NCT04694417

Prevention of Leg Cramps Using Compression Stockings or Magnesium Supplements in the Age Group of 50 to 84

Prevention of Leg Cramps Using Compression Stockings or Magnesium Supplements in the Age Group of 50 to 84: a Study Protocol for a Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Tampere University Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 84 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Muscle Cramp
• Stockings, Compression
• Magnesium

Interventions

Type	Name	Description
OTHER	Compression stocking	Please see the description of the intervention in another section
DIETARY_SUPPLEMENT	Magnesium tablet	Please see the description of the intervention in another section
OTHER	Placebo tablet	Please see the description of the intervention in another section

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-07-31
• Completion: 2021-12-31
• First posted: 2021-01-05
• Last updated: 2021-01-05