Topical Magnesium and Muscle Cramps in Dialysis Patients.

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Chronic Kidney Diseases, End Stage Renal Disease, Dialysis Related Complications

Intervention / Treatment
-----------------
* Drug: Transdermal Magnesium
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised placebo-controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transdermal Magnesium<br>5 sprays each on the 2 most effected areas for muscle cramps twice a day | Drug: Transdermal Magnesium<br>* Magnesium<br>* Other names: Topical Magnesium;|
| Placebo Comparator: Placebo<br>5 sprays each on the 2 most effected areas for muscle cramps twice a day | Drug: Placebo<br> <br> |

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 |