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Trial registered on ANZCTR


Registration number
ACTRN12617000164392
Ethics application status
Approved
Date submitted
2/11/2016
Date registered
31/01/2017
Date last updated
20/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing Muscle Cramps in Individuals on Dialysis
Scientific title
Skeletal muscle cramps in the cramp prone dialysis population – to understand the cause and a novel treatment strategy "CrampsAway" Trademark: A feasibility study.
Secondary ID [1] 290395 0
None
Universal Trial Number (UTN)
U1111-1188-7077
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Kidney Disease 300733 0
Muscle Cramps 300817 0
Condition category
Condition code
Renal and Urogenital 300640 300640 0 0
Kidney disease
Musculoskeletal 300641 300641 0 0
Other muscular and skeletal disorders
Alternative and Complementary Medicine 301150 301150 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A double-blinded placebo controlled studywill test the effectiveness of a single dose of CrampsAway Trademark at alleviating and preventing mild-electrical stimulation induced muscle cramps in dialysis patients.

CrampsAway Trademark is a non-pharmaceutical (complementary alternative medicine) product avaliable in Pharmacies and online in USA. It is a proprietary formulation containing a food grade acid, water soluble vitamins, minerals, and water.

CrampsAway Trademark is given a 1 fluid ounce (~30 mL) solution, The participants will take it as per manufactures instruction - the product is swirled in the mouth for 15 seconds before it is swallowed. CrampsAway Trademark will be taken infront of the investigators.

This study comprises of two Parts. The first is to show that we can induce muscle cramp for at least 1 minute after mild-electrical stimulation. The second is to test the effectiveness of CrampsAway at alleviated muscle cramp. All participants will be enrolled in Part one of the study. In those participants who we are unable to induce muscle cramp for at least 1 minute during Part one, will be no longer required to participate. As this becomes an exclusion criteria for Part two.

In Part one lasting approximately 1.5 hours, muscle cramp will be induced with mild-electrical stimulation of the Abductor Hallicus and or Medial Gastrocnemius. Whilst measuring the electromyograph activity generated. A incremental graded 150-stimulus train is used to induce muscle cramp, with a maximum current of 80 milliamps at a maximum stimulation frequency of 70 hertz, until muscle cramp lasting greater than 1 minute is elicited or as tolerated by each participant. The electrical stimulation will be administered by the investigators.

CrampsAway Trademark or Placebo product (randomised order) will be administered in Part two which will occur at least 2 days after the completion of Part one. The mild-electrical stimulation protocol will again be used to for the generation of muscle cramp using the same protocol as in Part 1 is evident. As soon as muscle cramp is evident from the electromyograph recording following electical stimulation CrampsAway Trademark or the placebo will be taken, At least a week wash-out will separate the two phases in Part 2, with each session lasting approximately 1.5 hours.
Intervention code [1] 296228 0
Treatment: Other
Comparator / control treatment
Single dose of CrampsAway Trademark will given and during a separate experimental trial a Placebo containing water, organic agave nector, orange flavour and potassium sorbet will be administered as per the CrampsAway Trademark manufacturers instructions.
Control group
Placebo

Outcomes
Primary outcome [1] 299982 0
Does CrampsAway Trademark alleviate muscle cramp within 60 seconds of taking it.

This will be assessed by continuously measuring and then analysing the duration and magnitude of muscle cramp activity with electromyography (EMG). Comparisions in this signal between active vs. Placebo treatment will be compared.
Timepoint [1] 299982 0
The EMG activity is continuously measured during the and for 2 minutes following mild-electrical stimulation when the muscle cramp is occuring. Alterations in this signal between active vs. Placebo treatment will be compared.
Secondary outcome [1] 328743 0
Does CrampsAWAY Trademark increase muscle cramp threshold.

A further attempt will be made to induce muscle cramp as evident when measuring EMG with the minimal stimualtion intensity. Differences in the stimulation required to induce muscle cramp will be compared between pre-treatment and post-treatment.
Timepoint [1] 328743 0
15 minutes following active and Placebo treatment.

Eligibility
Key inclusion criteria
Age > 18 years.
Those that have End-stage Kidney Disease and are treated with dialysis.
Reporting themselves as frequently suffering from Muscle Cramps.
Able to give informed consent.
Medically stable for at least the last one month.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A history of peripheral neuropathy.
Underlying primary muscle disorder.
Acutely unwell.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2017
Actual
Date of last participant enrolment
Anticipated
1/12/2017
Actual
Date of last data collection
Anticipated
29/12/2017
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 8352 0
New Zealand
State/province [1] 8352 0

Funding & Sponsors
Funding source category [1] 294863 0
Commercial sector/Industry
Name [1] 294863 0
CrampsAway Trademark
Country [1] 294863 0
United States of America
Primary sponsor type
University
Name
University of Otago
Address
University of Otago
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 293703 0
None
Name [1] 293703 0
Address [1] 293703 0
Country [1] 293703 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296198 0
Southern Health and Disabilities Ethics Committees
Ethics committee address [1] 296198 0
C/- Ministry of Health
PO Box 5013
Wellington 6145
Ethics committee country [1] 296198 0
New Zealand
Date submitted for ethics approval [1] 296198 0
08/11/2016
Approval date [1] 296198 0
07/03/2017
Ethics approval number [1] 296198 0
16/STH/194

Summary
Brief summary
Muscle cramps are a sudden, involuntary and painful contraction of a muscle, and are associated with repetitive and abnormal firing of motor neurons (i.e. neuromuscular disorder). The dialysis population are more cramp prone. However, muscle cramps are poorly understood due to their sporadic nature of occurrence and there are no recommended evidence-based therapies. The aims of this study are twofold: First, can muscle cramp be elicited in an experimental-controlled setting using mild-electrical stimulation. Second, can a novel non-pharmaceutical agent CrampsAWAY Trademark alleviate induced muscle cramp. This study will increase the understanding of cramp and potentially lead to an evidence-based therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69954 0
Prof Rob Walker
Address 69954 0
Department of Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 69954 0
New Zealand
Phone 69954 0
+64274359552
Fax 69954 0
Email 69954 0
[email protected]
Contact person for public queries
Name 69955 0
Luke Wilson
Address 69955 0
Department of Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 69955 0
New Zealand
Phone 69955 0
+64274491401
Fax 69955 0
Email 69955 0
[email protected]
Contact person for scientific queries
Name 69956 0
Luke Wilson
Address 69956 0
Department of Medicine
Dunedin School of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 69956 0
New Zealand
Phone 69956 0
+64274491401
Fax 69956 0
Email 69956 0
[email protected]

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