Preventing Muscle Cramps in Individuals on Dialysis

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2017
INTERVENTION: 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. CONDITION: End Stage Kidney Disease Muscle Cramps PRIMARY OUTCOME: 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. SECONDARY OUTCOME: 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. 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.
Epistemonikos ID: 751a5f5bfffa2ab135e68db76d8dfe13252d0280
First added on: Aug 25, 2024