The Effect of Core Stabilization Exercises in People With Chronic Low Back Pain
Primary Purpose
Non-specific Low Back Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Core Exercise Group
Routine Therapy Group
Sponsored by
About this trial
This is an interventional treatment trial for Non-specific Low Back Pain focused on measuring core exercises, multifidus muscle, lumbar, chronic low back pain, Magnetic resonance imaging, multifidus cross-sectional area
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
Sites / Locations
- Selcuk University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Core Exercise Group
Routine Therapy Group
Arm Description
Core Exercise Group will performe core stabilization exercises and routine physiotherapy exercises.
Routine Therapy Group will performe routine physiotherapy exercises.
Outcomes
Primary Outcome Measures
Measurement of the amount of adipose tissue and CSA of the muscle by MRI
Axial images obtained from the multi-point DIXON (mDIXON) sequence will be used to determine the cross-sectional area and amount of adipose tissue of the lumbar multifidus muscle. The bilateral cross-sectional areas of the lumbar multifidus muscle from the L1-2, L2-3, L3-4, L4-5 and L5-S1 intervertebral disc levels will be calculated by drawing the outlines of the fascial borders of the muscles. Muscle CSA and amount of adipose tissue will be calculated. Subtracting the amount of adipose tissue from the CSA resulting in the functional CSA of the muscle. There will be two measurements, at baseline before the start of program and at the end of the eight weeks intervention.
Visual Analog Scale
Pain will be measured using a 10 cm visual analog scale (VAS). Min pain score is 0, max pain score is 10. Participants will mark a point on the VAS that matches the amount of pain they feel.
Oswestry Disability Index
Oswestry Disability Index evaluates the extent to which the patient's level of function is restricted by the pain.. Oswestry Disability Index consists of 10 sections, each section the total possible score is ranging from 0 to 5. The score obtained from all questions is added and multiplied by two. The result is noted as a percentage.
0% to 20%= Minimal disability
21% to 40%= Moderate disability
41% to 60%= Severe disability
61% to 80%= Crippling back pain
81% to 100%= Bed-bound or exaggerating symptoms
Sahrmann Core Stability Test
The Sahrmann core stability test is a 5-level test used to evaluate the ability of the core muscles to stabilize the spine. While the participant lying in a crook-supine position, the PBU will be inflated to 40 mmHg. Participants will perform the Sahrmann five-level test. A deviation of pressure more than 10 mmHg indicates that the stabilization action of stabilizer muscle has been lost.
Secondary Outcome Measures
Full Information
NCT ID
NCT05302349
First Posted
March 21, 2022
Last Updated
March 21, 2022
Sponsor
Mehmet Akif Guler
Collaborators
Ankara Yildirim Beyazıt University
1. Study Identification
Unique Protocol Identification Number
NCT05302349
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mehmet Akif Guler
Collaborators
Ankara Yildirim Beyazıt University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-specific Low Back Pain
Keywords
core exercises, multifidus muscle, lumbar, chronic low back pain, Magnetic resonance imaging, multifidus cross-sectional area
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled
Masking
Outcomes Assessor
Masking Description
The radiologist evaluating the MR images will not know which participant is on which arm.
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Core Exercise Group
Arm Type
Experimental
Arm Description
Core Exercise Group will performe core stabilization exercises and routine physiotherapy exercises.
Arm Title
Routine Therapy Group
Arm Type
Active Comparator
Arm Description
Routine Therapy Group will performe routine physiotherapy exercises.
Intervention Type
Other
Intervention Name(s)
Core Exercise Group
Intervention Description
Core Exercise Group Procedure:
Weeks 1-4 (Five days a week)
Hotpack ultrasound, conventional TENS, stretching exercises and strengthening exercises for low back pain.
Core stabilization exercise :
Active pelvic floor exercise (supine position)
Bridge exercise (supine position)
Back Extension and Ball Back Extension exercises (prone position)
Abdominal and Oblique Crunch exercises (supin position)
Leg lift exercise (prone position)
Plank and Side Plank exercise
Superman exercise
Weeks 5-8 (Three days a week)
Stretching exercises and strengthening exercises for low back pain.
Core stabilization exercise :
The same exercises as for Weeks 1-4 will perform.
Intervention Type
Other
Intervention Name(s)
Routine Therapy Group
Intervention Description
Routine Therapy Group Procedure:
Weeks 1-4 (Five days a week)
1. Hotpack ultrasound, conventional TENS, stretching exercises and strengthening exercises for low back pain.
Weeks 5-8 (Three days a week)
1.Stretching exercises and strengthening exercises for low back pain.
Primary Outcome Measure Information:
Title
Measurement of the amount of adipose tissue and CSA of the muscle by MRI
Description
Axial images obtained from the multi-point DIXON (mDIXON) sequence will be used to determine the cross-sectional area and amount of adipose tissue of the lumbar multifidus muscle. The bilateral cross-sectional areas of the lumbar multifidus muscle from the L1-2, L2-3, L3-4, L4-5 and L5-S1 intervertebral disc levels will be calculated by drawing the outlines of the fascial borders of the muscles. Muscle CSA and amount of adipose tissue will be calculated. Subtracting the amount of adipose tissue from the CSA resulting in the functional CSA of the muscle. There will be two measurements, at baseline before the start of program and at the end of the eight weeks intervention.
Time Frame
Baseline - End of the eighth week
Title
Visual Analog Scale
Description
Pain will be measured using a 10 cm visual analog scale (VAS). Min pain score is 0, max pain score is 10. Participants will mark a point on the VAS that matches the amount of pain they feel.
Time Frame
Baseline - End of the eighth week
Title
Oswestry Disability Index
Description
Oswestry Disability Index evaluates the extent to which the patient's level of function is restricted by the pain.. Oswestry Disability Index consists of 10 sections, each section the total possible score is ranging from 0 to 5. The score obtained from all questions is added and multiplied by two. The result is noted as a percentage.
0% to 20%= Minimal disability
21% to 40%= Moderate disability
41% to 60%= Severe disability
61% to 80%= Crippling back pain
81% to 100%= Bed-bound or exaggerating symptoms
Time Frame
Baseline - End of the eighth week
Title
Sahrmann Core Stability Test
Description
The Sahrmann core stability test is a 5-level test used to evaluate the ability of the core muscles to stabilize the spine. While the participant lying in a crook-supine position, the PBU will be inflated to 40 mmHg. Participants will perform the Sahrmann five-level test. A deviation of pressure more than 10 mmHg indicates that the stabilization action of stabilizer muscle has been lost.
Time Frame
Baseline - End of the eighth week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet Akif Güler
Phone
+90 542 464 4209
Email
makif.guler@selcuk.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Akif Güler, MSc/PT
Organizational Affiliation
Selcuk University / Faculty of Health Sciences / Department of Physiotherapy and Rehabilitation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ertuğrul Demirdel, Asst. Prof
Organizational Affiliation
Ankara Yildirim Beyazit University / Faculty of Health Sciences / Department of Physiotherapy and Rehabilitation
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ilknur Albayrak Gezer, Assoc. Prof
Organizational Affiliation
Selcuk University / Faculty of Medicine / Department of Physical Therapy and Rehabilitation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alaaddin Nayman, Assoc. Prof
Organizational Affiliation
Selcuk University / Faculty of Medicine / Department of Radiology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ezgi Akyıldız Tezcan, MD
Organizational Affiliation
Cumra Public Hospital / Department of Physical Therapy and Rehabilitation
Official's Role
Study Director
Facility Information:
Facility Name
Selcuk University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
City
Konya
State/Province
Selcuklu
ZIP/Postal Code
42131
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Core Stabilization Exercises in People With Chronic Low Back Pain
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