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Completed

NCT Number: NCT05811572

Investigation of Pelvic Floor Muscle Strength in Low Back Pain

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

Completed

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Bandırma Onyedi Eylül University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Balıkesir, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

measurement of pelvic floor muscle with perinometer

Device

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Roland morris disability questionnaire

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gulhan Yilmaz Gokmen

Other

Registry information

Official study title

Investigation of Pelvic Floor Muscle Strength in Women With Low Back Pain

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 13, 2023
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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