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Prevalence and Risk Factors of Nocturnal Leg Cramps in Young Adults 1
Prevalence and Risk Factors of Nocturnal Leg Cramps in Young Adults 1
Prevalence and Risk Factors of Nocturnal Leg Cramps in Young Adults 1
Submitted to:
Dr. Mohsana Tariq
Session (2016-2021)
2
Declaration of Originality
We, the undersigned, hereby declare that this entire project is our own work. The report results from
our own investigations, except where otherwise stated. Explicit references acknowledge other sources.
This report has not been submitted to any other university or institute to award any degree. The result
of the project is purely based on our analysis, suggestions, and discussion with the supervisor.
Signed: (Group 6)
3
This is to certify that the work in the thesis entitled “Prevalence and Risk Factors of Nocturnal Leg
Cramps in Young Adults” is a record of an original research work carried out under my supervision and
guidance in partial fulfillment of the requirements for the award of the degree of Doctor of Physical
Therapy (DPT). The matter embodied in this thesis has not been submitted to any other University or
Institute for the award of any Degree or Diploma.
----------------------------------
Supervisor
-------------------------------
Head of Department
4
Acknowledgment
Firstly, we are grateful to Allah Almighty, who is most Beneficent & merciful in enabling us to complete
this project.
We want to show our sincere gratitude to our research advisor, Dr. Mohsana Tariq (Sargodha Medical
College department of Allied Health Sciences). She not only provided us with guidance and inspiration in
the early stage of our research but also gave us her painstaking support, constant encouragement, and
helpful criticism throughout our work. We are particularly grateful for her wholehearted assistance,
which enables us to complete the dissertation in time and in an excellent way.
We appreciate the efforts made by all our volunteers for their selfless contribution. Without them, we
could never have finalized our survey and collected data successfully.
Last but not least, we also thank all participants' families and colleagues for their active support and
collaboration during the survey, which greatly facilitated the process of data collection.
By:
Ayesha Ijaz 4331
IN THE NAME OF ALLAH, WHO IS MOST BENEFICENT & MERCIFUL, INDEED WE BELONG TO ALLAH &
INDEED TO HIM WE WILL RETURN.
Table of Content
CONTENTS
Introduction...............................................................................................................................................12
Risks..........................................................................................................................................................13
7
Muscular Fatigue...................................................................................................................................13
During The Day Inactivity....................................................................................................................14
Placement of the Body..........................................................................................................................14
Getting Old............................................................................................................................................14
Pregnancy..............................................................................................................................................14
Medication-Induced Adverse Effects........................................................................................................14
Definition..............................................................................................................................................14
Prevalence.............................................................................................................................................15
Pathophysiology....................................................................................................................................16
Diagnostic Evaluation...........................................................................................................................18
Treatment..............................................................................................................................................19
Mild Physical Activity..........................................................................................................................19
Getting Lots of Water............................................................................................................................19
Changing Footwear...............................................................................................................................20
Pharmacological Intervention....................................................................................................................20
Quinine..................................................................................................................................................20
Risks:....................................................................................................................................................20
Efficacy.................................................................................................................................................21
Non-Pharmaceutical Interventions........................................................................................................22
Stretching before Sleep Reduce the Frequency and Severity of Nocturnal Leg Cramps in Older Adults
..............................................................................................................................................................22
Objective...............................................................................................................................................23
Rationale of Study:................................................................................................................................23
Literature Review..................................................................................................................................25
Material and Method.................................................................................................................................28
3.1 Study Design...................................................................................................................................28
3.2 Settings............................................................................................................................................28
3.3 Duration of Study............................................................................................................................28
3.4 Sample Size.....................................................................................................................................28
3.5 Population WRT 9 cities.................................................................................................................28
3.6 Error................................................................................................................................................28
3.7 Confidence level..............................................................................................................................28
3.8 Response distribution......................................................................................................................28
3.9 Sample size.....................................................................................................................................28
8
LIST OF FIGURES
Figure 17: Bar Chart of Hours per Day You Stand at Your Work
Figure 18: Bar Chart Showing Last 12 Months, Cramps in Your Calf or Feet at Night
Figure 19: Bar chart of how painful they have been?
Figure 20: Bar chart of what you do to get relief from your muscle cramp?
Figure 21: Bar chart of rate pain according to Visual Analogue Scale
Figure 22: Pie-Chart of Visual Analogue Scale
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LIST OF TABLES
Table 1: Descriptive Statistics of Age:
Table 2: Descriptive Statistics of Occupation:
Table 3: Descriptive statistics of Gender
Table 4: Descriptive statistics of City Name
Table 5: Descriptive statistics of Smoking
Table 6: Descriptive Statistics of muscle cramps, involuntary painful muscle contraction occurring at
rest
Table 7: Descriptive statistics of how often have you experienced these symptoms?
Table 8: Descriptive statistics of Cramp localization
Table 9: Descriptive statistics of when you have cramp?
Table 10: Descriptive statistics of how long cramp last?
Table 11: Descriptive statistics of aggravating factor
Table 12: Descriptive statistics of Medication:
Table 13: Descriptive statistics of duration of standing work
Table 14: Descriptive statistics of consecutive standing hours
Table 15: Descriptive Statistics of Type of Shoes Worn on Job
Table 16: Descriptive statistics of stand usually while working
Table 17: Descriptive statistics of hours per day you stand at your work
Table 18: Descriptive statistics of during past 12 months, cramps in your calf or feet at night
Table 19: Descriptive statistics of how painful they have been?
Table 20: Descriptive statistics of what you do to get relief from your muscle cramp?
Table 21: Descriptive statistics of rate pain according to visual analogue scale
Table 22: Descriptive statistics of visual analogue scale
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Abbreviations
ABSTRACT
Background:
Nocturnal leg cramps are painful and involuntary muscle contractions that occur in the legs during sleep,
particularly the calves. The cramps may be felt just before falling asleep or upon awakening and typically
last less than five minutes. They mainly affect calf muscles, but they can also affect the foot and thighs.
Leg cramps can strike anyone at any age, although they are more prevalent and often more severe as
age progresses. In a general practice-based study of 233 patients aged 60 and above, about a third, had
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rest cramps in the previous two months, including half of those aged 80 and up, 40% had cramps more
than three times per week, 21% regarded their symptoms as quite upsetting. According to most
research, women, particularly older women, are more likely to experience nocturnal cramps.
Objective:
To study prevalence and risk factors of nocturnal leg cramps in young adults in Punjab. Moreover, to
analyze the risk factors of nocturnal leg cramps.
Result
Based on this study it is concluded that Nocturnal Leg Cramps are directly associated with prolong
standing for 3 to 4 hours without changing body position. Moreover, it shows that majority of people
felt cramps in their calf muscles.
Conclusion:
Nocturnal leg cramps were more prevalent in teachers, labors and medical professionals and associated
risk factors were prolong standing, medications, and foot wear.
Keywords:
Nocturnal Leg Cramps, Muscle Cramps, Pain, Prevalence, Risk Factors
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1
Introduction
INTRODUCTION
Leg cramps, also known as nocturnal or resting leg cramps, are abrupt, involuntary, and painful
muscle spasms that mainly affect the calf muscles or the tiny muscles of the foot .In ;2002, an assessment
of the state of knowledge on the topic revealed a number of important gaps, including ambiguity about
safety and efficacy of quinine, a lack of alternative drugs, and a lack of data for physical cramp
prevention .This article examines the current understanding about the diagnosis, frequency, aetiology, and
treatment of nocturnal leg cramps.(Rabbitt, Mulkerrin et al. 2016)
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Leg cramps are excruciatingly painful and incapacitating, lasting approximately nine minutes per
episode. Hours of recurrent episodes and residual pain may follow the acute episode. Leg cramps are
most common at night and are associated with secondary insomnia. Cramping of the posterior calf
muscles is common but cramping of the foot and thigh is also common. Leg cramps are also known as
spasms, tightening, twinges, strains, and tetany, swelling, or muscle seizures. Cramps can be isometric or
cause limb movement, such as extreme plantar flexion.(Allen and Kirby 2012)
Leg pain and discomfort are common complaints in any primary care clinic. Nocturnal leg cramps
(NLC) and restless leg syndrome (RLS) are two common causes of pain or discomfort in the legs (RLS).
NLC manifests as painful and sudden contractions, primarily in the calf. NLC is primarily diagnosed
clinically, with some investigations required to rule out other mimics. RLS is a condition characterised by
the discomfort or urge to move the lower limbs while at rest or in the evening/night. Because RLS and leg
cramps are so similar, there is a risk of misdiagnosis and misclassification. In this paper, we will look at
the pathophysiology of each entity, as well as their diagnosis and treatment.(Tipton and Wszołek 2017)
Sleep-related leg cramps, also known as NLCs, are painful muscle spasms that occur during night
and are eased by stretching the afflicted muscles. NLCs have been documented in around 25% of patients
with various sleep-related issues, with 6% reporting moderate to severe NLCs. In a recent survey, cramps
associated with sleep disruption were recorded in people of various ages. NLCs can occur at any age, but
they become more prevalent and severe as people get older. They're linked to poor sleep quality and, as a
result, a reduced health-related quality of life.(Tipton and Wszołek 2017)
RISKS
Muscular Fatigue
The existing data implies that muscle exhaustion is a key cause of nocturnal leg cramps, according
to a review. Leg cramps are more common among athletes who engage in higher amounts of activity than
the average person. Some people may have more cramping later in the day as a result of overexertion,
such as exercising muscles really vigorously for a long time. Long durations of standing during the day,
which is common in many industries, can cause muscle tiredness. Muscles tear out during the day and are
more prone to cramping later in the evening.(Allen and Kirby 2012)
night in someone who does not stretch their muscles or exercise regularly. Less physically active persons
may have shorter muscles, which increases the risk of cramping and spasms.(Allen and Kirby 2012)
Getting Old
Leg cramps during the night may become more common as people get older. According to a study
published in the journal BMC Family Practice, chronic nocturnal leg cramps affect up to 33% of persons
over the age of 50Trusted Source.(Allen and Kirby 2012)
Pregnancy
Leg cramps at night could potentially be linked to pregnancy. This could be related to the body's
higher dietary needs or hormonal changes during pregnancy.(Allen and Kirby 2012)
Teriparatide (Forteo)
Raloxifene (Evista)
Levalbuterol (Xopenex)
Albuterol/Ipratropium (Combivent
Conjugated Estrogens
Pregabalin
Intravenous Iron
Sucrose
Naproxen(Allen and Kirby 2012)
Definition
The inability to agree on a specific definition of nocturnal leg cramps has hampered progress in
this area. Although the most recent International Classification of Sleep Disorders (2014) definition may
be useful in the future, it has not yet been widely adopted. This section describes three diagnostic criteria.
A painful sensation in the leg or foot accompanied by involuntary muscle hardening or tightening,
indicating a powerful muscle contraction. The painful muscular contractions occur while you are in bed
and can occur while you are awake or asleep. Forceful stretching of the afflicted muscles alleviates pain
by relieving contraction.
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Muscle cramps caused by neuromuscular or systemic illnesses, in contrast to nocturnal leg cramps,
are more likely to occur during the day or affect other sections of the body. While the majority of
cramps in normal controls were nocturnal and occurred in the calves in one study, cramps in
amyotrophic lateral sclerosis patients were frequently located in the distal small muscles of the toes or
feet, as well as those of the fingers or hands, were primarily movement-induced, and occurred both
during the day and at night .Other muscular cramps occur in certain circumstances, such as after
strenuous, frequently unfamiliar activity or during dialysis. (Rabbitt, Mulkerrin et al. 2016)
Prevalence
Prevalence is about 60% in adults; these nocturnal cramps cause sleep difficulties due to painful
tightening of leg muscles. Nocturnal leg cramps are most common and frequently unreported to
physicians. 16 to 18 years of the population at its peak occurrence, but there is no case outline less than
eight years of age. There are 7 % nocturnal leg cramps reported in the pediatric population. Moreover,
40% of nocturnal leg cramps above 50 years of age in the general population, their rate of occurrence
increases with age). Leg cramps are increasingly common as people get older. In both Australia and
Canada, one study reported a significantly higher rate of cramps in the summer compared to the winter
months, using fresh quinine prescriptions. Leg cramps in the middle of the night can have a significant
influence on one's quality of life. In addition to the misery produced by pain, people who have cramps
frequently report more sleep interruptions, poorer sleep quality, and daily somnolence than matched
controls who do not have cramps .(Rabbitt, Mulkerrin et al. 2016)
Sleep disruption during pregnancy can cause excessive daytime sleepiness, decreased daytime
performance, inability to concentrate, irritability, and the possibility of a longer labor and an increased
risk of operative birth. A sleep disorder, such as leg cramps, a common but benign disorder, or restless
legs syndrome, a sensorimotor disorder, can cause sleep disruption. Both disrupt sleep, are distressing for
the pregnant woman, and mimic each other as well as other serious disorders. Leg cramps can affect up to
30% of pregnant women, and restless legs syndrome can affect up to 26% of pregnant women. (Hensley
and health 2009)
We used data from the National Health and Nutrition Examination Survey to assess the prevalence of
NLC at the population level, as well as relationships with a wide range of possible correlates (NHANES).
To assess NLC correlates in a representative US population sample, researchers used the 2005–2006
NHANES wave as a test sample and the 2007–2008 wave as a validation sample.
Female sex, leg claudication, electrolyte imbalance, pregnancy, peripheral neuropathy, peripheral
vascular disease, angina, and arthritis are some of the other factors that have been linked to NLC. Inhaled
long-acting beta-agonists, statins, and diuretics are some of the possible pharmaceutical causes.
According to current prevalence estimates, leg cramps affect 37–50% of older persons. In one study, 24
percent of individuals with NLC described their symptoms as "very unpleasant" in an older demographic.
However, because only a small percentage of patients report them in clinical interactions, they are
frequently overlooked by physicians. A better understanding of the epidemiology of NLC is the first step
in developing therapeutically useful strategies for detecting and treating the disease.
Pathophysiology
Leg cramps' exact cause is unknown, but several myopathic, neurologic, and metabolic causes
have been proposed. Leg cramps are idiopathic in the vast majority of instances. Muscle cramps are
caused by the repeated firing of motor unit action potentials at a much faster rate than involuntary
contractions. The majority of data implies that this is caused by spontaneous motor neuron discharges
rather than a central or muscle origin. Impaired excitability of anterior horn cells or intramuscular motor
nerve terminals are two factors that may play a role. The production of motor discharges is influenced by
afferent fibers, and sensory input disturbances may contribute to muscular cramps.
Motor neuron loss, which is more severe in the legs than in the arms, is frequent in later age and
may lead to an increased likelihood of leg cramps in the elderly. A case–control study of mostly elderly
adults found that those who had nocturnal cramps scored lower on tests of lower limb muscle strength
than those who did not. Mechanical factors such as tendon shortening in later life and extended
immobility can potentially contribute to cramp development by increasing nerve terminal excitability.
Leg cramps are thought to start in the lower motor neuron, where hyperactive, high-frequency,
involuntary nerve discharge occurs. Our "civilized" lifestyle, according to some scientists, no longer
necessitates repetitive squatting, which stretches the leg tendons and muscles. Others have argued that
because the foot is passively in plantar flexion and the calf muscle fibers are already maximally shortened
in the nighttime recumbent position, unrestrained nerve activation causes cramping.
According to research, leg cramps are caused by muscle exhaustion. According to studies of
endurance athletes, leg cramps are associated with a higher-than-normal intensity of exercise. Standing
labor has advantages and disadvantages for both men and women. In a sexually stratified study, both male
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and female workers were significantly more likely to develop varicose veins after prolonged standing.
Nighttime leg cramps, on the other hand, were only common among male workers who stood for long
periods of time. According to the models that included gender, prolonged standing, and professions in
that order, gender is not significantly related to varicose veins once jobs are included in the model. Long
periods of standing at work could be a bigger role in varicose veins and nighttime cramps than biological
variations between men and women. For the prevention of spider veins and nighttime leg cramps,
appropriate measures to halt or reduce extended standing at workplace should be implemented.
There is being a significant relationship between alcohol intake and nocturnal leg cramps. Patients who
are chronic drinkers has been more prone to get nocturnal leg cramps than those who are not. Amount of
intake does not matter according to a study. Exercise-induced cramps and nocturnal cramps have been
linked to hypovolemia (dehydration) or electrolyte imbalances like potassium, sodium, or magnesium.
Leg cramps are not linked to changes in creatinine, calcium, magnesium, sodium, potassium, zinc, sugar,
transaminase, total bilirubin, or albumin levels, according to a study of individuals with nonalcoholic
cirrhosis. Lots of drugs have been linked to muscle cramps, but only very few of them are unique to the
legs. Although the total incidence is relatively low, intravenous iron sucrose, conjugated estrogens,
Raloxifene (Evista), naproxen (Naprosyn), and Teriparatide (Forteo) are the most usually associated
medications with leg cramps such as clonazepam (Klonopin), citalopram (Celexa), celecoxib (Celebrex),
gabapentin (Neurontin), and zolpidem (Ambien). Leg cramps were linked to quinine usage in the year
after new prescriptions for diuretics, statins, and inhaled long acting beta2 agonists, according to a recent
study. However, the study was hampered by worsening medical situations (such as myocardial
infarctions) and an increase in the number of participants.(Allen and Kirby 2012)
Leg cramps are linked to a number of medical conditions. Legs cramping were experienced in 75
percent of outpatient veterans with peripheral arterial disease, 63 percent of those with hypokalemia, and
62 percent of those with cardiovascular disease, according to a study. Leg cramps are observed in about
60% of patients with cirrhosis, the majority of whom are elder individuals with severe disease. Leg
cramping have been connected to neurological disorders like Parkinson's disease and nerve damage. Leg
cramps are also linked to lumbar canal stenosis. Leg cramps may be caused by nerve injury caused by
cancer treatment, according to a tiny study that found leg cramps in 82 % of cancer patients. Cramping is
associated to hemodialysis, but not to chronic renal disease.(Rabbitt, Mulkerrin et al. 2016)
Leg cramps have been associated to venous insufficiency, although research has not established
that cramps are induced by hypo-perfusion or toxic metabolites, as venous insufficiency treatment has not
been shown to improve cramps. Leg cramps have long been connected with pregnancy, albeit it can be
difficult to distinguish between pregnancy and venous insufficiency as the major reason. Although
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cramps can be associated with central neurological conditions such as Parkinson's disease and multiple
sclerosis, possibly as a result of spinal disinhibition or immobility, cramps are most commonly associated
with disorders affecting the lower motor neuron. Cramps are a common early symptom of MND,
occurring in more than 60% of those with polyneuropathy. A small study of patients with cramps but no
neuropathic complaints who had skin biopsies revealed a high prevalence of small-fiber neuropathy, a
condition that primarily affects the elderly.(Allen and Kirby 2012)
Diagnostic Evaluation
The key to determining the reason of leg cramps is to look at the patient's medical history.
Symptoms include nocturnal incidence, apparent muscle tension, and abrupt, acute pain. A review of
drugs and current medical conditions must be included in the history. Although it is important to
recognize and discuss underlying medical disorders, there is no evidence that treating these illnesses helps
leg cramp symptoms. Leg cramps are difficult to detect on physical examination since they are
uncontrolled, spontaneous, and generally occur at night. The results of the examination could point to an
underlying medical problem, such as peripheral arterial disease. Inspection of the legs and feet, pulse
palpation, and assessment of touch and pinprick sensations, strength, and deep tendon reflexes are all part
of a proper examination.
To determine cardiovascular risk factors, blood pressure should be assessed. Tremors, gait
disruption, and asymmetry are all symptoms of neurologic illness. Leg cramps have no demonstrated link
with electrolyte disorders, anemia, glucose levels, thyroid hormone, or kidney illness, therefore routine
blood tests are not useful in the diagnosis. Selected blood tests, such as hepatic enzyme values for
cirrhosis, blood lipids for cardiovascular illness, and vitamin B12 readings for associated neuropathy,
may be advised in specific patients to diagnose underlying medical disorders. Other diagnostic tests,
including as nerve conduction, ultrasonography, and angiography, are also not required unless they are
needed to confirm certain medical disorders. There has been no research into how addressing underlying
medical conditions affects leg cramps. Nonetheless, the occurrence of "leg cramps" provides a valuable
opportunity for family doctors to correctly diagnose diseases such as venous stasis, peripheral vascular
disease, or nerve damage. It can be difficult to distinguish between leg cramps and restless legs syndrome,
so a test of dopaminergic medications is a sensible stance for a patient with combined symptoms.(Allen
and Kirby 2012)
Treatment
Leg cramp management has been described as frustrating and difficult for clinicians and patients alike.
It has been suggested that many people do not benefit from the treatments prescribed and that many more
do not receive any treatment at all, but these claims have not been investigated.
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The most common interventions can be broadly classified as drug or non-drug interventions. Quinine
sulphate (El-Tawil 2010), gabapentin (Miller 2005), magnesium (Frusso 1999; Roffe 2002; Sohrabvand
2006), and vitamin E are common drug interventions. Calcium channel blockers (Connolly 1992;
Burnakis 2000) (Baltodano 1988), Naftidrofuryl oxalate (Young 1993), and calcium (Baltodano 1988).
(Sohrabvand 2006).
Non-drug interventions mentioned in the Stretching of the muscles (Daniel 1979; Jones 1983.
Massage (Jones 1983; Kanaan 2001; Matsumoto 2009);
Matsumoto 2009); relaxation (Joekes 1982); sensory nerve stimulation (Bentley 1996); footwear
modifications (Roberts 1965); weight loss (Roberts 1965).
Weight loss (Roberts 1965); physical activity (Miller 2005); avoiding
Physical exhaustion (Roberts 1965); heat therapy (Jones 1983); compression garments (Young
2009); night ankle swelling
Night ankle dorsiflexion splints (Miller 2005); placebo (Miller 2005); reassurance (Butler 2002);
and sleeping changes (Gootnick 1943; Moss 1948; Cutler 1984).
Abdulla 1999; Leung 1999; Kanaan 2001; Warburton 1987) and
Sitting position (Roberts 1965). Sleeping with a horseshoe is one of history's more contentious
inventions (Simchak 1991),
A magnet (Fowler 1973), corks (Warburton 1987), or potatoes (Warburton 1987)
Beneath the mattress (Warburton 1987).
Changing Footwear
Cramping can be reduced by wearing more supportive shoes. Shoes with a supportive sole or that are
specifically designed for medical use are ideal. If a person has no experience with shoes, a podiatrist can
assist him. (Grandner and Winkelman 2017)
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PHARMACOLOGICAL INTERVENTION
Quinine
Quinine and also its variants are alkaloids found in the cinchona tree's bark. They have been used to
treat leg cramps for decades because they diminish the responsiveness of the motor neuron in response
to nerve stimulation. Quinine is also used to flavor foods and beverages, such as tonic water as well as
bitter lemon. A classic mixer glass of tonic water is full 7–14 mg of quinine, depending on the brand.
Quinine users got an extra day without cramps on average out of every 14 days, a 20% reduction. The
intensity of the cramps was reduced by 0.12, or 10%, on a scale of 1 to 3 (moderate to severe). (Rabbitt,
Mulkerrin et al. 2016)
Risks:
Quinine use has been linked to a variety of serious and sometimes fatal immune-mediated
responses, including thrombocytopenia. Thrombocytopenia affects between 1:1,000 and 1:3,500 quinine
users, according to a 1994 US Food and Drug Administration (FDA) investigation a more recent estimate
implies a rate of 1.7/1,000 person-years. Quinine is second only to its stereoisomer quinidine as a cause of
drug-induced thrombocytopenia and the most prevalent cause of drug-induced thrombotic
macroangiopathy, according to systematic reviews. Such reactions are not dose-dependent and can occur
after consuming quinine-containing beverages (implying that the true frequency of quinine-induced
reactions is likely to be underestimated). Immune-mediated responses usually happen within 3 weeks
after starting quinine, although they might happen longer, especially if you use it intermittently.
Other quinine issues are dose-dependent, and serum quinine levels are significantly linked to the
incidence of these adverse effects. Quinine overdose, which can occur inadvertently in the elderly, is
exceedingly harmful and can result in death from heart failure as well as chronic vision impairment and
blindness. ‘Cinchonas,' a constellation of symptoms including nausea, vomiting, headache, vertigo, visual
abnormalities, tinnitus, and hearing impairment, can occur with therapeutic doses of quinine. These
adverse effects are normally reversible when you stop taking the medicine.
In comprehensive Danish epidemiological research of 1,35,000 patients with heart failure, quinine
was shown to be taken by more than 10% at some stage and was linked to an elevated mortality risk,
especially in those using concurrent beta-blockers and early in treatment. Although the mechanism for the
increase in deaths was unclear, and such studies by definition cannot rule out all potential contributing
effects, this was a large and thorough study, and the conclusion that "the risk of quinine being a serious
risk to heart failure patients is very high" seems reasonable. Because altered pharmacokinetics with age
results in greater uptake, less effective metabolism, a significantly longer half-life, higher blood quinine
concentrations, and a greater risk of drug accumulation with chronic treatment, even in healthy older
24
subjects, the rate and severity of adverse effects may be greater in older people. Even low-dose quinine
produces measurable but clinically silent impairment in hearing and vestibular function testing in so many
young healthy volunteers. Older adults, especially those with pre-existing sensory impairments, are more
susceptible to such consequences; conversely, the presence of pre-existing visual or hearing impairments
may disguise early indicators of quinine poisoning. Finally, several of the quinine-interacting medicines
are likely being used by aged patients.(Rabbitt, Mulkerrin et al. 2016)
Efficacy
A 2015 Cochrane review found 23 randomized controlled trials (RCTs) including over 1,500
participants, predominantly older people with unexplained nocturnal leg cramps (median 300 (range 200–
500) mg/day). Quinine reduced the number of cramps by 28% during a 2-week period when compared to
placebo (absolute difference of about 2.5 cramps). Quinine users got an extra day without cramps on
average out of every 14 days, a 20% reduction. The intensity of the cramps was reduced by 0.12, or 10%,
on a scale of 1 to 3 (moderate to severe). Though all of these distinctions were statically important, the
0.12 decrease in cramp severity was less than the 0.16 drop on a 3-point life quality measure that would
be considered the lowest clinically relevant difference. There was inadequate information to determine
the best dosage or treatment duration for quinine.
The fact that certain people can benefit significantly with quinine may be obscured by aggregated
data. Individual benefit can be assessed in N-of-1 trials, in which people serve as their own controls. In a
series of N-of-1 trials, ten patients who'd been taking quinine for cramps having undergone three double-
blind crossover testing in which they alternated among quinine and placebo for four weeks at a time,
quinine was obviously beneficial for only three patients, six showed a non-significant benefit, and one
showed no benefit (though all decided to continue quinine post-study).
Despite the generally favorable findings with quinine, RCTs of this and other medicines reveal
that a strong placebo response is common. It's likely that this is a regression to the mean, which could be
exacerbated by seasonal differences in cramp frequency. Only one study has looked into the effects of
stopping quinine treatment over a long period of time. 94 of 191 patients in general practice who had been
prescribed quinine for night cramps were advised to stop taking it as part of a trial of stretching exercises.
At 12 weeks, those who received this counsel were more than three times as likely (absolute difference
26%) to cease using quinine, and discontinuation was not linked to an increase in cramp symptoms. In
comparison to vitamin E alone, a quinine–vitamin E combination, or xylocaine injections into in the
gastrocnemius muscles, quinine had no significant differences in efficacy. On all outcome metrics, a
quinine–theophylline combination appeared to be considerably better than quinine alone despite
significant methodological concerns.
25
Despite the generally favorable findings with quinine, RCTs of this and other medicines reveal
that a strong placebo response is common. It’s likely that this is a regression to the mean, which could be
exacerbated by seasonal differences in cramp frequency. Only one study has looked into the effects of
stopping quinine treatment over a long period of time .94 of 191 patients in general practice who had been
prescribed quinine for night cramps were advised to stop taking it as part of a trial of stretching exercises.
At 12 weeks, those who received this counsel were more than three times as likely (absolute difference
26%) to cease using quinine, and discontinuation was not linked to an increase in cramp symptoms.
(Rabbitt, Mulkerrin et al. 2016)
Non-Pharmaceutical Interventions
Cramps can be relieved by extending the impacted muscles or tightening an antagonist group of
muscles via reciprocal inhibition reflexes. Calf cramps can be relieved by forced dorsiflexion of the ankle
with the knee extended, for example. As a result, preventive stretching has been proposed as a mechanism
to reduce nighttime leg cramps. Footwear adjustments, night ankle dorsiflexion splints, changes in sleep
pattern, prevention of heavy bed covers, and folklore treatments such as lying with something like a
horseshoe or potato beneath the mattress have all been described as non-drug interventions. Cramping can
be relieved by avoiding long periods of standing for several hours. Reduced leg cramps can be achieved
by avoiding smoking and consuming less alcohol.(Rabbitt, Mulkerrin et al. 2016)
Stretching before Sleep Reduce the Frequency and Severity of Nocturnal Leg Cramps in
Older Adults
Is it possible to reduce the frequency and severity of nocturnal leg cramps in adults by stretching
the calf and hamstring muscles each day just before bed? Intention-to-treat analysis in a randomized trial
with concealed allocation. Eighty adults over the age of 55 with nocturnal leg cramps who were not
receiving quinine treatment. For six weeks, the experimental group stretched their calf and hamstring
muscles before bedtime. There were no specific stretching exercises performed by the control group. Both
groups went about their regular business. The frequency of nocturnal leg cramps was recorded in a daily
diary by the participants. On a 10-cm visual analogue scale, participants also recorded the severity of their
pain from nocturnal leg cramps. Aside from that, adverse events were documented. The study was
finished by all participants. The experimental group had a considerably lower rate of nocturnal leg cramps
at six weeks, with an average difference of 1.2 cramps each night (95 percent CI 0.6 to 1.8). On the 10-cm
visual analogue scale, the severity of nocturnal leg cramps was reduced substantially more in the
experimental group than in the control group, with a mean difference of 1.3 cm (95 percent CI 0.9 to 1.7).
In older persons, stretching before bedtime lowers the frequency and severity of nocturnal leg cramps.
(Hallegraeff, Van Der Schans et al. 2012)
26
Myofascial-Release Technique
According to several authors, neuromuscular structures in muscle, tendons, and nerve fibers appear to be
the cause of muscle cramps. Musculoskeletal problems associated with a sedentary lifestyle, as well as
employment postures, prolonged standing, and the western habit of sitting rather than squatting, have
been linked to cramps, particularly NLC. Patients who have cramps have a higher chance of developing
peripheral vascular disease than those who do not. Stretching before bedtime can help elderly people with
nocturnal leg cramps reduce the frequency and intensity of their cramps. NLC can be relieved with
stretching procedures such as Myofacial Release. Self-Myofacial Release (SMFR) is a type of Myofacial
Release (MFR) performed by the individual rather than a therapist, and it is usually done with the aid of a
tool. Self-MFR is a low-cost, readily available method of relieving muscle and soft tissue pain while
maintaining flexibility. Foam rollers and roller myofascial release are two of the most popular self-MFR
devices. MFR is used to treat a variety of musculoskeletal disorders; it is used to treat a variety of
problems, and many types of treatment, including trigger-point therapy and proprioceptive neuromuscular
facilitation, fall under the myofascial broader category. (Garrison 2014)
Objective:
To study prevalence and risk factors of nocturnal leg cramps in young adults in Punjab. Moreover, to
analyze the risk factors of nocturnal leg cramps.
Rationale of Study:
The sole rationale of this study was to focus on the direct interactive association between the prevalence
and risk factors of nocturnal leg cramps among young men and women. Also, prolonged standing at work
might be a more critical risk factor for nocturnal leg cramps than biological differences among men and
women.
Nevertheless, nowadays, this condition has prevailed among young adults as well. As this was obvious
from the studies that age related factors were causing nocturnal leg cramps in the older population, then
why was this condition increasing among the young population?
A scientific question has been raised in our minds: What was the particular reason behind this particular
condition that has been increased among young adults? What were the specific risk factors that were the
source of this condition among a specific population of age 20-40 years? So we have decided to choose
this topic because we were intended to know about the specific reason why this was more common in
young adults.
27
2
Literature Review
Literature Review
Sayaka Roy in 2020 conducted a study among diabetic patients to find out occurrence of nocturnal
leg cramps, its causes and available treatment methodologies. He performed cross sectional study on
two groups and found that in type 2 diabetics prevalence of NLC was 75.5% while in type 1 diabetics it
was 57.5%. He also observed that imbalance of electrolytes, low glucose level, nerve pathologies are
28
also related with occurrence of NLC among diabetics. According to his research, stretching was effective
for non-pharmacological treatment of NLC. He concluded that root cause of NLC among diabetics was
still not confirmed because of presence of other pathologies, which affected their life style and daily
activities.(Roy 2020)
Grandner and Winkelman in 2017 analyzed the prevalence of NLC in US population having heart
and sleep problems. According to his study NLC were more common among population who were
insomniac, taking sleeping pills, abnormal BMI readings having cardiac problems and general poor
health.(Grandner and Winkelman 2017)
Hallegraeff et al in 2017 performed ten observational studies and eight randomized control trials
to find the difference between RLS and NLC in older people above 50. He proposed that diagnostic
criteria for NLC includes seven properties that are severe pain, time interval ranging from seconds to few
minutes, area of cramps in lower limbs, recurrent pain, cramps in specific muscle, stress and sleep
disturbance. He concluded that above criteria was helpful for medical specialist to make a differential
diagnosis of NLC and RLS.(Hallegraeff, De Greef et al. 2017)
Mansouri et al. in 2016 performed cross sectional study among pregnant ladies. The objective of
his study was to find how complications during and after pregnancy, abnormal eating habits, lack of
activity during pregnancy were risk factors for NLC. NLC were more common after 27 weeks of
pregnancy and can be cured by taking nutritional supplements.(Mansouri, Mirghafourvand et al. 2016)
Garrison SR, Dormuth CR, Morrow RL, Carney GA, Khan KMJC in 2015 conducted a study on
seasonal effects of nocturnal leg cramps. He did research in all age groups in summers and winters and
compared the results. He found that the prevalence of nocturnal leg cramps was higher in midsummers
than in winters.(Garrison, Dormuth et al. 2015)
Rana AQ, Khan F, Mosabbir A, Ondo WJEron in 2014 studied Differentiating Nocturnal Leg Cramps
and Restless Leg Syndrome. He identified nocturnal leg cramps that were intense pain, duration of pain
ranging from seconds to 10 minutes. He also identified the location of pain primarily present in the calf,
foot, and hamstring and its relation to sleep disturbance and stress.(Rana, Khan et al. 2014)
Yeh C, Walters AS, Tsuang JWJS, breathing in 2012 studied the restless leg syndrome and analyzed
the relationship between the prevalence of nocturnal leg cramps, its risk factors, and the people having
a sedentary lifestyle. He found that the prevalence rate of restless leg syndrome in the general
population was 5 to 15%, and 2.5% of adult’s required medical interventions. The risk factors that he
29
included in his study for restless leg syndrome were Female gender, Pregnancy, Low iron level, Low
socioeconomic status, poor health, Elderly age, and positive family history for restless leg syndrome. He
concluded that there are different pharmacological and non-pharmacological interventions for restless
leg syndrome.(Yeh, Walters et al. 2012)
Bahk JW, Kim H, Jung-Choi K, Jung M-C, Lee IJE in 2011 studied to evaluate the connections and
difference in gender and contrast between the occupational features and symptoms of varicosity of
veins and nocturnal leg cramps in nurses. One hundred eighty-one nurses were included in his study
that had varicose veins. He concluded that with every one hour increase in standing time per day,
susceptibility of varicose veins was 27% greater. Furthermore, prolonged standing was the leading cause
of varicose veins in nurses, leading to Nocturnal Leg Cramps. Therefore, efficient interventions to
prevent varicosity of veins and nocturnal leg cramps should be implemented to interrupt or reduce long-
term employment.(Bahk, Kim et al. 2011)
30
3.2 Settings
The data was collected from 9 cities from Punjab including Jariwala, Sargodha, Dinga, Lahore, Joharabad,
Toba Tek Singh, Fateh Purr, Gujranwala, and Dera Ismail khan from working young adults between 20-40
years of population.
2
Z x p ( 1− p )
e2
2
1+ Z x p(1− p)
2
e N
3.6 Error
The study error was 5%.
DATA ANALYSIS:
The data was obtained and recorded in tabulated form, charts, and graphs. Moreover, descriptive
analysis was done using Statistical Procedure of Social Sciences (SPSS version 24.0).
Inclusion Criteria
Following subjects were included in our study
Age: 20- 40
32
Gender: Both
MucCulloh (2002) summarized that long standing for 8 hours causes leg cramps.
Meigsen and Hanneke (2017) reported that working for 2.5 hours in Long-standing cause’s leg
cramps, and in 18% of respondents, it exceeded 4 hours.
Hughes at El. 2011. In the guideline adopted by ARON and suggested that long-standing for 2
hours can cause fatigue which may lead to leg cramps.
Exclusion Criteria
Following subjects were excluded from our study.
Statistical Analysis:
SPSS stands for Statistical Package for Social Sciences, and it is a program that researchers used to
perform statistical analysis. There were 16 variables in this procedure. Variables are traits of interest
that could be observed and measured.
Descriptive statistics are a type of descriptive co-efficient that describes a data collection; it might be a
representation of the complete population or a sample of it. Descriptive statistics were used to
characterize the fundamental characteristics of a study's data. They offered short summaries of samples
and metrics, as well as basic graphic analysis. Percentages and frequency tables were plotted, and Pi or
Car Charts was plotted to show the percentages of different variables.
33
4
Results
34
300 100.0
This table shows age of 300 participants including in this study, minimum age 21 years, maximum age 48
years.
business 33 11.0
37
doctor 56 18.7
DVM 9 3.0
none 35 11.7
PT 70 23.3
sale man 10 3.3
student 13 4.3
teacher 74 24.7
Total 300 100.0
This table shows the occupation ‘s frequency and percentage of 300 participants including in this study.
Majority of participants were found teacher (frequency 74 and 24.7%).
38
This pie chart shows the occupation of 300 participants including in this study.
39
This bar chart shows gender of 300 participants, 145 males and 155 females.
40
Jarnwala 30 10.0
Dinga 30 10.0
Lahore 60 20.0
J0harabad 30 10.0
Gujranwala 30 10.0
Sargodha 30 10.0
This bar chart shows the frequency and percentage of smoking among 300 participants.
43
Muscle cramps, involuntary painful muscle contraction occurring at rest not Percen
associated with exercise in the last 3 months Frequency t
no 158 52.7
yes 142 47.3
Total 300 100.0
This bar chart shows the frequency and percentage of muscle cramps, involuntary painful muscle
contraction occurring at rest not associated with exercise in the last 3 months among 300 participants.
44
TABLE 8: DESCRIPTIVE
STATISTICS OF CRAMP
LOCALIZATION
This table shows the frequency and
percentage of cramp localization among 300 participants. Majority of cramps were found in calf muscles
(frequency 88 and 29.30%).
Fingers 28 9.3
abdomen 35 11.7
Neck 52 17.3
Calf 88 29.3
Total 300 100.0
This pie-chart shows the frequency and percentage of cramp localization among 300 participants.
This bar chart shows the frequency and percentage of when you have cramps among 300 participants.
Hours 52 17.3
Total 300 100.0
This bar chart shows the frequency and percentage of how long cramp last among 300 participants.
This Pie-chart shows the aggravating factor of 300 participants included in this study.
This Pie-chart shows the frequency and percentage of medication for more than a month among 300
participants included in this study.
included in this study. Majority of duration of standing work, between 2pm-7pm (frequency 111 and
37.00%).
50
This bar chart shows the frequency and percentage of duration of standing work among 300 participants
included in this study
1 hour 74 24.7
3 hours 131 43.7
4 hours 95 31.7
Total 300 100.0
This bar chart shows the frequency and percentage of consecutive standing hours among 300
participants included in this study.
This pie-chart shows the frequency and percentage of type of shoes worn on job among 300 participants
included in this study.
This bar chart shows the frequency and percentage of stand usually while working among 300
participants.
54
This bar chart shows the frequency and percentage of hours per day you stand at your work among 300
participants.
55
during past 12 months, cramps in your calf or feet at night more than once a
month Frequency Percent
Yes 50 16.7
Sometimes 188 62.7
No 62 20.7
Total 300 100.0
This bar chart shows the frequency and percentage of during past 12 months, cramps in your calf or feet
at night more than once a month of 300 participants.
56
This bar chart shows the frequency and percentage of how painful cramps have been among 300
participants
57
What you do to get relief from your muscle cramp? Frequency Percent
Nothing 108 36.0
over the counter pain medication 66 22.0
prescribed pain medication 68 22.7
Other 58 19.3
Total 300 100.0
This bar chart shows the frequency and percentage of what you do to get relief from your muscle cramp
among 300 participants.
58
This bar chart shows the frequency and percentage of rate pain according to visual analogue scale
among 300 participants
59
this study.
60
5
Discussion
DISCUSSION
Muscle cramps are sustained, painful contractions of muscle and are prevalent in patients with and
without medical conditions. Investigations are directed toward identifying physiological triggers or
medical conditions predisposing to cramps. Although cramps can be self-limiting, disabling, or sustained
muscle cramps should prompt investigation for underlying medical conditions. Lifestyle modifications.(1)
This was cross sectional study conducted to find the prevalence and risk factors for nocturnal leg cramps.
Convenience sampling was done, and data was collected through online form. Sample size was 300, both
61
males and females were included in the study. Age of participants was between 20 to 40 with maximum
9.0% (n=27) 32years old and 33 years old. Age is also a factor indicating the prevalence of leg cramps
among specific age group nocturnal leg cramp (NLC) increased with age. (2) Present study has teachers
are most 24.7% (n=74) common participants of this study and they reported more leg cramps which can
be associated with duration of their stand activity and duration. Present study found most common
aggravating factor found was standing (frequency 86 and 28.70%). Majority of consecutive standing
hours are 3 hours (frequency 131 and 43.70%).
A study reported risk factors included older age, a longer history of running, higher body mass index
(BMI), shorter daily stretching time, irregular stretching habits, and a positive family history of cramping.
(3) Present study found Majority of cramps were found in calf muscles (frequency 88 and 29.30%).
Nocturnal leg cramps reportedly occur frequently in the calf muscles. In most subjects (73%) the cramps
occur only at night; 20% of patients report cramps during the day and night, and 7% have only daytime
cramps. (4) While in this study 38.3% (n=115%) report leg cramp at night, 37.7% (n=113) participants
reported leg cramp at daytime and 24% (n=72) participants reported leg cramps during day and night.
Only day and nighttime cramp percentages are equal to previous findings while only day or only night
leg cramps percentages were not equal to previous findings.
Another study reported the prevalence and risk factors for muscle cramps was 25.9%. Age, female sex,
lower BMI, existence of comorbid diseases, and liver fibrosis were associated significantly with muscle
cramps.(5) Majority of participants were found with unbearable pain (frequency 132 and 44.00%). These
findings were inconsistent with previous study showing 40% participants have unbearable pain during
cramp. (6)
Majority of pain rate were found in mild pain (frequency 101 and 33.7%). A study supporting our
findings Prevalence was 24–25% reporting mild pain and 6% reporting moderate-severe pain NLC. Seven
diagnostic characteristics of nocturnal leg cramps: intense pain, period of duration from seconds to
maximum 10 minutes, location in calf or foot, location seldom in thigh or hamstrings, persistent
subsequent pain, sleep disruption and distress. (7)
62
63
6
Conclusion
CONCLUSION
Prevalence of nocturnal leg cramps was 38. 3% among the young population. It’s more prevalent in
medical professionals, teachers’ and labors. Foot wear, certain medications, standing duration and
certain medications like Beta blockers, Quinine, Verapamil, and Vitamin E. This study will pave further
ways for new researchers to find out prevalence and risk factors limitations in the young adults with
nocturnal leg cramps. Moreover, it will help to find out the accurate solutions for a better outcome
regarding those health issues in community.
LIMITATIONS
RECOMMENDATIONS
64
CONFLICT OF INTEREST
There were no conflicts of interest in this study. In this study, there are no personal gains or ambitions.
The key research requirement was to keep outside sources out of the picture.
The researcher did not work for anyone else during the research period. There was no financial support
from any organizations or individuals for the research. This study is unbiased and free of any personal
bias.
65
7
REFERENCES
REFERENCES
1. Katzberg HD. Neurogenic muscle cramps. Journal of Neurology. 2015;262(8):1814-21.
2. Grandner MA, Winkelman JW. Nocturnal leg cramps: Prevalence and associations with
demographics, sleep disturbance symptoms, medical conditions, and cardiometabolic risk
factors. PLoS One. 2017;12(6):e0178465.
3. Maughan RJ, Shirreffs SM. Muscle Cramping During Exercise: Causes, Solutions, and
Questions Remaining. Sports Medicine. 2019;49(2):115-24.
4. Kim D-H, Yoon DM, Yoon KB. The effects of myofascial trigger point injections on
nocturnal calf cramps. The Journal of the American Board of Family Medicine. 2015;28(1):21-7.
66
7. Hallegraeff J, de Greef M, Krijnen W, van der Schans C. Criteria in diagnosing nocturnal leg
cramps: a systematic review. BMC family practice. 2017;18(1):1-9.
8. Bahk, J. W., et al. (2011). "Relationship between prolonged standing and symptoms of
varicose veins and nocturnal leg cramps among women and men." Ergonomics 55(2): 133-139.
9. Garrison, S. R., et al. (2015). "Seasonal effects on the occurrence of nocturnal leg cramps: a
prospective cohort study." Canadian Medical Association Journal 187(4): 248-253.
10. Grandner, M. A. and J. W. Winkelman (2017). "Nocturnal leg cramps: Prevalence and
associations with demographics, sleep disturbance symptoms, medical conditions, and
cardiometabolic risk factors." PLOS ONE 12(6): e0178465.
11. Hallegraeff, J., et al. (2017). "Criteria in diagnosing nocturnal leg cramps: a systematic
review." BMC Family Practice 18(1).
12. Mansouri, A., et al. (2016). "Prevalence of Leg Cramps in the Third Trimester of Pregnancy
and Its Relationship to Nutritional Behavior and Consumption Supplementation in Pregnancy."
Journal of Sabzevar University of Medical Sciences 23(5): 740-747.
13. Rana, A. Q., et al. (2014). "Differentiating nocturnal leg cramps and restless legs syndrome."
Expert Rev Neurother 14(7): 813-818.
14. Roy, S. (2020). "Muscle cramps — a mini review of possible causes and treatment options
available with a special emphasis on diabetics — a narrative review." Clinical Diabetology 8(6):
310-317.
15. Yeh, P., et al. (2012). "Restless legs syndrome: a comprehensive overview on its
epidemiology, risk factors, and treatment." Sleep Breath 16(4): 987-1007.
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16. Allen, R. E. and K. A. J. A. f. p. Kirby (2012). "Nocturnal leg cramps." 86(4): 350-355.
17. Garrison, S. R. (2014). "Prophylactic stretching is unlikely to prevent nocturnal leg cramps."
J Physiother 60(3): 174.
18. Grandner, M. A. and J. W. Winkelman (2017). "Nocturnal leg cramps: Prevalence and
associations with demographics, sleep disturbance symptoms, medical conditions, and
cardiometabolic risk factors." PLOS ONE 12(6): e0178465.
19. Hallegraeff, J. M., et al. (2012). "Stretching before sleep reduces the frequency and severity
of nocturnal leg cramps in older adults: a randomised trial." J Physiother 58(1): 17-22.
20. Hensley, J. G. J. J. o. m. and w. s. health (2009). "Leg cramps and restless legs syndrome
during pregnancy." 54(3): 211-218.
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Ageing 45(6): 776-782.
22. Tipton, P. W. and Z. K. Wszołek (2017). "Restless legs syndrome and nocturnal leg cramps:
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8
Appendix
APPENDIX-1
QUESTIONNAIRE
The is an Online Google-Based Questionnaire and was designed to check the prevalence and risk factors
of nocturnal leg cramps among young adults in PUNJAB. The questionnaire was also designed to
evaluate how pain due to leg cramps effect the daily activities.
Name: Age:
Occupation: Gender:
Weight: Height:
Smoking:
1. In the last 3 months have you experienced muscle cramps, involuntary painful muscle
contraction occurring at rest, not associated with exercise?
o Yes
o No
2. How often have you experience these?
o Everyday\if daily, numbers of cramps per day____________
o Weekly \if weekly, numbers of cramps per week___________
o Monthly \ if monthly, number of cramps per month__________
o Cold
o Rest
o Sleep
o Standing
7. Have you been on any of the following medication for more than a month?
o Diuretics (water pills e.g., Lasix, Hydrochlorothiazide, spironolactone)
o Betablockers (e.g., Propranolol, Inderal, Atenolol, Metoprolol, Nadolol)
o Quinine
o Verapamil
o Vitamin E
11. Do you usually stand while you are working? (Respondents who reported that they usually stood
at work then asked?)
o Yes
o Sometimes
o No
12. How many hours per day do you stand at your work? (Respondents who reported over four
hours per day, were they defined as prolonged standing workers?)
o 3 hours
o 4 hours
o 5 hours
o 6 hours
13. During the past 12 months, have you had trouble with cramps in your calves or feet at night
more than once a month?
o Yes
o Sometimes
o No
14. How painful they have been?
o Very painful
o Slight painful
o Unbearable
15. What do you do to get relief from your muscle cramp?
o Nothing, they get better on their own
o I take over the Counter pain medications
o I take pain medication prescribed by my physician
o Other
16. Rate your pain scale according to Visual analogue scale:
o No pain
o Mild pain
o Moderate pain
72
o Severe pain
Appendix-11
Consent Form
I have read the study participant information sheet and I agree to take part in the study. I understand
that my participation in this study is entirely voluntary and that I do not have to answer any questions
that I do not wish to. I understand that my participation in this study is confidential, and that all data
collected will be anonymized. I understand that my data will only be used for the purpose of the
research project described in this form.
Name of participant:
Signature of participant:
Date: