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)
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
This study's planned enrollment of 60 is close to the median of 62 across 363 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Birmingham Women's NHS Foundation Trust is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Started Nov 2017 (actual). Primary completion is estimated for Oct 2018, 10 months after the start.
Of 178 non-industry interventional studies with no phase under Dysmenorrhea, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's planned 10 months is above that.
Counting every sponsor, half of 188 studies reached it within 8 months; a quarter within 3 and three quarters within 16.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Birmingham Women's NHS Foundation Trust