Low Back Pain, MechanicalNCT05811572
Investigation of Pelvic Floor Muscle Strength in Low Back Pain
An observational study of Low Back Pain, Mechanical and Pelvic Floor Muscle Weakness, run by Gulhan Yilmaz Gokmen at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the effect of pelvic floor muscle strength on women with non-specific low back pain Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Low Back Pain, Mechanical, Pelvic Floor Muscle Weakness, Non-specific Low Back Pain
- What is being tested?
- measurement of pelvic floor muscle with perinometer
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2022to 3 Mar 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 50 years
- Women only
- Adult
Study population: Women with and without non-specific low back pain
Who may be able to join
- being a woman
- 18-50 years old
- BMI≤30
- For The NSLBP Group:
- diagnosed with non-specific low back pain by a specialist physician,
- have low back pain for at least 3 months,
- have no pain radiating to the leg,
- have low back pain 3 or higher on the visual analog scale (VAS, 0-10 scale)
Who cannot join
- have a somatic or psychiatric disorder,
- have signs and symptoms associated with other conditions such as nerve root compression (at least 2 of these symptoms: weakness, reflex changes or loss of sensation associated with the same spinal nerve),
- have had previous spinal surgery or are scheduled for surgery,
- Pregnant
- have neurological and pelvic inflammatory diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bandırma Onyedi Eylül University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Balıkesir
About this study
Official title: Investigation of Pelvic Floor Muscle Strength in Women With Low Back Pain
To evaluate the effect of pelvic floor muscle strength on women with non-specific low back pain
- Conditions
- Low Back Pain, Mechanical, Pelvic Floor Muscle Weakness, Non-specific Low Back Pain, Disability Physical, Pain
- Being tested
- measurement of pelvic floor muscle with perinometer
- Keywords
- Non-specific low back pain, perinometer, Pelvic Floor Muscle, Disability, Pain
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of pelvic floor muscle with perinometerDevice
Also called Roland morris disability questionnaire, Visual Analog Scale (VAS)
Questions the person's perceptions about low back pain and related disability VAS questions the person's perceptions about low back pain severity
| Study group | Role | What they receive |
|---|---|---|
| With Non-Specific Low Back Pain | pelvic floor muscles measurement with perinometer Receives: Device: measurement of pelvic floor muscle with perinometer | |
| Without Low Back Pain | pelvic floor muscles measurement with perinometer Receives: Device: measurement of pelvic floor muscle with perinometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
pelvic floor muscle strength
It was done with a manual perinometer. A manometer measuring between 0 and 25 mbar was used. The manometer is connected to the vaginal probe by a plastic, hollow, 75 cm long tube. The diameter of the vaginal probe is 3.5 cm and the length is 15 cm. The vaginal probe is inserted intravaginally to a depth of 5-10 cm. With the person in the supine position, with the knees flexed at 45 degrees, the measurement is made with a perineometer 3 times. For each measurement, the vaginal probe is removed and reinserted intravaginally. Each measurement starts when the indicator part on the manometer is 0 mbar and the patient is asked to tighten the pelvic floor muscles maximally. The average of the three measurements gives the mean pelvic floor muscle strength value.
Measured: 1 day
Secondary outcomes (2)
Roland morris disability questionnaire
First published in 1983 and reviewed in 2000, the Roland-Morris Disability Questionnaire(RMDQ) is designed to assess self-rated physical disability caused by low back pain.There are different questionnaires available, which differ from each other in the number of statements: 24-, 18- and 11-item questionnaires. The score ranges from 0 (no disability) to 24 (max. disability) depending on the questionnaire used.
Measured: 1 day
Visual analog scale
On a 10-centimeter ruler drawn from zero to ten, the individual is asked to mark the most severe pain they have experienced in the last 24 hours. Values of 1-2-3 describe mild pain, values of 4-5-6 describe moderate pain, and 7-8-9-10 describe severe pain.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start3 Jun 2022
- Primary completion15 Jan 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhan Yilmaz Gokmen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gulhan Yilmaz Gokmen, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811572
- Sponsor's protocol ID
- 00-2020-0018
- Status last verified
- Mar 2023
- First submitted
- 31 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Pelvic Floor Muscle Strength in Women With Low Back Pain
- ClinicalTrials.gov ID
- NCT05811572
- Acronym / sponsor ID
- 00-2020-0018
- Conditions
- Low Back Pain, Mechanical, Pelvic Floor Muscle Weakness, Non-specific Low Back Pain, Disability Physical, Pain
- Keywords
- Non-specific low back pain, perinometer, Pelvic Floor Muscle, Disability, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Gulhan Yilmaz GokmenUniversity, hospital or other
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 13 Apr 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.
To evaluate the effect of pelvic floor muscle strength on women with non-specific low back pain
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Non-Specific Low Back Pain | – | Device: measurement of pelvic floor muscle with perinometerpelvic floor muscles measurement with perinometer |
| Without Low Back Pain | – | Device: measurement of pelvic floor muscle with perinometerpelvic floor muscles measurement with perinometer |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women with and without non-specific low back pain
Key inclusion criteria (8 listed)
- being a woman
- 18-50 years old
- BMI≤30
- diagnosed with non-specific low back pain by a specialist physician,
- have low back pain for at least 3 months,
Key exclusion criteria (5 listed)
- have a somatic or psychiatric disorder,
- have signs and symptoms associated with other conditions such as nerve root compression (at least 2 of these symptoms: weakness, reflex changes or loss of sensation associated with the same spinal nerve),
- have had previous spinal surgery or are scheduled for surgery,
- Pregnant
- have neurological and pelvic inflammatory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of pelvic floor muscle with perinometerAlso: Roland morris disability questionnaire, Visual Analog Scale (VAS)Questions the person's perceptions about low back pain and related disability VAS questions the person's perceptions about low back pain severity | Device | With Non-Specific Low Back Pain, Without Low Back Pain |
Primary outcome
pelvic floor muscle strength
Time frame: 1 day
It was done with a manual perinometer. A manometer measuring between 0 and 25 mbar was used. The manometer is connected to the vaginal probe by a plastic, hollow, 75 cm long tube. The diameter of the vaginal probe is 3.5 cm and the length is 15 cm. The vaginal probe is inserted intravaginally to a depth of 5-10 cm. With the person in the supine position, with the knees flexed at 45 degrees, the measurement is made with a perineometer 3 times. For each measurement, the vaginal probe is removed and reinserted intravaginally. Each measurement starts when the indicator part on the manometer is 0 mbar and the patient is asked to tighten the pelvic floor muscles maximally. The average of the three measurements gives the mean pelvic floor muscle strength value.
2 secondary outcomes
Roland morris disability questionnaire
Time frame: 1 day
Visual analog scale
Time frame: 1 day
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 13 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Low Back Pain, Mechanical and Pelvic Floor Muscle Weakness, run by Gulhan Yilmaz Gokmen at 1 site in Turkey (Türkiye).
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 8 inclusion and 5 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 13 Apr 2023. 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 Turkey (Türkiye). 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?
pelvic floor muscle strength (time frame: 1 day). 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 13 Apr 2023.