Leg cramps are painful sensations of tightening in the muscles of the legs, that are often associated with secondary insomnia. They are common especially at an older age. There is no evidence that any method of prevention of nocturnal leg cramps would be both safe and effective. There are no previous trials concerning cramp prevention by using compression stockings. The objective of this study is to assess in a prospective randomised controlled trial whether leg cramps can be prevented by daily use of knee-length compression stockings or magnesium supplements.
Leg cramps are painful sensations of tightening in the muscles of the legs that commonly appear during the night and are often associated with secondary insomnia. They are common especially in older age. There is no evidence that any method of prevention of nocturnal leg cramps is both safe and effective. There are no previous trials concerning cramp prevention by using compression stockings. The objective of this study is to assess in a prospective randomised controlled trial whether leg cramps can be prevented by the daily use of knee-length compression stockings or magnesium supplements. Methods The study will be set in Finland, and 50-84-year-old volunteers will be recruited through Google Ads, the Finnish Health Library and Finnish primary health care centres. The participants must have a minimum of two episodes of leg cramps per week for the past four weeks to be included in the study. The participants (n = 225) will be allocated to three equal groups: the compression stocking arm, the magnesium supplement arm and the placebo arm. The participants will go through four weeks of follow-up without intervention, and then another four weeks of follow-up with the assigned intervention. The material for the study will be collected through electronic questionnaires. Discussion This protocol describes a study that compares compression stockings, magnesium supplements and placebo for the prevention of leg cramps. The results of this study can significantly improve knowledge on the methods of preventing leg cramps.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
225
Please see the description of the intervention in another section
Please see the description of the intervention in another section
Please see the description of the intervention in another section
The change in quantity of leg cramps
The change in quantity of leg cramps from the four-week follow-up period (prior to the intervention) to the four-week intervention period will be assessed on the basis of the participants' responses to the survey. The number of cramps will be recoded on a weekly online survey during four weeks before intervention and during the four-week intervention period. The change in the number of cramps from the four-week period prior the intervention to the intervention period will be calculated. The difference between groups will be analyzed by one-way analysis of variance of repeated measurements.
Time frame: 8 weeks
The change in intensity of leg cramps
The possible change in the intensity of leg cramps from the four-week follow-up period (prior to the intervention) to the four-week intervention period will be assessed on the basis of the participants' responses to the survey. The intensity of cramps will be recoded on a weekly online survey during the four weeks before intervention and during the four-week intervention period. The possible change in the intensity of cramps from the four-week period prior the intervention to the intervention period will be assessed.
Time frame: 8 weeks
The change in quantity of nocturnal awakening due to the cramps
The change in the quantity of nocturnal awakenings due to the cramps from the four-week follow-up period (prior to the intervention) to the four-week intervention period will be assessed on the basis of the participants' responses to the survey. The number of cramps will be recoded on a weekly online survey during four weeks before intervention and during the four-week intervention period. The change in the number of nocturnal awakenings due to the cramps from the four-week period prior the intervention to the intervention period will be calculated. The difference between groups will be analyzed by one-way analysis of variance of repeated measurements.
Time frame: 8 weeks
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