Morphological Changes in Back Muscles With Low Back Pain Patients

NCT ID: NCT06071364

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 58 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-01-31

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.

Detailed Description

Low back pain (LBP) is one of the most common musculoskeletal disorders leading to inactivity, postural disorders, and muscle problems and can result in disability, reduced quality of life, and workforce loss.

Low back pain is commonly classified as non-specific (90%) or specific (10%) according to reported cause and as acute (<6 weeks), subacute (6-12 weeks) or chronic (more than12 weeks) according to duration of symptoms.

Many factors have been reported to play a role in the etiology of Chronic non-specific Low back pain (CNSLBP) including occupational factors, personal factors, and behavioral risk factors. In addition, recent studies associate low back pain with physical factors such as lumbar spinal stiffness, muscle shortness, and decreased endurance and muscle strength.

Many studies have mainly focused on the morphological aspects of paraspinal muscles including lumbar multifidus , Erector spinae and Quadratus lumborum muscles, which play an essential role in patients with CNSLBP in terms of functional disability and the planning of rehabilitation modalities.

Twenty-nine subjects with CNSLBP and 29 age-matched healthy controls will be recruited through direct referral. They will be asked to sign the informed consent form.

To authors knowledge no previous research had investigated the correlation between morphological changes and strength of back muscles in subjects with CNSLBP

The finding of this proposed work may help researchers interested in CNSLBP's etiology and natural course which can be considered a topic that are still poorly understood. To reduce the occurrence and severity of CNSLBP, it is essential to help understand its cause and determine whether there are any risk factors that may be changed.

The finding of this proposed work may benefit patients diagnosed with CNSLBP. If the diagnosis of back pain, function, and muscle strength in those patients become more clear , not only this may make them return to work early but may also improve psychological status.

Conditions

Chronic Non-specific Low Back Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Ultrasonography imaging and Hand-held dynamometer (HHD)

Intervention Type: 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

Twenty-nine subjects without symptoms of low back pain

Ultrasonography imaging and Hand-held dynamometer (HHD)

Intervention Type: 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

Interventions

Ultrasonography imaging and Hand-held dynamometer (HHD)

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Subjects of both genders with CNSLBP (pain> 3 months)

2. The subject's age ranged between 18 and 45.

3. waist-to-height ratio (WHtR) < 0.5 or = 0.5

Exclusion Criteria

1. Untreated neurological and/or mental illness

2. History of trauma in the last 6 months.

3. Sacroiliac joint pathologies.

4. Spinal fracture or dislocation.

5. Spinal instability (e.g., spondylolisthesis or retrolisthesis)

6. Sensitivity to ultrasound gel diagnosed by a medical doctor.

7. Serious musculoskeletal problems or other pathologies.

8. Previous surgery in lower limb(s)

9. Females during Pregnancy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

omnia Yasser Mohamed Talat Harb

OTHER

Sponsor Role: lead

Responsible Party

omnia Yasser Mohamed Talat Harb

principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

omnia yasser, master

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Omnia Yasser, Master

Role: CONTACT

monyyasser36@gmail.com

01064840245

Nesreen Fawzy, lecturer

Role: CONTACT

dr_nesreenfawzy@cu.edu.eg

01127283925

Facility Contacts

Omnia Yasser, master

Role: primary

monyyasser36@gmail.com

01064840245

Nesreen Fawzy, lecturer

Role: backup

dr_nesreenfawzy@cu.edu.eg

01127283925

Other Identifiers

P.T.REC/012/004639

Identifier Type: -

Identifier Source: org_study_id