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临床试验/NCT03227523
NCT03227523Unknown不适用

Nonspecific Low Back Pain in Association With Chronic Obstructive Pulmonary Disease: A Descriptive Observational Cross-Sectional Study

University of Alcala1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
134
试验地点
1
主要终点
Respiratory muscle strength (MIP = maximum inspiratory pressure).

研究概览

简要总结

Introduction. Nonspecific low back pain (NSLBP) is a very prevalent medical condition, especially in subjects with chronic obstructive pulmonary disease (COPD).

The diaphragm is a respiratory muscle, but it takes part in trunk stabilization on lumbar spine. NSLBP is related to lack of spinal control. The COPD symptoms include lack of efficiency in diaphragm, which could be connected to NSLBP.

Hypothesis and objectives. COPD can contribute to NSLBP. It is associated with diaphragm weakness, severity of respiratory function, lower level of physical activity and quality of life in COPD.

Methods. A descriptive observational cross-sectional study was conducted with two groups: the first one with subjects with COPD and the second one with subjects without it. Data were collected on: pulmonary function; respiratory muscles strength; trunk postural control; quality of life with COPD; physical activity level; lumbar pain presence, intensity and disability. Data were collected in a single session.

详细描述

Introduction/Background. Nonspecific low back pain (NSLBP) is a very prevalent medical condition (84% of the general population has suffered from it throughout its lifetime). Its prevalence stands out in individuals with respiratory disease, especially in subjects with chronic obstructive pulmonary disease (COPD).

Even if there are many theories that create a relationship between the two clinical conditions (such as inflammation associated with smoking), the postural control one is quite impressive.

The diaphragm is the main muscle of breathing with its inspiratory function, but it takes part in trunk stabilization on lumbar spine. NSLBP is related to lack of spinal control. The COPD symptoms include lack of efficiency in diaphragm (deformation, weakness and fatigability), which could be connected to NSLBP.

Hypothesis and objectives. The starting hypothesis is that NSLBP is a result of an associated pulmonary disease. COPD can contribute, correlate or even predispose them. NSLBP is associated with diaphragm weakness, severity of respiratory function, COPD severity, lower level of physical activity and quality of life in COPD.

Methods. A descriptive observational cross-sectional study was conducted with two groups: the first one with 67 subjects, diagnosed with COPD, and the second one with 67 subjects without pulmonary disease. Data were collected on: pulmonary function, spirometry; respiratory muscles strength by measuring maximal inspiratory and expiratory pressures (MIP, MEP); trunk postural control by motor control tests (KLAT, ASLR); quality of life with COPD, through the COPD Assessment Test (CAT); physical activity level, using the Modified Baecke Physical Activity Questionnaire (MBPAQ); pain localization, through a body map; pain intensity, using Visual Analogue Scale (VAS) and disability, related to lumbar pain (if there is one), using the Oswestry Disability Index (ODI).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participating voluntarily and signing the informed consent;
  • No exacerbations during the last 3 months, prior to the study (COPD group);
  • Being non-smokers during the last 10 years (not COPD group).

排除标准

  • Diagnosis of disease that may affect the participation to the study (cardiovascular/ musculoskeletal/ neurological/ neurodegenerative disease);
  • Diagnosis of specific low back pain (lumbar surgery, infection, tumor, fracture, structural deformity, inflammatory disorder, radicular syndrome or cauda equina syndrome);
  • Performing a physical therapy program or having performed it in the last 3 months, prior to the study.

结局指标

主要结局

Respiratory muscle strength (MIP = maximum inspiratory pressure).

时间窗: 1 day.

MIP in centimetres of water (cmH2O).

Respiratory muscle strength (MEP = maximum expitaroy pressure).

时间窗: 1 day.

MEP in cmH2O.

次要结局

  • Postural control (Motor control test: KLAT = knee lift abdominal test).(1 day.)
  • Postural control (Motor control test: ASLR = active straight leg raise).(1 day.)
  • Physical activity level (MBPAQ = Modified Baecke Physical Activity Questionnaire).(1 day.)
  • Disability related to low back pain (ODI = Oswestry Disability Index).(1 day.)
  • Intensity of the pain (VAS = visual analogue scale).(1 day.)
  • Pulmonary Fuction Testing in COPD (Spirometry: FEV1 = forced expiratiry volume in the first second; FVC = forced vital capacity; FEV1/FVC ratio).(1 day.)
  • Quality of life in COPD (CAT = COPD Assessment Test).(1 day.)

研究者

发起方
University of Alcala
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicola Sante Diciolla

Physiotherapist

University of Alcala

研究点 (1)

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