Spinal Mobilization and Manipulation for Nonspecific Low Back Pain (SMM-LBP)
Effects of Spinal Mobilization and Manipulation Added to Conventional Physiotherapy on Pain Intensity, Functional Disability, Fear-Avoidance Beliefs, and Lumbar Range of Motion in Individuals With Non-Specific Low Back Pain: A Randomized Controlled Trial
Low back pain is one of the most common musculoskeletal disorders worldwide and is a major cause of pain and disability. Manual therapy techniques such as spinal mobilization and spinal manipulation are frequently used together with conventional physiotherapy; however, their additional benefits remain unclear.
This randomized controlled trial aims to investigate whether adding spinal mobilization and spinal manipulation to conventional physiotherapy improves pain intensity, functional disability, fear-avoidance beliefs, and lumbar range of motion in individuals with non-specific low back pain. Participants will be randomly assigned to receive either conventional physiotherapy alone or conventional physiotherapy combined with spinal mobilization and manipulation. Outcome measures will be assessed before and after the six-week intervention. The findings of this study may provide evidence regarding the effectiveness of combining manual therapy with conventional physiotherapy for the management of non-specific low back pain.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Background
Non-specific low back pain is one of the leading causes of disability worldwide and is associated with substantial physical, psychological, and socioeconomic burden. Conservative physiotherapy is recommended as the first-line treatment, and manual therapy techniques such as spinal mobilization and spinal manipulation are frequently used as adjunctive interventions. However, evidence regarding their additional effectiveness when combined with conventional physiotherapy remains limited.
Objective
The aim of this randomized controlled trial is to investigate the effects of spinal mobilization and manipulation in addition to conventional physiotherapy on pain intensity, functional disability, fear-avoidance beliefs, and lumbar range of motion in individuals with non-specific low back pain.
Methods
Thirty participants with non-specific low back pain will be randomly allocated to either a conventional physiotherapy group or a conventional physiotherapy plus spinal mobilization and manipulation group. Both groups will receive conventional physiotherapy three times per week for six consecutive weeks. The intervention group will additionally receive spinal mobilization and spinal manipulation performed by an experienced physiotherapist.
Pain intensity will be assessed using the Visual Analog Scale (VAS), functional disability using the Roland-Morris Disability Questionnaire (RMDQ), fear-avoidance beliefs using the Fear-Avoidance Beliefs Questionnaire (FABQ), and lumbar range of motion using a universal goniometer. Outcome assessments will be performed at baseline and after completion of the six-week intervention.
Expected Outcomes
It is hypothesized that adding spinal mobilization and spinal manipulation to conventional physiotherapy will result in greater improvements in pain intensity, functional disability, fear-avoidance beliefs, and lumbar range of motion compared with conventional physiotherapy alone.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Ali Yıldırım, PhD
- Номер телефона: +905399306460
- Электронная почта: devri-alem-61@hotmail.com
Места учебы
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Istanbul, Турция (Туркие), 34744
- Ozel Mediworld
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Adults aged 18 to 60 years.
- Diagnosis of non-specific low back pain.
- Symptoms persisting for more than 12 weeks.
- Able to understand the study procedures and provide written informed consent.
- Willing to participate in the study and comply with the intervention protocol
Exclusion Criteria:
- Structural spinal abnormalities.
- Spinal infection or tumor.
- Inflammatory spinal diseases.
- Neurological disorders or neurological deficits.
- Psychiatric disorders.
- Pregnancy.
- History of recent spinal surgery.
- Chronic or systemic diseases that could affect participation.
- Conditions that could interfere with adherence to the treatment protocol
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Активный компаратор: Conventional Physiotherapy Group
Participants received conventional physiotherapy consisting of superficial heat application using a hot pack (20 minutes), transcutaneous electrical nerve stimulation (TENS) (20 minutes), therapeutic ultrasound (5 minutes), and supervised therapeutic exercises (20 minutes), administered three times per week for six consecutive weeks.
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Participants received conventional physiotherapy consisting of superficial heat application using a hot pack (20 minutes), transcutaneous electrical nerve stimulation (TENS) (20 minutes), therapeutic ultrasound (5 minutes), and supervised therapeutic exercises (20 minutes).
The intervention was administered three times per week for six consecutive weeks, resulting in a total of 18 treatment sessions.
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Экспериментальный: Conventional Physiotherapy + Spinal Mobilization and Manipulation Group
Participants received the same conventional physiotherapy program as the active comparator group.
In addition, spinal mobilization according to the Maitland concept and high-velocity, low-amplitude (HVLA) spinal manipulation were applied by an experienced physiotherapist three times per week for six consecutive weeks.
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Participants received conventional physiotherapy consisting of superficial heat application using a hot pack (20 minutes), transcutaneous electrical nerve stimulation (TENS) (20 minutes), therapeutic ultrasound (5 minutes), and supervised therapeutic exercises (20 minutes).
The intervention was administered three times per week for six consecutive weeks, resulting in a total of 18 treatment sessions.
Spinal mobilization and spinal manipulation were administered sequentially during the same treatment session.
Grade III central posterior-anterior oscillatory mobilization according to the Maitland concept was applied to the identified hypomobile lumbar segment, followed immediately by a high-velocity, low-amplitude (HVLA) rotational thrust manipulation performed in the side-lying position.
The intervention was individualized according to each participant's clinical presentation, symptom response, and joint mobility assessment.
All procedures were performed by the same physiotherapist with more than 10 years of clinical experience in orthopedic manual therapy, three times per week for six consecutive weeks.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Pain intensity measured using the Visual Analog Scale (VAS)
Временное ограничение: Baseline and after 6 weeks of intervention
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Pain intensity will be assessed under three conditions (at rest, during activity, and at night) using a 10-cm Visual Analog Scale (VAS).
Scores range from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.
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Baseline and after 6 weeks of intervention
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Functional disability measured using the Roland-Morris Disability Questionnaire (RMDQ)
Временное ограничение: Baseline and after 6 weeks of intervention
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Functional disability will be assessed using the 24-item Roland-Morris Disability Questionnaire (RMDQ).
Scores range from 0 to 24, with higher scores indicating greater disability.
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Baseline and after 6 weeks of intervention
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Fear-avoidance beliefs measured using the Fear-Avoidance Beliefs Questionnaire (FABQ)
Временное ограничение: Baseline and after 6 weeks of intervention
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Fear-avoidance beliefs will be evaluated using the Fear-Avoidance Beliefs Questionnaire (FABQ), including physical activity and work subscales.
Higher scores indicate greater fear-avoidance beliefs.
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Baseline and after 6 weeks of intervention
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Lumbar range of motion
Временное ограничение: Baseline and after 6 weeks of intervention
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Lumbar flexion, extension, lateral flexion, and rotation will be measured using a universal goniometer.
Three measurements will be obtained for each movement, and the mean value will be used for analysis.
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Baseline and after 6 weeks of intervention
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 1915
Планирование данных отдельных участников (IPD)
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Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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