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Trials Nov 2021Leg cramps are painful sensations of tightening in the muscles of the legs that commonly appear during the night and are often associated with secondary insomnia. They...
BACKGROUND
Leg cramps are painful sensations of tightening in the muscles of the legs that commonly appear during the night and are often associated with secondary insomnia. They are common especially in older age. There is no evidence that any method of prevention of nocturnal leg cramps is both safe and effective. There are no previous trials concerning cramp prevention by using compression stockings. The objective of this study is to assess in a prospective randomised controlled trial whether leg cramps can be prevented by the daily use of knee-length compression stockings or magnesium supplements.
METHODS
The study will be set in Finland, and 50-84-year-old volunteers will be recruited through Google Ads, the Finnish health library website and Finnish primary health care centres. The participants must have a minimum of two episodes of leg cramps per week for the past 4 weeks to be included in the study. The participants (n = 225) will be allocated to three equal groups: the compression stocking arm, the magnesium supplement arm and the placebo arm. The participants will go through 4 weeks of follow-up without intervention and then another 4 weeks of follow-up with the assigned intervention. The material for the study will be collected through electronic questionnaires.
DISCUSSION
This protocol describes a study that compares compression stockings, magnesium supplements and placebo for the prevention of leg cramps. The results of this study can significantly improve knowledge on the methods of preventing leg cramps.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04694417. Registered on Jan 4, 2021.
Topics: Aged; Aged, 80 and over; Humans; Leg; Magnesium; Middle Aged; Muscle Cramp; Prospective Studies; Randomized Controlled Trials as Topic; Stockings, Compression
PubMed: 34844641
DOI: 10.1186/s13063-021-05753-0 -
PloS One 2020Oral magnesium for leg cramps treatment in pregnancy is a controversial issue according to recent Cochrane systematic review. This study aims to evaluate the efficacy of... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Oral magnesium for leg cramps treatment in pregnancy is a controversial issue according to recent Cochrane systematic review. This study aims to evaluate the efficacy of Mg++ supplementation in leg cramps treatment in pregnancy.
METHODS
This observational clinical trial studied 132 pregnant women with leg cramps in the first trimester of pregnancy. At baseline, 74 (56.3%) had two leg cramps episodes per week, 28 (21.1%) three episodes, 13 (9.8%) four episodes and 9 (6.8%) five or more episodes. They were randomized 1:1 to 300 mg/day of oral Mg++ citrate (n = 66) or placebo (n = 66). The primary outcome was the frequency of leg cramps episodes per week reported by pregnant women. Secondary outcomes were the ocurrence of leg cramps and oral magnesium side effects.
RESULTS
130 pregnant women completed the study and the two groups were comparable according to some sociodemographic and clinical characteristics. After 4 weeks of intervention it was observed a 28.4% (39/132) (CI 95%: 20.9-37.0) reduction of leg cramps in all participants and no difference between the two groups was found; reduction of 27.2% (18/66) (CI 95%: 17.0-39.6) in Mg++ group and 32.8% (21/66) (CI 95%: 21.6-45.7) in the placebo group. The OR of leg cramps was 1.3 (CI 95%: 0.6-2.9), p = 0.527, taking the placebo group as reference. Among pregnant women who remained with leg cramps the mean of leg cramps episodes per week showed no significance difference between the Mg++ and placebo groups; t-student test: p = 0.408. Four pregnant women showed gastrointestinal side effects; 2 in each group had nauseas and diarrhoea.
CONCLUSION
Oral magnesium supplementation during pregnancy did not reduce the ocurrence and frequency of episodes of leg cramps.
Topics: Administration, Oral; Adult; Citric Acid; Dietary Supplements; Drug Administration Schedule; Female; Gastrointestinal Diseases; Humans; Muscle Cramp; Organometallic Compounds; Placebo Effect; Pregnancy; Young Adult
PubMed: 31923242
DOI: 10.1371/journal.pone.0227497 -
BMC Nephrology Aug 2021Inadequate refilling from extravascular compartments during hemodialysis can lead to intradialytic symptoms, such as hypotension, nausea, vomiting, and cramping/myalgia....
BACKGROUND
Inadequate refilling from extravascular compartments during hemodialysis can lead to intradialytic symptoms, such as hypotension, nausea, vomiting, and cramping/myalgia. Relative blood volume (RBV) plays an important role in adapting the ultrafiltration rate which in turn has a positive effect on intradialytic symptoms. It has been clinically challenging to identify changes RBV in real time to proactively intervene and reduce potential negative consequences of volume depletion. Leveraging advanced technologies to process large volumes of dialysis and machine data in real time and developing prediction models using machine learning (ML) is critical in identifying these signals.
METHOD
We conducted a proof-of-concept analysis to retrospectively assess near real-time dialysis treatment data from in-center patients in six clinics using Optical Sensing Device (OSD), during December 2018 to August 2019. The goal of this analysis was to use real-time OSD data to predict if a patient's relative blood volume (RBV) decreases at a rate of at least - 6.5 % per hour within the next 15 min during a dialysis treatment, based on 10-second windows of data in the previous 15 min. A dashboard application was constructed to demonstrate how reporting structures may be developed to alert clinicians in real time of at-risk cases. Data was derived from three sources: (1) OSDs, (2) hemodialysis machines, and (3) patient electronic health records.
RESULTS
Treatment data from 616 in-center dialysis patients in the six clinics was curated into a big data store and fed into a Machine Learning (ML) model developed and deployed within the cloud. The threshold for classifying observations as positive or negative was set at 0.08. Precision for the model at this threshold was 0.33 and recall was 0.94. The area under the receiver operating curve (AUROC) for the ML model was 0.89 using test data.
CONCLUSIONS
The findings from our proof-of concept analysis demonstrate the design of a cloud-based framework that can be used for making real-time predictions of events during dialysis treatments. Making real-time predictions has the potential to assist clinicians at the point of care during hemodialysis.
Topics: Blood Volume; Body Fluid Compartments; Cloud Computing; Early Diagnosis; Female; Humans; Hypotension; Kidney Failure, Chronic; Machine Learning; Male; Middle Aged; Muscle Cramp; Prognosis; Proof of Concept Study; Renal Dialysis; Vomiting
PubMed: 34372809
DOI: 10.1186/s12882-021-02481-0 -
Supportive Care in Cancer : Official... Jun 2022Treatment with the tyrosine kinase inhibitor (TKI) imatinib in patients with gastrointestinal stromal tumours (GIST) causes symptoms that could negatively impact...
PURPOSE
Treatment with the tyrosine kinase inhibitor (TKI) imatinib in patients with gastrointestinal stromal tumours (GIST) causes symptoms that could negatively impact health-related quality of life (HRQoL). Treatment-related symptoms are usually clinician-reported and little is known about patient reports. We used survey and online patient forum data to investigate (1) prevalence of patient-reported symptoms; (2) coverage of symptoms mentioned on the forum by existing HRQoL questionnaires; and (3) priorities of prevalent symptoms in HRQoL assessment.
METHODS
In the cross-sectional population-based survey study, Dutch GIST patients completed items from the EORTC QLQ-C30 and Symptom-Based Questionnaire (SBQ). In the forum study, machine learning algorithms were used to extract TKI side-effects from English messages on an international online forum for GIST patients. Prevalence of symptoms related to imatinib treatment in both sources was calculated and exploratively compared.
RESULTS
Fatigue and muscle pain or cramps were reported most frequently. Seven out of 10 most reported symptoms (i.e. fatigue, muscle pain or cramps, facial swelling, joint pain, skin problems, diarrhoea, and oedema) overlapped between the two sources. Alopecia was frequently mentioned on the forum, but not in the survey. Four out of 10 most reported symptoms on the online forum are covered by the EORTC QLQ-C30. The EORTC-SBQ and EORTC Item Library cover 9 and 10 symptoms, respectively.
CONCLUSION
This first overview of patient-reported imatinib-related symptoms from two data sources helps to determine coverage of items in existing questionnaires, and prioritize HRQoL issues. Combining cancer-generic instruments with treatment-specific item lists will improve future HRQoL assessment in care and research in GIST patients using TKI.
Topics: Cross-Sectional Studies; Fatigue; Gastrointestinal Stromal Tumors; Humans; Imatinib Mesylate; Muscle Cramp; Protein Kinase Inhibitors; Quality of Life; Surveys and Questionnaires
PubMed: 35233640
DOI: 10.1007/s00520-022-06929-3 -
Medicine Nov 2019The aim of this study was to evaluate the variables associated with patient-reported symptoms and the impact of symptoms on health-related quality-of-life (HRQoL) in...
PURPOSE
The aim of this study was to evaluate the variables associated with patient-reported symptoms and the impact of symptoms on health-related quality-of-life (HRQoL) in patients with chronic myeloid leukemia (CML) receiving tyrosine kinase inhibitors (TKIs).
METHODS
Anonymous Chinese-language questionnaires were distributed to adults with chronic-phase CML (CML-CP) receiving TKIs therapy >3 months regarding symptoms' incidence, severity, and HRQoL. The multivariate cumulative logistic regression model was built to identify variables associated with the symptoms. General Linear Model was used to model the relationship between symptoms and HRQoL using stepwise-forward algorithm.
RESULTS
A total of 1142 respondents were included in this study. The top 10 common TKI-related symptoms were fatigue, periorbital and lower limb edema, chest distress and shortness of breath, memory deterioration, skin color change, alopecia, muscle cramp, weight gain and musculoskeletal pain, and itchy skin. One hundred forty-one (50%) females ≤50 years reported menstrual disorders. Female, married, therapy duration 1 to 3 years, and foreign generic TKIs were associated with increased symptoms' frequency and severity. In contrast, receiving nilotinib or dasatinib, and achieving a complete cytogenetic response but not complete molecular response were associated with fewer and milder symptoms. Chest distress and shortness of breath and loss of appetite were associated with both lower physical component summary (PCS) and mental component summary (MCS) scores; fatigue, musculoskeletal pain, dizziness and abdominal pain, were associated with lower PCS score; anxiety-depression, was associated with lower MCS score in multivariate analyses.
CONCLUSIONS
Demographic and social variables, type of TKI-therapy, therapy duration, and depth of response were associated with patient-reported symptoms in persons with chronic phase CML. Certain symptoms have adverse impact on HRQoL.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Dasatinib; Female; Humans; Leukemia, Myeloid, Chronic-Phase; Male; Middle Aged; Patient Reported Outcome Measures; Protein Kinase Inhibitors; Protein-Tyrosine Kinases; Pyrimidines; Quality of Life; Time Factors; Treatment Outcome; Young Adult
PubMed: 31770225
DOI: 10.1097/MD.0000000000018079 -
Frontiers in Genetics 2022Myotonia congenita (MC) is a rare neuromuscular disease caused by mutations within the gene encoding skeletal muscle chloride channels. MC is characterized by delayed...
Myotonia congenita (MC) is a rare neuromuscular disease caused by mutations within the gene encoding skeletal muscle chloride channels. MC is characterized by delayed muscle relaxation during contraction, resulting in muscle stiffness. There is a lack of MC case reports and data on the prevalence among Malaysians. We report a clinical case of a 50-year-old woman presents with muscle stiffness and cramp episodes that started in early childhood. She had difficulty initiating muscle movement and presented with transient muscle weakness after rest, which usually improved after repeated contraction (warm-up phenomenon). She was diagnosed with MC after myotonic discharge on electromyography (EMG). Her brother had similar symptoms; however, no additional family members showed MC symptoms. Serum creatine kinase levels were elevated in both the proband and her brother with 447 U/L and 228 U/L recorded, respectively. Genetic analysis by whole-exome sequencing (WES) revealed a previously reported pathogenic gene variant c.1667T>A (p.I556N). Genetic screening of all family members revealed that the same variant was observed in the children of both the proband and her brother; however, the children did not present with either clinical or electrophysiological MC symptoms. The multiplex ligation-dependent probe amplification (MLPA) analysis conducted identified neither exon deletion nor duplication in . In conclusion, this report describes the first case of MC in Malaysia in which incomplete penetrance observed in this family is caused by a known pathogenic variant.
PubMed: 36659963
DOI: 10.3389/fgene.2022.972007 -
European Journal of Neurology Sep 2022Nabiximols is a therapeutic option for patients with multiple sclerosis (MS) spasticity whose symptoms are poorly controlled by conventional oral first-line medications....
A real-world evidence study of nabiximols in multiple sclerosis patients with resistant spasticity: Analysis in relation to the newly described 'spasticity-plus syndrome'.
BACKGROUND AND PURPOSE
Nabiximols is a therapeutic option for patients with multiple sclerosis (MS) spasticity whose symptoms are poorly controlled by conventional oral first-line medications. This study aimed to assess the relationship between changes in spasticity severity (measured on the 0-10 numeric rating scale [NRS]) and the presence of associated symptoms in patients treated with nabiximols, and to investigate the presence of the newly described 'spasticity-plus syndrome'.
METHODS
We analyzed real-world data from the Italian Medicines Agency e-Registry on 1138 patients with MS spasticity who began treatment with nabiximols. Evaluation time points were baseline, 4 weeks, and 3, 6, 12 and 18 months after treatment start.
RESULTS
Common symptoms associated with MS spasticity in this cohort were pain (38.4% at baseline), sleep disturbances (32.7%), and spasms/cramps (28.5%). Pain was frequently clustered with sleep disturbances (57.2% of pain cases) and spasms/cramps (43.9%). Approximately one-third of patients with data at all evaluation time points maintained treatment at 18 months. Nabiximols reduced the baseline mean spasticity 0-10 NRS score by 24.6% at Week 4, and by 33.9% at 18 months in treatment continuers. Nabiximols resolved a range of MS spasticity-associated symptoms at Week 4, and after 18 months in treatment continuers.
CONCLUSION
This real-world analysis supports the concept of a spasticity-plus syndrome and suggests that nabiximols can favorably impact a range of spasticity-associated symptoms.
Topics: Cannabidiol; Central Nervous System Diseases; Dronabinol; Drug Combinations; Humans; Multiple Sclerosis; Muscle Cramp; Muscle Spasticity; Pain; Spasm; Treatment Outcome
PubMed: 35590453
DOI: 10.1111/ene.15412 -
Acta Myologica : Myopathies and... Mar 2022McArdle's disease is an autosomal recessive glycogenosis due to mutation in the myophosphorylase gene () resulting in a pure myopathy. The clinical onset typically...
McArdle's disease is an autosomal recessive glycogenosis due to mutation in the myophosphorylase gene () resulting in a pure myopathy. The clinical onset typically occurs in childhood with cramps, myalgia, and intolerance to physical exercise, although late onset forms are also reported. We describe a case of a 17-year-old male complaining of cramps and myalgia following brief and intense exercise. The patient reported marked improvement in muscle fatigability few minutes after starting aerobic exercise. When he was a child, he had experienced few episodes of vomiting, nausea, and black colored urine following physical activity. Laboratory testings revealed high creatine kinase serum levels. Genetic testings for metabolic myopathies demonstrated a compound heterozygous for two mutations (p.R570Q and p.K754Nfs*49) allowing the diagnosis of McArdle's disease. To date, 183 mutations in the PYGM gene are listed in Human Gene Mutation Database Professional 2021.2, but this novel compound heterozygosis has never been reported before.
Topics: Adolescent; Glycogen Phosphorylase, Muscle Form; Glycogen Storage Disease Type V; Humans; Male; Muscle Cramp; Mutation; Myalgia
PubMed: 35465342
DOI: 10.36185/2532-1900-067 -
Human Genetics Dec 2023Machado-Joseph disease (MJD/SCA3) is the most frequent dominant ataxia worldwide. It is caused by a (CAG) expansion. MJD has two major ancestral backgrounds: the Machado...
Machado-Joseph disease (MJD/SCA3) is the most frequent dominant ataxia worldwide. It is caused by a (CAG) expansion. MJD has two major ancestral backgrounds: the Machado lineage, found mainly in Portuguese families; and the Joseph lineage, present in all five continents, probably originating in Asia. MJD has been described in a few African and African-American families, but here we report the first diagnosed in Sudan to our knowledge. The proband presented with gait ataxia at age 24; followed by muscle cramps and spasticity, and dysarthria, by age 26; he was wheel-chair bound at 29 years of age. His brother had gait problems from age 20 years and, by age 21, lost the ability to run, showed dysarthria and muscle cramps. To assess the mutational origin of this family, we genotyped 30 SNPs and 7 STRs flanking the ATXN3_CAG repeat in three siblings and the non-transmitting father. We compared the MJD haplotype segregating in the family with our cohort of MJD families from diverse populations. Unlike all other known families of African origin, the Machado lineage was observed in Sudan, being shared with 86 Portuguese, 2 Spanish and 2 North-American families. The STR-based haplotype of Sudanese patients, however, was distinct, being four steps (2 STR mutations and 2 recombinations) away from the founder haplotype shared by 47 families, all of Portuguese extraction. Based on the phylogenetic network constructed with all MJD families of the Machado lineage, we estimated a common ancestry at 3211 ± 693 years ago.
Topics: Male; Humans; Young Adult; Adult; Machado-Joseph Disease; Portugal; Muscle Cramp; Dysarthria; Phylogeny; Africa, Eastern
PubMed: 37957369
DOI: 10.1007/s00439-023-02611-8 -
BMC Nephrology Feb 2020Hemodialysis sessions frequently become unstable from complications such as intradialytic hypotension and untoward symptoms. Previous patient safety initiatives promote...
BACKGROUND
Hemodialysis sessions frequently become unstable from complications such as intradialytic hypotension and untoward symptoms. Previous patient safety initiatives promote prevention of treatment complications; yet, they have placed little specific focus on avoidable session instability. A patient-centered definition of session instability grounded in patient experiences, and an understanding of patient perceptions of causes and solutions to instability, may enable such efforts.
METHODS
Twenty-five participants participated in three focus groups and/or a survey. They were purposively sampled for variation in region of residence, and sensitivity to patient well-being. Focus group recordings were analyzed using descriptive coding, in vivo coding, and thematic analysis.
RESULTS
Patients define unstable sessions ("bad runs") as those in which they experience severe discomfort or unanticipated events that interfere with their ability to receive therapy. Bad runs were characterized primarily by cramping, low blood pressure ("crashing"), cannulation-related difficulties ("bad sticks"), and clotting of the dialysis circuit or vascular access. Patients believed that cramping and crashing could be explained by both patient and clinician behavior: patient fluid consumption and providers' fluid removal goals. Patients felt that the responsibility for cannulation-related problems lay with dialysis staff, and they asked for different staff or self-cannulated as solutions. Clotting was viewed as an idiosyncratic issue with one's body, and perceived solutions were clinician-driven. Patients expressed concern about "bad runs" on their ability to achieve fluid balance.
CONCLUSIONS
Findings point to novel priorities for efforts to enhance hemodialysis session stability, and areas in which patients can be supported to become involved in such efforts.
Topics: Adult; Aged; Blood Coagulation; Cross-Sectional Studies; Female; Focus Groups; Humans; Hypotension; Male; Middle Aged; Muscle Cramp; Renal Dialysis; Water-Electrolyte Balance; Water-Electrolyte Imbalance
PubMed: 32103726
DOI: 10.1186/s12882-020-01726-8