Effects of Foundation and Functional Inspiratory Muscle Training in Non-Specific Chronic Low Back Pain

Официальное название

Comparison of the Effects of Foundation and Functional Inspiratory Muscle Training in Addition to Classical Physiotherapy in Non-Specific Chronic Low Back Pain

Обзор

This study was planned to examine the effects of basic and functional respiratory muscle training on pain, disability level, and functionality. In this study, participants will be randomly divided into 3 groups. The first group will be treated with physical therapy applications applied in state hospitals for 10 weeks. The second group will receive basic respiratory muscle training treatment in addition to physical therapy in state hospitals. The third group will receive respiratory muscle training with exercise in addition to physical therapy in state hospitals. Evaluations will be made before the first session, after the 30th session, in the 3rd month, in the 6th month, and in the 1st year. There is no interventional method in the evaluations. Pain intensity, disability level, physical activity status, quality of life, fear of movement, pain catastrophizing, anxiety and depression levels will be questioned with scales. In physical measurements, participant's aerobic capacity will be measured with the 2-Minute Walk Test, participants's flexibility with the sit-and-long test, participants's respiratory muscle strength with the MIP/MEP device, participants's core endurance with the trunk flexor muscle endurance test, participants's lower and upper extremity muscle strength with a handheld dynamometer, participants's postural control with the Biodex balance device, and participants's muscle thickness with an ultrasound.

Вмешательства

• Другое Classical Physiotherapy Group
  Classical physiotherapy group (CF) will be treated face to face for 30 sessions in total, 3 days a week, 10 weeks. Hotpack, Ultrasound, TENS and Basic Exercises will be applied to the CF group. Hotpack will be applied superficially to the lumbar region for 15 minutes. Ultrasound 1MHz- 1.5 Wt/cm2 will be applied to the lumbar region. TENS 50 Hz will be applied for 15 minutes, leaving the painful area in the middle. Basic exercises will be applied as 8-12 repetitions, 2 sets. The number of repetit
• Другое Foundation Inspiratory Muscle Training in Addition to Classical Physiotherapy
  In addition to Classical Physiotherapy, Foundation Inspiratory Muscle Training (IKE) will be treated face to face for 30 sessions, 3 days a week, 10 weeks. On other days, IKE will be applied at home for 15 minutes in the morning and evening for a total of 30 minutes and will be followed up with a diary. IKE will be applied with a device that can load with threshold pressure. The IKE group will continue the exercise program for 10 weeks. The intensity of the exercise will be adjusted to 40-50% MI
• Другое Functional Inspiratory Muscle Training Group in Addition to Classical Physiotherapy
  Functional Inspiratory Muscle Training Group will receive functional inspiratory muscle training in addition to classical physiotherapy, 3 days a week, 10 weeks, 30 sessions in total, face-to-face treatment. On other days, foundation-ICE will be applied at home for 15 minutes in the morning and evening, for a total of 30 minutes, and will be followed with a diary. The same protocol will be applied with the foundation IKE group for teaching the respiratory cycle in the first 4 weeks, and resisted

Первичные конечные точки

• Evaluation of Sociodemographic Information [Срок оценки: Baseline]
• Evaluation of Sociodemographic Information [Срок оценки: Baseline]
• Evaluation of Sociodemographic Information [Срок оценки: Baseline]
• Assessment of Pain Intensity [Срок оценки: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
• Evaluation of Disability Level [Срок оценки: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
• Respiratory Muscle Strength Assessment [Срок оценки: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
• Diaphragm, Transversus abdominis and Multifidus, Muscle Thickness Evaluation [Срок оценки: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]

Вторичные конечные точки (12)

• Physical Activity Assessment [Срок оценки: Baseline]
• Evaluation of Exercise Capacity [Срок оценки: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
• Evaluation of Flexibility [Срок оценки: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
• Lower and Upper Extremity Muscle Strength [Срок оценки: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
• Core Endurance Assessment [Срок оценки: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
• Postural Control Evaluation [Срок оценки: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
• Evaluation of Quality of Life [Срок оценки: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
• Fear of Movement [Срок оценки: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
• Pain Catastrophizing [Срок оценки: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
• Anxiety and Depression [Срок оценки: Baseline- 10 weeks- 3 Months- 6 Months- 1 Year]
• Treatment Satisfaction [Срок оценки: 10 weeks]
• Willingness for Treatment [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Volunteering to participate in the study,
• Being between the ages of 18-65,
• Having low back pain that has been ongoing for at least 3 months (12 weeks),
• Having a Visual Analog Scale (VAS) of pain intensity of ≥3,
• Being right-hand dominant.

Критерии исключения

• Not volunteering to participate in the study,
• Having a history of cancer,
• Having a spinal infection,
• Having a rheumatological condition,
• Having a spinal fracture,
• Having red flag signs (sudden and unexpected weight loss, fever, etc.)
• Having a psychological disorder,
• Having a previous spinal surgery,
• Having radiculopathy (neuropathic pain along the lower extremity due to nerve root compression),
• Not continuing home exercises more than 80%,
• Having an anatomical and congenital abnormality

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

Turkey (Türkiye) · 1 центр

• Kırşehir Ahi Evran University — Kırşehir

Публикации

• Kolar P, Sulc J, Kyncl M, Sanda J, Cakrt O, Andel R, Kumagai K, Kobesova A. Postural function of the diaphragm in persons with and without chronic low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):352-62. doi: 10.2519/jospt.2012.3830. Epub 2011 Dec 21. PMID 22236541
• Janssens L, Brumagne S, Polspoel K, Troosters T, McConnell A. The effect of inspiratory muscles fatigue on postural control in people with and without recurrent low back pain. Spine (Phila Pa 1976). 2010 May 1;35(10):1088-94. doi: 10.1097/BRS.0b013e3181bee5c3. PMID 20393397
• Finta R, Nagy E, Bender T. The effect of diaphragm training on lumbar stabilizer muscles: a new concept for improving segmental stability in the case of low back pain. J Pain Res. 2018 Nov 28;11:3031-3045. doi: 10.2147/JPR.S181610. eCollection 2018. PMID 30568484
• Calvo-Lobo C, Almazan-Polo J, Becerro-de-Bengoa-Vallejo R, Losa-Iglesias ME, Palomo-Lopez P, Rodriguez-Sanz D, Lopez-Lopez D. Ultrasonography comparison of diaphragm thickness and excursion between athletes with and without lumbopelvic pain. Phys Ther Sport. 2019 May;37:128-137. doi: 10.1016/j.ptsp.2019.03.015. Epub 2019 Mar 28. PMID 30954705

Идентификаторы

NCT: NCT06696300 · 2024/19

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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