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Trial record 1 of 6 for:    Dysmenorrhea | United Kingdom
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Pulsed Electromagnetic Field Treatment for Painful Periods (PUMMP)

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ClinicalTrials.gov Identifier: NCT03394547
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : June 13, 2018
Sponsor:
Collaborator:
BioElectronics Corporation
Information provided by (Responsible Party):
Thomas Justin Clark, Birmingham Women's NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Dysmenorrhea Device: Allay Device: Placebo Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Care Provider, 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.
Primary Purpose: Treatment
Official Title: PUlsed electroMagnetic Field Treatment for Painful Periods: A Randomised Control Trial
Actual Study Start Date : November 3, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active Treatment
Treatment for 2 menstrual cycles using the pulsed shortwave therapy Allay® device (BioElectronics Corp, Frederick USA)
Device: Allay
pulsed shortwave therapy treatment for painful periods

Placebo Comparator: Placebo
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
A placebo device is given which is identical to the Allay device but emits no pulsed shortwave therapy.

No Intervention: No treatment
No intervention is given and a menstrual diary is completed for 2 cycles.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Impact upon associated cyclical symptoms [ Time Frame: 2 months ]
    Measured through the validated menstrual symptoms questionnaire the Menorrhagia Multi-Attribute Scale

  2. Improvement in quality of life as measured through a validated quality of life assessment tool (SF-36 questionnaire). [ Time Frame: 2 months ]
    Measured through a validated quality of life questionnaire (SF36)

  3. Device acceptability as measured on a 5-point Likert scale ranging from "unacceptable" to "totally acceptable". [ Time Frame: 2 months ]
    Measured by those allocated a device on a 5-point Likert scale ranging from "unacceptable" to "totally acceptable".

  4. Reduction in use of analgesia [ Time Frame: 2 months ]
    Measured through a record of analgesia used during menstrual cycle



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03394547


Contacts
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Contact: Justin Clark 07967724697 t.j.clark@doctors.org.uk
Contact: helen stevenson 07854031663 h_stevenson27@hotmail.com

Locations
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United Kingdom
University of Birmimgham Recruiting
Birmingham, United Kingdom
Contact: Justin Clark         
Sponsors and Collaborators
Birmingham Women's NHS Foundation Trust
BioElectronics Corporation
Investigators
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Principal Investigator: Justin Clark Birmingham Women's NHS Foundation Trust

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Responsible Party: Thomas Justin Clark, Chief Investigator, Birmingham Women's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03394547     History of Changes
Other Study ID Numbers: BirmimghamWHC
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen, hydrocodone drug combination
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents