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Study Design: A prospective randomized controlled trial (RCT) in persons with spinal cord injury (SCI) and ongoing pressure injury (PI)., Objectives: The main aim was to perform a cost-utility analysis (CUA) alongside the RCT comparing regular care to regular care with additional videoconference consultations. Secondary aims were to assess costs and greenhouse gas emission related to transportation in the two study groups., Setting: Two spinal cord units in Norway., Methods: Participants were allocated to a regular care group (RCG) and a regular care group with additional videoconference (VCG), in a 1-year follow-up between 2016 and 2018. Costs were prospectively collected, and health-related quality of life (HRQoL) data were collected at baseline and 12 months. The outcome was quality-adjusted life years (QALYs), derived from the EQ-5D-5L questionnaire. Results are reported as incremental cost-effectiveness ratio (ICER), expressed as the cost per additional QALY gained. Transportation related costs and environmental emissions were compared by t-tests., Results: There were 56 participants included, 28 in each group. Of these 27 in the VCG and 26 in the RCG completed. Three participants died. The mean cost per patient was € 8819 in the VCG and € 3607 in the RCG, with 0.1 QALYs gained in the VCG. No significant differences were identified regarding HRQoL or secondary outcomes., Conclusion: The VCG costs € 5212 more for an additional 0.1 QALYs, giving an ICER of € 52,120 per QALY. No significant differences were found regarding transportation-related costs, or emission of greenhouse gases., Trial Registration: www., Clinicaltrials: gov ; NCT02800915, TeleSCIpi. CRISTIN.no. https://app.cristin.no/projects/show.jsf?id=545284 . Sunnaas Rehabilitation hospital's web page, available at https://www.sunnaas.no/fag-og-forskning/fagstoff/sar ., (© 2024. The Author(s).)

This exploratory descriptive study aimed to describe characteristics and management of background pain related to chronic leg ulcers. A total of 121 participants were recruited from two wound care clinics using a consecutive sampling method. Data were obtained through screening interview, clinical examination, and questionnaires. The mean average background pain intensity was 4.5 (SD 2.56) (CI 95% 4.0-5.0). Pain interfered mostly with general activity (mean 4.3), sleep (mean 4.1), and walking ability (mean 4.0) (0-10 NRS). The most frequently reported descriptors of background pain were 'tender', 'stabbing', 'aching', and 'hot-burning'. Most of the participants stated that the pain was intermittent. Less than 60% had analgesics prescribed specifically for ulcer related pain, and the respondents reported that pain management provided a mean pain relief of 45.9% (SD 33.9, range 0-100). The findings indicate that ulcer related background pain is a significant problem that interferes with daily function, and that pain management in wound care is still inadequate., (© 2021 The Authors. International Wound Journal published by Medicalhelplines.com Inc (3M) and John Wiley & Sons Ltd.)

Background: Geographical, financial and travel-related barriers may impact access to necessary health care for people in need of long-term follow-up., Objective: The goal of the research was to perform a nonblinded, randomized, controlled trial on health-related quality of life (HRQoL), healing, interaction, and satisfaction of patients with spinal cord injury (SCI) and PI receiving multidisciplinary videoconference consultations from a wound clinic to the participant's home versus regular outpatient care. The multidisciplinary team consisted of a medical doctor, a wound nurse, and an occupational therapist. In both groups, district nurses attended the consultations at the participant's home., Methods: A total of 56 participants, 28 in each group, were randomized to a videoconference group (VCG) or a regular care group (RCG). Validated questionnaires were used to measure and compare the follow-up effect on HRQoL. Percentage reduction of wound volume was measured at end of the follow-up. A Likert scale was used to measure the satisfaction of the patients and district nurses regarding the interaction between different modalities of care in the 2 groups., Results: The HRQoL did not show significant differences between the 2 groups (P values ranging from .09 to .88) or the rate of PI healing, experienced interaction, and satisfaction in the groups. A total of 67% (37/55) of all PIs healed, 64% (18/28) in the VCG and 70% (19/27) in the RCG. Mean reduction in ulcer volume was 79% in the VCG and 85% in the RCG (P=.32). A Kaplan-Meier plot with a logrank test regarding time to healing did not show any significant difference between the 2 groups., Conclusions: Videoconference-based care seems to be a safe and efficient way to manage PIs in terms of HRQoL, healing, interaction, and satisfaction compared to conventional care for people with SCI. This should be considered when planning for future care. SCI has a huge impact on the individual, the family, and the health care system. There is an urgent need to improve systems of care so that individuals who live far from specialists and require long-term follow-up for conditions such as PI can get optimal treatment., Trial Registration: ClinicalTrials.gov NCT02800915; https://clinicaltrials.gov/ct2/show/NCT02800915 and Current Research Information System in Norway (CRISTIN) 545284; https://app.cristin.no/projects/show.jsf?id=545284., (©Ingebjørg Irgens, Jana Midelfart-Hoff, Rolf Jelnes, Marcalee Alexander, Johan Kvalvik Stanghelle, Magne Thoresen, Tiina Rekand. Originally published in JMIR Formative Research (https://formative.jmir.org), 19.04.2022.)

Study Design: A national, retrospective, cross-sectional study., Objectives: To analyze the prevalence of pressure injury (PI), and characteristics associated with PI development in the hospitalized population of persons with a newly acquired spinal cord injury (SCI) between 2004 and 2014., Setting: All three specialized Spinal Cord Units in Norway., Methods: Demographic data related to prevalence and potential risk factors were retrieved from the electronic medical record (EMR). Statistical analyses were performed, using IBM SPSS Statistics, version 23., Results: We identified 1012 individuals with a new SCI. Mean age at injury was 48 years (SD 19). The period prevalence of PI was 16% (95% CI = 0.14-0.19), and identified PI associations were complete SCI (OR = 0.1), being injured abroad (OR = 2.4), bowel (OR = 13), and bladder (OR = 9.2) dysfunction; comorbidities like diabetes mellitus 1 (OR = 7.9), diagnosed depression (OR = 3.8), ventilator support (OR = 3.0), drug abuse (OR = 3.0), and concurrent traumatic brain injury (OR = 1.7). Individuals in the age group of 15-29 years had higher odds of PI compared with middle-aged individuals (45-59 years)., Conclusion: PI is a serious complication after SCI. The association between depression or comorbidity and PI occurrence should be investigated more thoroughly. We recommend implementation of a simple follow-up program regarding observation and prevention of PI. Increased awareness of factors that could contribute to PI will help to focus on better prevention and early recognition of PI. This will contribute to more optimal rehabilitation.

The aim of the study was to evaluate the use of freeze-dried and dissected small muscle biopsy specimens ("dry") for the determination of human muscle electrolyte content and ouabain binding capacity, compared with an easier method, without this freeze-drying step ("wet"). Freeze-drying and dissection of muscle biopsy specimens reduced the variation in the determination of muscle potassium and magnesium content. The total coefficient of variation was 8.6% in the dry determination of muscle potassium content and 13.5% in the wet determination (P < 0.05). In the determination of muscle magnesium content, the total coefficient of variation was 7.4% in the dry determination and 13.7% when determined wet (P < 0.005). Muscle sodium content had a very large coefficient of variation, independent of the method used. The content of dry solids was too high in biopsies which were incubated in Tris-vanadate buffer (31.9%), compared to biopsies which were not incubated in Tris-vanadate buffer (24.9%, P < 0.001). Hereby, the measured ouabain binding capacity became too high when measured wet. In conclusion, muscle electrolyte content and ouabain binding capacity should be determined after drying and microdissection of the biopsies, because this method confers the least variation and the highest accuracy., (Copyright 1998 Academic Press.)

Patients with primary hyperparathyroidism have increased bone turnover, but it is less well documented how brief periods of excess parathyroid hormone (PTH) (endogenous or exogenous) affect bone metabolism. In the present double blind study, we examined the effect of either ethylenediaminetetraacetatic acid (EDTA) or placebo on serum levels of PTH and biochemical markers of bone turnover in 15 women and 39 men (aged 41 to 81 years) suffering intermittent claudication due to atherosclerosis. Disodium EDTA was administered as 20 repeated infusions of 3 grams during a period of 5-9 weeks. Serum calcium and serum phosphate decreased following treatment (p < 0.001) and remained unchanged in the placebo group. However, the differences between the groups were insignificant (ANOVA p = 0.13 and p < 0.10, respectively). PTH increased 2 1/2 fold following EDTA treatment (p < 0.001, ANOVA). The change in serum PTH was inversely correlated with the change in serum calcium (r = -0.53, p < 0.01). In the EDTA group, urinary hydroxyproline/creatinine and calcium/creatinine increased after treatment (ANOVA p < 0.001 and p < 0.05, respectively). Serum bone alkaline phosphatase decreased significantly in the EDTA group immediately after treatment (p < 0.001, ANOVA) and returned to baseline level at three months while only an insignificant decrease in serum osteocalcin was seen following treatment. We conclude that EDTA treatment increases endogenous PTH secretion considerably and leads to increased bone resorption. However, no changes in osteoblastic markers indicating increased activation of bone remodeling could be demonstrated. Our findings support that chelation therapy with EDTA is accompanied by bone loss.

Objective: To study whether intravenous disodium-ethylene diamine tetraacetic acid (EDTA) affects blood lipids in patients with intermittent claudication., Design: Double-blind, randomized, placebo-controlled trial., Participants: Twenty-nine patients with intermittent claudication (systolic ankle-brachial blood pressure index < 0.8; pain free walking distance 50-200 m)., Intervention: 3 g EDTA or placebo (isotonic saline) per infusion over a period of 5-9 weeks to a total of 57 g EDTA. Patients received vitamins, minerals and trace-elements daily., Results: 14 patients received EDTA and 15 placebo. There was no statistically significant difference in the plasma concentration of cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol or triglyceride between the 2 groups., Conclusion: Treatment with EDTA does not alter blood lipids in patients with intermittent claudication.

During the period July 1987-April 1988, ninety-one patients with arterial insufficiency in the lower limbs were referred to the Department of Thoracic and Vascular Surgery at Aalborg Hospital. The mean delay between contact with the general practitioner and the vascular surgeon was nine months. Twenty-nine of the patients contacted alternative therapists before referral to the vascular surgeon. Twenty-five of these patients had suffered from intermittent claudication for at least two years and the total cost of treatment was 76,013 Danish crowns (900 Danish crowns or approximately pounds 75 per patient).

A 62-year-old man suffering intermittent claudication had 20 infusions of EDTA in a double blind, placebo controlled trial. No effect on symptoms or systolic ankle/brachial blood pressure index was found. Following the trial, he received 30 further infusions of EDTA in a private clinic. The systolic ankle/brachial index was unchanged throughout the total period as measured in Hillerød Central Hospital. However, the private clinic found a significant increase in the index following EDTA treatment. The reason for this discrepancy could be poor technique in the clinic or it could be due to bias or manipulation. The discrepancy explains the difference between the positive results claimed by the private EDTA clinics and the results of the double blind placebo controlled Danish trial.

Intermittent claudication is a symptom triggered from the musculature during walking. The pathogenesis of the pain is unknown. All patients with peripheral vascular disease must abstain from smoking, perform physical exercise and dietary advice is sometime needed. Reconstructive vascular surgery or percutaneous transluminal angioplasty (PTA) are indicated when the occupational pattern and, in some instances, the recreational activities, are threatened. The results of these treatments are good. For various reasons a number of patients, however, cannot be offered these treatments. These patients must be informed of the importance of physical exercise and discontinuation of smoking. Some of these patients can be offered supplementary medical treatment (e.g. pentoxifylline).

A double-blind, randomized multicentre study was undertaken to evaluate the possible effect of chelation treatment with ethylenediamine-tetraacetic acid (EDTA) in patients with severe intermittent claudication. A total of 153 patients received 20 intravenous infusions of either 3 g Na2EDTA or placebo during a period of 5-9 weeks. Vitamin, mineral and trace element supplements were administered orally. The changes observed in the pain-free and maximal walking distances, measured on a treadmill, were similar in the two groups. During the 3-month (n = 149) and 6-month (n = 123) follow-up period, no long-term therapeutic effect of EDTA could be demonstrated. The ankle-brachial blood pressure index remained unchanged throughout the study period. This study failed to demonstrate any effect of EDTA chelation treatment in intermittent claudication.

In a randomized, double-blind, controlled study, 153 patients with claudication were each given either 20 infusions of Na2EDTA or 20 infusions of saline. Walking distances and ankle/brachial indices were measured before, during, and after treatment. In 30 patients, angiograms and transcutaneous oxygen tensions were obtained before, during, and after treatment. The patients' subjective evaluations of the effect of treatment were also recorded. It is concluded that EDTA chelation therapy has no effect in patients with intermittent claudication in the legs caused by arteriosclerosis.

Primary aorto-enteric fistulas is now being a rare occurrence because of an aggressive approach in terms of surgery of abdominal aortic aneurysms. Three cases is presented in an attempt to elucidate the ethiology, pathogenesis and diagnostic possibilities when dealing with primary aorto-enteric fistulas. The clinical presentation of the patients with primary aorto-enteric fistulas is inconstant, but a hightened index of suspicion should be present when a patient presents with gastrointestinal bleeding of obscure origin, abdominal or back pain and an abdominal mass. Endoscopy and diagnostic imaging may detect a fistula, but a high rate of false negative investigations are produced. The result of diagnostic workup is often laparotomy, which is the safest diagnostic method and may save the patients life.

A method for continuous measurement of subcutaneous adipose tissue blood flow in the forefoot over 24 h (SBF) is described. The method is based on the radioisotope wash-out principle using 133-Xenon (133Xe). A portable semiconductor detector is placed just above a local depot of 37-74 kBq 133Xe in 0.1 ml isotonic saline, injected into the subcutaneous adipose tissue in the forefoot. The detector is connected to a memory unit allowing for storage of data. Because of the short distance, the recorded elimination rate constant must be corrected for combined convection and diffusion of the radioactive indicator. Characteristic 24-h blood flow patterns were unveiled in patients with normal peripheral circulation and in patients having ischaemic nocturnal rest pain. In normal subjects, SBF doubled from day to night. This is ascribed to the local veno-arteriolar sympathetic axon reflex, which induces vasoconstriction when the transmural pressure of the veins exceeds approximately 25 mmHg. In patients having ischaemic rest pains SBF was reduced by 37% on the average from day to night. This was caused by nocturnal hypotension, which is reflected proportionally in the foot. As the resistance vessels most probably are fully dilatated in feet with rest pain, the blood pressure drop during sleep causes the perfusion pressure and, therefore, blood flow to drop below a certain critical limit. There was a pronounced correlation between the reduction systemic mean arterial blood pressure and SBF. The patients complaining of intermittent claudication, but no rest pains, demonstrated a variety of changes in SBF compatible with the continuous spectrum of peripheral arteriosclerotic disease. The reduced blood flow during sleep in patients having ischaemic rest pains give rise to the concept of the development of gangrene during sleep.

During a 4 1/2-years period sigmoideoscopy was performed when patients developed diarrhea and/or unexpected low abdominal pain within the first days following aortic reconstruction. In our investigation rigid sigmoideoscopy, revealed all the cases of major ischemic colitis.

The effect of initial elective arterial reconstructive surgery was evaluated in relation to employment and social status. Ninety patients with intermittent claudication were followed for a period of 3.5 years. The male to female ratio was 1:12. At the time of operation, all the patients were under the age of 60 years and potentially professionally active. The indication for operation in fifty-nine patients was intermittent claudication. For thirty-one patients, the indication for operation was ischaemic rest pain, gangrene or ulcer. Fifty-six patients (74%) returned to active employment following vascular reconstructive surgery. It is concluded that reconstructive vascular surgery is of great importance for rehabilitation and in the success of resumption of active employment.

This study evaluates iliofemoral bypass reconstruction in limb-salvage, graft patency, and appearance of contralateral symptoms. The study included 62 consecutive iliofemoral bypass reconstructions during 1980-82. The indication for surgery was disabling intermittent claudication in 19% of the patients and severe ischaemia in 81%. At follow-up 42 patients were examined, 16 were dead and 4 were lost to follow-up. The primary mortality was 5%. At 3 years postoperatively the survival rate was 78%, ipsilateral limb-salvage 88%, graft patency 83%, and patency of the contralateral iliofemoral segment 92%. During the follow-up period reconstructive vascular surgery on the contralateral aortoiliac segment was performed in only 3 patients. The results of the iliofemoral bypass reconstruction in this study were comparable to the results of aortic bifurcation grafts, and the patency of the contralateral iliofemoral segment was higher than might have been expected. The iliofemoral bypass reconstruction seems to be useful for patients with unilateral affection of the iliofemoral segment, for limb-salvage concerning patients in poor general condition, and for patients who have had a contralateral amputation.