Non-specific Low Back PainNCT05302349
The Effect of Core Stabilization Exercises in People With Chronic Low Back Pain
A study testing Core Exercise Group and Routine Therapy Group in people with Non-specific Low Back Pain, run by Mehmet Akif Guler at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-specific Low Back Pain
- What is being tested?
- Core Exercise Group and Routine Therapy Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2022to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with low back pain for at least 3 months or more
- Age between 18 and 65 years
- Ability to give informed consent
Who cannot join
- 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
Show all 12Show fewer
- Unexplained or unintentional weight loss
- Perineal numbness, Bladder dysfunction
- Progressive weakness in lower limbs
- Fracture
- Fever
- Cauda equina syndrome
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University, Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Konya, Selcuklu, 42131
About this study
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
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.
- Conditions
- Non-specific Low Back Pain
- Being tested
- Core Exercise Group, Routine Therapy Group
- Keywords
- core exercises, multifidus muscle, lumbar, chronic low back pain, Magnetic resonance imaging, multifidus cross-sectional area
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Exercise GroupOther
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.
Routine Therapy GroupOther
Routine Therapy Group Procedure:
Weeks 1-4 (Five days a week)
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Core Exercise Group | Experimental | Core Exercise Group will performe core stabilization exercises and routine physiotherapy exercises. Receives: Other: Core Exercise Group |
| Routine Therapy Group | Active comparator | Routine Therapy Group will performe routine physiotherapy exercises. Receives: Other: Routine Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline - End of the eighth week
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.
Measured: Baseline - End of the eighth week
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
Measured: Baseline - End of the eighth week
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.
Measured: Baseline - End of the eighth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study startMar 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-specific Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mehmet Akif Guler
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Yildirim Beyazıt University
- Responsible party
- Sponsor-investigator, Mehmet Akif Guler, Selcuk University
- Investigators
- Mehmet Akif Güler, MSc/PT, Principal investigator, Selcuk University / Faculty of Health Sciences / Department of Physiotherapy and RehabilitationErtuğrul Demirdel, Asst. Prof, Study chair, Ankara Yildirim Beyazit University / Faculty of Health Sciences / Department of Physiotherapy and RehabilitationIlknur Albayrak Gezer, Assoc. Prof, Study director, Selcuk University / Faculty of Medicine / Department of Physical Therapy and RehabilitationAlaaddin Nayman, Assoc. Prof, Study director, Selcuk University / Faculty of Medicine / Department of RadiologyEzgi Akyıldız Tezcan, MD, Study director, Cumra Public Hospital / Department of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302349
- Sponsor's protocol ID
- 2022-695
- Status last verified
- Mar 2022
- First submitted
- 21 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guler MA, Demirdel E, Gezer IA, Nayman A, Tezcan EA. Effect of core stabilization exercises on lumbar multifidus morphology and functional outcomes in chronic non-specific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Dec 28;27(1):83. doi: 10.1186/s12891-025-09433-x.
PubMed 41455992
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05302349
- Acronym / sponsor ID
- 2022-695
- Conditions
- Non-specific Low Back Pain
- Keywords
- core exercises, multifidus muscle, lumbar, chronic low back pain, Magnetic resonance imaging, multifidus cross-sectional area
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Mehmet Akif GulerUniversity, hospital or other
- Collaborators
- Ankara Yildirim Beyazıt University
- Study start
- Mar 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Core Exercise Group | Experimental | Other: Core Exercise GroupCore Exercise Group will performe core stabilization exercises and routine physiotherapy exercises. |
| Routine Therapy Group | Active comparator | Other: Routine Therapy GroupRoutine Therapy Group will performe routine physiotherapy exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with low back pain for at least 3 months or more
- Age between 18 and 65 years
- Ability to give informed consent
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core Exercise GroupCore Exercise Group Procedure: Weeks 1-4 (Five days a week) 1. Hotpack ultrasound, conventional TENS, stretching exercises and strengthening exercises for low back pain. 2. 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) 1. Stretching exercises and strengthening exercises for low back pain. 2. Core stabilization exercise : * The same exercises as for Weeks 1-4 will perform. | Other | Core Exercise Group |
| Routine Therapy GroupRoutine 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. | Other | Routine Therapy Group |
Primary outcome
Measurement of the amount of adipose tissue and CSA of the muscle by MRI
Time frame: Baseline - End of the eighth week
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
Time frame: Baseline - End of the eighth week
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
Time frame: Baseline - End of the eighth week
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
Time frame: Baseline - End of the eighth week
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 41455992Guler MA, Demirdel E, Gezer IA, Nayman A, Tezcan EA. Effect of core stabilization exercises on lumbar multifidus morphology and functional outcomes in chronic non-specific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Dec 28;27(1):83. doi: 10.1186/s12891-025-09433-x.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Akif Güler, MSc/PT principal investigator
Selcuk University / Faculty of Health Sciences / Department of Physiotherapy and Rehabilitation
Ertuğrul Demirdel, Asst. Prof study chair
Ankara Yildirim Beyazit University / Faculty of Health Sciences / Department of Physiotherapy and Rehabilitation
Ilknur Albayrak Gezer, Assoc. Prof study director
Selcuk University / Faculty of Medicine / Department of Physical Therapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Exercise Group and Routine Therapy Group in people with Non-specific Low Back Pain, run by Mehmet Akif Guler at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Akif Güler (+90 542 464 4209, makif.guler@selcuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the amount of adipose tissue and CSA of the muscle by MRI (time frame: Baseline - End of the eighth week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05302349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.