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Nonspecific Low Back Pain in Association With Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT03227523
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Sponsor:
Collaborator:
Comité de Ética para la Investigación del Hospital Universitario Ramón y Cajal
Information provided by (Responsible Party):
Nicola Sante Diciolla, University of Alcala

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.


Condition or disease
Low Back Pain Chronic Obstructive Pulmonary Disease

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.


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Study Type : Observational
Estimated Enrollment : 134 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Nonspecific Low Back Pain in Association With Chronic Obstructive Pulmonary Disease: A Descriptive Observational Cross-Sectional Study
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
subjects with copd
subjects without pulmonary disease



Primary Outcome Measures :
  1. Respiratory muscle strength (MIP = maximum inspiratory pressure). [ Time Frame: 1 day. ]
    MIP in centimetres of water (cmH2O).

  2. Respiratory muscle strength (MEP = maximum expitaroy pressure). [ Time Frame: 1 day. ]
    MEP in cmH2O.


Secondary Outcome Measures :
  1. Postural control (Motor control test: KLAT = knee lift abdominal test). [ Time Frame: 1 day. ]
    KLAT in millimetres of mercury (mmHg).

  2. Postural control (Motor control test: ASLR = active straight leg raise). [ Time Frame: 1 day. ]
    ASLR in mmHg.

  3. Physical activity level (MBPAQ = Modified Baecke Physical Activity Questionnaire). [ Time Frame: 1 day. ]
    MBPAQ in n/47,56.

  4. Disability related to low back pain (ODI = Oswestry Disability Index). [ Time Frame: 1 day. ]
    ODI in percetage (%).

  5. Intensity of the pain (VAS = visual analogue scale). [ Time Frame: 1 day. ]
    VAS in n/100 millimetres (mm).

  6. Pulmonary Fuction Testing in COPD (Spirometry: FEV1 = forced expiratiry volume in the first second; FVC = forced vital capacity; FEV1/FVC ratio). [ Time Frame: 1 day. ]
    FEV1 and FVC, measured in millilitres (mL) will be combinde to reporrt the ratio FEV1/FVC in percentage (%).

  7. Quality of life in COPD (CAT = COPD Assessment Test). [ Time Frame: 1 day. ]
    CAT in n/40.


Other Outcome Measures:
  1. Demographic characteristics (age). [ Time Frame: 1 day. ]
    Age in years.

  2. Demographic characteristics (gender). [ Time Frame: 1 day. ]
    Genders: masculine (M); femenine (F).

  3. Anthropometric measurements (weight; height; BMI = body mass index). [ Time Frame: 1 day. ]
    Weight and height will be combined to report BMI in kilogrammes/square metres (kg/m2).



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227523


Contacts
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Contact: Nicola Sante Diciolla, Physical Therapy +34 695 069 558 nicola.s.diciolla@gmail.com

Locations
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Spain
University of Alcalá Recruiting
Alcalá de Henares, Madrid, Spain, 28871
Contact: Nicola Sante Diciolla    +34 695 069 558    nicola.s.diciolla@gmail.com   
Sponsors and Collaborators
University of Alcala
Comité de Ética para la Investigación del Hospital Universitario Ramón y Cajal

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Responsible Party: Nicola Sante Diciolla, Physiotherapist, University of Alcala
ClinicalTrials.gov Identifier: NCT03227523     History of Changes
Other Study ID Numbers: 010-17
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nicola Sante Diciolla, University of Alcala:
low back pain
respiratory disorders
pulmonary disease, chronic obstructive
postural balance
functional laterality
diaphragm

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Back Pain
Low Back Pain
Respiratory Tract Diseases
Pain
Neurologic Manifestations
Signs and Symptoms