DysmenorrheaPUMMPNCT03394547
Pulsed Electromagnetic Field Treatment for Painful Periods
A study testing Allay in people with Dysmenorrhea, run by Birmingham Women's NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Allay
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Nov 2017to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age under 16 years.
- Trying to conceive or <6 weeks post partum
- Currently participating or planning to participate in another clinical trial
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Birmimgham
Birmingham
Justin Clark
About this study
Official title: PUlsed electroMagnetic Field Treatment for Painful Periods: A Randomised Control Trial
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.
Read the 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
- Conditions
- Dysmenorrhea
- Being tested
- Allay, Placebo
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllayDevice
pulsed shortwave therapy treatment for painful periods
PlaceboDevice
A placebo device is given which is identical to the Allay device but emits no pulsed shortwave therapy.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Active comparator | Treatment for 2 menstrual cycles using the pulsed shortwave therapy Allay® device (BioElectronics Corp, Frederick USA) Receives: Device: Allay |
| Placebo | Placebo comparator | 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. Receives: Device: Placebo |
| No treatment | No intervention | No intervention is given and a menstrual diary is completed for 2 cycles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
Secondary outcomes (4)
Impact upon associated cyclical symptoms
Measured through the validated menstrual symptoms questionnaire the Menorrhagia Multi-Attribute Scale
Measured: 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)
Measured: 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".
Measured: 2 months
Reduction in use of analgesia
Measured through a record of analgesia used during menstrual cycle
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start3 Nov 2017
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are allocated to 1 of 3 arms: either treatment with an active device, treatment with a placebo device, or no treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Birmingham Women's NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- BioElectronics Corporation
- Responsible party
- Principal investigator, Thomas Justin Clark, Birmingham Women's NHS Foundation Trust
- Investigators
- Justin Clark, Principal investigator, Birmingham Women's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394547
- Sponsor's protocol ID
- BirmimghamWHC
- Acronym
- PUMMP
- Status last verified
- Jun 2018
- First submitted
- 22 Nov 2017
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PUlsed electroMagnetic Field Treatment for Painful Periods: A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT03394547
- Acronym / sponsor ID
- PUMMP / BirmimghamWHC
- Conditions
- Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Birmingham Women's NHS Foundation TrustOther government
- Collaborators
- BioElectronics Corporation
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants are allocated to 1 of 3 arms: either treatment with an active device, treatment with a placebo device, or no treatment.
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Active comparator | Device: AllayTreatment for 2 menstrual cycles using the pulsed shortwave therapy Allay® device (BioElectronics Corp, Frederick USA) |
| Placebo | Placebo comparator | Device: PlaceboTreatment 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. |
| No treatment | No intervention | –No intervention is given and a menstrual diary is completed for 2 cycles. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Age under 16 years.
- Trying to conceive or <6 weeks post partum
- Currently participating or planning to participate in another clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allaypulsed shortwave therapy treatment for painful periods | Device | Active Treatment |
| PlaceboA placebo device is given which is identical to the Allay device but emits no pulsed shortwave therapy. | Device | Placebo |
Primary outcome
A reduction in dysmenorrhea as measured by the highest pain score on a 10cm visual analogue scale.
Time frame: 2 months
Measured as highest pain score on a 10cm visual analogue scale
4 secondary outcomes
Impact upon associated cyclical symptoms
Time frame: 2 months
Improvement in quality of life as measured through a validated quality of life assessment tool (SF-36 questionnaire).
Time frame: 2 months
Device acceptability as measured on a 5-point Likert scale ranging from "unacceptable" to "totally acceptable".
Time frame: 2 months
Reduction in use of analgesia
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Clark principal investigator
Birmingham Women's NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allay in people with Dysmenorrhea, run by Birmingham Women's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin Clark (07967724697, t.j.clark@doctors.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A reduction in dysmenorrhea as measured by the highest pain score on a 10cm visual analogue scale. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2018.