Background
Method
Sourcing information
Selection criteria
Data extraction
Quality assessment
Delphi sub-study
Results
Randomisation | Concealed randomization | Blinded patients | Blinded treaters | Blinded Assessors | Groups comparable | Loss to follow up | Intention to treat | Groups treated equaly | |
---|---|---|---|---|---|---|---|---|---|
Connolly 1992 [29] 6/9 | + | - | + | + | - | - | + | + | + |
Coppin 2005 [5] 8/9 | + | + | - | + | + | + | + | + | + |
Garrison 2011 [17] 9/9 | + | + | + | + | + | + | + | + | + |
Hallegraeff 2012 [9] 9/9 | + | + | + | + | + | + | + | + | + |
Jansen 1997 [18] 9/9 | + | + | + | + | + | + | + | + | + |
Roffe 2002 [19] 8/9 | + | + | + | + | - | + | + | + | + |
Serrao 2001 [14] 3/9 | + | - | - | - | - | - | + | - | + |
Young 1993 [15] 1/9 | - | - | ? | ? | ? | ? | - | ? | + |
Groups well defined | Selection bias | Exposure | Outcome | Blinding | Follow-up | Loss to follow up | Confounding | Generalizability | |
---|---|---|---|---|---|---|---|---|---|
Angeli 1996 [20] 6/9 | + | - | + | + | - | + | + | - | + |
Baskol 2004 [21] 6/9 | + | + | + | + | - | ? | ? | + | + |
Garrison 2015 [22] 9/9 | + | + | + | + | + | + | + | + | + |
Garrison 2012 [2] 6/9 | + | - | - | + | + | + | + | - | + |
Hawke 2013 [4] 9/9 | + | + | + | + | + | + | + | + | + |
Hawke 2013 [23] 9/9 | + | + | + | + | + | + | + | + | + |
Hirai 2000 [24] 4/9 | + | - | + | + | - | ? | ? | - | + |
Naylor 1994 [25] 5/9 | + | + | + | - | + | ? | ? | ? | + |
Nishant 2014 [26] 5/9 | + | - | + | + | - | + | - | - | + |
Oboler 1991 [27] 4/9 | + | - | + | + | - | ? | ? | - | + |
Randomized clinical trials | Study objective Number of participants Age Male | Diagnostic criteria | Comorbidities associated with NLC and medication use |
---|---|---|---|
Connolly 1993 [29] 6/9 | Efficacy of quinine
N = 27 59 yrs. Male 100% | Nocturnal leg cramps. Aged > 50. Foot, lower part of leg, sometimes thigh. Sleep interruption. | Coronary artery disease, Peripheral vascular disease, Hypertension, Diabetes Mellitus
Medication: diuretics |
Coppin 2005 [5] 8/9 | Effect of calf stretching
N = 181 75 yrs. Male 46% | Nocturnal leg cramps, aged > 60, painful and involuntary. Muscle spasms. Disrupt sleep. Disruption. Most commonly in the leg, relief by stretching. | Renal dialysis, asthma and hypertension.
Medication: diuretics, nifedipine, salbutamol and terbutaline |
Garrison 2011 [17] 9/9 | The effect of magnesium in individuals with leg cramps
N = 46 69 yrs. Male 30% | Leg cramps, aged > 50, at rest (bed or night). Legs and feet. Painful muscle contractions. | Participants with comorbidities excluded |
Hallegraeff 2012 [9] 9/9 | Effect of pre sleep stretching
N = 80 70 yrs. Male 50% | Nocturnal leg cramps, aged > 55, Suddenly, episodic. Involuntary. At rest or sleep. Calf, hamstrings or foot. Muscles are tender and hard. Intense painful. From seconds to minutes. Distress. Sleep disruption. Maximum ten minutes. | Varicose veins and arthritis. Physical inactivity and inadequate stretching and reduced muscle and tendon length.
Medication: diuretics, lithium, steroids, morphine |
Jansen 1997 [18] 9/9 | Efficacy of hydro quinine in muscle cramps
N = 102 54 yrs. Male 37% | Involuntary muscle contraction. Painful Sudden onset. Muscle hardening, maximum duration 10 minutes. | Not stated |
Roffe 2002 [19] 8/9 | The effect of magnesium in chronic non-pregnant individuals
N = 36 63 yrs. Male 58% | Leg cramps. Painful contractions of any muscle group in the leg. Sudden onset. Successive improvement. Palpable hardening of the muscle. Distress. | Arthritis, peripheral vascular disease, varicose veins, ankle oedema |
Serrao 2001 [14] 3/9 | To evaluate the efficacy and safety of gabapentin in the treatment of muscle Cramps
N = 30 54 yrs. 33% | Sudden, involuntary, painful contractions. Maximum of 10 minutes. Sleep disturbance. | Neuropathy, radiculopathy, Isaac’s syndrome, multiple sclerosis, Parkinson’s disease, vascular disease |
Young 1993 [15] 1/9 | The effect of naftidrofuryl in individuals with rest cramps
N = 14 61 yrs. Male 64% | Rest cramps. Night-time cramps. Foot, calf muscles. Distress. | Not stated |
Observational studies | |||
Angeli 1996 [20] | To define the features, prevalence, and pathophysiology of therapy for muscle and small muscles cramps in cirrhotic patients.
N = 192 56 yrs. Male 65% | A-symmetric involuntary contractions or stiffness in calves and feet. At rest or at night | Cirrhosis, vascular occlusive disease, peripheral neuropathy, diabetes mellitus, severe renal failure and postphlebitic syndrome |
Baskol 2004 [21] 6/9 | The prevalence of muscle cramps in non-alcoholic cirrhosis patients.
N = 65 52 yrs. Male 57% | Muscle cramps. Aged > 50. Involuntary. Painful, visible contraction. Sudden onset. At rest or sleep. From seconds to minutes. Affects quality of life. At least once per week. Sleep disruption. | Liver cirrhosis, diuretic, alcohol use, volume depletion, hyponatremia, haemodialysis, hypothyroidism, uraemia. |
Garrison 2015 [22] | Seasonally variation of symptom burden of leg cramps in the general population.
N = 31.339 69 yrs. Male 38% | Painful involuntary muscle cramps in the legs or feet during rest. It interrupts sleep. | Motor neuron disease, radiculopathy or hereditary cramp syndromes |
Garrison 2012 [16] 6/9 | Evaluating the association between diuretics, statins and long-acting β2 agonist’s use.
N = 3492 69 yrs. Male 39% | Nocturnal leg cramps. Painful legs or feet. During rest or sleep |
Medication: diuretics and long-acting β2 agonists |
Hawke 2013 [4] 9/9 | Impact of NLC on health related quality of life.
N = 160 71 yrs. Male 41% | Nocturnal leg cramps. Pain afterwards. Sleep disruption. Aged >60 with sleep disruption. Reduced quality of life. Gradually lessens. Sudden, involuntary painful contraction. At night and rest. Relief by stretching. | Participants with comorbidities known to cause cramp excluded |
Hawke 2013 [23] 9/9 | Factors associated with night-time calf muscle cramps
N = 160 71 yrs. Male 41% | Reduced strength dorsiflexion foot. Distress. Lesser quality of life. Interference of activities of daily living. | Hamstring tightness. Foot or leg coldness Participants with comorbidities known to cause cramp were excluded |
Hirai 2000 [24] 4/9 | NLC in general population and in patients with varicose veins
N = 333 Age not stated Male 26% | Muscle cramps. Aged >50. Intense painful with sudden onset in calf, foot or thigh. Maximum duration 10 minutes. At least once per week. | Varicose veins |
Naylor 1994 [25] 5/9 | Prevalence, severity and correlation with vascular diseases
N = 86 73 yrs. Male 44% | Rest cramps. Aged > 50. Distress. Less quality of life. | Peripheral vascular disease |
Nishant 2014 [26] 5/9 | Prevalence of nocturnal leg cramps in LSCS patients and in general population.
N = 70 56 yrs. Male 53% | Nocturnal cramps. Painful. Acute and involuntary. At sleep or rest. Knee flexion test might be indicative for NLC. | Amyotrophic lateral sclerosis, poliomyelitis, peripheral neuropathy, lumbar spinal radiculopathy; metabolic disorders including diabetes, pregnancy, uremia, liver cirrhosis, and hyper- and hypothyroidism; acute extracellular volume depletion including excessive perspiration, hemodialysis, diarrhea, and diuretic therapy; hereditary disorder. Hypertension, hypocalcaemia, hypokalaemia, vascular diseases.
Medications: diuretics, antidepressants, calcium blockers, statins, and steroid, nifedipine-blockers. |
Oboler 1991 [27] 4/9 | Prevalence and treatment regimens of NLC
N = 262 60 yrs. Male 95% | Painful and involuntary in the calf with a visible palpable knot. At rest or sleep. | Arthritis, Peripheral vascular disease, Hypokalaemia, Coronary artery disease, Hypertension, Kidney disease, Stroke, Diabetes Mellitus, Hypocalcaemia. |
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Heart and vascular diseases: coronary artery disease, peripheral vascular disease, hypertension, varicose veins, ankle oedema, vascular occlusive disease and leg claudication.
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Kidney diseases: renal dialysis, haemodialysis, uraemia, hypocalcaemia and hypokalaemia.
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Neurological diseases: neuropathies, motor neuron disease, radiculopathy or hereditary cramp syndromes, neuromuscular or neurological diseases, peripheral neuropathy, Amyotrophic Lateral Sclerosis, poliomyelitis, lumbar spinal radiculopathy, lumbar canal stenosis and stroke.
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Musculoskeletal disorders: arthritis and myopathies.
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Metabolic disorders: Diabetes Mellitus, plasma electrolyte abnormalities hepatic, liver cirrhosis, postphlebitic syndrome volume depletion, hyponatremia, hypothyroidism, hyper- and hypothyroidism and acute extracellular volume depletion including excessive perspiration.
Clinical classification characteristics
Nocturnal leg cramps | Restless leg syndrome | Periodic Limb Movement Disorder | |
---|---|---|---|
Pain | ✓ | ||
Intensely pain | ✓ | ||
From seconds to maximum 10 minutes | ✓ | ||
Calf or foot, seldom thigh | ✓ | ||
Persisting pain afterwards | ✓ | ||
Sleep disruption | ✓ | ||
Distress* | ✓ | ||
Irritating, burning, crawling sensations | ✓ | ||
In episodes | ✓ | ||
An urge to move | ✓ | ||
Reduction of symptoms by activity | ✓ | ||
No pain | ✓ | ✓ | |
Repeating and jerking movements | ✓ | ||
Duration 20-30 seconds | ✓ |
Delphi Study Items | Always | Mostly | Sometimes | Never | Not known |
---|---|---|---|---|---|
Are you known with NLC | 30* | 40 | 20 | 0 | 10** |
• NLC has a sudden onset | 33 | 56 | 11 | 0 | 0 |
NLC is only present at night | 11 | 68 | 11 | 0 | 11 |
• Pain and / or intense pain is the main characteristic | 10 | 80 | 0 | 0 | 10 |
• NLC duration varies from seconds to 10 minutes | 10 | 80 | 0 | 0 | 10 |
• NLC location is thigh, calf or foot | 33 | 45 | 11 | 0 | 11 |
• After reduction of NLC there will be pain afterwards | 0 | 50 | 40 | 0 | 10 |
• NLC might be associated with sleep disruption | 10 | 50 | 20 | 0 | 20 |
NLC is associated with medication use / comorbidity | 0 | 11 | 67 | 0 | 22 |
• NLC might be associated with distress | 10 | 10 | 60 | 10 | 10 |