PUMPP- Pulsed electromagnetic fields treatment for Painful Periods

  • Research type

    Research Study

  • Full title

    Pulsed shortwave therapy treatment for Painful Periods: a Randomised Control Trial.

  • IRAS ID

    227622

  • Contact name

    Justin Clark

  • Contact email

    justin.clark@bwnft.nhs.uk

  • Sponsor organisation

    BioElectronics Corporation

  • Duration of Study in the UK

    0 years, 7 months, 21 days

  • Research summary

    Dysmenorrhoea, or painful periods, is one of the most common gynaecological conditions affecting women during the reproductive years.

    The most common treatments for dysmenorrhoea are nonsteriodal anti-inflammatory drugs (NSAIDs), the combined oral contraceptive and the Levonorgestrel-releasing intrauterine system.The most common side effect for NSAIDs is gastro-oesophageal disease while hormonal contraceptives are associated with weight gain, venous thromboembolism and cardiovascular disease. Due to the side effects of medical therapy, like in other chronic pain conditions, there is interest in managing dysmenorrhoea with a more holistic approach.
    Devices that emit radio frequency electromagnetic energy have a long standing history in medical applications and treatment of pain.

    The use of miniature pulsed shortwave therapy (PSWT) device’s as an adjunct therapy used in the treatment of chronic pain, has shown a significant decrease in pain scores. Two randomized controlled trials (RCTs) have investigated the efficacy of the ActiPatch medical device, a PSWT device that has an identical mode of action to the device we aim to use in this study, in the treatment of chronic pain.

    We aim to carry out a randomised controlled trial into the use of the Allay PSWT device in the treatment of dysmenorrhoea to assess if there is a reduction in the mean pain score when using the device compared to a placebo or to no treatment.

    Women will be asked to record their pain levels on each day of their period on a 10cm Visual Analogue Scale, in which 0 indicates no pain and 10 indicates unbearable pain.

    Secondary outcomes will assess reduction in use of analgesia, the use of a health related quality of life assessment tool (SF-36 and MMAS validated questionnaires) and an assessment of acceptability of the device through a 5-point Likert scale ranking the device from “unacceptable” to “totally acceptable”.

  • REC name

    Wales REC 6

  • REC reference

    17/WA/0325

  • Date of REC Opinion

    3 Oct 2017

  • REC opinion

    Favourable Opinion