NCT04539691

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2021

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

2.5 years

First QC Date

August 31, 2020

Last Update Submit

June 24, 2021

Conditions

Period Pain

Outcome Measures

Primary Outcomes (1)

  • Pain score scale of 1-10 / 1 being less pain 10 being more pain

    Subject reported pain after wearing device

    40 minutes

Study Arms (2)

Magnet group

EXPERIMENTAL

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.

Device: Magnet

Sham group

SHAM COMPARATOR

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.

Device: Magnet

Interventions

MagnetDEVICE

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

Magnet groupSham group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAges 18-35 years of age with period pain score consistently equal to or greater than 6 on a pain scale of 0-10
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Pain not experienced on almost all menstrual cycles
  • Having secondary dysmenorrhea including endometriosis, fibroids or pelvic inflammatory disease
  • Having a pacemaker or any implanted wires or devices -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Southeastern University

Davie, Florida, 33328, United States

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Harvey Mayrovitz, PhD

    Nova Southeastern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Magnet and sham devices used weigh and look the same
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 7, 2020

Study Start

August 30, 2018

Primary Completion

March 8, 2021

Study Completion

March 8, 2021

Last Updated

June 29, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)