None listed
Conditions
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.
Interventions
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
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.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
A history of peripheral neuropathy. Underlying primary muscle disorder. Acutely unwell.
Outcome results
None listed