Morphological Changes in Back Muscles With Low Back Pain Patients

Recruiting

• Conditions: Chronic Non-specific Low Back Pain
• Interventions: Diagnostic Test: Ultrasonography imaging and Hand-held dynamometer (HHD)

• Registration Number: NCT06071364
• Lead Sponsor: omnia Yasser Mohamed Talat Harb

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.

Study Timeline

• Study Start: 2023-07-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-02
• Study First Posted: 2023-10-06
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-11
• Primary Completion: 2023-12
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronic nonspecific low back pain patients	Ultrasonography imaging and Hand-held dynamometer (HHD)	Twenty-nine participants experienced chronic non-specific low back pain for over three months without any referred pain in their legs.
Asymptomatic subjects	Ultrasonography imaging and Hand-held dynamometer (HHD)	Twenty-nine subjects without symptoms of low back pain

Primary Outcome Measures

Name	Time	Method
Muscle Fat infiltration	about 15 minutes	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.
Functional disability	from 5 to 10 minutes	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.
Muscle Thickness	about 15 minutes	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.
Back muscle strength	from 5 to 7 minutes	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) .
Muscle Cross Sectional Area	about 15 minutes	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.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt