Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 212
Filter
1.
Int J Womens Health ; 16: 1377-1387, 2024.
Article in English | MEDLINE | ID: mdl-39157003

ABSTRACT

Objective: This study aimed to estimate the prevalence and determine predictors of leg cramps among pregnant women in their third trimester. Methods: A sample of pregnant women in their third trimester who routinely visited local clinics in Jordan was recruited. Participants completed a socio-demographic and clinical characteristics questionnaire, the numeric pain rating scale (NPRS) for leg cramp pain intensity, the Arabic version of the Pregnant Physical Activity Questionnaire (PPAQ), the Nordic Musculoskeletal Questionnaire (NMQ), Short Form Health Survey (SF-12), Pittsburgh Sleep Quality Index (PSQI), and Hospital Anxiety and Depression Scale (HADS). In addition, magnesium (Mg) and calcium (Ca) serum levels were examined. Logistic regression analyses were used to identify predictors of leg cramps occurrence. A linear regression model was used to investigate predictors of leg cramps pain intensity among pregnant women who reported leg cramps. Results: Two hundred and five (n=205) pregnant women completed the study. The estimated prevalence of leg cramps was 58%. Logistic regression results showed that not receiving assistance with housework (OR 0.46, p=0.025), progress in the number of gestational weeks (OR 1.10, p=0.021), the number of previous pregnancies (OR 1.21, p=0.049), having leg swelling (OR 2.28, p=0.019), and having gastrointestinal (GIT) problems (OR 2.12, P=0.046) were associated with a higher odds of leg cramps occurrence. In the subsample with pregnant women with leg cramps, linear regression results showed that pregnant women with high school education versus elementary school (ß=0.70, p=0.012), number of working hours (ß=0.11, p=0.010), using vitamins supplements (ß=-1.70, p=0.043), having diabetes after pregnancy (ß=1.05, p=0.036), having sciatica (ß=0.58, p=0.028), having hip pain (ß =-.33, p=0.029), and higher PSQI total score (ß=0.09, p=0.020) were the significant predictors of leg cramp pain intensity. Conclusion: Many health-related conditions, as well as work and home-related work characteristics, may be considered risk factors for the occurrence of leg cramps and increased leg cramps pain intensity in pregnancy.

2.
Br J Anaesth ; 2024 Aug 05.
Article in English | MEDLINE | ID: mdl-39107166

ABSTRACT

Malignant hyperthermia susceptibility (MHS) designates individuals at risk of developing a hypermetabolic reaction triggered by halogenated anaesthetics or the depolarising neuromuscular blocking agent suxamethonium. Over the past few decades, beyond the operating theatre, myopathic manifestations impacting daily life are increasingly recognised as a prevalent phenomenon in MHS patients. At the request of the European Malignant Hyperthermia Group, we reviewed the literature and gathered the opinion of experts to define MHS-related myopathy as a distinct phenotype expressed across the adult lifespan of MHS patients unrelated to anaesthetic exposure; this serves to raise awareness about non-anaesthetic manifestations, potential therapies, and management of MHS-related myopathy. We focused on the clinical presentation, biochemical and histopathological findings, and the impact on patient well-being. The spectrum of symptoms of MHS-related myopathy encompasses muscle cramps, stiffness, myalgias, rhabdomyolysis, and weakness, with a wide age range of onset mainly during adulthood. Histopathological analysis can reveal nonspecific abnormalities suggestive of RYR1 involvement, while metabolic profiling reflects altered energy metabolism in MHS muscle. Myopathic manifestations can significantly impact patient quality of life and lead to functional limitations and socio-economic burden. While currently available therapies can provide symptomatic relief, there is a need for further research into targeted treatments addressing the underlying pathophysiology. Counselling early after establishing the MHS diagnosis, followed by multidisciplinary management involving various medical specialties, is crucial to optimise patient care.

3.
Gastroenterol Rep (Oxf) ; 12: goae078, 2024.
Article in English | MEDLINE | ID: mdl-39131950

ABSTRACT

Chronic liver disease (CLD) is a significant contributor to global mortality. For people who are living with CLD, however, there is a substantial and often overlooked burden of physical and psychological symptoms that significantly affect health-related quality of life. CLD frequently presents with a multitude of interrelated and intricate symptoms, including fatigue, pruritus, muscle cramps, sexual dysfunction, and falls. Increasingly, there is interest in studying and developing interventional strategies to provide a more global approach to managing these complex patients. Moreover, in addition to established guidelines for the management of conventional complications, such as ascites and hepatic encephalopathy, there have been efforts in developing evidence-based guidance for the treatment of the more subjective yet still problematic elements. This review will address the management of these less "classical" but nonetheless important symptoms.

4.
Hemodial Int ; 2024 Jul 16.
Article in English | MEDLINE | ID: mdl-39013840

ABSTRACT

INTRODUCTION: Leg muscle cramps and compromised sleep patterns are prevalent issues experienced by individuals undergoing hemodialysis treatment. The aim of this study was to assess the impact of massage therapy on hemodialysis patients experiencing cramping, specifically focusing on the frequency and severity of cramps, as well as the quality of sleep. METHODS: This research involved 36 hemodialysis patients. The intervention group received intradialytic massage targeting the lower extremities, administered three times a week for a total of six sessions over a 2-week period. Data collection utilized a Patient Information Form, the Pittsburgh Sleep Quality Index, the Visual Analog Scale, and a Patient Follow-Up Form. FINDINGS: The study revealed a significant reduction in both the frequency and severity of cramps experienced by patients in the intervention group during hemodialysis sessions and at home, from the end of one session to the beginning of the next, compared to the control group (p < 0.05). This effect was observed over the course of six dialysis sessions. Additionally, there was a notable decrease in the mean total score of the Pittsburgh Sleep Quality Index (PSQI) among participants in the intervention group, declining from 9.00 ± 3.79 prior to massage therapy to 5.94 ± 2.84 post-massage (p < 0.001). Conversely, no significant change was observed in the control group, highlighting a notable disparity between the intervention and control groups in terms of sleep quality improvement. DISCUSSION: The investigation revealed that employing intradialytic massage on the lower extremities led to a reduction in both the frequency and severity of cramps, while also eliciting a positive impact on the sleep quality of patients undergoing hemodialysis.

5.
Life (Basel) ; 14(4)2024 Mar 25.
Article in English | MEDLINE | ID: mdl-38672709

ABSTRACT

This prospective, observational, multicenter study assessed the tolerance of Dobenox Forte®, the first approved over-the-counter product containing calcium dobesilate, in 1795 outpatients with chronic venous disease (CVD) in daily clinical practice. In addition, the effectiveness (decrease in circumferences of a more affected limb at the ankle and middle part of the calf, and changes in the severity of CVD signs) was assessed. No adverse events related to use of the preparation were reported in a period of 64 ± 20 days. Dobenox Forte® use was associated with a reduction in calf circumference by 13.1 mm (95%CI: 12.2-14.1) and in ankle circumference by 9.7 mm (95%CI: 9.2-11.0) in patients reporting swelling of the lower legs (60.0% of the cohort). A reduction in calf and ankle circumference by at least 1 cm was achieved in 34.9% and 24.9% of patients, respectively. The percentages of patients reporting moderate to very severe lower limb heaviness decreased from 96.6% to 56.0%, calf cramps decreased from 91.0% to 41.0%, calf pain decreased from 89.2% to 43.7%, swelling decreased from 86.1% to 38.8%, and burning sensation that worsens when standing decreased from 79.0% to 33.7%. The medicinal product Dobenox Forte® is well tolerated by patients and seems to effectively reduce the symptoms of CVD.

6.
Eur J Oncol Nurs ; 69: 102540, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38461728

ABSTRACT

PURPOSE: This study aimed to explore the incidence and severity of vincristine-induced peripheral neuropathy (VIPN) in non-Hodgkin lymphoma (NHL) survivors (primary aim) and its impact on daily life by comparing common cancer symptoms, functional status, and quality of life (QoL) among survivors with acute, long-term, and non-VIPN (secondary aim). METHODS: This cross-sectional study examined 144 NHL survivors. Standardized questionnaires were used to assess common cancer symptoms, functional status, and QoL with the European Organization for the Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC-QLQ-C30). VIPN (Chemotherapy-Induced Peripheral Neuropathy) status was classified using EORTC-QLQ-CIPN20. A self-designed interference scale was developed to determine the impact of the VIPN on daily activities. The Kruskal-Wallis test and Spearman rank correlation were used in this study. RESULTS: Among the survivors of acute and long-term VIPN, the highest incidences and most severe symptoms were found for hand numbness and foot cramps. A significant moderate correlation was found between disturbances in daily activities and acute or long-term VIPN, including gait changes, going up or down the stairs, and imbalance-related falls. Acute and long-term VIPN survivors showed worse symptoms (fatigue, insomnia, and constipation) and lower QoL than non-VIPN survivors did. In acute VIPN, social function was significantly affected, whereas in long-term VIPN, emotional and cognitive functions were affected. CONCLUSION: Numbness and cramps should be addressed in survivors of acute and long-term VIPN. Preventing falls is recommended for NHL survivors with VIPN, and psychological support is suggested for long-term VIPN survivors.


Subject(s)
Lymphoma, Non-Hodgkin , Neoplasms , Peripheral Nervous System Diseases , Humans , Vincristine/adverse effects , Quality of Life/psychology , Cross-Sectional Studies , Functional Status , Hypesthesia , Muscle Cramp , Lymphoma, Non-Hodgkin/drug therapy , Lymphoma, Non-Hodgkin/psychology , Survivors , Peripheral Nervous System Diseases/chemically induced , Peripheral Nervous System Diseases/epidemiology
7.
Front Neurol ; 15: 1360521, 2024.
Article in English | MEDLINE | ID: mdl-38497037

ABSTRACT

Background: Muscle cramps are typically regarded as benign muscle overactivity in healthy individuals, whereas spasms are linked to spasticity resulting from central motor lesions. However, their striking similarities made us hypothesize that cramping is an under-recognized and potentially misidentified aspect of spasticity. Methods: A systematic search on spasms and cramps in patients with Upper Motor Neuron Disorder (spinal cord injury, cerebral palsy, traumatic brain injury, and stroke) was carried out in Embase/Medline, aiming to describe the definitions, characteristics, and measures of spasms and cramps that are used in the scientific literature. Results: The search identified 4,202 studies, of which 253 were reviewed: 217 studies documented only muscle spasms, 7 studies reported only cramps, and 29 encompassed both. Most studies (n = 216) lacked explicit definitions for either term. One-half omitted any description and when present, the clinical resemblance was significant. Various methods quantified cramp/spasm frequency, with self-reports being the most common approach. Conclusion: Muscle cramps and spasms probably represent related symptoms with a shared pathophysiological component. When considering future treatment strategies, it is important to recognize that part of the patient's spasms may be attributed to cramps.

9.
Molecules ; 29(3)2024 Jan 27.
Article in English | MEDLINE | ID: mdl-38338356

ABSTRACT

The status of parsley as a well-known folk medicine noted for its nutritional and medicinal properties prompted the exploration of its potential as a functional food and natural remedy. The paper aims to investigate the potential of parsley to enhance muscle function and alleviate psoriasiform dermatitis, eventually establishing it as a natural, well-tolerated alternative with specific benefits for both muscles and skin. This study examines the tolerability of parsley in a cohort of 937 participants by assessing immunoglobulin G (IgG) reactions. The findings reveal high tolerability, as 96.26% of participants experienced no adverse effects. Among the 902 individuals lacking hypersensitivity, 37.02% reported muscle cramps, with a notable 15.02% reduction observed in the subgroup consuming parsley juice. In the subset of 32 subjects with dermatitis, the application of parsley extract ointment led to a significant decrease in dermatological parameters (redness, thickness, scaling). While the control group exhibited improvements, statistical significance was not observed. Notably, four categories of affected area reduction were identified, with scaling demonstrating the most pronounced impact. The results propose that parsley holds promise for favorable tolerability, contributing to the alleviation of muscle cramps and presenting an effective alternative in dermatitis treatment. Nonetheless, sustained validation through long-term studies is imperative to substantiate these preliminary findings.


Subject(s)
Dermatitis , Functional Food , Humans , Petroselinum , Muscle Cramp/drug therapy , Plant Extracts/pharmacology , Plant Extracts/therapeutic use , Dermatitis/drug therapy
10.
Transplant Cell Ther ; 30(3): 338.e1-338.e6, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38182005

ABSTRACT

Muscle cramps in patients with chronic graft-versus-host disease (cGVHD) are common and associated with impaired quality of life and symptom burden. Muscle cramps are not currently captured in the 2014 National Institutes of Health (NIH) response criteria, and thus characterization and response to immunomodulatory therapies are lacking. The objective of this study was to characterize muscle cramp frequency, duration, and pain level in patients with steroid-refractory cGVHD undergoing extracorporeal photopheresis (ECP). A single-center cohort of patients who underwent ECP for the indication of steroid-refractory cGVHD with muscle cramps at treatment initiation were followed from April 2021 to April 2023. Of 22 patients receiving ECP for cGVHD during the study period, 9 (41%) had muscle cramps at ECP initiation (6 males [66%]; median age, 59 years; range, 25 to 66 years). Seven of these 9 patients (78%) had multiple organs involved, and 7 (78%) had severe disease by the NIH Global Severity scale. Over a median treatment duration of 28 weeks (range, 10 to 48 weeks), 8 patients (89%) had decreased frequency of muscle cramps from a median of 5 episodes per week (range, 3 per day to 2 per week) to a median of <1 episode per week (range, 1 per month to 3 per week). The pain and duration of muscle cramps were not changed meaningfully. The NIH Global Severity score remained unchanged in 6 patients (67%) and was improved in 3 patients (33%). Muscle cramping is a morbid feature of cGVHD that may be sensitive to change with standard immunomodulatory therapies. Muscle cramp frequency should be further validated as a response measure in cGVHD.


Subject(s)
Bronchiolitis Obliterans Syndrome , Graft vs Host Disease , United States , Male , Humans , Middle Aged , Muscle Cramp/etiology , Muscle Cramp/therapy , Quality of Life , Graft vs Host Disease/therapy , Immunomodulation , Pain , Steroids
11.
Artif Organs ; 48(2): 175-181, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37916538

ABSTRACT

BACKGROUND: Many hemodialysis (HD) patients report intradialytic symptoms, and take time to recover postdialysis. To improve quality of life, patient groups have highlighted the need to reduce postdialysis fatigue and other peridialytic symptoms. As compartmental shifts of fluid during dialysis have been proposed to cause peridialytic symptoms we investigated whether patients dialysing with higher ultrafiltration rates (UFR) reported more intradialytic symptoms and recovery times. METHODS: We reviewed the hospital records of HD patients who completed a self-reported intradialytic symptom questionnaire, using a visual analogue scale, who had contemporaneous midweek pre- and postdialysis segmental bioimpedance measurements. RESULTS: Six hundred and five patients returned the peridialytic symptom questionnaire with pre- and postdialysis bioimpedance measurements. The majority were male (64.8%), mean age 64.2 ± 15.6 years, duration of dialysis treatment 26.8 (10.7-59.2) months, 85% treated by hemodiafiltration and mean dialysate temperature 35.4 ± 0.4°C. We divided patients into terciles according to UFR adjusted for weight, and there was a greater fall in the ratio of extracellular water (ECW) to total body water (TBW) postdialysis in the nonfistula arm from the lower to middle to higher tercile (0.8 (0-1.54) vs. 1.28 (0.52-1.85) vs. 1.54 (0.78-2.52)), trunk (1.5 (0.74-2.27) vs. 1.53 (0.99-2.2) vs. 1.98 (1.18-2.66)), left leg (1.56 (0.49-2.25) vs. 1.77 (1.24-2.43) vs. 2.08 (1.18-2.95)), lower versus higher tercile p < 0.05. However, no differences in intradialytic symptoms or postdialysis recovery times between the UFR terciles were observed. CONCLUSION: There were no differences in self-reported intradialytic symptoms or postdialysis recovery times with differing UFRs, despite changes in intracompartmental fluid shifts as measured by changes in ECW/TBW.


Subject(s)
Hemodiafiltration , Ultrafiltration , Humans , Male , Female , Middle Aged , Aged , Quality of Life , Renal Dialysis/adverse effects , Hemodiafiltration/adverse effects , Surveys and Questionnaires
12.
Cureus ; 15(10): e47797, 2023 Oct.
Article in English | MEDLINE | ID: mdl-38022185

ABSTRACT

Chronic exertional compartment syndrome is an incapacitating condition that primarily affects athletes and individuals with high activity levels. The exact etiology of the condition is unknown to date, but multiple factors play a role in its occurrence. The clinical presentation includes pain, tightness, muscle weakness, paresthesia, and cramps. Common tools utilized during the diagnostic approach include intramuscular compartment pressure measurement, advanced imaging to exclude other disorder entities, near-infrared spectrometry, and shear wave elastography, with the clinical diagnosis being the gold standard. Management includes both conservative and surgical options. Conservative treatment includes gait re-training and botulinum toxin injections. Further, the operative treatment has variable approaches and may be combined with conservative modalities. This article reviews the literature on chronic exertional compartment syndrome and elucidates future recommendations.

13.
Expert Opin Pharmacother ; 24(18): 2021-2033, 2023.
Article in English | MEDLINE | ID: mdl-37788098

ABSTRACT

INTRODUCTION: Acute gastrointestinal cramping pain (GICP) is a debilitating condition that affects many people worldwide, significantly reducing their quality of life. As such, prompt treatment is crucial. AREAS COVERED: This article will explore relevant literature from databases such as PubMed, Scopus, Google Scholar, Cochrane Library, and Web of Science. Additionally, we searched ClinicalTrials.gov and the WHO ICTRP database for the latest clinical trials. EXPERT OPINION: Consensus dictates that antispasmodics such as hyoscine-N-butyl bromide and mebeverine should be the primary treatment for GICP. If these prove ineffective, patients can switch to an antispasmodic with a different mode of action or add acetaminophen/NSAIDs for more severe cases. Currently, several antispasmodics are undergoing clinical trials, including drotaverine, alverine, pinaverium, otilonium bromide, fenoverine, tiropramide, otilonium bromide, trimebutine, and peppermint oil. Well-designed head-to-head studies are necessary to evaluate current antispasmodics' safety, efficacy, pharmacokinetic, and pharmacoeconomics profiles. Recent studies have shown that fixed-dose combinations of antispasmodics + NSAIDs or two different antispasmodics can improve patient compliance and synergistically reduce GICP. Therefore, it is recommended that the global availability and accessibility of these products be enhanced.


Subject(s)
Abdominal Pain , Anti-Inflammatory Agents, Non-Steroidal , Parasympatholytics , Quality of Life , Humans , Abdominal Pain/drug therapy , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Parasympatholytics/therapeutic use
14.
Medicina (Kaunas) ; 59(9)2023 Aug 22.
Article in English | MEDLINE | ID: mdl-37763625

ABSTRACT

Background and Objectives: Muscle cramps are often observed in patients with liver diseases, especially advanced liver fibrosis. The exact prevalence of muscle cramps in outpatients with liver diseases in Japan is unknown. Patients and Methods: This study examined the prevalence of, and therapies for, muscle cramps in outpatients with liver diseases in Tokyo, Japan. A total of 238 outpatients with liver diseases were retrospectively examined. We investigated whether they had muscle cramps using a visual analog scale (VAS) (from 0, none, to 10, strongest), and also investigated their therapies. Results: Muscle cramps were observed in 34 outpatients with liver diseases (14.3%); their mean VAS score was 5.53. A multivariate analysis demonstrated that older age (equal to or older than 66 years) was the only significant factor as-sociated with muscle cramps. The prevalence of muscle cramps among patients with liver diseases seemed not to be higher. The problem was that only 11 (32.4%) of 34 outpatients received therapy for their muscle cramps. Conclusions: Only age is related to muscle cramps, which is rather weak, and it is possible that this common symptom may not be limited to liver disease patients.


Subject(s)
Liver Diseases , Muscle Cramp , Humans , Muscle Cramp/epidemiology , Muscle Cramp/etiology , Japan/epidemiology , Tokyo , Outpatients , Retrospective Studies
15.
Ann Fam Med ; 21(5): 440-443, 2023.
Article in English | MEDLINE | ID: mdl-37748902

ABSTRACT

This study addresses the prevalence and characteristics of leg cramps in 294 primary care patients (mean age = 46.5 years), with 51.7% reporting leg cramps. Patients who experience resting or exercise-induced leg cramps were more likely to be older and female. Cramp severity averaged 5.6 on a scale of 1-10 and disturbed sleep "sometimes" or "often" in 55% of patients. Most patients did not discuss cramps with their clinician. Our study reveals a possible shift in patients who experience leg cramps to younger age and chronicity. Resting leg cramps should be reviewed by clinicians as a symptom of declining health and advancing aging.


Subject(s)
Leg , Muscle Cramp , Humans , Female , Middle Aged , Muscle Cramp/epidemiology , Muscle Cramp/etiology , Prevalence , Primary Health Care , Patient Reported Outcome Measures
16.
Yakugaku Zasshi ; 143(7): 617-620, 2023.
Article in English | MEDLINE | ID: mdl-37394456

ABSTRACT

Chemotherapy-induced myositis is a severe adverse event caused by chemotherapeutic agents such as immune checkpoint inhibitors (ICIs) or cytotoxic agents. We experienced a patient with gefitinib-induced myositis with symptoms of muscle cramps and stiffness in the limbs, and reported the treatment process. A 70-year-old woman received four courses of carboplatin (CBDCA)+pemetrexed (PEM)+gefitinib (intravenous CBDCA area under the curve (AUC) 5 and PEM 500 mg/m2, every 3 weeks, and oral gefitinib 250 mg daily), for epidermal growth factor receptor (EGFR) mutation-positive stage IV lung cancer treatment; followed by seven courses of PEM+gefitinib, and continued gefitinib monotherapy thereafter. Myositis occurred 5 months after the initiation of gefitinib monotherapy. She developed strong limb cramps despite regular oral administration of 400 mg acetaminophen three times a day and complained of pain on a numeric rating scale of 10/10. Her creatine kinase (CK) was elevated from the second course of CBDCA+PEM+gefitinib but was stable at grade 1-2 thereafter. However, the muscle symptoms disappeared with CK normalization within a few days of gefitinib discontinuation due to disease progression. The Naranjo Adverse Drug Reaction Scale score was 6, suggesting a probable association. Osimertinib (an EGFR tyrosine kinase inhibitor)-induced myositis has been reported, but similar events were first observed with gefitinib in this case. Consequently, when treating with gefitinib, myositis, including the CK variation, should be monitored and appropriately managed with multidirectional treatment.


Subject(s)
Carboplatin , Carcinoma, Non-Small-Cell Lung , Gefitinib , Lung Neoplasms , Myositis , Pemetrexed , Humans , Female , Aged , Myositis/chemically induced , Gefitinib/adverse effects , Muscle Cramp/etiology , Lung Neoplasms/drug therapy , Carboplatin/therapeutic use , Pemetrexed/therapeutic use , Carcinoma, Non-Small-Cell Lung/drug therapy , Neoplasm Staging , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Treatment Outcome
17.
Trials ; 24(1): 449, 2023 Jul 10.
Article in English | MEDLINE | ID: mdl-37430314

ABSTRACT

INTRODUCTION/AIMS: Muscle cramps are a common and often disabling symptom in amyotrophic lateral sclerosis (ALS), a devastating and incurable neurodegenerative disorder. To date, there are no medications specifically approved for the treatment of muscle cramps. Ameliorating muscle cramps in ALS may improve and sustain quality of life. A widely prescribed traditional Japanese (Kampo) medicine against muscle cramps, shakuyakukanzoto (TJ-68), has been studied in advanced liver disease, spinal stenosis, kidney failure, and diabetic neuropathy. The Japanese ALS Management Guideline mentions TJ-68 for difficult muscle cramps in ALS. Therefore, the rationale of our trial is to investigate the safety and effectiveness of TJ-68 in treating painful and disabling muscle cramps in people with ALS outside of Japan. Accordingly, we are conducting a randomized clinical trial to test the safety and efficacy of TJ-68 in participants with ALS reporting frequent muscle cramps using an innovative, personalized N-of-1 design. If successful, TJ-68 may be used for muscle cramps in a broader population of people with ALS. METHODS: This is a two-site, double-blind, randomized personalized N-of-1 early clinical trial with TJ-68. At least 22 participants with ALS and daily muscle cramps will receive drug or placebo for 2 weeks (one treatment period) followed by a 1-week washout in a four-period cross-over design. While the primary objective is to evaluate the safety of TJ-68, the study has 85% power to detect a one-point shift on the Visual Analog Scale for Muscle Cramps Affecting Overall Daily Activity of the Columbia Muscle Cramp Scale (MCS). Secondary outcomes include the full MCS score, a Cramp Diary, Clinical Global Impression of Changes, Goal Attainment Scale, quality of life scale and ALS functional rating scale-revised (ALSFRS-R). DISCUSSION: The study is underway. A personalized N-of-1 trial design is an efficient approach to testing medications that alleviate muscle cramps in rare disorders. If TJ-68 proves safe and efficacious then it may be used to treat cramps in ALS, and help to improve and sustain quality of life. TRIAL REGISTRATION: This clinical trial has been registered with ClinicalTrials.gov (NCT04998305), 8/9/2021.


Subject(s)
Amyotrophic Lateral Sclerosis , Drugs, Chinese Herbal , Humans , Amyotrophic Lateral Sclerosis/complications , Amyotrophic Lateral Sclerosis/diagnosis , Amyotrophic Lateral Sclerosis/drug therapy , Drug Combinations , Muscle Cramp/diagnosis , Muscle Cramp/drug therapy , Muscle Cramp/etiology , Quality of Life , Randomized Controlled Trials as Topic
18.
Front Nutr ; 10: 1119233, 2023.
Article in English | MEDLINE | ID: mdl-36908924

ABSTRACT

Introduction: Nocturnal leg cramps (NLCs) are sudden contractions of the leg muscles, usually in the posterior calf muscles at night, affecting sleep quality. Because the precise pathophysiology of NCLs is unclear, different interventions have been proposed. There is conflicting evidence regarding the efficacy of conventional interventions in preventing cramps. Thus, the present study aims to investigate the effects of vitamin K2 for NLCs in a prospective randomized, double-blind, controlled trial. Methods and analysis: This multicenter, randomized, double-blind, placebo-controlled clinical study will enroll older age (≥65-year-old) with two or more documented episodes of NLCs during 2 weeks of screening. Participants will be randomized to receive vitamin K2 or a similar-looking placebo for 8 weeks in a 1:1 ratio. Follow-up visits will be scheduled each week at the beginning of 4-week intervention, then participants will be visited semimonthly. The primary outcome is the difference in the mean number of NLCs per week in the vitamin K2 and placebo arms. The secondary outcomes include the severity and duration of NLCs in the vitamin K2 and placebo arms. Two hundred patients will be needed, for this two-treatment parallel design study, to achieve a probability is 90% that the study will detect a treatment difference at a two-sided 0.04 significance level, if the difference between treatments is 3.6 (difference in means between treatment arms) NLC events. Discussion: Nocturnal Leg Cramps (NLCs) are a common musculoskeletal disorder in the general population, but effective and safe interventions have not been established. Our previous study has shown vitamin K2 was effective to reduce the frequency, severity, and duration of dialysis-related muscle cramps with a good safety profile. This randomized controlled trial (RCT) of rigorous methodological design will help to establish the effectiveness of vitamin K2 for the management of NLCs in older population. The findings of this RCT will encourage the studies of vitamin K2 in musculoskeletal disorders. Clinical Trial Registration: www.ClinicalTrials.gov, identifier, NCT05547750.

19.
BMC Womens Health ; 23(1): 140, 2023 03 28.
Article in English | MEDLINE | ID: mdl-36978063

ABSTRACT

BACKGROUND: Dysmenorrhea has a significant negative impact on teenagers' quality of life, and its prevalence is increasing annually. Although studies have explored the factors affecting dysmenorrhea, it remains unclear how these factors interact with one another. This study aimed to explore the mediating role of binge eating and sleep quality between depression and dysmenorrhea. METHODS: This cross-sectional study recruited adolescent girls from the Health Status Survey of adolescents in Jinan, Shandong Province, and used multistage stratified cluster random sampling. Data was collected using an electronic questionnaire between March 9, 2022, and June 20, 2022. The Numerical Rating Scale and Cox Menstrual Symptom Scale were used to assess dysmenorrhea and the Patient Health Questionnaire-9 to assess depression. The mediation model was tested by Mplus 8.0, and the mediating effect was analyzed using the Product of Coefficients approach and the Bootstrap method. RESULTS: Among the total of 7818 adolescent girls included in this study, the prevalence of dysmenorrhea is 60.5%. A significant positive association was found between dysmenorrhea and depression. Binge eating and sleep quality seemingly mediate this association. The mediating effect of sleep quality (21.31%) was greater than that of binge eating (6.18%). CONCLUSIONS: The findings of this study point in the right direction for preventing and treating dysmenorrhea in adolescents. For adolescent dysmenorrhea, mental health should be considered and proactive steps taken for educating adolescents on healthy lifestyles to reduce negative consequences of dysmenorrhea. Longitudinal studies on the causal link and influence mechanisms between depression and dysmenorrhea should be conducted in the future.


Subject(s)
Binge-Eating Disorder , Dysmenorrhea , Female , Adolescent , Humans , Dysmenorrhea/epidemiology , Depression/epidemiology , Sleep Quality , Binge-Eating Disorder/complications , Binge-Eating Disorder/epidemiology , Quality of Life , Cross-Sectional Studies , Surveys and Questionnaires
20.
Brain Dev ; 45(7): 390-394, 2023 Aug.
Article in English | MEDLINE | ID: mdl-36922284

ABSTRACT

BACKGROUND: Muscle cramps are a common problem characterized by a sudden, painful, and involuntary contraction of a muscle or muscle group. Most muscle cramps develop in the calf muscles, particularly in situations of prolonged exercise; however, some may be related to underlying systemic conditions such as the hereditary angiopathy with nephropathy, aneurysms, and muscle cramps (HANAC) syndrome. Muscle cramps appear to be the initial symptom of the HANAC syndrome; however, the clinical characteristics of these muscle cramps have rarely been described in detail. CASE PRESENTATION: We report a familial case of autosomal-dominant muscle cramps in four members of a Japanese family spanning across three generations. The muscle cramps were recognized as systemic symptoms of the HANAC syndrome associated with a novel COL4A1 pathogenic variant, NM_001845:c.1538G > A, p.(Gly513Asp). The four affected individuals indicated that the first episodes of the muscle cramps occurred in early childhood. In addition, they reported that the muscle cramps are characterized by an abrupt onset of severe pain without muscle contraction. The painful recurrent attacks occurred spontaneously in various muscles throughout the body, but rarely in the calf muscle. The muscle pain lasts for several minutes, cannot be ameliorated by stretching the affected muscle, and leaves a feeling of discomfort that lasts for 24-48 h. The serum creatine kinase levels of the patients were persistently elevated; however, their electromyography results did not reveal any specific abnormalities. CONCLUSIONS: Recognition of the clinical characteristics of the muscle cramps in the HANAC syndrome may facilitate early diagnosis of the syndrome and enable proper treatment of the patients, improve their long-term outcomes, and facilitate the design and adaption of appropriate genetic counseling.


Subject(s)
Aneurysm , Kidney Diseases , Child, Preschool , Humans , Muscle Cramp/genetics , Collagen Type IV/genetics , Mutation/genetics , Aneurysm/complications , Syndrome
SELECTION OF CITATIONS
SEARCH DETAIL