Nonspecific Low Back Pain in Association With Chronic Obstructive Pulmonary Disease

NCT ID: NCT03227523

Last Updated: 2017-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 134 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-05-31

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.

Conditions

Low Back Pain; Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

subjects with copd

No interventions assigned to this group

subjects without pulmonary disease

No interventions assigned to this group

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Comité de Ética para la Investigación del Hospital Universitario Ramón y Cajal

UNKNOWN

Sponsor Role: collaborator

University of Alcala

OTHER

Sponsor Role: lead

Responsible Party

Nicola Sante Diciolla

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alcalá

Alcalá de Henares, Madrid, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Nicola Sante Diciolla, Physical Therapy

Role: CONTACT

nicola.s.diciolla@gmail.com

+34 695 069 558

Facility Contacts

Nicola Sante Diciolla

Role: primary

nicola.s.diciolla@gmail.com

+34 695 069 558

Other Identifiers

010-17

Identifier Type: -

Identifier Source: org_study_id