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Идёт набор NCT06671665

Effect of Manual Therapy on Low Back Pain in Osteopenic Postmenopausal Women

Без фазы С лечением Low Back Pain Osteopenia

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: calcium supplementation, Manual therapy.
Кому может быть актуально
Состояния в реестре: Low Back Pain, Osteopenia. Базовые параметры: 50 лет — 60 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Обзор

The purpose of this study is to determine the effect of manual therapy on low back pain in osteopenic postmenopausal women.

Подробное описание

Women spend nearly one-third of their life in menopause. In this period, besides other comorbid conditions, women suffer from various musculoskeletal disorders also. One such problem is chronic low back pain which is more prevalent in post-menopausal women. This condition affects daily living activities of a person ranging from standing up, walking, bending over, lifting, traveling, social interaction, dressing to sleeping, living with ongoing pain causes depression, anxiety, deterioration in quality of life for women themselves. Despite this, little attention has been paid to pain in the spine/low back ache which are equally prevalent in this period of life.

Although this poses a great medical and socioeconomic challenge to such extent that some researchers call it a lifestyle disease. It is the main cause of absence in the workplace and the 2nd cause of visiting primary health-care professionals. Spine pain has negative psychological consequences as it impairs daily functioning. Therefore, finding an effective method for treatment is important.

Manual treatments are one of the most applied methods within physiotherapy approaches in recent years. Manual treatment (in the form of craniosacral and visceral manipulation) claiming to release the tension of the muscles, ligaments, and fascia in the sacral area and activate central pain inhibitory centers. For this reason, we are conducting the present study with a new view to identify the effects of manual therapy practices in the form of craniosacral and visceral manipulation on pain, function, and BMD of the lumbar region, as well as quality of life in osteopenic post-menopausal women suffering from low back pain.

Вмешательства

  • Препарат calcium supplementation
    Patients in both groups received calcium supplementation in the form of tablets that contain 665 mg calcium citrate. Citrate is easily assimilated and metabolized which provides the maximum benefit of the formula. Dosage: one tablet daily.
  • Другое Manual therapy
    Manual therapy treatment will be in the form of craniosacral techniques and visceral manipulation techniques for 8 sessions in 12 weeks. Sessions will be divided into one session per week for the first 4 weeks then one session every two week for the next 8 weeks. Each session lasts for 45 minutes.

Первичные конечные точки

  • Assessment of Low back pain severity [Срок оценки: 12 weeks]
  • Measurement of lumbar curvature angle. [Срок оценки: 12 weeks]
  • Assessment of Lumbar Flexion [Срок оценки: 12 weeks]
  • Assessment of Lumbar Extension [Срок оценки: 12 weeks]
  • Assessment of Lumbar Lateral bending to the right side [Срок оценки: 12 weeks]
  • Assessment of Lumbar Lateral bending to the left side [Срок оценки: 12 weeks]
  • Assessment of functional disability related to low back pain [Срок оценки: 12 weeks]
Вторичные конечные точки (2)
  • Measurement of lumbar Bone Mineral Density (BMD) [Срок оценки: 12 weeks]
  • Assessment of quality of life [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • Ambulatory, sedentary, non-smoking women having natural menopause at least 1 year before participation in the study.
  • Their ages will range from 50 to 60 years old.
  • Their BMI will be > 30 kg/m2.
  • Pain before costal margin and above inferior gluteal fold.
  • Osteopenia.

Критерии исключения

  • Osteoporosis.
  • Having osteoporotic fractures.
  • Having a lumbar surgery previously.
  • Neurological disorder.
  • Known diseases affecting bone quality (hyperthyroidism, hyperparathyroidism, hypercortisolism, etc).
  • Receiving any medical or hormonal therapies that could affect the bone metabolism.
  • Receiving previous manual treatment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Cairo University — Giza

Идентификаторы

NCT: NCT06671665 · P.T.REC/012/005212

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗