Dysmenorrhea PrimaryDysmenorheaNCT05885945
Diaphragmmatic Muscle Strength and Balance in Women With Dysmenorhea
An observational study of Dysmenorrhea Primary, run by Catholic University of Murcia at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea Primary
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2023to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with primary dysmenorrhea
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Dysmenorrhea Primary
- Keywords
- dysmenorrhea, diaphragm, balance, muscular strength
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| dysmenorrhea | primary dysmenorrhea | |
| control | control not pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
stabilometric variables in bipodal and monopodal support
Measured: 2 months
diaphragmatic muscle strength
diaphragmatic muscle force through the maximum inspiratory pressure in the mouth
Measured: 2 months
Secondary outcomes (1)
sociodemographic variables
sociodemographic variables such as age, body mass index, personal data record, and data record related to pain and dysmenorrhea
Measured: 2 monsths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start15 Feb 2023
- Primary completion14 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe León Morillas, Catholic University of Murcia
- Investigators
- Felipe León-Morillas, Principal investigator, Catholic University of Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885945
- Sponsor's protocol ID
- TC-01/23
- Acronym
- Dysmenorhea
- Status last verified
- Jan 2024
- First submitted
- 23 May 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmmatic Muscle Strength and Balance in Women With Dysmenorhea
- ClinicalTrials.gov ID
- NCT05885945
- Acronym / sponsor ID
- Dysmenorhea / TC-01/23
- Conditions
- Dysmenorrhea Primary
- Keywords
- dysmenorrhea, diaphragm, balance, muscular strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Catholic University of MurciaUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dysmenorrhea | – | –primary dysmenorrhea |
| control | – | –control not pain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with primary dysmenorrhea
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Balance
Time frame: 2 months
stabilometric variables in bipodal and monopodal support
diaphragmatic muscle strength
Time frame: 2 months
diaphragmatic muscle force through the maximum inspiratory pressure in the mouth
1 secondary outcome
sociodemographic variables
Time frame: 2 monsths
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe León-Morillas principal investigator
Catholic University of Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysmenorrhea Primary, run by Catholic University of Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.