Muscle Cramp, Stockings, Compression, Magnesium
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERCompression stocking
Please see the description of the intervention in another section
DIETARY_SUPPLEMENTMagnesium tablet
Please see the description of the intervention in another section
OTHERPlacebo tablet
Please see the description of the intervention in another section
Sponsors
Tampere University
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
The participants assigned to the two tablet groups will be blinded to the intervention. The magnesium and placebo tablets that are used in the trial will be identical in terms of packaging and appearance. The compression stocking group cannot be blinded, but the participants will not know their allotted intervention until they have received it by mail delivery. The statisticians will be blinded to the group allocation by using codes to label the three groups and will randomly assign outcome assessors to the follow-up. The allocation sequence will be concealed until the end of the study. The allocation code will be stored in a separate file.
Eligibility
Sex/Gender
ALL
Age
50 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
* Minimum of two leg cramps per week in the past four weeks. * Age from 50 to 84 years.
Exclusion criteria
* Peripheral artery disease (confirmed or suspected). * Peripheral artery bypass surgery. * Grave peripheral neuropathy or any sensory disorder. * Allergy to the material of the compression stockings. * Grave renal failure (GFR under 30 ml/min). * The use of a magnesium carbonate product (e.g. Rennie® or Berocca®). * Cardiac failure with pulmonary oedema or massive lower limb swelling. * Lower limb soft tissue problems, including skin transplant, thinned skin, varicose ulcer, necrosis and any infection. * Lower limb deformity or atypical shape or size that could prevent the usage of compression stockings. * Continuous usage of compression stockings for any other reason than leg cramps.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in quantity of leg cramps | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in intensity of leg cramps | 8 weeks | 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. |
| The change in quantity of nocturnal awakening due to the cramps | 8 weeks | 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. |
Contacts
Primary ContactTuomas Koskela, Docent
Outcome results
None listed