Clinical trial NCT05302349: The Effect of Core Stabilization Exercises in People With Chronic Low Back Pain
Official title: The Effect of Core Stabilization Exercises on Pain Level, Functionality, Stability and Lumbar Multifidus Muscle Cross-sectional Area in People With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-speciﬁc Low Back Pain
Keywords: core exercises
multifidus muscle
lumbar
chronic low back pain
Magnetic resonance imaging
multifidus cross-sectional area
Lead sponsor: Selcuk University
Sponsor class: OTHER
Collaborators: name: Ankara Yildirim Beyazıt University
First posted: 2022-03-31
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled
Primary purpose: TREATMENT

Brief summary: Low back pain is a health problem that causes clinical, social and economic losses all over the world and affects the majority of the population. More than 80% of adults in the general population experience low back pain at least once in their lifetime. Although the incidence of chronic low back pain is so high, 85% of these pains do not have a pathoanatomical cause and these pains are defined as non-specific chronic low back pain. Exercise therapy is the key to the conservative management of nonspecific chronic low back pain. Lumbar stabilization exercises based on the principle of motor control of core muscles have also become popular in rehabilitation programs for low back pain in recent years.The core region is the lumbopelvic region of the body. The aim of the stabilization exercises is to teach to use the neutral position of the lumbar region and to keep the load on the dynamic and static structures at the lowest level. Core stabilization training begins with teaching the contraction of the transversus abdominus, deep spinal and multifidus muscle.Then, these exercises are planned specifically for the person from immobile positions to movements positions, from simple movements to combined movements, from gross patterns to fine motor patterns, from symmetrical movements to asymmetric movements. These exercises can be developed specifically for the region and pathology with the functions of the muscles in the region of the pathology. The lumbar multifidus muscle is known to be an important stabilizer of the lumbar region. In addition, the cross-sectional area of the lumbar multifidus muscle has short, thick, dense muscle fibers compared to other lumbar region muscles.These dense muscle fibers are compressed in a small space and have a high mass.This morphology allows the lumbar multifidus muscle to produce great force in a small working area and makes the muscle ideal for stability. In addition, the position of the lumbar multifidus muscle between the vertebrae increases its importance for stability. The aim of this study is to determine the effects of core stabilization exercises on the cross-sectional area (CSA) and amount of adipose tissue of the lumbar multifidus muscle in adults with chronic low back pain using magnetic resonance imaging (MRI), and also to examine the effects of these exercises on pain, functionality and lumbopelvic stability.


Eligibility criteria: Inclusion Criteria:

* Patient with low back pain for at least 3 months or more
* Age between 18 and 65 years
* Ability to give informed consent

Exclusion Criteria:

* History of previous previous spinal surgery
* Disc herniation with radiculopathy
* Pregnant or breastfeeding
* Systemic disease
* Low back pain due to specific and known causes (Spondylolisthesis, Spinal stenosis, Spondylolysis, Ankylosing spondylitis, Tumor, Structural deformity, Osteoporosis, Rheumatological disease, Infection)
* History of malignancies/cancer
* Unexplained or unintentional weight loss
* Perineal numbness, Bladder dysfunction
* Progressive weakness in lower limbs
* Fracture
* Fever
* Cauda equina syndrome

Primary outcomes:
measure: Measurement of the amount of adipose tissue and CSA of the muscle by MRI
timeFrame: Baseline - End of the eighth week
measure: Visual Analog Scale
timeFrame: Baseline - End of the eighth week
measure: Oswestry Disability Index
timeFrame: Baseline - End of the eighth week
measure: Sahrmann Core Stability Test
timeFrame: Baseline - End of the eighth week
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
state: Selcuklu
Study officials:
affiliation: Selcuk University / Faculty of Health Sciences / Department of Physiotherapy and Rehabilitation
name: Mehmet Akif Güler, MSc/PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara Yildirim Beyazit University / Faculty of Health Sciences / Department of Physiotherapy and Rehabilitation
name: Ertuğrul Demirdel, Asst. Prof
role: STUDY_CHAIR
affiliation: Selcuk University / Faculty of Medicine / Department of Physical Therapy and Rehabilitation
name: Ilknur Albayrak Gezer, Assoc. Prof
role: STUDY_DIRECTOR
affiliation: Selcuk University / Faculty of Medicine / Department of Radiology
name: Alaaddin Nayman, Assoc. Prof
role: STUDY_DIRECTOR
affiliation: Cumra Public Hospital / Department of Physical Therapy and Rehabilitation
name: Ezgi Akyıldız Tezcan, MD
role: STUDY_DIRECTOR
References: