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Набор скоро начнётся NCT07648927

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

Без фазы С лечением Low Back Pain Physical Therapy Lumbar Degenerative Disc Disease Lumbar Disc Herniation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Standard Physical Therapy Program.
Кому может быть актуально
Состояния в реестре: Low Back Pain, Physical Therapy, Lumbar Degenerative Disc Disease, Lumbar Disc Herniation. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Обзор

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.

Подробное описание

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.

The results of this study may improve understanding of the prognostic value of lumbar MRI findings and contribute to the development of more personalized rehabilitation approaches for patients with low back pain.

Вмешательства

  • Процедура Standard Physical Therapy Program
    Participants received a standardized physical therapy program consisting of 15 treatment sessions. The treatment protocol included hot pack application, therapeutic ultrasound, interferential current therapy, and transcutaneous electrical nerve stimulation (TENS). All interventions were administered as part of routine clinical care for low back pain.

Первичные конечные точки

  • Change in disability measured by the Oswestry Disability Index (ODI) [Срок оценки: Baseline and immediately after completion of the 15-session physical therapy program (approximately 3 weeks).]
Вторичные конечные точки (1)
  • Change in pain intensity measured by the Visual Analog Scale (VAS) [Срок оценки: Baseline and after completion of 15 physical therapy sessions (approximately 3 weeks)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Turkey (Türkiye) · 1 центр
  • Bahcesehir university — Istanbul

Идентификаторы

NCT: NCT07648927 · BAU-FTR-2026-07/03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗