NCT05339516

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

April 8, 2022

Last Update Submit

April 14, 2022

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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".

    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.

    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).

    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.

    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

    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.

    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.

    Baseline

Study Arms (2)

Healthy group

Women with low back pain

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30-65 ages women who live in city of Isparta in Turkey.

You may qualify if:

  • years women
  • Agreeing to involve in the study
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences

Isparta, 32100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Low Back PainSedentary BehaviorUrinary Incontinence

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological Manifestations

Central Study Contacts

Pinar Yasar, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant, Physiotherapist

Study Record Dates

First Submitted

April 8, 2022

First Posted

April 21, 2022

Study Start

November 29, 2021

Primary Completion

April 1, 2022

Study Completion

May 1, 2022

Last Updated

April 21, 2022

Record last verified: 2022-04

Locations