Investigation of Pelvic Floor Muscle Strength in Low Back Pain

NCT05811572 | Completed

• 1 other identifier: 00-2020-0018
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Non-specific low back pain; perinometer; Pelvic Floor Muscle; Disability; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Roland morris disability questionnaire

  1 day

• Visual analog scale

  1 day

Study Arms (2)

With Non-Specific Low Back Pain

pelvic floor muscles measurement with perinometer

Device: measurement of pelvic floor muscle with perinometer

Without Low Back Pain

pelvic floor muscles measurement with perinometer

Device: measurement of pelvic floor muscle with perinometer

Interventions

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

Also known as: Roland morris disability questionnaire, Visual Analog Scale (VAS)

With Non-Specific Low Back Pain; Without Low Back Pain

Eligibility Criteria

• Age: 18 Years - 50 Years
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women with and without non-specific low back pain

You may qualify if:

• being a woman
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Gulhan Yilmaz Gokmen: lead

Study Sites (1)

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

Balıkesir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain; Pain

Interventions

Visual Analog Scale

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 13, 2023
• Study Start: June 3, 2022
• Primary Completion: January 15, 2023
• Study Completion: March 3, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-03

Locations

TU (1)