Investigation of Pelvic Floor Muscle Strength in Low Back Pain

Completed

• Conditions: Pain; Pelvic Floor Muscle Weakness; Non-specific Low Back Pain; Disability Physical; Low Back Pain, Mechanical
• Interventions: Device: measurement of pelvic floor muscle with perinometer

• Registration Number: NCT05811572
• Lead Sponsor: Gulhan Yilmaz Gokmen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-03
• Primary Completion: 2023-01-15
• Status Verified: 2023-03
• Study Completion: 2023-03-03
• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-03-31
• Last Update Submitted: 2023-03-31
• Study First Posted: 2023-04-13
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Without Low Back Pain	measurement of pelvic floor muscle with perinometer	pelvic floor muscles measurement with perinometer
With Non-Specific Low Back Pain	measurement of pelvic floor muscle with perinometer	pelvic floor muscles measurement with perinometer

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Bandırma Onyedi Eylül University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation; 🇹🇷 Balıkesir, Turkey