Pulsed Electromagnetic Field Treatment for Painful Periods

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-03

Study Completion Date

2018-10-01

Brief Summary

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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.

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Detailed Description

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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

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Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are allocated to 1 of 3 arms: either treatment with an active device, treatment with a placebo device, or no treatment.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Participants will be randomly allocated to a treatment arm through telephone randomisation. If they are allocated to "no treatment" they will be aware of the management, however if allocated to use of a device the participant and care provider will be blinded to weather it is an active device or placebo device. The outcome assessor will be blinded to the treatment allocation.

Study Groups

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Active Treatment

Treatment for 2 menstrual cycles using the pulsed shortwave therapy Allay® device (BioElectronics Corp, Frederick USA)

Group Type ACTIVE_COMPARATOR

Allay

Intervention Type DEVICE

pulsed shortwave therapy treatment for painful periods

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

A placebo device is given which is identical to the Allay device but emits no pulsed shortwave therapy.

No treatment

No intervention is given and a menstrual diary is completed for 2 cycles.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Allay

pulsed shortwave therapy treatment for painful periods

Intervention Type DEVICE

Placebo

A placebo device is given which is identical to the Allay device but emits no pulsed shortwave therapy.

Intervention Type DEVICE

Eligibility Criteria

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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.