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临床试验/NCT07648927
NCT07648927尚未招募不适用

Evaluation of the Effectiveness of Physical Therapy for Low Back Pain According to Magnetic Resonance Imaging Findings

Bahçeşehir University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年6月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Change in disability measured by the Oswestry Disability Index (ODI)

研究概览

简要总结

Low back pain is a common musculoskeletal disorder associated with substantial disability and reduced quality of life. Although magnetic resonance imaging (MRI) is frequently used to identify structural spinal abnormalities, the relationship between MRI findings and treatment outcomes remains unclear. This retrospective study aims to evaluate whether the effectiveness of a standardized physical therapy program differs according to baseline lumbar MRI findings. Medical records of 120 patients with low back pain who underwent lumbar MRI and completed 15 sessions of physical therapy between January 2022 and February 2026 will be reviewed. Patients will be classified into three MRI-based groups: disc herniation, disc degeneration, and non-specific MRI findings. Treatment outcomes will be assessed using changes in Visual Analog Scale (VAS) pain scores and Oswestry Disability Index (ODI) scores before and after treatment. The findings may contribute to identifying patient subgroups that respond differently to conservative treatment and support more individualized rehabilitation strategies.

详细描述

Low back pain is one of the leading causes of disability worldwide and represents a major public health burden. Magnetic resonance imaging (MRI) is commonly used to evaluate lumbar spine pathologies such as disc herniation, disc degeneration, Modic changes, facet joint arthropathy, and spinal stenosis. However, previous studies have demonstrated that many degenerative MRI findings are also present in asymptomatic individuals, raising questions regarding their clinical significance and prognostic value.

Physical therapy is a cornerstone of conservative management for low back pain and has been shown to improve pain and functional outcomes. Nevertheless, treatment response varies considerably among patients, and factors influencing these differences remain incompletely understood. Baseline MRI findings may represent one potential predictor of treatment outcome, yet studies investigating this relationship are limited.

The present retrospective study will evaluate whether treatment outcomes following a standardized physical therapy program differ according to lumbar MRI findings. Medical records of patients aged 18-65 years who presented with low back pain to the Physical Medicine and Rehabilitation Clinic of Medical Park Göztepe Hospital between January 2022 and February 2026 will be reviewed. Eligible patients must have undergone lumbar MRI and completed a standardized 15-session physical therapy program consisting of hot pack application, ultrasound therapy, interferential current therapy, and transcutaneous electrical nerve stimulation (TENS).

Patients will be categorized into three MRI groups: disc herniation, disc degeneration and non-specific MRI findings. MRI images will be reviewed and classified by an experienced physiatrist. Pain intensity and functional disability routinely recorded before and after treatment using the Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) will be extracted from medical records.

The primary outcome will be the change in VAS pain score following treatment. Secondary outcomes will include changes in ODI scores. Comparisons of treatment response among MRI groups will be performed using appropriate parametric or non-parametric statistical tests. Multivariable regression analyses will be conducted to determine whether MRI findings independently predict treatment outcomes after adjustment for potential confounding factors.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 65 years.
  • Completion of 15 sessions of physical therapy.
  • Availability of accessible MRI images in the medical records.
  • No history of lumbar spine surgery.
  • Absence of conditions that may cause low back pain, including fibromyalgia, neuropathy, spondyloarthropathy, or scoliosis.

排除标准

  • Presence of comorbid conditions that may cause low back pain (fibromyalgia, rheumatologic diseases, scoliosis, herpes zoster, polyneuropathy, central pain syndromes).
  • Presence of systemic neuromuscular disorders.
  • Acute disc herniation or vertebral fracture.
  • Receipt of fewer or more than 15 sessions of physical therapy.
  • Missing data in follow-up records.
  • Use of analgesic medications during the treatment period.

研究组 & 干预措施

Patients with Low Back Pain Receiving Standard Physical Therapy

Other

Patients aged 18-65 years who presented with low back pain, underwent lumbar MRI examination, and completed a standardized 15-session physical therapy program consisting of hot pack application, ultrasound therapy, interferential current therapy, and transcutaneous electrical nerve stimulation (TENS). Participants will be retrospectively classified according to baseline MRI findings into disc herniation, disc degeneration, Modic changes, facet arthropathy, spinal stenosis, and non-specific MRI groups for outcome analyses.

干预措施: Standard Physical Therapy Program (Procedure)

结局指标

主要结局

Change in disability measured by the Oswestry Disability Index (ODI)

时间窗: Baseline and immediately after completion of the 15-session physical therapy program (approximately 3 weeks).

Functional disability will be assessed using the Oswestry Disability Index (ODI), which ranges from 0 to 100, where higher scores indicate greater disability and worse functional status. A reduction in score indicates improvement. The outcome measure will be the change in ODI score from baseline to completion of the 15-session physical therapy program.

次要结局

  • Change in pain intensity measured by the Visual Analog Scale (VAS)(Baseline and after completion of 15 physical therapy sessions (approximately 3 weeks))

研究者

发起方
Bahçeşehir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeynep Iyigun

prof., MD

Bahçeşehir University

研究点 (1)

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