An interventional study of Allay and Placebo in Dysmenorrhea, sponsored by Birmingham Women's NHS Foundation Trust. Status unknown at 1 site in United Kingdom. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-13.
Sponsored by Birmingham Women's NHS Foundation Trust · Not applicable, Interventional, and Treatment
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.
Women participating in the trial will be randomly allocated to any of the three arms of the study.
Primary Outcome measures are:
Improvement in quality of life as measured through a validated quality of life assessment tool (SF-36 questionnaire)
Exclusion Criteria:
Treatment for 2 menstrual cycles using the pulsed shortwave therapy Allay® device (BioElectronics Corp, Frederick USA)
Device: Allay
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
No intervention is given and a menstrual diary is completed for 2 cycles.
pulsed shortwave therapy treatment for painful periods
A placebo device is given which is identical to the Allay device but emits no pulsed shortwave therapy.
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
Time frame: 2 months
Impact upon associated cyclical symptoms
Measured through the validated menstrual symptoms questionnaire the Menorrhagia Multi-Attribute Scale
Time frame: 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)
Time frame: 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".
Time frame: 2 months
Reduction in use of analgesia
Measured through a record of analgesia used during menstrual cycle
Time frame: 2 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Birmingham Women's NHS Foundation Trust