Status:
UNKNOWN
Pulsed Electromagnetic Field Treatment for Painful Periods
Lead Sponsor:
Birmingham Women's NHS Foundation Trust
Collaborating Sponsors:
BioElectronics Corporation
Conditions:
Dysmenorrhea
Eligibility:
FEMALE
16+ years
Phase:
NA
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) ...
Eligibility Criteria
Inclusion
- 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
- Age under 16 years.
- Trying to conceive or \<6 weeks post partum
- Currently participating or planning to participate in another clinical trial
Key Trial Info
Start Date :
November 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03394547
Start Date
November 3 2017
End Date
October 1 2018
Last Update
June 13 2018
Active Locations (1)
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1
University of Birmimgham
Birmingham, United Kingdom