NCT03394547

Pulsed Electromagnetic Field Treatment for Painful Periods

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Birmingham Women's NHS Foundation Trust · Other Government
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Dysmenorrhea

Interventions

Type	Name	Description
DEVICE	Allay	pulsed shortwave therapy treatment for painful periods
DEVICE	Placebo	A placebo device is given which is identical to the Allay device but emits no pulsed shortwave therapy.

Timeline

• Start date: 2017-11-03
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2018-01-09
• Last updated: 2018-06-13

Locations

1 site across 1 country: United Kingdom