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

Muscle Cramp Clinical Trial

— CramP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04694417
• Other study ID #: TampereUH99
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2021
• Source: Tampere University Hospital
• Contact: Tuomas Koskela, Docent
• Phone: +358407390383
• Email: tuomas.koskela[@]tuni.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 225
• Est. completion date: December 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Magnesium
• Muscle Cramp
• Stockings, Compression

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	Tampere University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks