Low Back PainNCT03227523
Nonspecific Low Back Pain in Association With Chronic Obstructive Pulmonary Disease
An observational study of Low Back Pain and Chronic Obstructive Pulmonary Disease, run by University of Alcala at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Chronic Obstructive Pulmonary Disease
- How many people
- 134 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2017to 31 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Alcalá
Alcalá de Henares, Madrid, 28871
Nicola Sante Diciolla, +34 695 069 558, nicola.s.diciolla@gmail.com
About this study
Official title: Nonspecific Low Back Pain in Association With Chronic Obstructive Pulmonary Disease: A Descriptive Observational Cross-Sectional Study
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.
Read more
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.
Read the 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.
- Keywords
- low back pain, respiratory disorders, pulmonary disease, chronic obstructive, postural balance, functional laterality, diaphragm
- Medical subject headings
- Low Back Pain, Pulmonary Disease, Chronic Obstructive, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| subjects with copd | Not described | |
| subjects without pulmonary disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle strength (MIP = maximum inspiratory pressure).
MIP in centimetres of water (cmH2O).
Measured: 1 day.
Respiratory muscle strength (MEP = maximum expitaroy pressure).
MEP in cmH2O.
Measured: 1 day.
Secondary outcomes (7)
Postural control (Motor control test: KLAT = knee lift abdominal test).
KLAT in millimetres of mercury (mmHg).
Measured: 1 day.
Postural control (Motor control test: ASLR = active straight leg raise).
ASLR in mmHg.
Measured: 1 day.
Physical activity level (MBPAQ = Modified Baecke Physical Activity Questionnaire).
MBPAQ in n/47,56.
Measured: 1 day.
Disability related to low back pain (ODI = Oswestry Disability Index).
ODI in percetage (%).
Measured: 1 day.
Intensity of the pain (VAS = visual analogue scale).
VAS in n/100 millimetres (mm).
Measured: 1 day.
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 (%).
Measured: 1 day.
Quality of life in COPD (CAT = COPD Assessment Test).
CAT in n/40.
Measured: 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Jun 2017
- Primary completion31 Mar 2018 (estimated)
- Study completion31 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Collaborators
- Comité de Ética para la Investigación del Hospital Universitario Ramón y Cajal
- Responsible party
- Principal investigator, Nicola Sante Diciolla, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227523
- Sponsor's protocol ID
- 010-17
- Status last verified
- Jul 2017
- First submitted
- 17 Jul 2017
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonspecific Low Back Pain in Association With Chronic Obstructive Pulmonary Disease: A Descriptive Observational Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT03227523
- Acronym / sponsor ID
- 010-17
- Keywords
- low back pain, respiratory disorders, pulmonary disease, chronic obstructive, postural balance, functional laterality, diaphragm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Collaborators
- Comité de Ética para la Investigación del Hospital Universitario Ramón y Cajal
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 May 2018 (estimated)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subjects with copd | – | – |
| subjects without pulmonary disease | – | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory muscle strength (MIP = maximum inspiratory pressure).
Time frame: 1 day.
MIP in centimetres of water (cmH2O).
Respiratory muscle strength (MEP = maximum expitaroy pressure).
Time frame: 1 day.
MEP in cmH2O.
7 secondary outcomes
Postural control (Motor control test: KLAT = knee lift abdominal test).
Time frame: 1 day.
Postural control (Motor control test: ASLR = active straight leg raise).
Time frame: 1 day.
Physical activity level (MBPAQ = Modified Baecke Physical Activity Questionnaire).
Time frame: 1 day.
Disability related to low back pain (ODI = Oswestry Disability Index).
Time frame: 1 day.
Intensity of the pain (VAS = visual analogue scale).
Time frame: 1 day.
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.
Quality of life in COPD (CAT = COPD Assessment Test).
Time frame: 1 day.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Chronic Obstructive Pulmonary Disease, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola Sante Diciolla, Physical Therapy (+34 695 069 558, nicola.s.diciolla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscle strength (MIP = maximum inspiratory pressure). (time frame: 1 day.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.