Clinical trial NCT03227523: Nonspecific Low Back Pain in Association With Chronic Obstructive Pulmonary Disease
Official title: Nonspecific Low Back Pain in Association With Chronic Obstructive Pulmonary Disease: A Descriptive Observational Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Chronic Obstructive Pulmonary Disease
Keywords: low back pain
respiratory disorders
pulmonary disease, chronic obstructive
postural balance
functional laterality
diaphragm
Lead sponsor: University of Alcala
Sponsor class: OTHER
Collaborators: name: Comité de Ética para la Investigación del Hospital Universitario Ramón y Cajal
First posted: 2017-07-24
Enrollment: 134
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: According to the group, recruitment was or in the consultation of COPD of the University Hospital Ramón y Cajal in Madrid (for subjects diagnosed with COPD) or outside the hospital context (for subjects without lung disease).

Brief summary: 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.

Detailed description: 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).

The first group, with subjects diagnosed with COPD, was recruited in the hospital context, while the second one, with subjects without lung disease, was recruited in and out of the hospital context. Data were collected in a single session through tests for pulmonary function, respiratory muscle strength and trunk postural control. They were also collected using scales and questionnaires that measure the quality of life, physical activity level, pain and disability.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Respiratory muscle strength (MIP = maximum inspiratory pressure).
timeFrame: 1 day.
measure: Respiratory muscle strength (MEP = maximum expitaroy pressure).
timeFrame: 1 day.
Secondary outcomes:
measure: Postural control (Motor control test: KLAT = knee lift abdominal test).
timeFrame: 1 day.
measure: Postural control (Motor control test: ASLR = active straight leg raise).
timeFrame: 1 day.
measure: Physical activity level (MBPAQ = Modified Baecke Physical Activity Questionnaire).
timeFrame: 1 day.
measure: Disability related to low back pain (ODI = Oswestry Disability Index).
timeFrame: 1 day.
measure: Intensity of the pain (VAS = visual analogue scale).
timeFrame: 1 day.
measure: Pulmonary Fuction Testing in COPD (Spirometry: FEV1 = forced expiratiry volume in the first second; FVC = forced vital capacity; FEV1/FVC ratio).
timeFrame: 1 day.
measure: Quality of life in COPD (CAT = COPD Assessment Test).
timeFrame: 1 day.
Other outcomes:
measure: Demographic characteristics (age).
timeFrame: 1 day.
measure: Demographic characteristics (gender).
timeFrame: 1 day.
measure: Anthropometric measurements (weight; height; BMI = body mass index).
timeFrame: 1 day.
Locations:
city: Alcalá de Henares
country: Spain
facility: University of Alcalá
state: Madrid
Study officials:
References: