Pulsed Electromagnetic Field Treatment for Painful Periods (PUMMP)

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

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.

Study Overview

• Status: Unknown
• Conditions: Dysmenorrhea
• Intervention / Treatment: Device: Allay; Device: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Justin Clark; Phone Number: 07967724697; Email: t.j.clark@doctors.org.uk
• Study Contact Backup: Name: helen stevenson; Phone Number: 07854031663; Email: h_stevenson27@hotmail.com

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
    • Recruiting
    • University of Birmimgham
    • Contact: Justin Clark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Birmingham Women's NHS Foundation Trust
• Collaborators: BioElectronics Corporation
• Investigators: Principal Investigator: Justin Clark, Birmingham Women's NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (Actual): January 9, 2018

Study Record Updates

• Last Update Posted (Actual): June 13, 2018
• Last Update Submitted That Met QC Criteria: June 12, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: BirmimghamWHC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No