Topical Magnesium and Muscle Cramps in Dialysis Patients.

Topical Magnesium Supplementation for the Treatment of Muscle Cramps in Dialysis Patients

Oral magnesium supplementation has been widely used in the treatment of muscle cramps. Muscle cramps are common in dialysis patients but are not satisfactorily prevented by oral magnesium. Transdermal administration of magnesium has been promoted as a potential treatment for muscle cramps but this has not been investigated rigorously. We aim to evaluate the effectiveness of transdermal magnesium supplementation in reducing cramp frequency and severity. We will recruit current haemodialysis patients who suffer from muscle cramps into a randomised, placebo-controlled, cross-over design trial. Each intervention period will last 8 weeks with a 4-week washout period in between. We will measure muscle cramp frequency, duration and severity as the primary outcomes.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Diseases; End Stage Renal Disease; Dialysis Related Complications
• Intervention / Treatment: Drug: Placebo; Drug: Transdermal Magnesium

Detailed Description

Study participants will be provided with a cramp diary in which they will record the date, time, duration and severity of any muscle cramps they experience. Severity will be measured using a Likert scale in which participants will be asked to mark along a 10 cm line the severity of the pain they have experienced with each muscle cramp (ranging from no pain to the worst pain possible). The distance between "no pain" and the participant's mark will then be measured in centimetres (to one decimal point) to provide a precise value for muscle cramp severity. Participants will also be asked to record the duration of each muscle cramp they experience to the nearest minute.

Patients will be asked to record in their cramp diaries the nature of any unwanted skin changes they may have experienced during their participation in the study including when they first noticed these changes and the duration in which they were affected by them.

Serum magnesium, calcium and potassium levels will be measured and recorded before commencement of the study, at the end of the first stage of the study, at the end of the washout out period and at the end of the second stage of the study.

Patients will also be asked to describe their restless leg symptoms at different periods of the study from - no different to usual, better, much better, worse, much worse.

Participants will be seen by the investigators at enrolment into the study and at the end of the run-in period, first treatment period and second treatment period. In addition, participants will be asked to fill in a Likert scale regarding their views on how effective they believe the treatments were after each treatment period.

5.2 Study Plan

During the run-in period patients will make no changes to their treatments for their muscle cramps. During the treatment periods patients will be asked to apply five sprays of the intervention or placebo to the two sites of the body most commonly affected by muscle cramps, twice daily. During the two-week wash-out period there will be no spray applied.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Neil C Boudville, MBBS MMedSci; Phone Number: 61-8-6457-3333; Email: neil.boudville@uwa.edu.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of chronic kidney disease and receiving dialysis treatment
• Previous experience of at least 2 or more muscle cramps per month in at least 3 of the last 6 months
• Men or women aged 18 years and older
• Capacity to provide informed consent

Exclusion Criteria:

• Patients less than 18 years of age
• Women who are pregnant and the human fetus
• Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study and/or likely to cause death within the study duration
• Participation in another clinical during the last 12 weeks
• Known allergic reactions against any component of the study drug or its comparator(s)
• Known contraindication to any component of the study drug or its comparator(s)
• Concurrent diseases which exclude the administration of therapy as outlined by the study protocol
• Subjects who, in the opinion of the investigator, are not likely to complete the study for whatever reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Transdermal Magnesium; 5 sprays each on the 2 most effected areas for muscle cramps twice a day	Drug: Transdermal Magnesium; Magnesium; Other Names: Topical Magnesium
PLACEBO_COMPARATOR: Placebo; 5 sprays each on the 2 most effected areas for muscle cramps twice a day	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the average number of muscle cramps per week between magnesium and placebo treatments	final 3 weeks	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in average cramp duration between magnesium and placebo treatments	final 3 weeks	3 weeks
Difference in average cramp severity between magnesium and placebo treatments	final 3 weeks	3 weeks
Percentage change in serum magnesium concentration from baseline and at the end of each treatment stage		3 weeks
Difference in restless legs symptoms between the magnesium and placebo treatment stages.		3 weeks

Collaborators and Investigators

• Sponsor: Sir Charles Gairdner Hospital

Publications and helpful links

General Publications

• Garrison SR, Korownyk CS, Kolber MR, Allan GM, Musini VM, Sekhon RK, Dugre N. Magnesium for skeletal muscle cramps. Cochrane Database Syst Rev. 2020 Sep 21;9(9):CD009402. doi: 10.1002/14651858.CD009402.pub3.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2017
• Primary Completion (ANTICIPATED): March 31, 2018
• Study Completion (ANTICIPATED): December 31, 2018

Study Registration Dates

• First Submitted: March 13, 2017
• First Submitted That Met QC Criteria: March 16, 2017
• First Posted (ACTUAL): March 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Neurologic Manifestations; Renal Insufficiency; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Spasm; Muscle Cramp
• Other Study ID Numbers: 2016-158

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The plan at this stage is to have unidentified information available in a secure web-based environment.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No