Comparison of Abdominal Draw-in Maneuver With Real-time Ultrasound Imaging Biofeedback vs Conservative Physical Therapy in Patients With Chronic Low Back Pain

Официальное название

Comparison of Abdominal Draw-in Maneuver With Real-time Ultrasound Imaging Biofeedback vs Conservative Physical Therapy in Patients With Chronic Low Back Pain: A Prospective, Randomized Clinical Trial

Обзор

The aim of this study is to compare the effectiveness of abdominal drawing-in maneuver with real-time ultrasound biofeedback to conservative treatment in patients with chronic nonspecific low back pain.

Подробное описание

Low back pain is a common clinical condition among musculoskeletal disorders. It can be classified into two main categories: acute and chronic. Acute low back pain is usually limited to a duration of 6 weeks or less, whereas chronic low back pain refers to pain lasting 12 weeks or longer. Chronic low back pain is characterized by persistent and untreated pain, which can significantly affect individuals' physical and psychological health. A multidisciplinary approach is required for its treatment. Physical therapy, pharmacological approaches, psychotherapy, and exercise are the main treatment methods.

Exercise plays an active role in both the prevention and treatment of the disease. Among many exercise methods, the abdominal drawing-in maneuver has been proven effective in the literature. Biofeedback is a technique that helps individuals consciously control their physiological processes. Real-time ultrasound biofeedback stands out as a technique that directly visualizes musculoskeletal system functions. This method uses high-frequency sound waves to assess the dynamic movements of internal organs and muscle structures. Through this technology, individuals can visualize their movements in real time and consciously adjust their muscle activity or posture. It offers significant advantages, particularly in clinical and sports applications such as pelvic floor rehabilitation, postural balance training, and motor control skill development.

The aim of our study is to compare the effectiveness of exercises performed with real-time ultrasound biofeedback with those in patients receiving conservative treatment. Patients will be randomly assigned to two groups: Group 1: Patients receiving conservative treatment and performing the abdominal drawing-in maneuver with real-time ultrasound imaging biofeedback. Group 2 (Control Group): Patients receiving conservative treatment and performing the abdominal drawing-in maneuver with only verbal instruction. A total of 40 patients are planned to be included in the study.

Вмешательства

• Другое Conservative Physical Therapy
  Transcutaneous Electrical Nerve Stimulation (TENS):It is an electrotherapy modality commonly used in pain management. Conventional TENS will be applied to our patients. The frequency of Conventional TENS will be 50 Hz, the pulse duration will be 80 µs, the amplitude will be of mild to moderate intensity as perceived by the patient, and the duration will be 20 minutes. Hot Pack:It is a superficial heat therapy method commonly used to reduce muscle spasms, increase circulation, and alleviate pain
• Другое Abdominal Draw-in Manuever
  Starting Position: The patient lies in a supine position with knees bent and feet flat on the ground. The neck and spine are kept in a neutral position. Breath Control: The patient focuses on abdominal expansion while inhaling and flattening the abdomen while exhaling. Transversus Abdominis Activation: The patient attempts to draw the abdominal muscles inward (pulling the navel toward the spine). During this movement, care should be taken to avoid pressing the lower back against the ground or co
• Другое Real-Time Ultrasound Biofeedback with Abdominal Draw-In Manuever
  The patient, who has been instructed on the abdominal drawing-in exercise, assumes a supine position with knees bent. The ultrasound screen is positioned so that both the practitioner and the patient can see it. The researcher places the linear ultrasound probe on the patient's transversus abdominis muscle to obtain an image, which is then shown to the patient for awareness. The patient is instructed to keep their eyes on the screen and follow their muscle activity throughout the exercise. Durin

Первичные конечные точки

• Visual Analogue Scale [Срок оценки: before treatment]
• Visual Analogue Scale [Срок оценки: In the 3rd week of treatment]
• Muscle Thickness [Срок оценки: before treatment]
• Muscle Thickness [Срок оценки: In the 3rd week of treatment]

Вторичные конечные точки (8)

• Berg Balance Scale [Срок оценки: before treatment]
• Berg Balance Scale [Срок оценки: In the 3rd week of treatment]
• Oswestry Disability Index [Срок оценки: before treatment]
• Oswestry Disability Index [Срок оценки: In the 3rd week of treatment]
• Lomber Range of Motion [Срок оценки: before treatment]
• Lomber Range of Motion [Срок оценки: In the 3rd week of treatment]
• EQ-5D-3L General Quality of Life Scale [Срок оценки: before treatment]
• EQ-5D-3L General Quality of Life Scale [Срок оценки: In the 3rd week of treatment]

Критерии участия

Критерии включения

• The duration of low back pain is at least 3 months.
• Low back pain with or without radiation to the lower extremities.
• Age between 18-65 years.
• Chronic nonspecific low back pain patients.

Критерии исключения

• Neuropathic pain complaints.
• Pregnancy status.
• History of infection, cancer, or trauma.
• Neurological abnormalities.
• History of lumbar spine surgery.
• History of conservative physical therapy and/or injections in the lumbar region within the last 6 months.
• Neurological diseases such as Parkinson's or Multiple Sclerosis.
• Systemic diseases that prevent exercise.
• Patients with a Mini-Mental Test score below 24.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Abant Izzet Baysal University — Bolu

Идентификаторы

NCT: NCT06856642 · AIBU-FTR-SK-09

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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