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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03394547
Other study ID # BirmimghamWHC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 3, 2017
Est. completion date October 1, 2018

Study information

Verified date June 2018
Source Birmingham Women's NHS Foundation Trust
Contact Justin Clark
Phone 07967724697
Email t.j.clark@doctors.org.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date October 1, 2018
Est. primary completion date October 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Allay
pulsed shortwave therapy treatment for painful periods
Placebo
A placebo device is given which is identical to the Allay device but emits no pulsed shortwave therapy.

Locations

Country Name City State
United Kingdom University of Birmimgham Birmingham

Sponsors (2)

Lead Sponsor Collaborator
Birmingham Women's NHS Foundation Trust BioElectronics Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 2 months
Secondary Impact upon associated cyclical symptoms Measured through the validated menstrual symptoms questionnaire the Menorrhagia Multi-Attribute Scale 2 months
Secondary 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) 2 months
Secondary 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". 2 months
Secondary Reduction in use of analgesia Measured through a record of analgesia used during menstrual cycle 2 months
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