Pulsed Electromagnetic Field Treatment for Painful Periods — PUMMP  

Dysmenorrhea Clinical Trial

Official title: PUlsed electroMagnetic Field Treatment for Painful Periods: A Randomised Control Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Dysmenorrhea

• NCT number: NCT03394547
• Study type: Interventional
• Source: Birmingham Women's NHS Foundation Trust
• Contact: Justin Clark
• Phone: 07967724697
• Email: t.j.clark@doctors.org.uk
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2017
• Completion date: October 1, 2018