Muscle CrampCramPNCT04694417
Prevention of Leg Cramps Using Compression Stockings or Magnesium Supplements in the Age Group of 50 to 84
A study testing Compression stocking and Magnesium tablet in people with Muscle Cramp and Stockings, Compression, run by Tampere University Hospital.
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. Read more about this study
- Who is it for?
- Ages 50 to 84 years
- Conditions the study is for
- Muscle Cramp, Stockings, Compression, Magnesium
- What is being tested?
- Compression stocking and Magnesium tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum of two leg cramps per week in the past four weeks.
- Age from 50 to 84 years.
Who cannot join
- 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®).
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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
- Being tested
- Compression stocking, Magnesium tablet, Placebo tablet
- Medical subject headings
- Muscle Cramp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression stockingOther
Please see the description of the intervention in another section
Magnesium tabletDietary supplement
Please see the description of the intervention in another section
Placebo tabletOther
Please see the description of the intervention in another section
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (2)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Feb 2021 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscle CrampStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University
- Responsible party
- Principal investigator, Tuomas-Heikki Koskela, Tampere University Hospital
- Investigators
- Tuomas Koskela, Docent, Study director, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694417
- Sponsor's protocol ID
- TampereUH99
- Acronym
- CramP
- Status last verified
- Jan 2021
- First submitted
- 30 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Kuusipalo A, Laitila J, Lehtonen E, Joensuu J, Mustajoki P, Mustonen P, Huhtala H, Kaila M, Koskela TH. Secondary prevention of leg cramps using compression stockings or magnesium supplements: a three-arm randomized clinical trial. Trials. 2026 Feb 13;27(1):216. doi: 10.1186/s13063-025-09370-z.
PubMed 41680812Joensuu 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.
PubMed 34844641
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04694417
- Acronym / sponsor ID
- CramP / TampereUH99
- Conditions
- Muscle Cramp, Stockings, Compression, Magnesium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Compression stocking | Experimental | Other: Compression stockingCompression 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 | Active comparator | Dietary Supplement: Magnesium tabletMagnesium 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. |
| Placebo | Placebo comparator | Other: Placebo tabletThe 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. |
Who may qualify
- Ages
- 50 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Minimum of two leg cramps per week in the past four weeks.
- Age from 50 to 84 years.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression stockingPlease see the description of the intervention in another section | Other | Compression stocking |
| Magnesium tabletPlease see the description of the intervention in another section | Dietary supplement | Magnesium |
| Placebo tabletPlease see the description of the intervention in another section | Other | Placebo |
Primary outcome
The change in quantity of leg cramps
Time frame: 8 weeks
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.
2 secondary outcomes
The change in intensity of leg cramps
Time frame: 8 weeks
The change in quantity of nocturnal awakening due to the cramps
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Derived from this study: PubMed 41680812Kuusipalo A, Laitila J, Lehtonen E, Joensuu J, Mustajoki P, Mustonen P, Huhtala H, Kaila M, Koskela TH. Secondary prevention of leg cramps using compression stockings or magnesium supplements: a three-arm randomized clinical trial. Trials. 2026 Feb 13;27(1):216. doi: 10.1186/s13063-025-09370-z.
- Derived from this study: PubMed 34844641Joensuu 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuomas Koskela, Docent study director
Tampere University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Compression stocking and Magnesium tablet in people with Muscle Cramp and Stockings, Compression, run by Tampere University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuomas Koskela, Docent (+358407390383, tuomas.koskela@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in quantity of leg cramps (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04694417, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.