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

NCT04694417 | Unknown

• 1 other identifier: TampereUH99
• Study Type: interventional
• Target: 225
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Muscle Cramp; Stockings, Compression; Magnesium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The change in intensity of leg cramps

  8 weeks

• The change in quantity of nocturnal awakening due to the cramps

  8 weeks

Study Arms (3)

Compression stocking

EXPERIMENTAL

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.

Other: Compression stocking

Magnesium

ACTIVE COMPARATOR

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.

Dietary Supplement: Magnesium tablet

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo tablet

Interventions

Compression stocking OTHER

Please see the description of the intervention in another section

Compression stocking

Magnesium tablet DIETARY_SUPPLEMENT

Please see the description of the intervention in another section

Magnesium

Placebo tablet OTHER

Please see the description of the intervention in another section

Placebo

Eligibility Criteria

• Age: 50 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum of two leg cramps per week in the past four weeks.
• Age from 50 to 84 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tampere University Hospital: lead
• Tampere University: collaborator

Related Publications (1)

• Joensuu J, Mustajoki PP, Mustonen PK, Kaila M, Koskela T. Prevention of leg cramps by using compression stockings or magnesium supplements in the 50-84 age group: study protocol for a randomised controlled trial. Trials. 2021 Nov 29;22(1):860. doi: 10.1186/s13063-021-05753-0.

  PMID: 34844641 DERIVED

MeSH Terms

Conditions

Muscle Cramp

Interventions

Stockings, Compression; Magnesium

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Compression Bandages; Bandages; Equipment and Supplies; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Tuomas Koskela, Docent

  Tampere University Hospital

  STUDY DIRECTOR

Central Study Contacts

Tuomas Koskela, Docent

CONTACT

+358407390383; tuomas.koskela@tuni.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (tenure track)

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: February 1, 2021
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share