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Идёт набор NCT06985849

Effects of Feldenkrais and Otago Exercise Protocols for Mechanical 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: Feldenkrais method, Otago exercise protocol..
Кому может быть актуально
Состояния в реестре: Low Back Pain. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пакистан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Low back pain (LBP) is a common health issue-affecting individual across diverse ages and socio- economic backgrounds, with approximately 80% of the population experiencing this musculoskeletal concern at some point in their lives. Despite its prevalence, the prognosis for LBP is generally favorable, emphasizing the importance of effective management strategies aimed at reducing pain and improving functional ability. The Feldenkrais Method and the Otago Exercise Programme (OEP) are two interdisciplinary approaches that have demonstrated promise in addressing mechanical non-specific low back pain. This study aims to evaluate the effectiveness of these two intervention protocols in alleviating chronic low back pain while concurrently enhancing functional abilities and reducing the risk of falls among older adults. The study will be a randomized controlled trial conducted on participants. Data will be collected from Farooq hospital and Boston physiotherapy and wellness clinic. This study will be completed in time duration of 10 months after the approval of synopsis. Non-probability convenience sampling technique will be used and participant's age between 45-65, having mechanical low back pain for more than 3 months will be recruited in study after computer generated randomization. However, participants who have any chronic illness like recurrent spinal surgery, Malignancy, Spine Infection, Spinal fracture and congenital disturbance shall be excluded from this study. The subjects will be divided into two groups. Group A will receive awareness through movement sessions of trunk mobility, which will be guided verbally(such as rolling head left and right, bringing knees to chest, tilting to the sides, rolling pelvis.) and Group B will receive lower limb strength and balance exercises like knee extensions and hip abduction. All these sessions will be of 30 minutes to for 2 sessions per week for 6 weeks. Pre and post assessments will be conducted and the tools that will be used are NPRS for pain, Universal goniometer for ROM, Functional disability (Oswestry Disability Index), Falls-related self-efficacy will be assessed by the Activities-Specific Balance Confidence (ABC) Scale. and Balance (Berg Balance Scale). Data will be analyzed by using SPSS version 26.0.

Вмешательства

  • Другое Feldenkrais method
    "Activating flexors" "The pelvic clock"twisting)."Side lying lesson for improving the integration of arms, shoulders and spine" (reaching motion of shoulders in different directions)."Transitioning from supine to side lying to sitting" (lying supine involving flexion, extension, and twisting)."Twisting on the side" "Twisting from supine with head fixed to the side" (by limiting the movement of the head, the rib cage is forced to participate in the twisting motion) "Lengthening the hamstrings" "A
  • Другое Otago exercise protocol.
    The study began by completing all 3-outcome measures by first asking about their pain intensity then by checking their balance through Berg Balance Scale and then checking the level of function through ODI questionere. The OEP included the following exercises: knee extension and knee flexion, hip abduction, calf raises, toe raises, sit to stand, semi squats from a standing position, tandem stand, tandem walk, sideways walking, backwards walking, heel walking, toe walking, one leg stand, and walk

Первичные конечные точки

  • Berg Balance Scale ( BBS) [Срок оценки: baseline and fourth week]
  • Oswestry Disability Index (ODI) [Срок оценки: baseline and fourth week]

Критерии участия

Критерии включения

  • • Age group 18 to 65 year (3)
  • Both gender male and female
  • LBP (duration ≥ 3 months) (3)
  • NPRS score ≥ 4/10 (indicating moderate pain)
  • ODI: Score ≥ 20/100 (indicating moderate disability)
  • BBS: Score ≤ 45/56 (indicating balance impairment)
  • BC Scale score: ≤ 60/100 (indicating moderate to low balance confidence)
  • Ability to walk independently
  • No severe cognitive impairment
  • Patient willing to perform in the study

Критерии исключения

  • • Recurrent spinal surgery(3)
  • Malignancy
  • Spine Infection
  • Spinal fracture
  • Congenital disturbance
  • Severe LBP (NPRS ≥ 9/10)
  • Significant balance impairment (BBS ≤ 20/56)
  • Severe disability (ODI ≥ 60/100)
  • ABC Scale score: ≥ 80/100 (indicating high balance confidence)
  • Older individuals with specific health conditions, such as cardiovascular disease and diabetes

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

Пакистан · 1 центр
  • Farooq Hospital — Lahore

Публикации

  • Gianola S, Bargeri S, Del Castillo G, Corbetta D, Turolla A, Andreano A, Moja L, Castellini G. Effectiveness of treatments for acute and subacute mechanical non-specific low back pain: a systematic review with network meta-analysis. Br J Sports Med. 2022 Jan;56(1):41-50. doi: 10.1136/bjsports-2020-103596. Epub 2021 Apr 13. PMID 33849907
  • Senbursa G, Pekyavas NO, Baltaci G. Comparison of Physiotherapy Approaches in Low Back Pain: A Randomized Controlled Trial. Korean J Fam Med. 2021 Mar;42(2):96-106. doi: 10.4082/kjfm.20.0025. Epub 2020 May 22. PMID 32438535
  • Ahmadi H, Adib H, Selk-Ghaffari M, Shafizad M, Moradi S, Madani Z, Partovi G, Mahmoodi A. Comparison of the effects of the Feldenkrais method versus core stability exercise in the management of chronic low back pain: a randomised control trial. Clin Rehabil. 2020 Dec;34(12):1449-1457. doi: 10.1177/0269215520947069. Epub 2020 Jul 29. PMID 32723088

Идентификаторы

NCT: NCT06985849 · REC/RCR & AHS/24/0181

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗