search
Back to results

Pulsed Electromagnetic Field Treatment for Painful Periods (PUMMP)

Primary Purpose

Dysmenorrhea

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Allay
Placebo
Sponsored by
Birmingham Women's NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of BirmimghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Active Treatment

Placebo

No treatment

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Impact upon associated cyclical symptoms
Measured through the validated menstrual symptoms questionnaire the Menorrhagia Multi-Attribute Scale
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)
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".
Reduction in use of analgesia
Measured through a record of analgesia used during menstrual cycle

Full Information

First Posted
November 22, 2017
Last Updated
June 12, 2018
Sponsor
Birmingham Women's NHS Foundation Trust
Collaborators
BioElectronics Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT03394547
Brief Title
Pulsed Electromagnetic Field Treatment for Painful Periods
Acronym
PUMMP
Official Title
PUlsed electroMagnetic Field Treatment for Painful Periods: A Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 3, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Anticipated)
Study Completion Date
October 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Birmingham Women's NHS Foundation Trust
Collaborators
BioElectronics Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment
Arm Type
Active Comparator
Arm Description
Treatment for 2 menstrual cycles using the pulsed shortwave therapy Allay® device (BioElectronics Corp, Frederick USA)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
No intervention is given and a menstrual diary is completed for 2 cycles.
Intervention Type
Device
Intervention Name(s)
Allay
Intervention Description
pulsed shortwave therapy treatment for painful periods
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
A placebo device is given which is identical to the Allay device but emits no pulsed shortwave therapy.
Primary Outcome Measure Information:
Title
A reduction in dysmenorrhea as measured by the highest pain score on a 10cm visual analogue scale.
Description
Measured as highest pain score on a 10cm visual analogue scale
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Impact upon associated cyclical symptoms
Description
Measured through the validated menstrual symptoms questionnaire the Menorrhagia Multi-Attribute Scale
Time Frame
2 months
Title
Improvement in quality of life as measured through a validated quality of life assessment tool (SF-36 questionnaire).
Description
Measured through a validated quality of life questionnaire (SF36)
Time Frame
2 months
Title
Device acceptability as measured on a 5-point Likert scale ranging from "unacceptable" to "totally acceptable".
Description
Measured by those allocated a device on a 5-point Likert scale ranging from "unacceptable" to "totally acceptable".
Time Frame
2 months
Title
Reduction in use of analgesia
Description
Measured through a record of analgesia used during menstrual cycle
Time Frame
2 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justin Clark
Phone
07967724697
Email
t.j.clark@doctors.org.uk
First Name & Middle Initial & Last Name or Official Title & Degree
helen stevenson
Phone
07854031663
Email
h_stevenson27@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Clark
Organizational Affiliation
Birmingham Women's NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Birmimgham
City
Birmingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Clark

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Pulsed Electromagnetic Field Treatment for Painful Periods

We'll reach out to this number within 24 hrs