Impacts of Static Magnetic Fields on Dysmenorrhea Pain

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

Study Overview

• Status: Completed
• Conditions: Period Pain
• Intervention / Treatment: Device: Magnet

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Davie, Florida, United States, 33328
      • Nova Southeastern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria: Female with period pain score consistently equal to or greater than 6 on a pain scale of 0-10 -

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Magnet; Magnet or Sham is worn by subject in close proximity to their described maximum pain site
Sham Comparator: 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.	Device: Magnet; Magnet or Sham is worn by subject in close proximity to their described maximum pain site

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score scale of 1-10 / 1 being less pain 10 being more pain	Subject reported pain after wearing device	40 minutes

Collaborators and Investigators

• Sponsor: Nova Southeastern University
• Investigators: Principal Investigator: Harvey Mayrovitz, PhD, Nova Southeastern University

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2018
• Primary Completion (Actual): March 8, 2021
• Study Completion (Actual): March 8, 2021

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: 2018-614-NSU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No