Investigation of Pelvic Floor Muscle Strength in Low Back Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05811572
• Other study ID #: 00-2020-0018
• Status: Completed
• Start date: June 3, 2022
• Est. completion date: March 3, 2023

Study information

• Verified date: March 2023
• Source: Bandirma Onyedi Eylül University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 3, 2023
• Est. primary completion date: January 15, 2023
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Disability Physical
• Low Back Pain
• Low Back Pain, Mechanical
• Muscle Weakness
• Non-specific Low Back Pain
• Pain
• Pelvic Floor Muscle Weakness

Intervention

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

Locations

Country	Name	City	State
Turkey	Bandirma Onyedi Eylül University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation	Balikesir

Sponsors (1)

Lead Sponsor	Collaborator
Gulhan Yilmaz Gokmen

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Secondary	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.	1 day
Secondary	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.	1 day