Pulsed Electromagnetic Field Treatment for Painful Periods

Study Overview
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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.

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

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

Conditions
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Dysmenorrhea

Intervention / Treatment
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* Device: Allay
* Device: Placebo


Participation Criteria
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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. Exclusion Criteria: Age under 16 years. Trying to conceive or <6 weeks post partum Currently participating or planning to participate in another clinical trial

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are allocated to 1 of 3 arms: either treatment with an active device, treatment with a placebo device, or no treatment.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Treatment<br>Treatment for 2 menstrual cycles using the pulsed shortwave therapy Allay® device (BioElectronics Corp, Frederick USA) | Device: Allay<br>* pulsed shortwave therapy treatment for painful periods<br>|
| Placebo Comparator: Placebo<br>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. | Device: Placebo<br>* A placebo device is given which is identical to the Allay device but emits no pulsed shortwave therapy.<br>|
| No Intervention: No treatment<br>No intervention is given and a menstrual diary is completed for 2 cycles. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A reduction in dysmenorrhea as measured by the highest pain score on a 10cm visual analogue scale. | Measured as highest pain score on a 10cm visual analogue scale | 2 months | 

Secondary Outcome Measures

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