Investigation of Pelvic Floor Muscle Strength in Low Back Pain

Sponsor
Gulhan Yilmaz Gokmen (Other)
Overall Status
Completed
CT.gov ID
NCT05811572
Collaborator
(none)
72
1
9
8

Study Details

Study Description

Brief Summary

To evaluate the effect of pelvic floor muscle strength on women with non-specific low back pain

Condition or Disease Intervention/Treatment Phase
  • Device: measurement of pelvic floor muscle with perinometer

Study Design

Study Type:
Observational
Actual Enrollment :
72 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Investigation of Pelvic Floor Muscle Strength in Women With Low Back Pain
Actual Study Start Date :
Jun 3, 2022
Actual Primary Completion Date :
Jan 15, 2023
Actual Study Completion Date :
Mar 3, 2023

Arms and Interventions

Arm Intervention/Treatment
With Non-Specific Low Back Pain

pelvic floor muscles measurement with perinometer

Device: measurement of pelvic floor muscle with perinometer
Questions the person's perceptions about low back pain and related disability VAS questions the person's perceptions about low back pain severity
Other Names:
  • Roland morris disability questionnaire
  • Visual Analog Scale (VAS)
  • Without Low Back Pain

    pelvic floor muscles measurement with perinometer

    Device: measurement of pelvic floor muscle with perinometer
    Questions the person's perceptions about low back pain and related disability VAS questions the person's perceptions about low back pain severity
    Other Names:
  • Roland morris disability questionnaire
  • Visual Analog Scale (VAS)
  • Outcome Measures

    Primary Outcome Measures

    1. pelvic floor muscle strength [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.

    Secondary Outcome Measures

    1. Roland morris disability questionnaire [1 day]

      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.

    2. Visual analog scale [1 day]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:
    • 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)

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bandırma Onyedi Eylül University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Balıkesir Turkey

    Sponsors and Collaborators

    • Gulhan Yilmaz Gokmen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gulhan Yilmaz Gokmen, Assistant Professor, Bandırma Onyedi Eylül University
    ClinicalTrials.gov Identifier:
    NCT05811572
    Other Study ID Numbers:
    • 00-2020-0018
    First Posted:
    Apr 13, 2023
    Last Update Posted:
    Apr 13, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gulhan Yilmaz Gokmen, Assistant Professor, Bandırma Onyedi Eylül University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 13, 2023