Effects of a Hip Flexor and Extensor Muscle Training Program in Individuals with Chronic Mechanical Low Back Pain

Обзор

The goal of this clinical trial is to evaluate the effect of a physiotherapy intervention program in the lumbopelvic area in chronic low back pain patients. The main questions it aims to answer are: 1. Is a specific stretching and strengthening program for the hip musculature beneficial for function and symptom reduction in patients with non-specific chronic low back ain? 2. Are patients who have greater hip extension dysfunction going to benefit more from a specific program of stretching and strengthening of hip muscles? 3. Are there more alteration in pelvis alignement and movement in standig position compared to seated position in those patiens with lesser hip range of movement? 4. Are patiens with lesser hip range of movement going to show more dysfunction in the lumbopelvic region? Participants will: * Visit the physiotherapy clinic once a week to complete the therapeutic exercise session. * Repeat the session in their houses if its possible between 3 or 4 times a week and record the number of days they repeat the session at home. * Answer some questionaires at the begining of the intervention, after 4 weeks, a month and three months.

Подробное описание

This study aims to enhance healthcare interventions for chronic low back pain, focusing specifically on patients whose pain may be linked to restricted hip extension mobility. Patients will be referred from the healthcare system to the physiotherapy center, where the principal investigator, Lucía Vicente, will randomize participants into either the intervention or control group. Each participant will complete an initial evaluation at the start of the intervention and again after 4 weeks. Additional questionnaires will be administered one and three months post-intervention. Pelvic movement changes will also be tracked before each in-person session. The program will focus on strengthening the pelvic muscles, particularly by targeting hip extensor strengthening and hip flexor stretching.

Вмешательства

• Поведенческое Program to improve lumbopelvic function.
  Each individual will receive a weekly session log at the start of the intervention, allowing them to record the total number of sessions performed between in-person visits and the perceived exertion. In the strengthening phase, both compound and isolated exercises will be performed. These exercises will be of low intensity and maintained for prolonged periods until the patient reaches fatigue or can no longer perform the repetitions correctly. If the patient reaches 40 repetitions, the exercise
• Поведенческое generic health care
  The patients will receive 10 physiotherapy sessions at the health center throughout 4 weeks.They will be taught active exercises and undergo passive therapies to address their low back pain. Each session will last approximately 30 minutes. The intervention will therefore be variable depending on the assigned physiotherapist, as there is no standardized protocol for action.

Первичные конечные точки

• Hip flexors range of movement [Срок оценки: From the enrollement to the end of the treatment at 4 weeks]
• Hip flexors range of movement [Срок оценки: From the enrollement to the end of the treatment at 4 weeks]

Вторичные конечные точки (4)

• Pain [Срок оценки: From enrollment through the end of the 4-week treatment, and again one month after.]
• Oswestry Disability Index [Срок оценки: From enrollment through the end of the 4-week treatment, and again one month after.]
• Pelvis saggital movement [Срок оценки: From the enrollement to the end of the treatment at 4 weeks. For participants enrolled in the program to improve lumbopelvic function, this assessment will also be performed after each physiotherapy session.]
• Pain during pelvic tilting [Срок оценки: From the enrollement to the end of the treatment at 4 weeks. For participants enrolled in the program to improve lumbopelvic function, this assessment will also be performed after each physiotherapy session.]

Критерии участия

Критерии включения

• Age greater than 18 and less than 70 years.
• Low back pain lasting more than 3 months defined as: "Pain or discomfort localized below the costal margin and above the gluteal fold, with or without referred pain to the leg."
• Low back pain with a mechanical component.
• Signed informed consent prior to participation in the study.

Критерии исключения

• A specific cause for their low back pain (trauma, spondylolisthesis, vertebral fractures, etc.), have undergone any surgical procedures on the spine or hip, or have other diseases or conditions (neurological issues, joint replacements, etc.).
• Cognitive impairment and inability to comprehend.
• Injections in the last 6 months or physiotherapy treatment in the last 3 months.

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

Испания · 1 центр

• Centro Clinico de Fisioterapia OMT — Zaragoza

Публикации

• Iversen VM, Norum M, Schoenfeld BJ, Fimland MS. No Time to Lift? Designing Time-Efficient Training Programs for Strength and Hypertrophy: A Narrative Review. Sports Med. 2021 Oct;51(10):2079-2095. doi: 10.1007/s40279-021-01490-1. Epub 2021 Jun 14. PMID 34125411
• Jimenez-Del-Barrio S, Mingo-Gomez MT, Estebanez-de-Miguel E, Saiz-Cantero E, Del-Salvador-Miguelez AI, Ceballos-Laita L. Adaptations in pelvis, hip and knee kinematics during gait and muscle extensibility in low back pain patients: A cross-sectional study. J Back Musculoskelet Rehabil. 2020;33(1):49-56. doi: 10.3233/BMR-191528. PMID 31403939
• Zafereo J, Devanna R, Mulligan E, Wang-Price S. Hip stiffness patterns in lumbar flexion- or extension-based movement syndromes. Arch Phys Med Rehabil. 2015 Feb;96(2):292-7. doi: 10.1016/j.apmr.2014.09.023. Epub 2014 Oct 13. PMID 25312581
• Vigotsky AD, Lehman GJ, Contreras B, Beardsley C, Chung B, Feser EH. Acute effects of anterior thigh foam rolling on hip angle, knee angle, and rectus femoris length in the modified Thomas test. PeerJ. 2015 Sep 24;3:e1281. doi: 10.7717/peerj.1281. eCollection 2015. PMID 26421244

Идентификаторы

NCT: NCT06787209 · PI24/303

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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