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Набор скоро начнётся NCT06586450

Effect of Low Level Laser Versus Interferential Current on Postmenopausal Low Back Pain

Без фазы С лечением Low Back Pain

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: Low level laser therapy, Interferential current, Core stability exercise.
Кому может быть актуально
Состояния в реестре: Low Back Pain. 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

This study will be conducted to compare the effect of low-level laser and interferential current on postmenopausal low back pain.

Подробное описание

Low back pain (LBP) is a major health problem affecting majority of the people at some point of their life.The prevalence of postmenopausal LBP is 32.4%. It has major implication for quality of life, such as limitation of daily activities and physiological stress, being one of the main causes of work absenteeism.

The prolonged use of NSAIDs is associated with cardiovascular, hepatic, and renal problems. Therefore, there is a need for emphasis on alternative methods of conservative treatment as non-pharmacological and non-invasive therapy to relieve postmenopausal LBP.

Low level laser has been proven to have an impact on postmenopausal LBP, through several mechanisms as (a) increased endogenous opioid neurotransmitter production ;(b)raised threshold to thermal pain and enhanced local blood circulation ; (c)increased oxygen consumption by accelerating the redox reaction rate of the electron respiratory chain of mitochondria ; (d) increased adenosine triphosphate (ATP) production at the cellular level ;(e) increased production of the anti-inflammatory cytokines.

Also, another non- invasive technique is the interferential current which is one of the existing electrotherapy treatments used to reduce pain and has been studied for its effectiveness in relieving LBP through its deeper penetration into the tissues.

So, this study will be conducted to provide new evidence and information about the efficacy of low-level laser versus interferential current on LBP in postmenopausal women

Вмешательства

  • Устройство Low level laser therapy
    The participants will receive Low Level Laser on lumbo-pelvic region for 20 min/sessions,3 sessions / week for 12 weeks, with the following parameters: Wavelength: 808 nm, continuous mode, Output power: 160 mw, Penetration depth: 4 cm, Power density:0.16 J/cm2.
  • Устройство Interferential current
    All participants will receive interferential current on lumbopelvic region ( quadripolar technique) for 25 min/session, 3 sessions/week for 12 weeks, with the following parameters: carrier frequency of 4 KHZ and sweep frequency 95 HZ, intensity based on patient's tolerance without muscle contraction.
  • Другое Core stability exercise
    The participants will perform core stability exercises for 15 min 3 time/week in the form of Prone Gluteal Squeezes, Pelvic Bridging, Curl Up Exercise, and Double Knee to Chest Stretching Exercises.

Первичные конечные точки

  • Pain severity [Срок оценки: 12 weeks]
  • Lumbar flexion range of motion [Срок оценки: 12 weeks]
  • Lumbar extension range of motion [Срок оценки: 12 weeks]
  • Lumbar lateral flexion range of motion [Срок оценки: 12 weeks]
Вторичные конечные точки (1)
  • Functional disability [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • Sixty postmenopausal women (at least one year after stoppage menses).
  • Their age will be ranged from 50 to 60 years.
  • Their body mass index (BMI) will be less than 30 kg/m2.
  • All of them suffer from chronic low back pain (at least 3 months).
  • The score of pain will be 2 or more according to visual analogue scale (VAS).

Критерии исключения

  • Spinal fracture or any other neurological disorder.
  • Lumbar disc herniation, degenerative joint diseases, or spondylolisthesis.
  • BMI>30 kg/m2
  • Gynecological Diseases as Chronic pelvic pain or genital prolapse.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Ola Saad El Naggar — Alexandria

Идентификаторы

NCT: NCT06586450 · P.T.REC/012/005317

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗