Pulsed Electromagnetic Field Treatment for Painful Periods

Not Applicable

• Conditions: Dysmenorrhea
• Interventions: Device: Allay; Device: Placebo

• Registration Number: NCT03394547
• Lead Sponsor: Birmingham Women's NHS Foundation Trust

Brief 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

Study Timeline

• Study Start: 2017-11-03
• Study First Submitted: 2017-11-22
• Study First Submitted QC: 2018-01-08
• Study First Posted: 2018-01-09
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-12
• Last Update Posted: 2018-06-13
• Primary Completion: 2018-10-01
• Study Completion: 2018-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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 the duration of the trial.

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Treatment	Allay	Treatment for 2 menstrual cycles using the pulsed shortwave therapy Allay® device (BioElectronics Corp, Frederick USA)
Placebo	Placebo	Treatment for 2 menstrual cycles using a placebo device which is identical in appearance to the active device but does not emit any pulsed shortwave therapy.

Primary Outcome Measures

Name	Time	Method
A reduction in dysmenorrhea as measured by the highest pain score on a 10cm visual analogue scale.	2 months	Measured as highest pain score on a 10cm visual analogue scale

Secondary Outcome Measures

Name	Time	Method
Impact upon associated cyclical symptoms	2 months	Measured through the validated menstrual symptoms questionnaire the Menorrhagia Multi-Attribute Scale
Improvement in quality of life as measured through a validated quality of life assessment tool (SF-36 questionnaire).	2 months	Measured through a validated quality of life questionnaire (SF36)
Device acceptability as measured on a 5-point Likert scale ranging from "unacceptable" to "totally acceptable".	2 months	Measured by those allocated a device on a 5-point Likert scale ranging from "unacceptable" to "totally acceptable".
Reduction in use of analgesia	2 months	Measured through a record of analgesia used during menstrual cycle

Trial Locations

Locations (1)

University of Birmimgham; 🇬🇧 Birmingham, United Kingdom