Effect Of Paraspinal Muscle Thickness On The Benefit Of Core Stabilization

NCT ID: NCT06969508

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-04-15

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.

Conditions

Back Pain Lower Back Chronic; Lumbar Disc Degenerative Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with Lumbar disc herniation

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

Group Type: EXPERIMENTAL

core stabilitation exercises

Intervention Type: OTHER

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.

Interventions

core stabilitation exercises

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medipol University Hospital

OTHER

Sponsor Role: collaborator

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Mucahit Atasoy, MD

Asst. Prof. MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

İstanbul Çam and Sakura City Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 23867731 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38035307 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23284879 (View on PubMed)

Other Identifiers

2024-KAEK-11

Identifier Type: -

Identifier Source: org_study_id