Morphological Changes in Back Muscles With Low Back Pain Patients

NCT06071364 | Unknown

• 1 other identifier: P.T.REC/012/004639
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the morphological changes in the lumbar multifidus, Erector spinae and Quadratus lumborum muscles and to investigate whether they are correlated with trunk extensor muscle strength in CNSLBP subjects. and to compare between these morphological changes during rest and contraction and to compare these results with control group. Twenty-nine subjects with CNSLBP and 29 age-matched healthy controls will be assessed by ultrasonography to detect the morphological changes of these muscles during rest and contraction ,and assessed strength of back extensors by hand-held dynamometer, and assessed functional disability by Arabic version of Oswestry disability index . They will be asked to sign the informed consent form.

Conditions

Chronic Non-specific Low Back Pain

Outcome Measures

Primary Outcomes (5)

• Functional disability

  Functional disability will be measured by Arabic version of Oswestry Disability Index (ODI). The ODI is a 10-item self-assessing questionnaire, each item contains 6 levels of answers that can be scored from 0 (minimum degree of difficulty in that activity) to 5 (maximum degree of difficulty). These items are pain, personal care, lifting and moving objects, walking, sitting, standing, sleep disorders caused by the low back pain, sex life, social life, and traveling The Arabic version of ODI has been established as a valid measure, and demonstrated excellent intra-observer reliability.

  from 5 to 10 minutes

• Back muscle strength

  will be measured by Hand-held dynamometer (HHD): assessing isometric lumbar muscles strength. In a clinical setting, it is viewed as easy to use, portable and cost-effective for the precise measurement of lumbar muscles strength. Intra-rater and inter-rater reliability of hand-held dynamometer for assessing isometric lumbar muscle strength in asymptomatic healthy population showed an excellent intra-rater (ICC 2, k = 0.95 to 0.97) and inter-rater (ICC 2, k = 0.94 to 0.95) .

  from 5 to 7 minutes

• Muscle Thickness

  evaluate the thickness of lumbar extensors lumbar multifidus, erector spinae and quadratus lumborum muscles and will be assessed by an experienced and qualified radiologist using US unit at rest and contraction on both right and left sides.

  about 15 minutes

• Muscle Cross Sectional Area

  evaluate cross -sectional area of lumbar extensors lumbar multifidus, erector spinae and quadratus lumborum muscles and will be assessed by an experienced and qualified radiologist using US unit during rest and contraction on both right and left sides.

  about 15 minutes

• Muscle Fat infiltration

  evaluate Fat infiltration of lumbar extensors lumbar multifidus, erector spinae and quadratus lumborum muscles and will be assessed by an experienced and qualified radiologist using US unit during rest and contraction on both right and left sides.

  about 15 minutes

Study Arms (2)

chronic nonspecific low back pain patients

Twenty-nine participants experienced chronic non-specific low back pain for over three months without any referred pain in their legs.

Diagnostic Test: Ultrasonography imaging and Hand-held dynamometer (HHD)

Asymptomatic subjects

Twenty-nine subjects without symptoms of low back pain

Diagnostic Test: Ultrasonography imaging and Hand-held dynamometer (HHD)

Interventions

Ultrasonography imaging and Hand-held dynamometer (HHD) DIAGNOSTIC_TEST

Ultrasound imaging system will be used to evaluate the thickness, cross -sectional area and fat infiltration of lumbar extensors lumbar multifidus , erector spinae and quadratus lumborum muscles. The hand-held dynamometer assessing isometric lumbar muscles strength

Asymptomatic subjects; chronic nonspecific low back pain patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Outpatient clinic of Mallawi Hospital

You may qualify if:

• Subjects of both genders with CNSLBP (pain\> 3 months)
• The subject's age ranged between 18 and 45.
• waist-to-height ratio (WHtR) \< 0.5 or = 0.5

You may not qualify if:

• Untreated neurological and/or mental illness
• History of trauma in the last 6 months.
• Sacroiliac joint pathologies.
• Spinal fracture or dislocation.
• Spinal instability (e.g., spondylolisthesis or retrolisthesis)
• Sensitivity to ultrasound gel diagnosed by a medical doctor.
• Serious musculoskeletal problems or other pathologies.
• Previous surgery in lower limb(s)
• Females during Pregnancy.

Sponsors & Collaborators

• omnia Yasser Mohamed Talat Harb: lead
• Cairo University: collaborator

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

Study Officials

• omnia yasser, master

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omnia Yasser, Master

CONTACT

01064840245; monyyasser36@gmail.com

Nesreen Fawzy, lecturer

CONTACT

01127283925; dr_nesreenfawzy@cu.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 6, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)