Pulsed Electromagnetic Field Treatment for Painful Periods

NCT03394547 | Unknown DMC

• 1 other identifier: BirmimghamWHC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Impact upon associated cyclical symptoms

  2 months

• Improvement in quality of life as measured through a validated quality of life assessment tool (SF-36 questionnaire).

  2 months

• Device acceptability as measured on a 5-point Likert scale ranging from "unacceptable" to "totally acceptable".

  2 months

• Reduction in use of analgesia

  2 months

Study Arms (3)

Active Treatment

ACTIVE COMPARATOR

Treatment for 2 menstrual cycles using the pulsed shortwave therapy Allay® device (BioElectronics Corp, Frederick USA)

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.

Device: Placebo

No treatment

NO INTERVENTION

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

Interventions

Allay DEVICE

pulsed shortwave therapy treatment for painful periods

Active Treatment

Placebo DEVICE

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

Placebo

Eligibility Criteria

• Age: 16 Years+
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age under 16 years.
• Trying to conceive or \<6 weeks post partum
• Currently participating or planning to participate in another clinical trial

Sponsors & Collaborators

• Birmingham Women's NHS Foundation Trust: lead
• BioElectronics Corporation: collaborator

Study Sites (1)

University of Birmimgham

Birmingham, United Kingdom

RECRUITING

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Justin Clark

  Birmingham Women's NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin Clark

CONTACT

07967724697; t.j.clark@doctors.org.uk

helen stevenson

CONTACT

07854031663; h_stevenson27@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Model Details: Participants are allocated to 1 of 3 arms: either treatment with an active device, treatment with a placebo device, or no treatment.

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: January 9, 2018
• Study Start: November 3, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: June 13, 2018

Record last verified: 2018-06

Locations

GB (1)