Pulsed Electromagnetic Field Treatment for Painful Periods

Dysmenorrhea Clinical Trial

— PUMMP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03394547
• Other study ID #: BirmimghamWHC
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: June 2018
• Source: Birmingham Women's NHS Foundation Trust
• Contact: Justin Clark
• Phone: 07967724697
• Email: t.j.clark[@]doctors.org.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Device:
• Allay
pulsed shortwave therapy treatment for painful periods
• Placebo
A placebo device is given which is identical to the Allay device but emits no pulsed shortwave therapy.

Locations

Country	Name	City	State
United Kingdom	University of Birmimgham	Birmingham

Sponsors (2)

Lead Sponsor	Collaborator
Birmingham Women's NHS Foundation Trust	BioElectronics Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Impact upon associated cyclical symptoms	Measured through the validated menstrual symptoms questionnaire the Menorrhagia Multi-Attribute Scale	2 months
Secondary	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
Secondary	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
Secondary	Reduction in use of analgesia	Measured through a record of analgesia used during menstrual cycle	2 months