Impacts of Static Magnetic Fields on Dysmenorrhea Pain

NCT ID: NCT04539691

Last Updated: 2021-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-30

Study Completion Date

2021-03-08

Brief Summary

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Study to determine the effectiveness of a certain type of magnet to reduce period pain

Detailed Description

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Young women with their period pain levels of 6 or greater on a pain scale of 0-10 will wear a concentric magnet or a sham that is positioned close to the maximum pain site. The pain score after wearing either the magnet or sham will be recorded.

Conditions

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Period Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Magnet and sham devices used weigh and look the same

Study Groups

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Magnet group

Women wearing magnet

a magnet, or sham device indistinguishable from the magnet (determined randomly), will be placed on her abdomen. If the pain is predominately in her abdomen, the device will be placed on the location with the most pain. If the pain is predominantly in the subjects back, the device will be placed on the lower abdomen on the midline between the umbilicus and the pubic bone.

Group Type EXPERIMENTAL

Magnet

Intervention Type DEVICE

Magnet or Sham is worn by subject in close proximity to their described maximum pain site

Sham group

Women wearing sham

a magnet, or sham device indistinguishable from the magnet (determined randomly), will be placed on her abdomen. If the pain is predominately in her abdomen, the device will be placed on the location with the most pain. If the pain is predominantly in the subjects back, the device will be placed on the lower abdomen on the midline between the umbilicus and the pubic bone.

Group Type SHAM_COMPARATOR

Magnet

Intervention Type DEVICE

Magnet or Sham is worn by subject in close proximity to their described maximum pain site

Interventions

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Magnet

Magnet or Sham is worn by subject in close proximity to their described maximum pain site

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

1. Pain not experienced on almost all menstrual cycles
2. Having secondary dysmenorrhea including endometriosis, fibroids or pelvic inflammatory disease
3. Having a pacemaker or any implanted wires or devices -
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nova Southeastern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harvey Mayrovitz, PhD

Role: PRINCIPAL_INVESTIGATOR

Nova Southeastern University

Locations

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Nova Southeastern University

Davie, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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2018-614-NSU

Identifier Type: -

Identifier Source: org_study_id

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