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Healthcare (Basel, Switzerland) Jun 2024To determine whether allied health interventions delivered using telehealth provide similar or better outcomes for patients compared with traditional face-to-face... (Review)
Review
To determine whether allied health interventions delivered using telehealth provide similar or better outcomes for patients compared with traditional face-to-face delivery modes. A rapid systematic review using the Cochrane methodology to extract eligible randomized trials. Trials were eligible for inclusion if they compared a comparable dose of face-to-face to telehealth interventions delivered by a neuropsychologist, occupational therapist, physiotherapist, podiatrist, psychologist, and/or speech pathologist; reported patient-level outcomes; and included adult participants. MEDLINE, CENTRAL, CINAHL, and EMBASE databases were first searched from inception for systematic reviews and eligible trials were extracted from these systematic reviews. These databases were then searched for randomized clinical trials published after the date of the most recent systematic review search in each discipline (2017). The reference lists of included trials were also hand-searched to identify potentially missed trials. The risk of bias was assessed using the Cochrane Risk of Bias Tool Version 1. Fifty-two trials (62 reports, = 4470) met the inclusion criteria. Populations included adults with musculoskeletal conditions, stroke, post-traumatic stress disorder, depression, and/or pain. Synchronous and asynchronous telehealth approaches were used with varied modalities that included telephone, videoconferencing, apps, web portals, and remote monitoring, Overall, telehealth delivered similar improvements to face-to-face interventions for knee range, Health-Related Quality of Life, pain, language function, depression, anxiety, and Post-Traumatic Stress Disorder. This meta-analysis was limited for some outcomes and disciplines such as occupational therapy and speech pathology. Telehealth was safe and similar levels of satisfaction and adherence were found across modes of delivery and disciplines compared to face-to-face interventions. Many allied health interventions are equally as effective as face-to-face when delivered via telehealth. Incorporating telehealth into models of care may afford greater access to allied health professionals, however further comparative research is still required. In particular, significant gaps exist in our understanding of the efficacy of telehealth from podiatrists, occupational therapists, speech pathologists, and neuropsychologists. PROSPERO (CRD42020203128).
PubMed: 38921331
DOI: 10.3390/healthcare12121217 -
The Cochrane Database of Systematic... Feb 2024Morton's neuroma (MN) is a painful neuropathy resulting from a benign enlargement of the common plantar digital nerve that occurs commonly in the third webspace and,... (Review)
Review
BACKGROUND
Morton's neuroma (MN) is a painful neuropathy resulting from a benign enlargement of the common plantar digital nerve that occurs commonly in the third webspace and, less often, in the second webspace of the foot. Symptoms include burning or shooting pain in the webspace that extends to the toes, or the sensation of walking on a pebble. These impact on weight-bearing activities and quality of life.
OBJECTIVES
To assess the benefits and harms of interventions for MN.
SEARCH METHODS
On 11 July 2022, we searched CENTRAL, CINAHL Plus EBSCOhost, ClinicalTrials.gov, Cochrane Neuromuscular Specialised Register, Embase Ovid, MEDLINE Ovid, and WHO ICTRP. We checked the bibliographies of identified randomised trials and systematic reviews and contacted trial authors as needed.
SELECTION CRITERIA
We included all randomised, parallel-group trials (RCTs) of any intervention compared with placebo, control, or another intervention for MN. We included trials where allocation occurred at the level of the individual or the foot (clustered data). We included trials that confirmed MN through symptoms, a clinical test, and an ultrasound scan (USS) or magnetic resonance imaging (MRI).
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methodological procedures. We assessed bias using Cochrane's risk of bias 2 tool (RoB 2) and assessed the certainty of the evidence using the GRADE framework.
MAIN RESULTS
We included six RCTs involving 373 participants with MN. We judged risk of bias as having 'some concerns' across most outcomes. No studies had a low risk of bias across all domains. Post-intervention time points reported were: three months to less than 12 months from baseline (nonsurgical outcomes), and 12 months or longer from baseline (surgical outcomes). The primary outcome was pain, and secondary outcomes were function, satisfaction or health-related quality of life (HRQoL), and adverse events (AE). Nonsurgical treatments Corticosteroid and local anaesthetic injection (CS+LA) versus local anaesthetic injection (LA) Two RCTs compared CS+LA versus LA. At three to six months: • CS+LA may result in little to no difference in pain (mean difference (MD) -6.31 mm, 95% confidence interval (CI) -14.23 to 1.61; P = 0.12, I = 0%; 2 studies, 157 participants; low-certainty evidence). (Assessed via a pain visual analogue scale (VAS; 0 to 100 mm); a lower score indicated less pain.) • CS+LA may result in little to no difference in function when compared with LA (standardised mean difference (SMD) -0.30, 95% CI -0.61 to 0.02; P = 0.06, I = 0%; 2 studies, 157 participants; low-certainty evidence). (Function was measured using: the American Orthopaedic Foot and Ankle Society Lesser Toe Metatarsophalangeal-lnterphalangeal Scale (AOFAS; 0 to 100 points) - we transformed the scale so that a lower score indicated improved function - and the Manchester Foot Pain and Disability Schedule (MFPDS; 0 to 100 points), where a lower score indicated improved function.) • CS+LA probably results in little to no difference in HRQoL when compared to LA (MD 0.07, 95% CI -0.03 to 0.17; P = 0.19; 1 study, 122 participants; moderate-certainty evidence), and CS+LA may not increase satisfaction (risk ratio (RR) 1.08, 95% CI 0.63 to 1.85; P = 0.78; 1 study, 35 participants; low-certainty evidence). (Assessed using the EuroQol five dimension instrument (EQ-5D; 0-1 point); a higher score indicated improved HRQoL.) • The evidence is very uncertain about the effects of CS+LA on AE when compared with LA (RR 9.84, 95% CI 1.28 to 75.56; P = 0.03, I = 0%; 2 studies, 157 participants; very low-certainty evidence). Adverse events for CS+LA included mild skin atrophy (3.9%), hypopigmentation of the skin (3.9%) and plantar fat pad atrophy (2.6%); no adverse events were observed with LA. Ultrasound-guided (UG) CS+LA versus non-ultrasound-guided (NUG) CS+LA Two RCTs compared UG CS+LA versus NUG CS+LA. At six months: • UG CS+LA probably reduces pain when compared with NUG CS+LA (MD -15.01 mm, 95% CI -27.88 to -2.14; P = 0.02, I = 0%; 2 studies, 116 feet; moderate-certainty evidence). (Assessed with a pain VAS.) • UG CS+LA probably increases function when compared with NUG CS+LA (SMD -0.47, 95% CI -0.84 to -0.10; P = 0.01, I = 0%; 2 studies, 116 feet; moderate-certainty evidence). We do not know of any established minimum clinical important difference (MCID) for the scales that assessed function, specifically, the MFPDS and the Manchester-Oxford Foot Questionnaire (MOXFQ; 0 to 100 points; a lower score indicated improved function.) • UG CS+LA may increase satisfaction compared with NUG CS+LA (risk ratio (RR) 1.71, 95% CI 1.19 to 2.44; P = 0.003, I = 15%; 2 studies, 114 feet; low-certainty evidence). • HRQoL was not measured. • UG CS+LA may result in little to no difference in AE when compared with NUG CS+LA (RR 0.42, 95% CI 0.12 to 1.39; P = 0.15, I = 0%; 2 studies, 116 feet; low-certainty evidence). AE included depigmentation or fat atrophy for UG CS+LA (4.9%) and NUG CS+LA (12.7%). Surgical treatments Plantar incision neurectomy (PN) versus dorsal incision neurectomy (DN) One study compared PN versus DN. At 34 months (mean; range 28 to 42 months), PN may result in little to no difference for satisfaction (RR 1.06, 95% CI 0.87 to 1.28; P = 0.58; 1 study, 73 participants; low-certainty evidence), or for AE (RR 0.95, 95% CI 0.32 to 2.85; P = 0.93; 1 study, 75 participants; low-certainty evidence) compared with DN. AE for PN included hypertrophic scaring (11.4%), foreign body reaction (2.9%); AE for DN included missed nerve (2.5%), artery resected (2.5%), wound infection (2.5%), postoperative dehiscence (2.5%), deep vein thrombosis (2.5%) and reoperation with plantar incision due to intolerable pain (5%). The data reported for pain and function were not suitable for analysis. HRQoL was not measured.
AUTHORS' CONCLUSIONS
Although there are many interventions for MN, few have been assessed in RCTs. There is low-certainty evidence that CS+LA may result in little to no difference in pain or function, and moderate-certainty evidence that UG CS+LA probably reduces pain and increases function for people with MN. Future trials should improve methodology to increase certainty of the evidence, and use optimal sample sizes to decrease imprecision.
Topics: Humans; Morton Neuroma; Anesthetics, Local; Quality of Life; Pain; Atrophy
PubMed: 38334217
DOI: 10.1002/14651858.CD014687.pub2 -
The Journal of Foot and Ankle Surgery :... 2024Percutaneous Achilles tendon lengthening is an effective surgical procedure to treat and prevent forefoot and midfoot ulcerations in patients with diabetes. Patients... (Review)
Review
Percutaneous Achilles tendon lengthening is an effective surgical procedure to treat and prevent forefoot and midfoot ulcerations in patients with diabetes. Patients with diabetes are prone to plantar ulcerations due to a combination of factors, such as peripheral neuropathy, decreased tendon elasticity, peripheral vascular disease, and hyperglycemia. Complications such as re-ulceration and transfer lesion to the heel, associated with a calcaneal gait secondary to over-lengthening, are possible with percutaneous Achilles tendon lengthening. Although percutaneous Achilles tendon lengthening is well accepted, the overall incidence of complication has not been well described. A systematic review of the reported data was performed to determine the incidence of complication for percutaneous tendo-Achilles lengthening when used for the treatment and prevention of diabetic plantar ulcerations. Nine studies involving 490 percutaneous lengthening procedures met the inclusion criteria. The overall complication rate was 27.8% (8% with transfer heel ulcerations). Given the high rate of complications associated with a percutaneous Achilles tendon lengthening, careful patient selection and consideration of these risks should be considered prior to proceeding with this procedure. Additional prospective comparative analyses with standardization of surgical technique, degrees of lengthening achieved, and post-operative weightbearing and immobilization modalities are needed to decrease incidence of complication and achieve higher healing rates.
Topics: Humans; Diabetic Foot; Achilles Tendon; Tenotomy; Postoperative Complications
PubMed: 38307408
DOI: 10.1053/j.jfas.2024.01.013 -
BMJ Open May 2023Non-medical prescribing (NMP) is a key feature of the UK healthcare system that refers to the legal prescribing rights granted to nurses, pharmacists and other...
OBJECTIVES
Non-medical prescribing (NMP) is a key feature of the UK healthcare system that refers to the legal prescribing rights granted to nurses, pharmacists and other non-medical healthcare professionals who have completed an approved training programme. NMP is deemed to facilitate better patient care and timely access to medicine. The aim of this scoping review is to identify, synthesise and report the evidence on the costs, consequences and value for money of NMP provided by non-medical healthcare professionals.
DESIGN
Scoping review DATA SOURCES: MEDLINE, Cochrane Library, Scopus, PubMed, ISI Web of Science and Google Scholar were systematically searched from 1999 to 2021.
ELIGIBILITY CRITERIA
Peer-reviewed and grey literature written in English were included. The research was limited to original studies evaluating economic values only or both consequences and costs of NMP.
DATA EXTRACTION AND SYNTHESIS
The identified studies were screened independently by two reviewers for final inclusion. The results were reported in tabular form and descriptively.
RESULTS
A total of 420 records were identified. Of these, nine studies evaluating and comparing NMP with patient group discussions, general practitioner-led usual care or services provided by non-prescribing colleagues were included. All studies evaluated the costs and economic values of prescribing services by non-medical prescribers, and eight assessed patient, health or clinical outcomes. Three studies showed pharmacist prescribing was superior in all outcomes and cost saving at a large scale. Others reported similar results in most health and patient outcomes across other non-medical prescribers and control groups. NMP was deemed resource intensive for both providers and other groups of non-medical prescribers (eg, nurses, physiotherapists, podiatrists).
CONCLUSIONS
The review demonstrated the need for quality evidence from more rigorous methodological studies examining all relevant costs and consequences to show value for money in NMP and inform the commissioning of NMP for different groups of healthcare professionals.
Topics: Humans; Delivery of Health Care; Health Personnel; Pharmacists; Allied Health Personnel
PubMed: 37130673
DOI: 10.1136/bmjopen-2022-067907 -
Advances in Skin & Wound Care Jan 2023To review the literature to determine whether compression therapies and nutrition status influence venous ulcer healing.
OBJECTIVE
To review the literature to determine whether compression therapies and nutrition status influence venous ulcer healing.
DATA SOURCE
A systematized bibliographic review was carried out by searching PubMed, Scopus, and Cochrane databases for studies published between 2015 and 2020, using descriptors in Spanish and English.
STUDY SELECTION
After establishing the research question and applying the filters based on inclusion and exclusion criteria, 114 articles were found. After screening, 11 articles were selected for the review: 8 were identified in the literature search, and 3 were added from the bibliographic references of other studies.
DATA EXTRACTION
The authors developed a data extraction sheet that recorded the following variables: author, country, year of publication, level of evidence, research design, therapy type, initial ulcer size, active ulcer history, pain, healed wounds, wound reduction, therapy tolerance, nutrition assessment method, body mass index, and nutrition disorders.
DATA SYNTHESIS
Four studies analyzed the relationship between nutrition status and venous ulcer healing, finding that these patients tend to have a high body mass index; a deficit of nutrients such as vitamin A, D, or zinc; and an excess of lipids and carbohydrates. Seven studies compared different types of compression to determine which provided the best results, with two- and four-layer therapy being the most commonly used. Variables such as small wound size and recent onset were associated with better prognosis.
CONCLUSIONS
In terms of nutrition, the parameters analyzed are very limited. Although several studies show that two-layer therapy produces the greatest ulcer healing, there is not enough information to recommend one type of therapy over the other. Therefore, more clinical trials are needed to study broader nutrition parameters and compare the types of therapy under matched conditions to determine their influence on ulcer healing.
Topics: Humans; Varicose Ulcer; Ulcer; Nutritional Status; Body Mass Index; Wound Healing
PubMed: 36537775
DOI: 10.1097/01.ASW.0000902492.97059.f2 -
Advances in Skin & Wound Care Dec 2022To determine if health education has an influence on podiatric knowledge, self-care, and conditions in adults with diabetes mellitus.
OBJECTIVE
To determine if health education has an influence on podiatric knowledge, self-care, and conditions in adults with diabetes mellitus.
DATA SOURCES
The authors conducted a literature search for Spanish-, English-, and Portuguese-language publications using PubMed, Scopus, Dialnet, and CUIDEN.
STUDY SELECTION
Selected keywords related to diabetes, health education, (diabetic) foot, and self-care were searched, and the titles, abstracts, and relevant full-text articles were screened. Thirteen studies were selected with a total of 1,296 participants. Four were randomized controlled trials, and nine were quasi-experimental studies.
DATA EXTRACTION
Data pertaining to preventive intervention and study outcomes were extracted.
DATA SYNTHESIS
The preventive interventions used varied from traditional educational workshops and one-on-one patient education to new technological strategies. Three different outcomes were evaluated in each study: podiatric knowledge (n = 4), foot self-care (n = 13), and foot problems (n = 2).
CONCLUSIONS
Health education interventions increase podiatric self-care in adults with diabetes mellitus. These interventions appear to contribute positively to foot health and podiatric knowledge.
Topics: Adult; Humans; Self Care; Diabetes Mellitus; Podiatry; Health Education
PubMed: 36179316
DOI: 10.1097/01.ASW.0000884328.49506.7a -
Medicina (Kaunas, Lithuania) Dec 2021: Smart wearable devices are effective in diabetic foot ulcer (DFU) prevention. However, factors determining their acceptance are poorly understood. This systematic... (Review)
Review
: Smart wearable devices are effective in diabetic foot ulcer (DFU) prevention. However, factors determining their acceptance are poorly understood. This systematic review aims to examine the literature on patient and provider perspectives of smart wearable devices in DFU prevention. : PubMed, Scopus, and Web of Science were systematically searched up to October 2021. The selected articles were assessed for methodological quality using the quality assessment tool for studies with diverse designs. A total of five articles were identified and described. The methodological quality of the studies ranged from low to moderate. Two studies employed a quantitative study design and focused on the patient perspective, whereas three studies included a mixed, quantitative/qualitative design and explored patient or provider (podiatrist) perspectives. Four studies focused on an insole system and one included a smart sock device. The quantitative studies demonstrated that devices were comfortable, well designed and useful in preventing DFU. One mixed design study reported that patients did not intend to adopt an insole device in its current design because of malfunctions, a lack of comfort. and alert intrusiveness, despite the general perception that the device was a useful tool for foot risk monitoring. Two mixed design studies found that performance expectancy was a predictor of a podiatrist's behavioural intention to recommend an insole device in clinical practice. Disappointing participant experiences negatively impacted the podiatrists' intention to adopt a smart device. The need for additional refinements of the device was indicated by patients and providers before its use in this population. The current evidence about patient and provider perspectives on smart wearable technology is limited by scarce methodological quality and conflicting results. It is, thus, not possible to draw definitive conclusions regarding acceptability of these devices for the prevention of DFU in people with diabetes.
Topics: Diabetes Mellitus; Diabetic Foot; Foot; Foot Orthoses; Humans; Shoes; Wearable Electronic Devices
PubMed: 34946304
DOI: 10.3390/medicina57121359 -
Obesity (Silver Spring, Md.) Nov 2021Weight-biased attitudes and views held by health care professionals can have a negative impact on the patient-provider relationship and the provision of care, but... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Weight-biased attitudes and views held by health care professionals can have a negative impact on the patient-provider relationship and the provision of care, but studies have found mixed results about the extent and nature of bias, which warrants a review of the evidence.
METHODS
A systematic review and random-effects meta-analysis were conducted by including studies up to January 12, 2021.
RESULTS
A total of 41 studies met inclusion criteria, with 17 studies providing sufficient data to be meta-analyzed. A moderate pooled effect (standardized mean difference = 0.66; 95% CI: 0.37-0.96) showed that health care professionals demonstrate implicit weight bias. Health care professionals also report explicit weight bias on the Fat Phobia Scale, Antifat Attitudes Scale, and Attitudes Towards Obese Persons Scale. Findings show that medical doctors, nurses, dietitians, psychologists, physiotherapists, occupational therapists, speech pathologists, podiatrists, and exercise physiologists hold implicit and/or explicit weight-biased attitudes toward people with obesity. A total of 27 different outcomes were used to measure weight bias, and the overall quality of evidence was rated as very low.
CONCLUSIONS
Future research needs to adopt more robust research methods to improve the assessment of weight bias and to inform future interventions to address weight bias among health care professionals.
Topics: Bias; Health Personnel; Humans; Obesity; Physicians; Weight Prejudice
PubMed: 34490738
DOI: 10.1002/oby.23266 -
The Cochrane Database of Systematic... May 2021The World Health Organization (WHO) recommends that people of all ages take regular and adequate physical activity. If unable to meet the recommendations due to health...
BACKGROUND
The World Health Organization (WHO) recommends that people of all ages take regular and adequate physical activity. If unable to meet the recommendations due to health conditions, international guidance advises being as physically active as possible. Evidence from community interventions of physical activity indicate that people living with medical conditions are sometimes excluded from participation in studies. In this review, we considered the effects of activity-promoting interventions on physical activity and well-being in studies, as well as any adverse events experienced by participants living with inherited or acquired neuromuscular diseases (NMDs). OBJECTIVES: To assess the effects of interventions designed to promote physical activity in people with NMD compared with no intervention or alternative interventions.
SEARCH METHODS
On 30 April 2020, we searched Cochrane Neuromuscular Specialised Register, CENTRAL, Embase, MEDLINE, and ClinicalTrials.Gov. WHO ICTRP was not accessible at the time.
SELECTION CRITERIA
We considered randomised or quasi-randomised trials, including cross-over trials, of interventions designed to promote physical activity in people with NMD compared to no intervention or alternative interventions. We specifically included studies that reported physical activity as an outcome measure. Our main focus was studies in which promoting physical activity was a stated aim but we also included studies in which physical activity was assessed as a secondary or exploratory outcome.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane procedures.
MAIN RESULTS
The review included 13 studies (795 randomised participants from 12 studies; number of participants unclear in one study) of different interventions to promote physical activity. Most studies randomised a minority of invited participants. No study involved children or adolescents and nine studies reported minimal entry criteria for walking. Participants had one of nine inherited or acquired NMDs. Types of intervention included structured physical activity support, exercise support (as a specific form of physical activity), and behaviour change support that included physical activity or exercise. Only one included study clearly reported that the aim of intervention was to increase physical activity. Other studies reported or planned to analyse the effects of intervention on physical activity as a secondary or exploratory outcome measure. Six studies did not report results for physical activity outcomes, or the data were not usable. We judged 10 of the 13 included studies at high or unclear risk of bias from incomplete physical activity outcome reporting. We did not perform a meta-analysis for any comparison because of differences in interventions and in usual care. We also found considerable variation in how studies reported physical activity as an outcome measure. The studies that reported physical activity measurement did not always clearly report intention-to-treat (ITT) analysis or whether final assessments occurred during or after intervention. Based on prespecified measures, we included three comparisons in our summary of findings. A physical activity programme (weight-bearing) compared to no physical activity programme One study involved adults with diabetic peripheral neuropathy (DPN) and reported weekly duration of walking during and at the end of a one-year intervention using a StepWatch ankle accelerometer. Based on the point estimate and low-certainty evidence, intervention may have led to an important increase in physical activity per week; however, the 95% confidence interval (CI) included the possibility of no difference or an effect in either direction at three months (mean difference (MD) 34 minutes per week, 95% CI -92.19 to 160.19; 69 participants), six months (MD 68 minutes per week, 95% CI -55.35 to 191.35; 74 participants), and 12 months (MD 49 minutes per week, 95% CI -75.73 to 173.73; 70 participants). Study-reported effect estimates for foot lesions and full-thickness ulcers also included the possibility of no difference, a higher, or lower risk with intervention. A sensor-based, interactive exercise programme compared to no sensor-based, interactive exercise programme One study involved adults with DPN and reported duration of walking over 48 hours at the end of four weeks' intervention using a t-shirt embedded PAMSys sensor. It was not possible to draw conclusions about the effectiveness of the intervention from the very low-certainty evidence (MD -0.64 hours per 48 hours, 95% CI -2.42 to 1.13; 25 participants). We were also unable to draw conclusions about impact on the Physical Component Score (PCS) for quality of life (MD 0.24 points, 95% CI -5.98 to 6.46; 35 participants; very low-certainty evidence), although intervention may have made little or no difference to the Mental Component Score (MCS) for quality of life (MD 5.10 points, 95% CI -0.58 to 10.78; 35 participants; low-certainty evidence). A functional exercise programme compared to a stretching exercise programme One study involved adults with spinal and bulbar muscular atrophy and reported a daily physical activity count at the end of 12 weeks' intervention using an Actical accelerometer. It was not possible to draw conclusions about the effectiveness of either intervention (requiring compliance) due to low-certainty evidence and unconfirmed measurement units (MD -8701, 95% CI -38,293.30 to 20,891.30; 43 participants). Functional exercise may have made little or no difference to quality of life compared to stretching (PCS: MD -1.10 points, 95% CI -5.22 to 3.02; MCS: MD -1.10 points, 95% CI -6.79 to 4.59; 49 participants; low-certainty evidence). Although studies reported adverse events incompletely, we found no evidence of supported activity increasing the risk of serious adverse events.
AUTHORS' CONCLUSIONS
We found a lack of evidence relating to children, adolescents, and non-ambulant people of any age. Many people living with NMD did not meet randomised controlled trial eligibility criteria. There was variation in the components of supported activity intervention and usual care, such as physical therapy provision. We identified variation among studies in how physical activity was monitored, analysed, and reported. We remain uncertain of the effectiveness of promotional intervention for physical activity and its impact on quality of life and adverse events. More information is needed on the ITT population, as well as more complete reporting of outcomes. While there may be no single objective measure of physical activity, the study of qualitative and dichotomous change in self-reported overall physical activity might offer a pragmatic approach to capturing important change at an individual and population level.
Topics: Bias; Exercise; Health Promotion; Humans; Muscle Stretching Exercises; Neuromuscular Diseases; Outcome Assessment, Health Care; Quality of Life; Randomized Controlled Trials as Topic; Resistance Training; Time Factors; Walking
PubMed: 34027632
DOI: 10.1002/14651858.CD013544.pub2 -
The Cochrane Database of Systematic... May 2021Lower limb muscle cramps are common and painful. They can limit exercise participation, and reduce quality of sleep, and quality of life. Many interventions are... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Lower limb muscle cramps are common and painful. They can limit exercise participation, and reduce quality of sleep, and quality of life. Many interventions are available for lower limb cramps; some are controversial or could cause harm, and often, people experience no benefit from the interventions used. This is an update of a Cochrane Review first published in 2012. We updated the review to incorporate new evidence.
OBJECTIVES
To assess the effects of non-drug, non-invasive therapies for lower limb muscle cramps.
SEARCH METHODS
In August 2018 and May 2020, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, the World Health Organization International Clinical Trials Registry Platform, ClinicalTrials.gov, and reference lists of included studies. We imposed no restrictions by language or publication date.
SELECTION CRITERIA
We included all randomised controlled trials (RCTs) of non-drug, non-invasive interventions tested over at least four weeks, for lower limb muscle cramps in any group of people, except pregnant women. The primary outcome was cramp frequency. Secondary outcomes were cramp pain severity, cramp duration, health-related quality of life, quality of sleep, participation in activities of daily living, proportion of participants reporting lower limb muscle cramps, and adverse events.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials, assessed risk of bias, and cross-checked data extraction and analyses according to standard Cochrane procedures.
MAIN RESULTS
We included three trials, with 201 participants, all 50 years of age and older; none had neurological disease. All trials evaluated a form of stretching for lower limb muscle cramps. A combination of daily calf and hamstring stretching for six weeks may reduce the severity of night-time lower limb muscle cramps (measured on a 10 cm visual analogue scale (VAS) where 0 = no pain and 10 cm = worst pain imaginable) in people aged 55 years and older, compared to no intervention (mean difference (MD) -1.30, 95% confidence interval (CI) -1.74 to -0.86; 1 RCT, 80 participants; low-certainty evidence). The certainty of evidence was very low for cramp frequency (change in number of cramps per night from week zero to week six) comparing the stretching group and the no intervention group (MD -1.2, 95% CI -1.8 to -0.6; 80 participants; very low-certainty evidence). Calf stretching alone for 12 weeks may make little to no difference to the frequency of night-time lower limb muscle cramps in people aged 60 years and older (stretching group median number of cramps in the last four weeks (Md) 4, interquartile range (IQR) 8; N = 48; sham stretching group Md 3, IQR 7.63; N = 46) (U = 973.5, z = -0.995, P = 0.32, r = 0.10; 1 RCT, 94 participants; low-certainty evidence). This trial did not report cramp severity. The evidence is very uncertain about the effects of a combination of daily calf, quadriceps, and hamstring stretching on the frequency and severity of leg cramps in 50- to 60-year-old women with metabolic syndrome (N = 24). It was not possible to fully analyse the frequency data and the scale used to measure cramp severity is not validated. No study reported health-related quality of life, quality of sleep, or participation in activities of daily living. No participant in these three studies reported adverse events. The evidence for adverse events was of moderate certainty as the studies were too small to detect uncommon events. In two of the three studies, outcomes were at risk of recall bias, and tools used to measure outcomes were not validated. Due to limitations in study designs that led to risks of bias, and imprecise findings with wide CIs, we cannot be certain that findings of future studies will be similar to those presented in this review.
AUTHORS' CONCLUSIONS
A combination of daily calf and hamstring stretching for six weeks may reduce the severity of night-time lower limb muscle cramps in people aged 55 years and older, but the effect on cramp frequency is uncertain. Calf stretching alone compared to sham stretching for 12 weeks may make little or no difference to the frequency of night-time lower limb muscle cramps in people aged 60 years and older. The evidence is very uncertain about the effects of a combination of daily calf, quadriceps, and hamstring stretching on the frequency and severity of leg cramps in 50- to 60-year-old women with metabolic syndrome. Overall, use of unvalidated outcome measures and inconsistent diagnostic criteria make it difficult to compare the studies and apply findings to clinical practice. Given the prevalence and impact of lower limb muscle cramps, there is a pressing need to carefully evaluate many of the commonly recommended and emerging non-drug therapies in well-designed RCTs across all types of lower limb muscle cramps. A specific cramp outcome tool should be developed and validated for use in future research.
Topics: Activities of Daily Living; Age Factors; Aged; Bias; Female; Hamstring Muscles; Humans; Leg; Lower Extremity; Male; Middle Aged; Muscle Cramp; Muscle Relaxants, Central; Muscle Stretching Exercises; Pain Measurement; Quinine; Randomized Controlled Trials as Topic; Secondary Prevention
PubMed: 33998664
DOI: 10.1002/14651858.CD008496.pub3