Effects of Core Stability Exercises and Cognitive Tasks on Chronic Non-specific Back Pain

Официальное название

Effects of Core Stability Exercises and Cognitive Tasks Compared to General Exercises and Cognitive Tasks on Chronic Non-specific Back Pain

Обзор

This randomized control trial study aims to compare the effect of core stability exercises and cognitive tasks with general exercises and cognitive tasks on pain, disability, and postural control strategies of chronic non-specific low back pain patients. The main questions are: 1. Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in reducing the pain of chronic non-specific low back pain patients? 2. Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in reducing the disability of chronic non-specific low back pain patients? 3. Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in improving postural stability parameters of chronic non-specific low back pain patients? 4. Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in improving stabilogram diffusion analysis parameters of chronic non-specific low back pain patients? This study is designed to apply two exercise protocols on two groups of 17 people with non-specific back pain. Group A will receive core stability exercises along with cognitive tasks, and group B will receive general exercises along with cognitive tasks.

Подробное описание

Patients will be aged between 18-50 years. All patients meeting the inclusion criteria will receive 16 training sessions (thrice a week). The primary outcome measure will be pain and disability. Secondary outcome measures will be postural control strategies (including postural control stability and stabilogram diffusion analysis), quality of life, fear of movement, and fear-avoidance beliefs that will be assessed before and after training sessions and at 3-month follow-up; only primary outcomes will be evaluated in each group.

Вмешательства

• Другое exercise therapy
  Exercise therapy is one of the rehabilitation methods that is defined as a regimen or plan of physical activities designed and prescribed to facilitate the patient's recovery from diseases and any conditions which disturb their movement and activity of daily life or maintain a state of well-being through neuro re-education, gait training, and therapeutic exercises.

Первичные конечные точки

• Oswestry Disability Index [Срок оценки: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "]

Вторичные конечные точки (11)

• Center of pressure (COP) sway range for anteroposterior (AP range) [Срок оценки: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "]
• COP sway range for mediolateral (MA range) [Срок оценки: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "]
• COP sway velocity [Срок оценки: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "]
• Sway area [Срок оценки: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "]
• Short-term diffusion coefficient of stabilogram diffusion plot [Срок оценки: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "]
• Long-term diffusion coefficient of stabilogram diffusion plot [Срок оценки: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "]
• Critical point coordinates. [Срок оценки: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "]
• 12-item short form health survey [Срок оценки: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "]
• Tampa scale for kinesiophobia [Срок оценки: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "]
• Fear-avoidance beliefs questionnaire [Срок оценки: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks "]
• Visual analog scale [Срок оценки: "Baseline (pre-intervention)", "change from baseline immediately after the intervention at five weeks ", "change from baseline at three months "]

Критерии участия

Критерии включения

• Orthopedist-confirmed diagnosis of chronic nonspecific low back pain that has lasted at least three months since its onset.
• Pain score of 3 or more on a visual analog scale.
• Pain during quiet standing.
• Cognitive level above 24 based on mini-mental state examination (MMSE).

Критерии исключения

• Radicular pain and any neurological signs.
• Uncorrected vision impairment.
• Hearing problems.
• Vestibular dysfunctions.
• Cognitive deficit.
• Previous spinal surgery.
• Severe deformity or injury to the lower extremities.

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

Иран · 1 центр

• Iran University of Medical Sciences — Tehran

Публикации

• Frizziero A, Pellizzon G, Vittadini F, Bigliardi D, Costantino C. Efficacy of Core Stability in Non-Specific Chronic Low Back Pain. J Funct Morphol Kinesiol. 2021 Apr 22;6(2):37. doi: 10.3390/jfmk6020037. PMID 33922389
• Agnus Tom A, Rajkumar E, John R, Joshua George A. Determinants of quality of life in individuals with chronic low back pain: a systematic review. Health Psychol Behav Med. 2022 Jan 5;10(1):124-144. doi: 10.1080/21642850.2021.2022487. eCollection 2022. PMID 35003902
• van Tulder M, Becker A, Bekkering T, Breen A, del Real MT, Hutchinson A, Koes B, Laerum E, Malmivaara A; COST B13 Working Group on Guidelines for the Management of Acute Low Back Pain in Primary Care. Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S169-91. doi: 10.1007/s00586-006-1071-2. No abstract av PMID 16550447
• Lamoth CJ, Stins JF, Pont M, Kerckhoff F, Beek PJ. Effects of attention on the control of locomotion in individuals with chronic low back pain. J Neuroeng Rehabil. 2008 Apr 25;5:13. doi: 10.1186/1743-0003-5-13. PMID 18439264
• Kanekar N, Aruin AS. Aging and balance control in response to external perturbations: role of anticipatory and compensatory postural mechanisms. Age (Dordr). 2014 Jun;36(3):9621. doi: 10.1007/s11357-014-9621-8. Epub 2014 Feb 16. PMID 24532389
• Hodges PW, Richardson CA. Inefficient muscular stabilization of the lumbar spine associated with low back pain. A motor control evaluation of transversus abdominis. Spine (Phila Pa 1976). 1996 Nov 15;21(22):2640-50. doi: 10.1097/00007632-199611150-00014. PMID 8961451
• Bussey MD, Aldabe D, Shemmell J, Jowett T. Anticipatory postural control differs between low back pain and pelvic girdle pain patients in the absence of visual feedback. Hum Mov Sci. 2020 Feb;69:102529. doi: 10.1016/j.humov.2019.102529. Epub 2019 Nov 11. PMID 31726292
• Hodges PW. Changes in motor planning of feedforward postural responses of the trunk muscles in low back pain. Exp Brain Res. 2001 Nov;141(2):261-6. doi: 10.1007/s002210100873. PMID 11713638

Идентификаторы

NCT: NCT05832918 · IUMS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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