Low Back PainNCT05339516
The Association Between Urinary Incontinence, Physical Performance, Physical Activity Levels in Women With Low Back Pain
An observational study of Low Back Pain and Physical Inactivity, run by Pinar Yasar at 1 site in Turkey (Türkiye).
Trial summary
The study is searching for the correlation between low back pain(LBP), physical performance, urinary incontinence and physical activity levels in women. Lower physical performance, more frequent urinary incontinence and less physical activity are expected in women who have LBP. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Physical Inactivity, Urinary Incontinence
- How many people
- 146 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Nov 2021to May 2022
- How long will I take part?
- 1 Day
- 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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30-65 ages women who live in city of Isparta in Turkey.
Who may be able to join
- 30-65 years women
- Agreeing to involve in the study
- 30-65 years women
- Having low back pain for at least 3 months
- Scoring pain at least 1 in Visual Analog Scale(VAS)
- Agreeing to involve in the study
Who cannot join
- Any kind of surgery history in low back area
- Surgery history in lower limbs
- Acute low back pain
- Having a neurological disease
- Having sensory deficists
- The ones with rheumatological diseases which can cause low back pain
- Being pregnant
- Having a disc hernia pressuring to sacral nerves
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Faculty of Health Sciences
Isparta, 32100
Pınar Yasar, MSc, +905350145340, pinarergoz@gmail.com
About this study
Official title: The Association Between Urinary Incontinence, Physical Performance and Physical Activity Level in Women With Low Back Pain a Cross-Sectional Study
The study is searching for the correlation between low back pain(LBP), physical performance, urinary incontinence and physical activity levels in women. Lower physical performance, more frequent urinary incontinence and less physical activity are expected in women who have LBP.
- Conditions
- Low Back Pain, Physical Inactivity, Urinary Incontinence
- Medical subject headings
- Low Back Pain, Sedentary Behavior, Urinary Incontinence
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 |
|---|---|---|
| Healthy group | Not described | |
| Women with low back pain | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale(VAS)
Visual Analogue Scale (VAS) will be used to evaluate the severity of low back pain. The back pain they feel during activity and rest will be questioned separately from the participants. For this assessment, patients will be asked to mark their pain intensity on a 10-centimeter line. Pain intensity will be determined by measuring the distance of the marked point to the "0" point with a tape measure. Scoring is made between 0-10 and "0 means no pain"- "10 means the most severe pain imaginable".
Measured: Baseline
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
The six-question form allows evaluation of the frequency of urinary incontinence and during which activities it occurs. The validity and reliability study of the Turkish version of the test was done by Çetinel et al. made by Scoring is done with frequency, amount and degree of impact questions, a total score between 0-21 is obtained. A low score indicates that urinary incontinence affects the quality of life less, and a high score indicates that the involvement is high. For the ICIQ-SF, a score of 8 and above was determined as the most appropriate cut-off value for irritating urine leakage.
Measured: Baseline
International Physical Activity Questionnaire(IPAQ)
The physical activity level of the participants will be evaluated with the International Physical Activity Questionnaire (IPAQ). The survey consists of a total of 5 sections and 27 questions. Information is obtained about the light, moderate and vigorous activities that the person has done in the last week and the sitting time. For physical activities performed for at least 10 minutes, the MET value (metabolic equivalent) is multiplied by the number of days and minutes to obtain the MET-min/week score. Classification according to the energy level spent in METs is made as no physical activity (MET=<600), insufficient activity (MET=600-3000), and adequate activity level (MET= >3000).
Measured: Baseline
Muscle Strength Testing
The muscle strength of the participants will be determined by the Manual Muscle Test. The person is asked to move against gravity by taking the appropriate position for the muscle to be evaluated. If the movement can be done up to the desired part (3) it is scored as medium, if it receives minimal resistance (3+) if it gets a little good from the middle, if it can get moderate resistance (4) good, if it can get full resistance (5) it is normal. Muscle strength of the shoulder and elbow flexors in the upper extremity and hip flexors in the lower extremities will be evaluated.
Measured: Baseline
Endurance Testing
Trunk Flexor Endurance test and Wall-Sit-Hold Test will be used to evaluate trunk and lower extremity endurance.
Wall-Sit- Hold Test: The participant leans his back against the wall, spreads his feet shoulder-width apart and squats by bringing his knees to 90 degrees of flexion. The time during which the position can be held is recorded
Measured: Baseline
Agility Testing
Burpee Agility Test will be used for the agility evaluation of the participants. The test consists of 4 stages. Initially, the standing participant moves into a half-squat position, then into a stance on the floor with hands and feet close together. Then the participant takes the plank position with the arms fully extended by throwing his legs back and then returning to the previous position. He then stands up and returns to the starting position and claps his hands above his head once. The standard test duration is 3 minutes, but a modified version of 1 minute will be used in order to be applicable to individuals with low physical activity.
Measured: Baseline
Flexibility Testing
Flexibility will be assessed with the sit and reach test. The person sits in a long sitting position with his legs straight, the soles of the feet are in contact with the 31 cm high evaluation table. The participant is then asked to reach forward as far as he can, keeping his knees straight, with one hand on the other. Starting position and the farthest point that the middle finger can reach at the end of the movement is measured and the difference is recorded.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start29 Nov 2021
- Primary completionApr 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 146 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Pinar Yasar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pinar Yasar, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339516
- Sponsor's protocol ID
- 72867572-050.01.04-
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Urinary Incontinence, Physical Performance and Physical Activity Level in Women With Low Back Pain a Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05339516
- Acronym / sponsor ID
- 72867572-050.01.04-
- Conditions
- Low Back Pain, Physical Inactivity, Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Pinar YasarUniversity, hospital or other
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 21 Apr 2022 (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.
The study is searching for the correlation between low back pain(LBP), physical performance, urinary incontinence and physical activity levels in women. Lower physical performance, more frequent urinary incontinence and less physical activity are expected in women who have LBP.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy group | – | – |
| Women with low back pain | – | – |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30-65 ages women who live in city of Isparta in Turkey.
Key inclusion criteria (6 listed)
- 30-65 years women
- Agreeing to involve in the study
- 30-65 years women
- Having low back pain for at least 3 months
- Scoring pain at least 1 in Visual Analog Scale(VAS)
Key exclusion criteria (8 listed)
- Any kind of surgery history in low back area
- Surgery history in lower limbs
- Acute low back pain
- Having a neurological disease
- Having sensory deficists
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
Visual Analog Scale(VAS)
Time frame: Baseline
Visual Analogue Scale (VAS) will be used to evaluate the severity of low back pain. The back pain they feel during activity and rest will be questioned separately from the participants. For this assessment, patients will be asked to mark their pain intensity on a 10-centimeter line. Pain intensity will be determined by measuring the distance of the marked point to the "0" point with a tape measure. Scoring is made between 0-10 and "0 means no pain"- "10 means the most severe pain imaginable".
International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time frame: Baseline
The six-question form allows evaluation of the frequency of urinary incontinence and during which activities it occurs. The validity and reliability study of the Turkish version of the test was done by Çetinel et al. made by Scoring is done with frequency, amount and degree of impact questions, a total score between 0-21 is obtained. A low score indicates that urinary incontinence affects the quality of life less, and a high score indicates that the involvement is high. For the ICIQ-SF, a score of 8 and above was determined as the most appropriate cut-off value for irritating urine leakage.
International Physical Activity Questionnaire(IPAQ)
Time frame: Baseline
The physical activity level of the participants will be evaluated with the International Physical Activity Questionnaire (IPAQ). The survey consists of a total of 5 sections and 27 questions. Information is obtained about the light, moderate and vigorous activities that the person has done in the last week and the sitting time. For physical activities performed for at least 10 minutes, the MET value (metabolic equivalent) is multiplied by the number of days and minutes to obtain the MET-min/week score. Classification according to the energy level spent in METs is made as no physical activity (MET=<600), insufficient activity (MET=600-3000), and adequate activity level (MET= >3000).
Muscle Strength Testing
Time frame: Baseline
The muscle strength of the participants will be determined by the Manual Muscle Test. The person is asked to move against gravity by taking the appropriate position for the muscle to be evaluated. If the movement can be done up to the desired part (3) it is scored as medium, if it receives minimal resistance (3+) if it gets a little good from the middle, if it can get moderate resistance (4) good, if it can get full resistance (5) it is normal. Muscle strength of the shoulder and elbow flexors in the upper extremity and hip flexors in the lower extremities will be evaluated.
Endurance Testing
Time frame: Baseline
Trunk Flexor Endurance test and Wall-Sit-Hold Test will be used to evaluate trunk and lower extremity endurance. Wall-Sit- Hold Test: The participant leans his back against the wall, spreads his feet shoulder-width apart and squats by bringing his knees to 90 degrees of flexion. The time during which the position can be held is recorded
Agility Testing
Time frame: Baseline
Burpee Agility Test will be used for the agility evaluation of the participants. The test consists of 4 stages. Initially, the standing participant moves into a half-squat position, then into a stance on the floor with hands and feet close together. Then the participant takes the plank position with the arms fully extended by throwing his legs back and then returning to the previous position. He then stands up and returns to the starting position and claps his hands above his head once. The standard test duration is 3 minutes, but a modified version of 1 minute will be used in order to be applicable to individuals with low physical activity.
Flexibility Testing
Time frame: Baseline
Flexibility will be assessed with the sit and reach test. The person sits in a long sitting position with his legs straight, the soles of the feet are in contact with the 31 cm high evaluation table. The participant is then asked to reach forward as far as he can, keeping his knees straight, with one hand on the other. Starting position and the farthest point that the middle finger can reach at the end of the movement is measured and the difference is recorded.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
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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.
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 and Physical Inactivity, run by Pinar Yasar 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 21 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pinar Yasar, MSc (+905350145340, pinarergoz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale(VAS) (time frame: Baseline). The study lists 7 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 21 Apr 2022.