Clinical trial NCT06969508: Effect Of Paraspinal Muscle Thickness On The Benefit Of Core Stabilization
Official title: The Relationship Between Core Stabilization Exercises and Paraspinal Muscle Thickness in Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain Lower Back Chronic
Lumbar Disc Degenerative Disease
Keywords: Paraspinal Muscles
exercise
Low Back Pain
Lead sponsor: Medipol University
Sponsor class: OTHER
Collaborators: name: Istanbul Medipol University Hospital
First posted: 2025-05-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: VAS score
timeFrame: Baseline, 3 months, 6 months
measure: Brief Pain İnventory- Short Form
timeFrame: Baseline, 3 months, 6 months
measure: Oswestry Disability Index (ODI)
timeFrame: Baseline, 3 months, 6 months
measure: Baseline thickness of the paraspinal muscles
timeFrame: Baseline
Secondary outcomes:
measure: Correlation between baseline thickness of the paraspinal muscles as measured by MRI and the change in pain intensity
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul Çam and Sakura City Hospital
Study officials:
References:
citation: 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.
citation: Li 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.
citation: Wang 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.