Plain English Summary
Background and study aims:
Approximately one in three adults suffer from night leg cramps (NLC) for which there are few safe and effective treatment options. Magnesium oxide supplementation has been explored and found ineffective; however, foam containing magnesium sulfate applied to the skin of the legs has not been examined. This study aims to investigate how well magnesium sulfate foam works in reducing NLC compared with foam containing no active ingredients (dummy foam) and whether it has an effect on quality of life. The goal is to find a treatment that will reduce night leg cramps and improve quality of life.
Who can participate?
Adults aged 18-75 years who are experiencing a minimum of 3 night leg cramps a week.
What does the study involve?
Participants who are experiencing at least 3 night leg cramps a week are asked to join the study. Participants will be randomly allocated either Foam A or Foam B to use daily for 14 days. Participants will write down how many nights they cramp and their daily symptoms (for example, pain level and severity of cramps) every day for 14 days. Participants will also fill out surveys on if they feel fatigued, their social function, sleep quality, and emotional well-being before they start using the foam and at the end of the 14 days.
What are the possible benefits and risks of participating?
There are no direct benefits for participating in the study, however there could be potential benefits for those that have success with the intervention treatment. The only risk will be for those participants that may have sensitive skin. In the event the participants have a reaction to the foam (for example, the skin gets irritated), the participant does not have to complete the study.
Where is the study run from?
Arnold School of Public Health Research Center, University of South Carolina (USA).
When is the study starting and how long is it expected to run for?
January 2017 to February 2018
Who is funding the study?
Avadim Health, Inc
Who is the main contact?
Toni M. Torres-McGehee
torresmc@mailbox.sc.edu
Trial website
Contact information
Type
Public
Primary contact
Prof Toni Torres-McGehee
ORCID ID
http://orcid.org/0000-0001-7963-5356
Contact details
1300 Wheat Street
Blatt PE Center EXSC 212
Columbia
SC
29208
United States of America
Type
Scientific
Additional contact
Dr Scott Strayer
ORCID ID
Contact details
3209 Colonial Dr
Columbia
29203
United States of America
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of low pH magnesium sulfate foam on night leg cramps: A double-blind randomized trial
Acronym
NLC Foam Study
Study hypothesis
We hypothesized that a topical foam with magnesium sulfate (Theraworx Relief®+Mg) would decrease night leg cramp (NLC) spasm frequency and severity and improve quality of life measures compared with a low pH topical foam (Theraworx Relief®-pH).
Ethics approval
University of South Carolina Institutional Review Board for Human Research, 1/9/2017. (Ame1_Pro00061216 by Expedited Review)
Study design
Randomized double-blind controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Home
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Night leg cramps
Intervention
This was a home-based intervention within a Southeastern US urban community. Prior to enrolling participants in the study, all foam bottles were packaged by the manufacturer with the same label and shipping boxes were pre-labeled with A or B and shipped to the investigators. Advertisements were placed throughout primary care physician offices, pharmacies and the local university student health center in Columbia, SC, inviting individuals suffering from NLC to participate in the trial. Participants included were male and female adults who experienced a minimum of 3 night cramps per week. The participants were randomized to group A or B using the online randomization scheme sealed envelope™ (https://www.sealedenvelope.com/simple-randomiser/v1/lists). As eligible participants enrolled in the study, they were assigned an ID number and corresponding group. Both investigators and participants were blind to the intervention treatments. The intervention group was given 5 bottles of low pH topical foam with magnesium sulfate (Theraworx Relief®+Mg) and followed a treatment plan for 14 consecutive days. The control group was given 5 bottles of the low pH topical foam (Theraworx Relief®-pH) and followed a treatment plan for 14 consecutive days. All pre- and post- data were collected within home and lab settings at the Arnold School of Public Health from May 2017 through February 2018. After all data was collected and analyzed, the manufacturer provided formulations of each foam to the investigators to determine group assignment.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
Number of NLCs per week during the 14 consecutive days of the intervention
Secondary outcome measures
1. Social function assessed using the Restless Leg Syndrome Quality of Life Questionnaire at baseline and day 14
2. Daily function assessed using the Restless Leg Syndrome Quality of Life Questionnaire at baseline and day 14
3. Sleep quality assessed using the Restless Leg Syndrome Quality of Life Questionnaire at baseline and day 14
4. Emotional well-being were assessed by using the Restless Leg Syndrome Quality of Life Questionnaire at baseline and day 14
5. Daytime fatigue assessed using the Multi-Dimensional Fatigue Inventory at baseline and day 14
Overall trial start date
05/01/2017
Overall trial end date
15/02/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18-75 years
2. Experiencing a minimum of 3 NLCs a week
Participant type
Mixed
Age group
Mixed
Gender
Both
Target number of participants
50 was the target, however we were only able to recruit 36 to complete the entire study. We had a total of 57 inquiries, with 18 being excluded due to not meeting the criteria, and 7 did not return recruitment calls. We had 39 start the study, with 3 dropping out for non-compliance of the study or they didn't see immediate results.
Participant exclusion criteria
1. Patients nearing death
2. Taking medications causing NLCs
3. Adverse response to any topical foams
4. Allergy to magnesium or sulfur
5. Skin cuts
6. Active tissue or bone infections
7. Current foot or leg fractures
Recruitment start date
01/04/2017
Recruitment end date
15/02/2018
Locations
Countries of recruitment
United States of America
Trial participating centre
Public Health Research Center
921 Assembly Street
Columbia
29201
United States of America
Sponsor information
Organisation
University of South Carolina - Institutional Review Board
Sponsor details
Blatt PE Center - Exercise Science
1300 Wheat St
Columbia
29208
United States of America
803-777-6670
lisaj@mailbox.sc.edu
Sponsor type
Industry
Website
https://sc.edu/about/offices_and_divisions/research_compliance/irb/index.php
Funders
Funder type
Industry
Funder name
Avadim Health Inc
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We currently have already collected data and would like to register the trial and the submit for publication to JAMA Internal Medicine as soon as we get registered. Submission is pending registration of the trial.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from Toni Torres-McGehee (torresmc@mailbox.sc.edu). The study protocol, statistical analysis plan, and individual participant data that underlie the results reported in this article, after deidentification (text, figures, and tables) can be shared. Data will be available beginning 3 months and ending 5 years following article publication. Data will be available for researchers who provide a methodically sound proposal to achieve aims in the approved proposal. Proposals should be directed to torresmc@mailbox.sc.edu. To gain access, applicants will need to sign a data access agreement.
Intention to publish date
01/12/2018
Participant level data
Available on request
Basic results (scientific)
Publication list