COPDNCT05366946
The Prevalence of Chronic Pain in COPD and Its Clinical Implications
An observational study of COPD, run by West Park Healthcare Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 45 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- Prevalence study
- How many people
- 128 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Nov 2015
- 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 45 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diagnosed with COPD according to GOLD criteria and history of smoking > 10 pack years
Who may be able to join
- No diagnosis of COPD or other respiratory conditions
- No recent history (within last 4 weeks) of musculoskeletal injury
Who cannot join
- Diagnosis of other respiratory disease, including COPD
- Recent musculoskeletal injury
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- COPD
- Being tested
- Prevalence study
- Keywords
- Pain
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevalence studyOther
Prevalence study of chronic pain in COPD vs healthy controls
| Study group | Role | What they receive |
|---|---|---|
| COPD - prevalence | Diagnosed with COPD (based on GOLD criteria and history of > 10 pack years of smoking) and no history of recent musculoskeletal injuries (within last 4 weeks) - prevalence study Receives: Other: Prevalence study | |
| Healthy controls - prevalence | Not diagnosed with COPD or other respiratory conditions or recent musculoskeletal injuries (within last 4 weeks) - prevalence study Receives: Other: Prevalence study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory
Collates information on pain intensity using numerical rating scales, with a higher score denoting greater intensity.
Measured: Day 1
Extended Aberdeen Back Pain Scale (EABPS)
Measure of neck, upper and lower back pain from 35 questions with an overall total score
Measured: Day 1
Self-reported Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS)
Consists of 9 items identifying the presence or absence of clinical signs and symptoms with a score of ≥ 12 indicative of neuropathic pain.
Measured: Day 1
Pain Catastrophizing Scale (PCS)
Assesses the presence and extent of catastrophic thoughts or feelings accompanying pain experiences from 13 questions.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study startJul 2014
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Park Healthcare Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roger Goldstein, West Park Healthcare Centre
- Investigators
- Roger Goldstein, MD, Principal investigator, West Park Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366946
- Sponsor's protocol ID
- JREB014
- Status last verified
- Apr 2022
- First submitted
- 20 Oct 2015
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Chronic Pain in COPD and Its Clinical Implications
- ClinicalTrials.gov ID
- NCT05366946
- Acronym / sponsor ID
- JREB014
- Conditions
- COPD
- Keywords
- Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- West Park Healthcare CentreUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 10 May 2022 (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.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD - prevalence | – | Other: Prevalence studyDiagnosed with COPD (based on GOLD criteria and history of > 10 pack years of smoking) and no history of recent musculoskeletal injuries (within last 4 weeks) - prevalence study |
| Healthy controls - prevalence | – | Other: Prevalence studyNot diagnosed with COPD or other respiratory conditions or recent musculoskeletal injuries (within last 4 weeks) - prevalence study |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed with COPD according to GOLD criteria and history of smoking > 10 pack years
Key inclusion criteria (2 listed)
- No diagnosis of COPD or other respiratory conditions
- No recent history (within last 4 weeks) of musculoskeletal injury
Key exclusion criteria (2 listed)
- Diagnosis of other respiratory disease, including COPD
- Recent musculoskeletal injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevalence studyPrevalence study of chronic pain in COPD vs healthy controls | Other | COPD - prevalence, Healthy controls - prevalence |
Primary outcome
Brief Pain Inventory
Time frame: Day 1
Collates information on pain intensity using numerical rating scales, with a higher score denoting greater intensity.
Extended Aberdeen Back Pain Scale (EABPS)
Time frame: Day 1
Measure of neck, upper and lower back pain from 35 questions with an overall total score
Self-reported Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS)
Time frame: Day 1
Consists of 9 items identifying the presence or absence of clinical signs and symptoms with a score of ≥ 12 indicative of neuropathic pain.
Pain Catastrophizing Scale (PCS)
Time frame: Day 1
Assesses the presence and extent of catastrophic thoughts or feelings accompanying pain experiences from 13 questions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
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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.
Roger Goldstein, MD principal investigator
West Park Healthcare Centre
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 COPD, run by West Park Healthcare Centre at 1 site in Canada.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 14 Jul 2022. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory (time frame: Day 1). The study lists 4 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 14 Jul 2022.