Morphological Changes in Back Muscles With Low Back Pain Patients

Chronic Non-specific Low Back Pain Clinical Trial

Official title:

Morphological Changes in Selected Back Muscles and Their Association With Back Extensors Strength in Subjects With Chronic Non-Specific Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06071364
• Other study ID #: P.T.REC/012/004639
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: January 2024

Study information

• Verified date: October 2023
• Source: Cairo University
• Contact: Omnia Yasser, Master
• Phone: 01064840245
• Email: monyyasser36[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Non-specific Low Back Pain
• Low Back Pain

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
omnia Yasser Mohamed Talat Harb	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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