Effect Of Paraspinal Muscle Thickness On The Benefit Of Core Stabilization

Medipol University60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: Baseline

Secondary Outcomes

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.

Time frame: Baseline, 6 months

Effect Of Paraspinal Muscle Thickness On The Benefit Of Core Stabilization

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes