search
Back to results

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

Primary Purpose

Muscle Cramp, Stockings, Compression, Magnesium

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Compression stocking
Magnesium tablet
Placebo tablet
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Muscle Cramp

Eligibility Criteria

50 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Compression stocking

    Magnesium

    Placebo

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    December 30, 2020
    Last Updated
    January 4, 2021
    Sponsor
    Tampere University Hospital
    Collaborators
    Tampere University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04694417
    Brief Title
    Prevention of Leg Cramps Using Compression Stockings or Magnesium Supplements in the Age Group of 50 to 84
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2021 (Anticipated)
    Primary Completion Date
    July 31, 2021 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tampere University Hospital
    Collaborators
    Tampere University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Muscle Cramp, Stockings, Compression, Magnesium

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    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.
    Allocation
    Randomized
    Enrollment
    225 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Compression stocking
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Magnesium
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Compression stocking
    Intervention Description
    Please see the description of the intervention in another section
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Magnesium tablet
    Intervention Description
    Please see the description of the intervention in another section
    Intervention Type
    Other
    Intervention Name(s)
    Placebo tablet
    Intervention Description
    Please see the description of the intervention in another section
    Primary Outcome Measure Information:
    Title
    The change in quantity of leg cramps
    Description
    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.
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    The change in intensity of leg cramps
    Description
    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.
    Time Frame
    8 weeks
    Title
    The change in quantity of nocturnal awakening due to the cramps
    Description
    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.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    84 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tuomas Koskela, Docent
    Phone
    +358407390383
    Email
    tuomas.koskela@tuni.fi
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tuomas Koskela, Docent
    Organizational Affiliation
    Tampere University Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The full protocol will be available in open access format. The datasets generated and analysed during this trial will be available from the corresponding author on reasonable request.
    Citations:
    PubMed Identifier
    34844641
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs