Clinical trial NCT03394547: Pulsed Electromagnetic Field Treatment for Painful Periods
Official title: PUlsed electroMagnetic Field Treatment for Painful Periods: A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysmenorrhea
Lead sponsor: Birmingham Women's NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: BioElectronics Corporation
First posted: 2018-01-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are allocated to 1 of 3 arms: either treatment with an active device, treatment with a placebo device, or no treatment.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: A reduction in dysmenorrhea as measured by the highest pain score on a 10cm visual analogue scale.
timeFrame: 2 months
Secondary outcomes:
measure: Impact upon associated cyclical symptoms
timeFrame: 2 months
measure: Improvement in quality of life as measured through a validated quality of life assessment tool (SF-36 questionnaire).
timeFrame: 2 months
measure: Device acceptability as measured on a 5-point Likert scale ranging from "unacceptable" to "totally acceptable".
timeFrame: 2 months
measure: Reduction in use of analgesia
timeFrame: 2 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University of Birmimgham
Study officials:
affiliation: Birmingham Women's NHS Foundation Trust
name: Justin Clark
role: PRINCIPAL_INVESTIGATOR
References: