Diaphragmmatic Muscle Strength and Balance in Women With Dysmenorhea (Dysmenorhea)

Analysis of stabilometric and respiratory variables in patients with dysmenorrhea during the first day of the menstrual cycle and any other day outside the cycle.

Study Overview

• Status: Completed
• Conditions: Dysmenorrhea Primary

Detailed Description

Sociodemographic variables such as age, height, body mass index.

Respiratory variables such as maximum inspiratory pressure (MIP), MIP reference %, and MIP predictive value.

Stabilometric variables we will measure the balance in condition of eyes open and eyes closed bipodal support and eyes open in monopodal support

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• Spain
  • Murcia
    • Guadalupe, Murcia, Spain, 30107
      • University Catholic of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Women with primary dysmenorrhea

Description

Inclusion Criteria:

• Adult women with primary dysmenorrhea.
• Not having had any type of childbirth (natural, caesarean section, etc).
• Not be positive in COVID. Antigen test in the last 24 hours or negative PCR in the last 48 hours.

Exclusion Criteria:

• Receive medical treatment during research.
• Have any orthopedic, neurological or systemic disease diagnosed other than primary dysmenorrhea.
• Be in follow-up with any medical treatment that does not be primary dysmenorrhea
• Women with a history of trauma or surgical treatment who involve the musculoskeletal system in the last year.
• Use of analgesics in the last 48 hours.
• Consumption of alcohol in the last 24 hours.
• Have a history or suspicion of pregnancy.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
dysmenorrhea; primary dysmenorrhea
control; control not pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance	stabilometric variables in bipodal and monopodal support	2 months
diaphragmatic muscle strength	diaphragmatic muscle force through the maximum inspiratory pressure in the mouth	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sociodemographic variables	sociodemographic variables such as age, body mass index, personal data record, and data record related to pain and dysmenorrhea	2 monsths

Collaborators and Investigators

• Sponsor: Catholic University of Murcia
• Investigators: Principal Investigator: Felipe León-Morillas, Catholic University of Murcia

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): June 14, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: balance; diaphragm; muscular strength; dysmenorrhea
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: TC-01/23

Drug and device information, study documents

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