Nonspecific Low Back Pain in Association With Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03227523
• Other study ID #: 010-17
• Status: Recruiting
• Phase: N/A
• First received: July 17, 2017
• Last updated: July 21, 2017
• Start date: June 1, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: July 2017
• Source: University of Alcala
• Contact: Nicola Sante Diciolla, Physical Therapy
• Phone: +34 695 069 558
• Email: nicola.s.diciolla[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: May 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Obstructive Pulmonary Disease
• Low Back Pain
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Spain	University of Alcalá	Alcalá de Henares	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
University of Alcala	Comité de Ética para la Investigación del Hospital Universitario Ramón y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic characteristics (age).	Age in years.	1 day.
Other	Demographic characteristics (gender).	Genders: masculine (M); femenine (F).	1 day.
Other	Anthropometric measurements (weight; height; BMI = body mass index).	Weight and height will be combined to report BMI in kilogrammes/square metres (kg/m2).	1 day.
Primary	Respiratory muscle strength (MIP = maximum inspiratory pressure).	MIP in centimetres of water (cmH2O).	1 day.
Primary	Respiratory muscle strength (MEP = maximum expitaroy pressure).	MEP in cmH2O.	1 day.
Secondary	Postural control (Motor control test: KLAT = knee lift abdominal test).	KLAT in millimetres of mercury (mmHg).	1 day.
Secondary	Postural control (Motor control test: ASLR = active straight leg raise).	ASLR in mmHg.	1 day.
Secondary	Physical activity level (MBPAQ = Modified Baecke Physical Activity Questionnaire).	MBPAQ in n/47,56.	1 day.
Secondary	Disability related to low back pain (ODI = Oswestry Disability Index).	ODI in percetage (%).	1 day.
Secondary	Intensity of the pain (VAS = visual analogue scale).	VAS in n/100 millimetres (mm).	1 day.
Secondary	Pulmonary Fuction Testing in COPD (Spirometry: FEV1 = forced expiratiry volume in the first second; FVC = forced vital capacity; FEV1/FVC ratio).	FEV1 and FVC, measured in millilitres (mL) will be combinde to reporrt the ratio FEV1/FVC in percentage (%).	1 day.
Secondary	Quality of life in COPD (CAT = COPD Assessment Test).	CAT in n/40.	1 day.