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. * 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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
University of Birmimgham
Birmingham, United Kingdom
RECRUITINGA 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
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