensional (3D) finite element analysis (FEA) allows characterizing the loads developed in the different anatomical structures of the foot in dynamic conditions. The aim of this study was to develop a subject specific 3D foot FE model (FEM) of a diabetic neuropathic (DNS) and a healthy (HS) subject, whose subject specificity can be found in term of foot geometry and boundary conditions. Kinematics, kinetics and plantar pressure (PP) data were extracted from the gait analysis trials of the two subjects with this purpose. The FEM were developed segmenting bones, cartilage and skin from MRI and drawing a horizontal plate as ground support. Materials properties were adopted from previous literature. FE simulations were run with the kinematics and kinetics data of four different phases of the stance phase of gait (heel strike, loading response, midstance and push off). FEMs were then driven by group gait data of 10 neuropathic and 10 healthy subjects. Model validation focused on agreement between FEM-simulated and experimental PP.     

Effects of seven potential probiotic strains on specific immune responses in healthy adults: a double-blind, randomized, controlled trial

This pilot study investigated the immunomodulatory properties of seven probiotic strains. Eighty-three healthy volunteers aged 18-62 years consumed 2 x 10(10) CFU of bacteria or a placebo (maltodextrin) over 3 weeks (D0-D21). Subjects received an oral cholera vaccine at D7 and at D14; blood and saliva samples were collected at D0, D21 and D28. Serum samples were analyzed for specific IgA, IgG and IgM, and saliva samples were analyzed for specific IgA only, by ELISA. Statistical analyses were based on Wilcoxon's signed-rank test (intragroup analyses) and exact median t-test (intergroup analyses). Salivary analysis showed no difference in specific IgA concentrations between groups. Serum analysis indicated an effect of some of the tested strains on specific humoral responses. Between D0 and D21, IgG increased in two probiotic groups, for example, Bifidobacterium lactis Bl-04 and Lactobacillus acidophilus La-14, compared with controls (P=0.01). Trends toward significant changes in immunoglobulin serum concentrations compared with controls (P<0.1) were found for six out of the seven probiotic strains. In conclusion, some strains of probiotics demonstrated a faster immune response measured with serum immunoglobulin indicators, especially IgG, although overall vaccination was not influenced. Specific strains of probiotics may thus act as adjuvants to the humoral immune response following oral vaccination.     

The effect of health on socioeconomic status: Using instrumental variables to revisit a successful randomized controlled trial

Poor health is widely recognized as a consequence of social disadvantage, but health problems may also help transmit social disadvantage over time and generations. Experimentally assigned health exposures, namely those tested in randomized controlled trials, may provide opportunities to estimate the causal effects of health on socioeconomic status (SES). We revisit data from the Diabetes Control and Complications Trial, a randomized controlled trial of glucose control therapy in Type 1 diabetic patients, and use treatment assignment as an instrument for health status to test the causal effect of treatment-related health improvement on subsequent SES measured during the trial's follow-up study, the Epidemiology of Diabetes Interventions and Complications study. We used the Two-Factor Hollingshead Index of Social Position, which comprises education and occupation, to measure SES. Glycated hemoglobin (HbA1c) served as a proxy for health status. Ordinary least squares (OLS) regression models showed that lower HbA1c at the trial's end was associated with higher SES at both the start of the follow-up and 17 years later. However, instrumental variable analyses showed no causal effect of HbA1c on SES, suggesting that OLS estimates are biased by endogeneity. Sensitivity analyses showed robustness to several alternate specifications. While the HbA1c advantage conferred by random assignment to treatment within the trial did not produce higher Hollingshead Index scores, we note that occupation and education categories may be harder to affect than are outcomes such as income. This analysis offers evidence that clinical trial data may be a rich and unrecognized resource for estimating health effects on SES.     

Effectiveness of cognitive behaviour therapy for the treatment of catastrophisation in patients with fibromyalgia: a randomised controlled trial

Introduction  

No randomised, controlled trials have been conducted to date on the efficacy of psychological and pharmacological treatments of pain catastrophising (PC) in patients with fibromyalgia. Our aim in this study was to assess the effectiveness of cognitive-behaviour therapy (CBT) and the recommended pharmacological treatment (RPT) compared with treatment as usual (TAU) at the primary care level for the treatment of PC in fibromyalgia patients.     

Comparative study of observed actions,motor imagery and control therapeutic exercise on the conditioned pain modulation in the cervical spine: a randomized controlled trial

Abstract

Aim: The aim of this study was to compare the effects of cervical exercise, motor imagery (MI) and action observation (AO) of cervical exercise actions on conditioned pain modulation and pressure pain thresholds. The second objective was to assess the effects of these interventions on cervical motor activity (ranges of motion and muscle endurance), attention, and the ability to generate motor images.

Study design: Single-blinded randomized controlled trial.

Materials and methods: Fifty-four healthy subjects were randomly assigned to each group. Response conditioned pain modulation, pressure pain threshold, were the main variables. The secondary outcome measures included, cervical range of motion, Neck flexor endurance test, mental movement representation associated and psychosocial variables.

Results: All groups showed significant differences in time factor for all evaluated variables (p?<?.01) except pressure pain threshold over the tibial region. The post hoc analysis revealed significant within-group differences in the AE and AO groups in conditioned pain modulation (p?<?.05), with medium effect size in time [AE (d –0.61); AO (d –0.74)].

Conclusion: The results showed that within-group changes in conditioned pain modulation, cervical muscle endurance, and attention where founded only in the AE and AO groups. Variations in pain thresholds at pressure in the trapezium area were also obtained in the three groups. Changes in the ranges of flexion-extension and rotation movement were presented exclusively in the exercise group, and in the capacity to generate motor images only in the AO group. However, there was no difference in the pressure pain threshold over the tibial region.     

The Mental Health in Diabetes Service (MINDS) to enhance psychosocial health: study protocol for a randomized controlled trial

BackgroundAfter a diagnosis of diabetes mellitus, people not only have to cope with the physical aspects and common complications that require daily self-management, they are also faced with ongoing psychosocial challenges. Subsequently they find themselves having to navigate the health system to engage multidisciplinary supports; the combination of these factors often resulting in reduced health-related quality of life. To maintain optimal diabetes control, interventions need to incorporate psychosocial supports and a skill base for disease management. Therefore, our aim was to evaluate an ‘Optimal Health Program’ that adopts a person-centred approach and engages collaborative therapy to educate and support the psychosocial health of people diagnosed with type I or II diabetes.MethodsThis prospective randomised controlled trial will include 166 people diagnosed with diabetes: 83 in the intervention (Optimal Health Program) and 83 in the control (usual care) group. Participants with type diabetes mellitus will be recruited through hospital outpatient clinics and diabetes community organisations. Participants in the intervention group will receive nine (8 + 1 booster session) sequential sessions, based on a structured treatment manual emphasising educational and psychosocial support self-efficacy and skills building. The primary outcome measures will be generalised self-efficacy (GSE) and health-related quality of life (AQoL-6D and EQ-5D). Secondary measures will be anxiety and depression (HADS), social and workplace functioning (WSAS), diabetes-related quality of life (DQoL), diabetes-related distress (PAID), and type of coping strategies (Brief COPE). In addition, a health economic cost analysis and process evaluations will be performed to assess the economic cost and efficacy of the program’s operations, implementation and service delivery.DiscussionWe envisage that the Optimal Health Program’s emphasis on self-efficacy and self-management will provide participants with the skills and knowledge to achieve increased empowerment and independence in aspects of health, which in turn, will help participants deal more effectively with the physical and psychosocial complexities of diabetes.

Trial registration

ACTRN12614001085662. Registered on 10 October 2014.