Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05366946 |
Other study ID # |
JREB014 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 2014 |
Est. completion date |
November 2015 |
Study information
Verified date |
April 2022 |
Source |
West Park Healthcare Centre |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This study explores the prevalence of chronic pain in individuals with COPD compared to
healthy controls and examines the clinical implications of pain on symptoms associated with
COPD, psychological effect and physical activity.
Description:
Chronic obstructive pulmonary disease (COPD) is a major public health problem with
considerable direct and indirect healthcare costs. COPD is a disease of the older age-group
which results in significant disability, high health care costs and is a leading cause of
morbidity. This rising disease burden is associated with the systemic effects of this
condition, with the clinical presentation of dyspnoea, reduced exercise capacity, fatigue and
anxiety all contributing to the reduced health-related quality of life (HRQoL) in people with
COPD . In addition to these symptoms, the clinical profile may be further complicated by the
presence of pain. Recent studies have found the prevalence of pain ranging from 37 to 72% in
COPD, although the duration and frequency of pain experiences across the disease spectrum
compared to healthy individuals have not been clearly defined. While chronic pain has been
associated with hyperinflation in patients with asthma, the association between pain and lung
disease severity, according to spirometry measures and hyperinflation has not been determined
in COPD.
According to analysis of body charts, common regions of pain in COPD are the chest, thorax
and neck, which are largely similar to healthy populations. However, it is not clear whether
the origin of the pain source is musculoskeletal and/or related to postural changes or is due
to other sources. Greater exploration of pain within specific spinal regions using well
validated tools which focus on musculoskeletal pain will provide further insight into
potential causes.
Patients with COPD frequently experience co-morbid conditions which include ischaemic heart
disease, diabetes, cancer and musculoskeletal conditions . Although increased pain intensity
in COPD appears to be associated with a higher number of co-morbidities, the relationship
between co-morbidities and locations of pain, duration, frequency in COPD is not clear. Some
concomitant conditions, such as musculoskeletal disorders may influence the prevalence and
experience of pain, but this has not been explored in COPD.
In patients with moderate to severe COPD, increased pain severity has been linked to greater
interference with activity and a poorer HRQOL. While this provides some insight into the
clinical impact of pain, it is equally important to identify the link between pain and other
commonly reported symptoms, including dyspnoea. Both pain and dyspnoea are recognised as
multidimensional phenomenons, with physiological and psychological consequences and to gain a
thorough understanding of each, evaluation of the sensory dimensions (intensity, quality,
time course and location) and affective dimensions (unpleasantness and consequent emotional
impact) is necessary. Patients with COPD have reported pain with coughing , but the link
between the extent of breathlessness, including that experienced during activity and the
experience of pain has not been determined. With the shared characteristics and common neural
pathways which subserve distress and discomfort in pain and dyspnoea, understanding the
relationship between these symptoms may provide further insight into the possible sources of
pain in COPD.
To achieve a thorough profile of pain, assessment of the psychosocial impact of pain,
including pain catastrophising is recommended. Pain catastrophising is associated with
heightened pain experiences, increased levels of disability and depression in non-respiratory
conditions and in cystic fibrosis. With anxiety and depression frequently reported in COPD,
these clinical symptoms may interact with pain experiences, but the extent to this is
unknown.
International guidelines for managing COPD advocate for the role of pulmonary rehabilitation,
with compelling evidence of improvement in exercise capacity, reduction in breathlessness and
improvement in HRQOL, irrespective of disease severity. As part of this, physical activity is
a critical element to disease management. Recently, pain was associated with reduced level of
physical activity in those with moderate to severe COPD. However, the relationship between
pain locations and the influence upon physical activity is unknown.
Clinical relevance This study aims to impact directly on the important clinical outcomes of
HRQOL and disease burden in COPD, markers that are strongly associated with hospitalisation
and health care utilisation. Understanding the extent of this comorbidity of pain, its
interaction with other symptoms and its broader clinical consequences is the first step in
identifying whether modifications to the management of COPD, including the development or
institution of therapeutic approaches to minimize pain are necessary. Understanding the
psychological consequences of pain in COPD is essential in prioritizing those patients who
may require further assessment and treatment of pain.