Dysmenorrhea
Conditions
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
Interventions
DEVICEAllay
pulsed shortwave therapy treatment for painful periods
DEVICEPlacebo
A placebo device is given which is identical to the Allay device but emits no pulsed shortwave therapy.
Sponsors
BioElectronics Corporation
Birmingham Women's NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes 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.
Intervention model description
Participants are allocated to 1 of 3 arms: either treatment with an active device, treatment with a placebo device, or no treatment.
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A reduction in dysmenorrhea as measured by the highest pain score on a 10cm visual analogue scale. | 2 months | Measured as highest pain score on a 10cm visual analogue scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact upon associated cyclical symptoms | 2 months | 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). | 2 months | 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. | 2 months | Measured by those allocated a device on a 5-point Likert scale ranging from unacceptable to totally acceptable. |
| Reduction in use of analgesia | 2 months | Measured through a record of analgesia used during menstrual cycle |
Countries
United Kingdom
Contacts
Primary ContactJustin Clark
Backup Contacthelen stevenson
Outcome results
None listed