- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07694219
Bowen Therapy and McGill Stabilization Exercises in Chronic Low Back Pain
Comparison of Bowen Therapy and McGill Stabilization Exercises on Pain, Range of Motion, and Disability in Chronic Low Back Pain: A Randomized Controlled Trial
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
This is a single-center, parallel-group, randomized controlled trial conducted at Sehat Medical Complex. A total of 100 participants aged 25-55 years with chronic nonspecific low back pain of more than three months' duration will be randomly allocated to one of two treatment groups using a computer-generated randomization sequence.
Participants in the experimental group will receive Bowen Therapy combined with the McGill stabilization exercise program, while participants in the comparator group will receive Bowen Therapy alone. Both groups will receive standard physiotherapy modalities, including a 10-minute moist hot pack and transcutaneous electrical nerve stimulation (TENS) before each treatment session. The intervention period will last six weeks, with treatment sessions conducted three times per week.
Outcome assessments will be performed at baseline and at Weeks 2, 4, and 6. Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS), lumbar range of motion will be assessed using a bubble inclinometer, and functional disability will be evaluated using the Modified Oswestry Disability Index (MODI). All assessments will be performed by the same trained physiotherapist to ensure measurement consistency.
The study has been approved by the Institutional Review Board of Sehat Medical Complex (Approval No. IREB-UOL-SMC/001-26/2024) and will be conducted in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all participants before enrollment. Statistical analysis will be performed using SPSS version 25.0. Descriptive statistics will summarize baseline characteristics, the Shapiro-Wilk test will assess data normality, and repeated-measures analysis of variance (RM-ANOVA) will be used to evaluate changes between groups over time. Statistical significance will be set at p < 0.05.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
-
Lahore, Пакистан, 54590
- Sehat Medical Complex
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- With chronic localized low back pain lasting over three months
- Without any signs of pain below the gluteal fold
- Fulfills the recommended diagnostic criteria of nonspecific chronic low back pain.
Exclusion Criteria:
- Lumbar disc herniation
- Lumbar canal stenosis
- Spondylolisthesis
- Spondylitis
- Radiculopathy
- Vertebral fracture
- Neurological deficits
- Pregnancy or radiating pain below the gluteal fold.
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 |
|---|---|
|
Экспериментальный: Bowen Therapy + McGill Stabilization Exercise
Participants received a combined intervention consisting of Bowen Therapy and McGill stabilization exercises for six weeks.
The McGill exercise program included curl-up, side-bridge, and bird-dog exercises performed three sessions per week on alternate days, with 30 repetitions and a 10-second isometric hold per repetition.
Conventional physiotherapy exercises, including single and double knee-to-chest stretches, prone lying, heel slides, supine bicycling, and bridging exercises, were also provided.
Before each treatment session, participants received a 10-minute moist hot pack and transcutaneous electrical nerve stimulation (TENS).
|
Bowen Therapy is a manual therapy involving gentle rolling movements applied over muscles, tendons, ligaments, and fascia using the fingers or thumbs. Treatment consisted of standardized movement sequences with 2-5 minute intervals between sets to facilitate neuromuscular integration. Each session included two to three repetitions per set and four to five sets, administered three times per week for six weeks. The McGill stabilization exercise program consisted of evidence-based core stabilization exercises including the curl-up, side-bridge, and bird-dog. Exercises were performed three times per week on alternate days for six weeks, with 30 repetitions and a 10-second isometric hold during each repetition. Participants also performed conventional physiotherapy exercises, including single and double knee-to-chest stretches, prone lying, heel slides, supine bicycling, and bridging exercises. |
|
Активный компаратор: Bowen Therapy Alone
Participants received Bowen Therapy alone for six weeks.
Bowen Therapy consisted of gentle rolling manual movements applied to muscles, tendons, ligaments, and fascia using the fingers or thumbs, with 2-5 minute intervals between movement sequences.
Each session included two to three repetitions per set and four to five sets following a standardized treatment protocol.
Participants also received standard physiotherapy modalities, including a 10-minute moist hot pack and transcutaneous electrical nerve stimulation (TENS) before each treatment session.
|
Bowen Therapy is a manual therapy involving gentle rolling movements applied over muscles, tendons, ligaments, and fascia using the fingers or thumbs.
Treatment consisted of standardized movement sequences with 2-5 minute intervals between sets to facilitate neuromuscular integration.
Each session included two to three repetitions per set and four to five sets, administered three times per week for six weeks.
Participants in both study groups received Bowen Therapy according to the same standardized protocol.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Pain Intensity Measured by the Numeric Pain Rating Scale (NPRS)
Временное ограничение: Baseline, Week 2, Week 4, and Week 6
|
Pain intensity will be assessed using the 11-point Numeric Pain Rating Scale (NPRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
|
Baseline, Week 2, Week 4, and Week 6
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Functional Disability Measured by the Modified Oswestry Disability Index (MODI)
Временное ограничение: Baseline, Week 2, Week 4, and Week 6
|
Functional disability will be assessed using the Modified Oswestry Disability Index (MODI).
Scores range from 0% to 100%, with higher scores indicating greater disability.
|
Baseline, Week 2, Week 4, and Week 6
|
Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- Fouladi N, Minoonejad H, Rajabi R. Comparing the effects of the postural restoration exercises with and without core stability exercises in patients with non-specific chronic low back pain. Journal of Modern Rehabilitation. 2023.
- Opara JA, Saulicz E, Szczygiel JW, Szczygiel K. Is the Central Sensitization in Chronic Nonspecific Low Back Pain Structural Phenomenon or Psychological Reaction? A Narrative Review. J Clin Med. 2025 Jan 17;14(2):577. doi: 10.3390/jcm14020577.
- Baek JE, Kim SH, Shin HJ, Cho HY. Effect of a Healing Program Using Marine Resources on Reducing Pain and Improving Physical Function in Patients with Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial Study. Medicina (Kaunas). 2025 Jan 21;61(2):172. doi: 10.3390/medicina61020172.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- IRB-UOL-SMC/001-27/2024
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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