Back Pain Lower Back ChronicNCT06969508
Effect Of Paraspinal Muscle Thickness On The Benefit Of Core Stabilization
A study testing core stabilitation exercises in people with Back Pain Lower Back Chronic and Lumbar Disc Degenerative Disease, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates whether the effects of core muscle strengthening exercises on chronic low back pain and deep back muscle (multifidus) thickness differ in patients with different baseline muscle thicknesses. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Back Pain Lower Back Chronic, Lumbar Disc Degenerative Disease
- What is being tested?
- core stabilitation exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 15 Apr 2025
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of chronic low back pain: Participants had to have experienced low back pain for at least 3 months,
- Lumbar MRI findings without severe pathology requiring surgical intervention: Participants' lumbar MRI scans, performed at least 6 months prior to enrollment, had to show evidence of low back pain-related findings but exclude conditions necessitating surgical treatment.
- Willingness to participate in the study and provide informed consent: Participants had to voluntarily agree to take part in the research and provide their written informed consent.
Who cannot join
- History of prior spinal surgery: Individuals who had undergone any previous surgical procedures on their spine were not eligible.
- Diagnosis of a neurological or rheumatological disease: Participants with pre-existing neurological conditions (e.g., radiculopathy with significant motor deficit) or rheumatological diseases (e.g., ankylosing spondylitis) were excluded.
- Cardiovascular or pulmonary comorbidities: Individuals with significant heart or lung conditions that could affect their ability to participate in the exercise program were excluded.
- Osteoporosis or osteoporotic vertebral fracture: Participants with known osteoporosis or a history of vertebral fracture due to osteoporosis were not eligible.
- Currently receiving physical therapy modalities or oral/algologic injections for low back pain: Individuals already undergoing other active treatments for their low back pain were excluded to avoid confounding the results.
- Unwillingness to participate in the study or provide informed consent: Individuals who did not want to take part in the research or were unable to provide their written informed consent were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Çam and Sakura City Hospital
Istanbul
About this study
Official title: The Relationship Between Core Stabilization Exercises and Paraspinal Muscle Thickness in Chronic Low Back Pain
This study investigates whether the effects of core muscle strengthening exercises on chronic low back pain and deep back muscle (multifidus) thickness differ in patients with different baseline muscle thicknesses. Pain levels will be measured before and after a 6-month exercise program in patients with different baseline muscle thicknesses. The aim is to determine whether the exercises are more or less effective depending on the baseline condition of these muscles. Understanding this may help personalize exercise treatments for chronic low back pain based on individual muscle characteristics.
Read the detailed description
This prospective, randomized study will investigate if the initial thickness of deep back muscles (multifidus and erector spinae), measured via existing lumbar MRI scans, influences the effectiveness of a 6-month core stabilization exercise program for chronic low back pain. Participants aged 20-60 with chronic low back pain (over 3 months) and a recent lumbar MRI will be recruited from Çam Sakura City Hospital. Individuals with prior spinal surgery, previous physical therapy, neurological or cardiorespiratory issues, or osteoporosis will be excluded.
At baseline, muscle thickness at the L4/L5 level will be measured. Participants will receive a home-based core stabilization exercise program. Pain and function will be assessed using VAS, Oswestry Disability Index, and SPI at baseline, 3, and 6 months. The study aims to determine if patients with different baseline muscle thicknesses show varying degrees of improvement in pain and function following the exercise program. Correlation and regression analyses will explore the relationship between initial muscle thickness and changes in outcome measures. The findings may help personalize exercise treatments for chronic low back pain based on individual muscle characteristics.
- Being tested
- core stabilitation exercises
- Keywords
- Paraspinal Muscles, exercise, Low Back Pain
- Medical subject headings
- Intervertebral Disc Degeneration, Motor Activity, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core stabilitation exercisesOther
The core stabilization exercise program aimed to strengthen deep spinal muscles: transversus abdominis (abdominal bracing), multifidus (segmental stability), and pelvic floor muscles (pelvic support). Participants received videotaped instructions for performing these exercises at home regularly for 6 months, with a gradual increase in difficulty.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Lumbar disc herniation | Experimental | This study involved a single cohort of participants who had been diagnosed with chronic non-specific low back pain. All participants had lumbar MRI scans performed at least 6 months prior to enrollment to confirm the absence of severe pathology requiring surgical intervention. This cohort received a 6-month exercise program specifically designed to target and strengthen the core stabilizing muscles of the spine, including the multifidus, transversus abdominis, and pelvic floor muscles. The exercise program was provided to participants through videotaped instructions demonstrating the correct form and technique for each exercise. Participants were instructed to perform these exercises at home, following the provided video guidance. At the beginning of the study, the thickness of their paraspinal muscles (specifically the multifidus) was measured. The study assessed the changes in their pain levels and functional status over the 6-month period, with measurements taken at baseline, 3 mon Receives: Other: core stabilitation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
Pain intensity was measured using a Visual Analog Scale (VAS) ranging from 0 to 10 centimeters (cm). Zero (0 cm) was equivalent to "no pain," and 10 centimeters (10 cm) indicated the "worst imaginable pain." Changes in VAS scores were assessed at 3 and 6 months to determine the effect of the exercise program on pain levels.
Measured: Baseline, 3 months, 6 months
Brief Pain İnventory- Short Form
Pain intensity was assessed using the Brief Pain Inventory - Short Form (BPI-SF). Participants were asked to rate their pain at its worst, least, average, and current level on a scale ranging from 0 to 10, where 0 indicated "no pain" and 10 indicated "pain as bad as you can imagine." Changes in these pain intensity scores were assessed at 3 and 6 months to determine the effect of the exercise program on different dimensions of pain experience.
Pain interference was assessed using the Brief Pain Inventory - Short Form (BPI-SF). Participants were asked to rate how much their pain interfered with seven aspects of their daily life (general activity, mood, walking ability, normal work, sleep, enjoyment of life, and relations with other people) on a scale ranging from 0 to 10, where 0 indicated "does not interfere" and 10 indicated "completely interferes." Changes in these pain interference scores (either individual item scores or a composite score calculated as the mean of the seven items)
Measured: Baseline, 3 months, 6 months
Oswestry Disability Index (ODI)
Functional disability was assessed using the Oswestry Disability Index (ODI), a ten-section questionnaire. Each section is scored from 0 (no disability) to 5 (severe disability). The total score, converted to a percentage ranging from 0% (no disability) to 100% (most severe disability), reflects the level of functional limitation due to back pain. Changes in the total ODI score were assessed at 3 and 6 months to evaluate the impact of the exercise program on functional disability.
Measured: Baseline, 3 months, 6 months
Baseline thickness of the paraspinal muscles
The thickness of the paraspinal muscles, specifically the multifidus muscle at the L4-L5 vertebral level, was measured on both the right and left sides at the beginning of the study using Magnetic Resonance Imaging (MRI). These measurements represent the initial size of the multifidus muscle in the participants prior to the start of the exercise program.
Measured: Baseline
Secondary outcomes (1)
Correlation between baseline thickness of the paraspinal muscles as measured by MRI and the change in pain intensity
This outcome measure will assess the statistical relationship between the initial thickness of the multifidus muscle (measured on both the right and left sides at baseline via MRI) and the change in pain intensity as reported on the Visual Analog Scale (VAS) from baseline to the 6-month follow-up. The correlation coefficient will indicate the strength and direction of this relationship.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Jun 2024
- Primary completion1 Dec 2024
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Back Pain Lower Back ChronicStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Medipol University Hospital
- Responsible party
- Principal investigator, Mucahit Atasoy, MD, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969508
- Sponsor's protocol ID
- 2024-KAEK-11
- Status last verified
- May 2025
- First submitted
- 24 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No. While we are open to sharing individual participant data (IPD) with other researchers upon reasonable request, there is no specific platform or repository designated for making this data publicly available. Interested researchers should contact the corresponding author to inquire about data sharing, and any data transfer will be subject to ethical considerations and data sharing agreements.
Publications
Wong AYL, Parent EC, Funabashi M, Stanton TR, Kawchuk GN. Do various baseline characteristics of transversus abdominis and lumbar multifidus predict clinical outcomes in nonspecific low back pain? A systematic review. Pain. 2013 Dec;154(12):2589-2602. doi: 10.1016/j.pain.2013.07.010. Epub 2013 Jul 16.
PubMed 23867731Li Y, Yan L, Hou L, Zhang X, Zhao H, Yan C, Li X, Li Y, Chen X, Ding X. Exercise intervention for patients with chronic low back pain: a systematic review and network meta-analysis. Front Public Health. 2023 Nov 17;11:1155225. doi: 10.3389/fpubh.2023.1155225. eCollection 2023.
PubMed 38035307Wang XQ, Zheng JJ, Yu ZW, Bi X, Lou SJ, Liu J, Cai B, Hua YH, Wu M, Wei ML, Shen HM, Chen Y, Pan YJ, Xu GH, Chen PJ. A meta-analysis of core stability exercise versus general exercise for chronic low back pain. PLoS One. 2012;7(12):e52082. doi: 10.1371/journal.pone.0052082. Epub 2012 Dec 17.
PubMed 23284879
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Core Stabilization Exercises and Paraspinal Muscle Thickness in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06969508
- Acronym / sponsor ID
- 2024-KAEK-11
- Keywords
- Paraspinal Muscles, exercise, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Collaborators
- Istanbul Medipol University Hospital
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 14 May 2025 (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.
This study investigates whether the effects of core muscle strengthening exercises on chronic low back pain and deep back muscle (multifidus) thickness differ in patients with different baseline muscle thicknesses. Pain levels will be measured before and after a 6-month exercise program in patients with different baseline muscle thicknesses. The aim is to determine whether the exercises are more or less effective depending on the baseline condition of these muscles. Understanding this may help personalize exercise treatments for chronic low back pain based on individual muscle characteristics.
Detailed description
This prospective, randomized study will investigate if the initial thickness of deep back muscles (multifidus and erector spinae), measured via existing lumbar MRI scans, influences the effectiveness of a 6-month core stabilization exercise program for chronic low back pain. Participants aged 20-60 with chronic low back pain (over 3 months) and a recent lumbar MRI will be recruited from Çam Sakura City Hospital. Individuals with prior spinal surgery, previous physical therapy, neurological or cardiorespiratory issues, or osteoporosis will be excluded.
At baseline, muscle thickness at the L4/L5 level will be measured. Participants will receive a home-based core stabilization exercise program. Pain and function will be assessed using VAS, Oswestry Disability Index, and SPI at baseline, 3, and 6 months. The study aims to determine if patients with different baseline muscle thicknesses show varying degrees of improvement in pain and function following the exercise program. Correlation and regression analyses will explore the relationship between initial muscle thickness and changes in outcome measures. The findings may help personalize exercise treatments for chronic low back pain based on individual muscle characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Lumbar disc herniation | Experimental | Other: core stabilitation exercisesThis study involved a single cohort of participants who had been diagnosed with chronic non-specific low back pain. All participants had lumbar MRI scans performed at least 6 months prior to enrollment to confirm the absence of severe pathology requiring surgical intervention. This cohort received a 6-month exercise program specifically designed to target and strengthen the core stabilizing muscles of the spine, including the multifidus, transversus abdominis, and pelvic floor muscles. The exercise program was provided to participants through videotaped instructions demonstrating the correct form and technique for each exercise. Participants were instructed to perform these exercises at home, following the provided video guidance. At the beginning of the study, the thickness of their paraspinal muscles (specifically the multifidus) was measured. The study assessed the changes in their pain levels and functional status over the 6-month period, with measurements taken at baseline, 3 mon |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of chronic low back pain: Participants had to have experienced low back pain for at least 3 months,
- Lumbar MRI findings without severe pathology requiring surgical intervention: Participants' lumbar MRI scans, performed at least 6 months prior to enrollment, had to show evidence of low back pain-related findings but exclude conditions necessitating surgical treatment.
- Willingness to participate in the study and provide informed consent: Participants had to voluntarily agree to take part in the research and provide their written informed consent.
Key exclusion criteria (6 listed)
- History of prior spinal surgery: Individuals who had undergone any previous surgical procedures on their spine were not eligible.
- Diagnosis of a neurological or rheumatological disease: Participants with pre-existing neurological conditions (e.g., radiculopathy with significant motor deficit) or rheumatological diseases (e.g., ankylosing spondylitis) were excluded.
- Cardiovascular or pulmonary comorbidities: Individuals with significant heart or lung conditions that could affect their ability to participate in the exercise program were excluded.
- Osteoporosis or osteoporotic vertebral fracture: Participants with known osteoporosis or a history of vertebral fracture due to osteoporosis were not eligible.
- Currently receiving physical therapy modalities or oral/algologic injections for low back pain: Individuals already undergoing other active treatments for their low back pain were excluded to avoid confounding the results.
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 stabilitation exercisesThe core stabilization exercise program aimed to strengthen deep spinal muscles: transversus abdominis (abdominal bracing), multifidus (segmental stability), and pelvic floor muscles (pelvic support). Participants received videotaped instructions for performing these exercises at home regularly for 6 months, with a gradual increase in difficulty. | Other | Patients with Lumbar disc herniation |
Primary outcome
VAS score
Time frame: Baseline, 3 months, 6 months
Pain intensity was measured using a Visual Analog Scale (VAS) ranging from 0 to 10 centimeters (cm). Zero (0 cm) was equivalent to "no pain," and 10 centimeters (10 cm) indicated the "worst imaginable pain." Changes in VAS scores were assessed at 3 and 6 months to determine the effect of the exercise program on pain levels.
Brief Pain İnventory- Short Form
Time frame: Baseline, 3 months, 6 months
Pain intensity was assessed using the Brief Pain Inventory - Short Form (BPI-SF). Participants were asked to rate their pain at its worst, least, average, and current level on a scale ranging from 0 to 10, where 0 indicated "no pain" and 10 indicated "pain as bad as you can imagine." Changes in these pain intensity scores were assessed at 3 and 6 months to determine the effect of the exercise program on different dimensions of pain experience. Pain interference was assessed using the Brief Pain Inventory - Short Form (BPI-SF). Participants were asked to rate how much their pain interfered with seven aspects of their daily life (general activity, mood, walking ability, normal work, sleep, enjoyment of life, and relations with other people) on a scale ranging from 0 to 10, where 0 indicated "does not interfere" and 10 indicated "completely interferes." Changes in these pain interference scores (either individual item scores or a composite score calculated as the mean of the seven items)
Oswestry Disability Index (ODI)
Time frame: Baseline, 3 months, 6 months
Functional disability was assessed using the Oswestry Disability Index (ODI), a ten-section questionnaire. Each section is scored from 0 (no disability) to 5 (severe disability). The total score, converted to a percentage ranging from 0% (no disability) to 100% (most severe disability), reflects the level of functional limitation due to back pain. Changes in the total ODI score were assessed at 3 and 6 months to evaluate the impact of the exercise program on functional disability.
Baseline thickness of the paraspinal muscles
Time frame: Baseline
The thickness of the paraspinal muscles, specifically the multifidus muscle at the L4-L5 vertebral level, was measured on both the right and left sides at the beginning of the study using Magnetic Resonance Imaging (MRI). These measurements represent the initial size of the multifidus muscle in the participants prior to the start of the exercise program.
1 secondary outcome
Correlation between baseline thickness of the paraspinal muscles as measured by MRI and the change in pain intensity
Time frame: Baseline, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Background: PubMed 23867731Wong AYL, Parent EC, Funabashi M, Stanton TR, Kawchuk GN. Do various baseline characteristics of transversus abdominis and lumbar multifidus predict clinical outcomes in nonspecific low back pain? A systematic review. Pain. 2013 Dec;154(12):2589-2602. doi: 10.1016/j.pain.2013.07.010. Epub 2013 Jul 16.
- Background: PubMed 38035307Li Y, Yan L, Hou L, Zhang X, Zhao H, Yan C, Li X, Li Y, Chen X, Ding X. Exercise intervention for patients with chronic low back pain: a systematic review and network meta-analysis. Front Public Health. 2023 Nov 17;11:1155225. doi: 10.3389/fpubh.2023.1155225. eCollection 2023.
- Background: PubMed 23284879Wang XQ, Zheng JJ, Yu ZW, Bi X, Lou SJ, Liu J, Cai B, Hua YH, Wu M, Wei ML, Shen HM, Chen Y, Pan YJ, Xu GH, Chen PJ. A meta-analysis of core stability exercise versus general exercise for chronic low back pain. PLoS One. 2012;7(12):e52082. doi: 10.1371/journal.pone.0052082. Epub 2012 Dec 17.
- Individual participant dataSharing planned: No. No. While we are open to sharing individual participant data (IPD) with other researchers upon reasonable request, there is no specific platform or repository designated for making this data publicly available. Interested researchers should contact the corresponding author to inquire about data sharing, and any data transfer will be subject to ethical considerations and data sharing agreements.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 stabilitation exercises in people with Back Pain Lower Back Chronic and Lumbar Disc Degenerative Disease, run by Medipol University 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 6 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: finished, as of the sponsor's last update on 14 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: Baseline, 3 months, 6 months). 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 NCT06969508, which also lists 3 linked publications.
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 14 May 2025.