Pulsed Electromagnetic Field Treatment for Painful Periods

Last updated: June 12, 2018
Sponsor: Birmingham Women's NHS Foundation Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Menstrual Disorders

Female Hormonal Deficiencies/abnormalities

Severe Premenstrual Symptom

Treatment

N/A

Clinical Study ID

NCT03394547
BirmimghamWHC
  • Ages > 16
  • Female
  • Accepts Healthy Volunteers

Study Summary

A single-centre, randomised controlled, double blind study comparing use of the Allay pulsed shortwave therapy treatment versus a placebo device or no treatment for management of primary dysmenorrhea.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female with persistent (>3months) cyclical period pain associated with menstruation (defined as 5 or more on VAS).

  • Able to give written, Informed consent

  • Able to wear device and keep up-to-date records of use

  • Agrees to attend follow up

  • If currently using hormonal contraception agrees to continue on the same dose for theduration of the trial.

Exclusion

Exclusion Criteria:

  • Age under 16 years.

  • Trying to conceive or <6 weeks post partum

  • Currently participating or planning to participate in another clinical trial

Study Design

Total Participants: 60
Study Start date:
November 03, 2017
Estimated Completion Date:
October 01, 2018

Study Description

Women participating in the trial will be randomly allocated to any of the three arms of the study.

  • Treatment for 2 menstrual cycles using the PSWT Allay device (BioElectronics Corp, Frederick USA)

  • Treatment for 2 menstrual cycles using a placebo device

  • No treatment. If they are allocated to a device both the participant and the clinician will be blinded at to weather they are using the active device or the placebo.

Primary Outcome measures are:

  • A reduction in dysmenorrhea as measured by the highest pain score on a 10cm visual analogue scale.

  • A reduction in average pain score on a 10cm visual analogue scale

  • A reduction in use of analgesia as recorded in a pain diary

  • Improvement in quality of life as measured through a validated quality of life assessment tool (SF-36 questionnaire)

    • Improvement in menstrual symptoms as recorded through a validated questionnaire (the Modified Menorrhagia Multi-attribute Scale (MMAS)).

  • Device acceptability as measured on a 5-point Likert scale ranging from "unacceptable" to "totally acceptable".

  • Impact upon associated cyclical symptoms as recorded in a patient symptom diary

Connect with a study center

  • University of Birmimgham

    Birmingham,
    United Kingdom

    Active - Recruiting

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