Prevention of Leg Cramps Using Compression Stockings or Magnesium Supplements in the Age Group of 50 to 84 (CramP)
Muscle Cramp, Stockings, Compression, Magnesium
About this trial
This is an interventional prevention trial for Muscle Cramp
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
Compression stocking
Magnesium
Placebo
Compression stockings are mainly used for the prevention and reduction of lower limb oedema or venous thrombosis. There are three compression classes used in health care. The compression stocking group of the study will receive CE-marked stockings within the compression class of 1 (25-40 mmHg compression). The correct size for the compression stockings will be defined by the reported circumference of the participant's ankle and calf. The participants will be given instructions to put the stockings on immediately after getting out of bed in the morning and to take them off before going to bed in the evening for the last four weeks of the study. Stockings within the mild compression class have no harmful effects on individuals when the exclusion criteria are considered. The participants will be instructed to communicate with a dedicated research assistant via e-mail or phone in case of any problems or questions.
Magnesium is a mineral substance which regulates many biochemical reactions in the body, for example protein synthesis and the function of the muscles and nerves. It has a significant role in controlling blood sugar, blood pressure, energy generation and the formation of the bones. The recommended dietary allowance for magnesium is 420 mg for males and 320 mg for females over 50 years old. Dark green vegetables, leguminous plants, nuts, seeds and wholegrains are good sources of magnesium (11,12). In the average Finnish diet, the recommendation is usually exceeded, and excessive amounts of magnesium in the body are extremely rare. The magnesium arm of the study will take oral tablets containing 620 mg of magnesium hydrochloride daily for the last four weeks of the study, which is equivalent to 250 mg of pure magnesium per day. The magnesium tablets for this study were manufactured and analysed by the Pharmia pharmaceutical company in Finland.
The placebo tablets will consist of microcrystalline cellulose, magnesium stearate (anti-caking agent) and silicon dioxide. The placebo tablets were manufactured and analysed by the Pharmia pharmaceutical company in Finland. The placebo arm will receive placebo tablets to be taken daily for the last four weeks of the study. The participants will not know whether they are randomised into the magnesium arm or the placebo arm. The packaging and the appearance of the placebo and magnesium tablets are identical.